Download List of UK Health Claims

Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID CARBOHYDRATES Carbohydrate Energise Re-energise post exercise 31 January 2008 RCT Wong SH & Williams C. 2000. Influence of different amounts of carbohydrate on endurance running capacity following short term recovery. Int J Sports Med. 21 (6): 444-452. Scientific Review Maughan R. 2002. The athlete’s diet: Nutritional goals and dietary strategies. Proc Nutr Soc. 61 (1):87-96. Abstract Rossiter A, Jakeman P, O’Sullivan A & Dunne C. 2007. Post-exercise feeding of carbohydrate-protein beverages on subsequent endurance performance. Med Sci Sports & Exerc. 39 (5); S363 806 Page 1,100 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrate electrolyte drinks RECOVERY Enhanced subsequent endurance capacity Delayed fatigue Claim to be only used for Foods for sport people under the Dir. 89/398/EEC. Metabolisable carbohydrates: = 75% of total energy. 340kJ/l (80kcal/l) = Energy = 1488kJ/l (350kcal/l). 20 mmol/l (460 mg/l) = Sodium (Na+) = 50 mmol/l (1150 mg/l). Review RCT Carbohydrates and fat for training and recovery. Burke LM, Kiens B, Ivy JL. J. Sports Sci. 22 (1): 15 - 30, 2004 1,612 Short-term recovery from prolonged constant pace running in a warm environment: the effectiveness of a carbohydrate-electrolyte solution. Bilzon JLJ, Allsopp AJ, Williams C. Eur. J. Appl. Physiol. 82: 305 - 312, 2000 The influence of ingesting a carbohydrate-electrolyte beverage during 4 hours of recovery on subsequent endurance capacity. Fallowfield JL, Williams C, Singh R. Int. J. Sport Nutr. 5: 285 - 299, 1995 The influence of a high carbohydrate intake during recovery from prolonged, constant-pace running. Fallowfield J and Williams C. Int. J. Sport Nutr. 7: 10 - 25, 1997 HYDRATION. 31 January 2008 Claim to be only used for Foods for sportpeople under the Dir. 89/398/EEC Metabolisable carbohydrates: = 75% of total energy. 340kJ/l (80kcal/l) = Energy = 1488kJ/l (350kcal/l). 20 mmol/l (460 mg/l) = 1,610 Page 1,101 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Sodium (Na+) = 50 mmol/l (1150 mg/l). Nature of Evidence SCF Review: Consensus Statement References Claim ID Report of the SCF on the Composition and Specification of Food Intended to Meet the Expenditure of Intense Muscular Effort, especially for Sportsmen (2001) SCF/CS/NUT/SPORT/5 Final. Consensus Statement of the IAAF 2007. Nutrition for Athletics. IOC Consensus Statement on Sports Nutrition 2003. Fluid replacement in sport and exercise – a consensus statement Maughan RJ, Goodman R, Griffin J, Irani M, Kirwan JP, Leiper JB, MacLaren DP, McLatchie G, Tsintsas K, Williams C, Wellington P, Wilson WM, Wotton S Br J Sp Med 27 (1): 34-35, 1993. American College of Sports Medicine Position Stand: Exercise and Fluid Replacement Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS Med Sci Sports Exerc. 39(2): 377-390, 2007. National Athletic Trainers’ Association Position Statement: Fluid Replacement for Athletes Casa DJ, Armstrong LE, Hillman SK, Montain SJ, Reiff RV, Rich BSE, Roberts WO, Stone JA J Athletic Training 35(2): 212-224, 2000. The effectiveness of commercially available sports drinks Coombes JS and Hamilton KL Sports Med 29 (3); 181-209, 2000. Fluid and carbohydrate replacement during intermittent exercise Shi X and Gisolfi CV 31 January 2008 Page 1,102 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Sports Med 25 (3): 157-172, 1998. Exercise performance Jeukendrup AE and Burke LM Chapter 18 In: Nutrition and Metabolism. (Gibney MJ MacDonald I, Roche HM eds). London, 2003. The importance of salt in the athletes diet Valentine V Current Sports Medicine Reports 6(4): 237-240, 2007. Formulating carbohydrate-electrolyte drinks for optimal efficacy Murray R and Stofan J Chapter 8 In Sports Drinks: Basic Science and Practical Aspects. (Maughan R. and Murray R. eds.) CRC Press, 2001. Post-exercise rehydration and recovery Shirreffs S Chapter 7 In Sports Drinks: Basic Science and Practical Aspects. (Maughan R and Murray R eds.) CRC Press, 2001. Effect of flavour and awareness of kilojoule content of drinks on preference and fluid balance in team sports Minehan MR, Riley MD, Burke LM Int J Sp Nutr 12: 81-92, 2002. Impact of beverage acceptability on fluid intake during exercise Passe DH, Horn M, Murray R Appetite 35; 219-229, 2000. Effect of drink flavour and NaCl on voluntary drinking and hydration in boys exercising in the heat 31 January 2008 Page 1,103 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Wilk B and Bar-Or O J Appl Physiol 80 (4): 1112-1117, 1996. ENDURANCE Increased endurance capacity; Increased endurance performance; Delayed Fatigue. 31 January 2008 Claim to be only used for Foods for sport people under the Dir. 89/398/EEC. Metabolisable carbohydrates: = 75% of total energy. 340kJ/l (80kcal/l) = Energy = 1488kJ/l (350kcal/l). 20 mmol/l (460 mg/l) = Sodium (Na+) = 50 mmol/l (1150 mg/l). 1,611 Page 1,104 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence SCF Review Consensus Statement Position Statement Review paper Nutrition Society Textbook Nutrition in Exercise and Sport Series Textbook RCT References Claim ID Report of the SCF on the Composition and Specification of Food Intended to Meet the Expenditure of Intense Muscular Effort, especially for Sportsmen (2001) SCF/CS/NUT/SPORT/5 Final. American College of Sports Medicine roundtable on hydration and physical activity: consensus statements Casa DJ, Clarkson PM, Roberts WO Curr Sports Med Rep 4: 115-127, 2005. Fluid replacement in sport and exercise – a consensus statement Maughan RJ, Goodman R, Griffin J, Irani M, Kirwan JP, Leiper JB, MacLaren DP, McLatchie G, Tsintsas K, Williams C, Wellington P, Wilson WM, Wotton S Br J Sp Med 27 (1): 34-35, 1993. Position Stand: Exercise and Fluid Replacement American College of Sports Medicine Med Sci Sports Exerc. 39(2): 377-390, 2007. Position Stand: Nutrition and athletic performance American Dietetic Association, Dietitians of Canada and the American college of Sports Medicine J Am Diet Assoc. 100: 1543-1556, 2000. National Athletic Trainers’ Association Position Statement: Fluid Replacement for Athletes Casa DJ, Armstrong LE, Hillman SK, Montain SJ, Reiff RV, Rich BSE, Roberts WO, Stone JA J Athletic Training 35(2): 212-224, 2000. The role of salt and glucose replacement drinks in the marathon 31 January 2008 Page 1,105 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Murray B Sports Med 37 (4-5): 358-360, 2007. The effectiveness of commercially available sports drinks Coombes JS and Hamilton KL Sports Med 29 (3); 181-209, 2000. Exercise performance Jeukendrup AE and Burke LM Chapter 18 In: Nutrition and Metabolism. (Gibney MJ MacDonald I, Roche HM eds). London, 2003. Formulating carbohydrate-electrolyte drinks for optimal efficacy Murray R and Stofan J Chapter 8 In Sports Drinks: Basic Science and Practical Aspects. (Maughan R. and Murray R. eds.) CRC Press, 2001. Periodic carbohydrate replacement during 50 min of high intensity cycling improves subsequent sprint performance. Ball TC, Headley SA, Vanderburgh PM, Smith JC. Int J Sport Nutr. 5: 151-158, 1995 Gastric emptying of fluids during variable-intensity running in the heat. Gant N, Leiper JB, Williams C. Int J Sp Nutr & Ex Met 17(3): 270-283, 2007 Carbohydrate and physical/mental performance during intermittent exercise to fatigue. Welsh RS, Davis M, Burke JR, Williams HG. Med Sci Sports Exerc 34(4): 723-731, 2002 Carbohydrate feedings during team sport exercise preserve physical and CNS function. 31 January 2008 Page 1,106 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Winnick JJ, Davis JM, Welsh RS, Carmichael MD, Murphy EA, Blackmon JA. Med Sci Sports Exerc37 (2): 306-315, 2005 Carbohydrate supplementation improves stroke performance in tennis. Vergauwen L, Brouns F, Hespel P. Med Sci Sports Exerc 30 (8): 1289-1295, 1998 Attenuation of the perception of effort and reduction in pleasure Claim to be only used for Foods for sport people under the Dir. 89/398/EEC. Metabolisable carbohydrates: = 75% of total energy. 340kJ/l (80kcal/l) = Energy = 1488kJ/l (350kcal/l). 20 mmol/l (460 mg/l) = Sodium (Na+) = 50 mmol/l (1150 mg/l). RCT Carbohydrate attenuates perceived exertion during intermittent exercise and recovery Utter AC, Kang J, Nieman DC, Dumke CL, McAnulty SR, McAnulty LS. Med Sci Sports Exerc. 39(5):880-885, 2007 1,613 Carbohydrate ingestion during prolonged high-intensity intermittent exercise: impact on affect and perceived exertion. Backhouse SH, Ali A, Biddle SJH, Williams C Scand J Med Sci Sports. 2007 Feb 19; [Epub ahead of print] Effect of carbohydrate and prolonged exercise on affect and perceived exertion. Backhouse SH, Bishop NC, Biddle SJH, Williams C. Med Sci Sports Exerc. 37(10):1768-1773, 2005 Winnick JJ, Davis JM, Welsh RS, Carmichael MD, Murphy EA, Blackmon JA. Carbohydrate feedings during team sport exercise preserve physical and CNS function. Med Sci Sports Exerc. 37(2):306-315, 2005 Carbohydrates and physical/mental performance during intermittent exercise to fatigue Welsh RS, Davis JM, Burke JR, Williams HG. Med Sci Sports Exerc. 34(4):723-31, 2002. 31 January 2008 Page 1,107 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrate electrolyte drinks with elevated sodium ENDURANCE IN HEAT Claim to be only used for Foods for sport people under the Dir. 89/398/EEC. Metabolisable carbohydrates: = 75% of total energy. 510kJ/l (120kcal/l) = Energy = 850kJ/l (200kcal/l). Sodium (Na+) = 32.5 mmol/l (750 mg/l) Review Consensus statement American College of Sports Medicine Position Stand: Exertional heat illness during training and competition. Armstrong LE, Casa DJ, Millard-Stafford M. Moran DS, Pyne-Scott W, Roberts WO. Med Sci Sports Exerc 39(3): 556-572, 2007 1,614 Factors influencing the restoration of fluid and electrolyte balance after exercise in the heat. Maughan RJ, Leiper JB, Sheriffs SM. Br J Sports Med 31(3): 175-182, 1997 Fluid replacement in sport and exercise – a consensus statement Maughan RJ, Goodman R, Griffin J, Irani M, Kirwan JP, Leiper JB, MacLaren DP, McLatchie G, Tsintsas K, Williams C, Wellington P, Wilson WM, Wotton S Br J Sp Med 27 (1): 34-35, 1993. Fluid and electrolyte balance in ultra-endurance sport. Rehrer NJ. Sports Med 31(10): 701-715, 2001. Fluid and fuel intake during exercise. Coyle EF. J Sports Sci 22: 39-55, 2004. 31 January 2008 Page 1,108 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates Supply of metabolic energy Physical endurance Reconstitution of liver and muscle glycogen stores 31 January 2008 Metabolisable carbohydrates: = 65% of total energy (for foods). Metabolisable carbohydrates: = 75% of total energy (for beverages Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Authoritative Body FAO. Report of a joint FAO/WHO expert consultation: carbohydrates in human nutrition, in FAO food and nutrition paper Rome, 1998. http://www.fao.org/DOCREP/w8079e/w8079e0 8.htm#physical%20activity Authoritative Body AFSSA (2004) Glucides et sante : etat des lieux, evaluation et recommandations. Authoritative Body FAO. Report of a joint FAO/WHO expert consultation: carbohydrates in human nutrition, in FAO food and nutrition paper Rome, 1998. http://www.fao.org/DOCREP/w8079e/w8079e0 8.htm#physical%20activity Authoritative Body AFSSA (2004) Glucides et sante : etat des lieux, evaluation et recommandations. 135 141 142 Page 1,109 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates - non- cariogenic e.g. isomaltulose; tagatose, polyols, polydextrose. Absence of, or low, fermentable carbohydrates Dental health 31 January 2008 According to US 21CFR §101.80: the food shall not lower plaque pH below 5,7 by bacterial fermentation during consumption and up to 30 min after consumption, as determined by plaque pH telemetry, and other comparable methods. Authoritative/Scientific Bodies Swedish Nutrition Foundation (SNF) http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm Authoritative/Scientific Bodies FDA Food and Drug Administration of the USA. Code of Federal Regulations; 21 CFR 101 Authoritative/Scientific Bodies NFC/FOSHU - Japan http://www.mhlw.go.jp/english/topics/foodsafety /fhc/index.html Authoritative/Scientific Bodies CH - Switzerland - Ordonnance du March 1995 sur les dennrees alimentaires et les objets usuels (ODAlOUs) http://www.admin.ch/ch/f/rs/c817_02.html http://www.bag.admin.ch/themen/ernaehrung/0 2907/03002/index.html?lang=fr Authoritative/Scientific Bodies EU Novel Food Approval for Isomaltulose: Initial Assessment Report of the competent German Authority (BfR) Authoritative/Scientific Bodies American Dental Association (2001). Role of Sugar-Free Foods and Medications in Maintaining Good Oral Health. http://www.ada.org/prof/resources/positions/sta tements/sugarfre.asp Authoritative/Scientific Bodies FDA (1996) Health claims: dietary sugar alcohols and dental caries. Federal Register 61 (154) 43433-43445, August 23, 1996, and 21CFR §101.80 144 Page 1,110 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Authoritative/Scientific Bodies FOSHU Japan: (1) FOSHU approved products classified by ingredients used and intended benefit or effect 1991-1997 at website of the International Association of Consumer Food Organisation at http://www.cspinet.org/reports/functionalfoods/t able4.html; (2) website of the Japan Health Nutrition Food Association (JHNFA); (3) Shimizu, T. (2003) Health claims on functional foods: the Japanese regulations and an international comparison. Nutrition Research Reviews 16, 241-252. [Note: the Japanese name of isomalt is “hydrogenised Palatniose”] Authoritative/Scientific Bodies Swiss Lebensmittelverordnung (LMV) of March, 1, 1995, as amended, Art. 176 Zuckerfreie Lebensmittel. Authoritative/Scientific Bodies WHO/FAO (2003) Diet, Nutrition and the Prevention of Chronic Diseases. Report of a Joint WHO/FAO Expert Consultation. WHO Technical report Series 916. WHO, Geneva. Authoritative/Scientific Bodies EU Directive 94/35/EC (Sweeteners, Preamble) Authoritative/Scientific Bodies European Commission, Health and Protection Directorate-General: Revision of the scientific opinion on the effects of xylitol and other polyols on caries development adopted by the Sceintific Committee on Medicianl Products and Medical Devices on 2 June 1999. Opinion adopted by the Scientific Committee on Medicianl Products and Medical Devices on 26th September 2002. Reviews Birkhead D, Takazoe I, Frostell G (1987) New experiments on Palatinose (isomaltulose) as a sugar substitute. Dtsch Zahnarztl Z 42, 124-127. Claim ID Page 1,111 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Oku T (1996) Oligosaccharides with beneficial health effects - a Japanese perspective. Nutr Rev 54, S59-S66. Reviews Takazoe I (1985) New trend on sweeteners in Japan. Intern Dent J 35, 58-65. Reviews Takazoe I (1989) Palatinose - an isomeric alternative to sucrose. In: Progess in Sweeteners (ed. TH Grenby), 143-167. Reviews Edgar WM, Dodds MWJ (1985) The effect of sweeteners on acid production plaque. Int Dent J 35, 18-22. Reviews Imfeld T (1993) Efficacy of sweeteners and sugar substitutes in caries prevention. Caries Res 27 (suppl 1) 50-55. Reviews Imfeld TN (1994) Clinical caries studies with polyalcohols – a literature review. Schweiz Monatsschr Zahnmed 104 (8) 941-945. Reviews Imfeld T, MOhlemann HR (1978) Cariogenicity and acidogenicity of food, confectionery and beverages. Pharmacology and Therapeutics in Dentistry 3, 53-68. Reviews Scheie AA, Fejerskov, OB (1998) Xylitol in caries prevention - what is the avidence for clinical efficiacy. Critical revies. Oral Diseases 4, 268-278. Reviews Van Loveren C (2004) Sugar alcohols - what is the evidence for caries-preventive and caries-therapeutic effects? Caries Research 38, 286-293. Reviews Featherstone JDB (1994) Effects of isomalt sweetener on the caries process: A review. J Clin Dent 5, 82 - 85. Claim ID Page 1,112 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Gehring F, Karle EJ (1981). The sugar substitute Palatinit® [isomalt] with special emphasis on microbiological and caries-preventing aspects. Zeitschrift Ernahrungswiss. 20, 96 - 106. Human studies in situ (pH telemetry) Expert opinion by Imfeld T (2006) of the University of Zurich following the requirements of the Swiss legislation (LMV Art. 176) and the methodology as laid down in the US FDA 21 CFR §101.80. Human studies in situ (pH telemetry) Takazoe I, Frostell G, Ohta K, Topitsoglou V, Sasaki N (1985) Palatinose - a sucrose substitute. Swed Dent J 9, 81-87. Human studies in situ (pH telemetry) Topitsoglou V, Sasaki N, Takazoe I, Frostell G (1984) Effect of frequent rinses with isomlatulose (palatinose) solution on acid production in human dental plaque. Caries Res 18. 47-51. In vitro and animal studies Ohta K, Takazoe I (1983) Effect of isomaltulose on acid production and insoluble glucan synthesis by Streptococcus mutans. Bull Tokyo Dent Coll 24, 1-11. In vitro and animal studies Ooshima T, Izumitani A, Sobue S, Okahashi N, Hamada S (1983) Non-cariogenicity of the disaccharide palatinose in experimental dental caries of rats. Infections and Immunity 39, 43-49. In vitro and animal studies Sasaki N, Topitsoglou V, Takazoe I, Frostell G (1985) Cariogenicity of isomaltulose (palatinose) , sucrose and mixtures of these sugars in rats infected with Streptococcus mutans E-49. Swed Dent J 9, 149-155. In vitro and animal studies Takazoe I, Frostell G, Ohta K, Topitsoglou V, Sasaki N (1985) Palatinose - a sucrose substitute. Swed Dent J 9, 81-87. Claim ID Page 1,113 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Edgar WM, Dodds MWJ (1985) The effect of sweeteners on acid production plaque. Int Dent J 35, 18-22. Individual Studies Imfeld T, Muehlemann HR (1978) Cariogenicity and acidogenicity of food, confectionery and beverages. Pharmacology and Therapeutics in Dentistry 3, 53-68. Human studies in situ (pH telemetry) Imfeld T, Muhlemann HR (1978) Cariogenicity and acidogenicity of food, confectionery and beverages. Pharmacology and Therapeutics in Dentistry 3, 53-68. Human studies in situ (pH telemetry) Takatsuka T (2002) Enamel remineralisation by isomalt toothpaste in situ. J Dent Res 81 (spec iss) ( Seq No 259, Presentation 2815). In vitro and animal studies Ciardi J, Bowen WH, Rolla G, Nagorski K (1983) Effect of sugar substitutes on bacterial growths, acid production and glucan synthesis. J Dent Res 62, 182 [AADR Abstracts No. 110]. In vitro and animal studies Gehring F, Karle EJ (1981). The sugar substitute Palatinit ® with special emphasis on microbiological and caries-preventing aspects. Zeitschrift Ernahrungswiss. 20, 96 – 106. In vitro and animal studies Grenby TH, Mistry M (1996) Laboratory studies of sweets re-formulated to improve their dental properties. Oral Diseases 2, 32-40. In vitro and animal studies Karle EJ, Gehring F (1979) Study of the cariogenicity of sugar substitutes in xerostomized rats. Dtsch Zahnarztl Z 34, 551-554. In vitro and animal studies Takatsuka T (2000) Influence of Palatinit (isomalt) and xylitol on demineralisation / remineralisation on bovine enamel. Cariology Today 1, 27-40. Claim ID Page 1,114 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References In vitro and animal studies Van der Hoeven JS (1979) Influence of disaccharide alcohols on the oral microflora. Caries Res 13, 301-306. In vitro and animal studies Van der Hoeven JS (1980) Cariogenicity of disaccharide alcohols in rats. Caries Res 14, 61-66. Review Foster-Powell K, Holt SH, Brand-Miller JC. International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr. 2002 Jul;76(1):5-5 Claim ID Carbohydrates in dairy products Foods with a low glycemic index (GI) give a low and slow blood glucose response 31 January 2008 GI <35 (ref glocose = 100) only to be used on dairy products containing at least 4g/100g of carbohydrates 745 Page 1,115 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates providing a source of glucose Cognitive/ mental performance; alertness; atention; memory 31 January 2008 Reviews and Individual Studies Bellisle F, Blundell JE, Dye L, Fantino M, Fern E, Fletcher RJ, Lambert J, Roberfroid M, Specter S, Westenhofer J and Westerterp-Plantenga MS (1998) Functional food science and behaviour and psychological functions. British Journal of Nutrition 80, (Suppl.1), S173 - S193. [PASSCLAIM] Reviews and Individual Studies Benton D, Owens DS, Parker PY. Blood glucose influences memory and attention in young adults. Neuropsychologia. 1994;32:595-607. Reviews and Individual Studies Benton D, Parker PY, Donohoe RT. The supply of glucose to the brain and cognitive functioning. J Biosoc Sci. 1996;28:463-479. Reviews and Individual Studies Benton D, Owens DS (1993) Blood glucose and human memory. Psychopharmacology 113, 83-88. Reviews and Individual Studies Benton, D. (2002). Carbohydrate ingestion, blood glucose and mood. Neuroscience and Biobehavioral Reviews 26, 293-308. Reviews and Individual Studies Donohoe RT, Benton D (1999) Cognitive function is susceptible to the level of blood glucose. Psychopharmacology 145, 378-385. Reviews and Individual Studies Foster JK, Lidder PG, Sunram SI (1998) Glucose and memory: fractionation of enhancement effects? Psychopharmacology 137, 259-270. Reviews and Individual Studies Gonder-Frederick L, Hall JL, Vogt J, Cox DJ, Green J, Gold PE (1987) Memory enhancement in elderly humans: effects of glucose ingestion. Physiol Behav 41, 503-4. 143 Page 1,116 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews and Individual Studies Hall JL, Gonder-Frederick LA, Chewning WW, Silveira J, Gold PE (1989) Glucose enhancement of performance on memory tests in young and aged humans. Neuropsychologia 27, 1129-38. Reviews and Individual Studies Kennedy DO and Scholey AB. Glucose administration, heart rate and cognitive performance: effects of increasing mental effort. Psychopharmacology. 2000;149:63-117. Reviews and Individual Studies Korol DL, Lexcen FJ, Parent M, Ragozzino M, Manning CA, Gold PE (1995) Effects of glucose on cognitive performance in college students. Soc Neurosci Abstr 21, 2085. Reviews and Individual Studies Messier C, Pierre J, Desrochers A, Gravel M. Dose-dependent action of glucose on memory processes in women: effect on serial position and recall priority. Cognitive Brain Research. 1998;7:221-233. Reviews and Individual Studies Morris N & Sarll P (2001) Drinking glucose improves listening span in students who miss breakfast. Educational Research 43, 201-207. Reviews and Individual Studies Owens DS & Benton D (1994) The impact of raising blood glucose on reaction times. Neuropsychobiology 30, 106-13. Reviews and Individual Studies Owens DS, Parker PY, Benton D (1997) Blood Glucose and Subjective Energy Following Cognitive Demand. Physiology and Behaviour 62, 471 – 478. Reviews and Individual Studies Parsons MW, Gold PE. Glucose enhancement of memory in elderly humans - an inverted-U dose-response curve. Neurobiology of Ageing. 1992;13:401-404. Claim ID Page 1,117 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews and Individual Studies Sunram-Lea SI, Foster JK, Durlach P, Perez C. Glucose facilitation of cognitive performance in healthy young adults: examination of the influence of fast-duration, time of day and pre-consumption plasma glucose levels. Psychopharmacology. 2001;157:46-54. Reviews and Individual Studies Sunram-Lea SI, Foster JK, Durlach P, Perez C (2002) Investigation into the significance of task difficulty and divided allocation of resources on the glucose memory facilitation effect. Psychopharmacology 160, 387-397. Claim ID Page 1,118 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates that induce a low glycaemic response Low impact on blood glucose/low glycaemic response/improved blood glucose control 31 January 2008 The glycaemic response induced is not more than half that of glucose (or equivalent substance e.g. maltodextrin), without increasing the fat content, assessed from blood glucose response curves (e.g. test food vs glucose) either based on a portion of the food providing 50g (minimum 10g) of total carbohydrates and dietary fibre (thus taking into account available carbohydrates and their replacements, e.g. polyols and dietary fibre) or based on the amount of carbohydrates in one serving of the food vs the equivalent amount of glucose. 1,593 Page 1,119 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Expert reviews, Reviews, Meta-analyses, Individual Studies 31 January 2008 References Claim ID Authoritative/Scientific Bodies WHO/FAO (2003). Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series 916, Geneva, 2003, pg 76. FAO/WHO (1998). Carbohydrates in Human Nutrition, FAO Food and Nutrition Paper No. 66, Report of a Joint FAO/WHO Expert Consultation Rome, 14-18 April 1997. Meta-Analyses Anderson J, Randles K, Kendall C, Jenkins D. (2004). Carbohydrate and fiber recommendations for individuals with diabetes: A quantitative assessment and meta-analysis of the evidence. Journal of the American College of Nutrition, Vol. 23, No. 1, 5-17. Brand Miller J. (2003). Low Glycaemic Index diets in the management of diabetes a meta-analysis of randomised control trials. Diabetes Care 26: 2261-2267. Bornet FRJ, Jardy-Gennetier A-E, Jacquet N and Stowell J (2007) Glycaemic response to foods: impact on satiety and long-term weight regulation. Appetite: In press Livesey G, Taylor R, Hulshof T, Howlett J. Glycemic response and health – a systematic review and meta-analysis: the database, study characteristics and macronutrient intakes. American Journal of Clinical Nutrition, In press. Opperman A, Venter C, Oosthuizen W, Thompson R, Vorster H (2004). Meta-analysis of the health effects of using the glycaemic index in meal planning. Br J Nutr, 92, 367-381. Thomas DE, Elliott EJ, Baur L. Low glycaemic index or low glycaemic load diets for overweight and obesity. Cochrane Database of Systematic Reviews 2007, issue 3: CD005105; DOI: 10.1002/14651858.pub2. Wolever TMS (2003). Carbohydrate and the Regulation of Blood Glucose and Page 1,120 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Metabolism. Nutrition Reviews, Vol. 61, No. 5, S40-S48. Reviews Augustin, S. Franceschi, DJA Jenkins, CWC Kendall, and C. La Vecchia (2002). Glycemic index in chronic disease: a review. Eur J Clin Nutr 56:1049-1071. [Carbohydrates and their glycemic effect]. Praxishandbuch Functional Food (eds. Erbersdobler, Meyer), 22. Akt.-Lfg. 12/2005, Behrs, Hamburg. Björck I, Liljeberg H, Östman E (2000). Low-glycaemic - index-foods. British Journal of Nutrition, Vol. 83, Suppl. 1; 149-155. Brand-Miller J (2003). Glycemic load and chronic disease. Nutr Rev 61, 49-55. Frost G and Dornhurst A. Glycemic Index. Encyclopedia of Human Nutrition, 2nd Edition. Eds Caballero B et al. Elsevier: London, UK, 2005 Howlett J, Ashwell M. Glycemic response and health: summary of a workshop. American Journal of Clinical Nutrition, In press. Jenkins DJA, Kendall CWC, Augustin LSA, Francheschi S, Hamidi M, Marchie A, Jenkins AL, Axelsen M (2002). Glycemic index: an overview of implications in health and disease. Am J Clin Nutr (suppl), 266S-273S. Leeds, A (2002). Glycemic index and heart disease. Am J Clin Nutr 2002 (Volume 76, No.1 (supplement): 286S-289S. Liu S (2002). Intake of refined carbohydrates and whole grain foods in relation to risk of type 2 diabetes mellitus and coronary heart disease. Journal of the American College of Nutrition, Vol. 21, No. 4, 298-306. Liu S, Willet WC (2002). Dietary glycemic load and atherothrombotic risk. Curr. Atheroscler. Rep. 4(6), 454-461. Livesey G (2003). Health potential of 31 January 2008 Page 1,121 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID polyols as sugar replacers, with emphasis on low glycaemic properties. Nutrition Research reviews, 16, 163-191. Livesey G (2005). Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 105-113. Livesey, G. (2006). Glycaemic control with unavailable carbohydrates including polyols. Foods Food Ingredients J Jpn 211: 445-455. Livesey G. Glycaemic response and health – meta-analyses. Ann Nutr Metab 2007, 51 (suppl 1): 51-52. Ludwig, DS (2002). The glycemic index – physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA 287, 2414-2423. Ludwig DS (2003). Dietary Glycemic Index and the Regulations of body weight. Lipids, Vol. 38, No. 2, 117-121. Monro, J. Expressing the glycaemic potency of foods. Proceedings of the Nutrition Society 64: 115-122. Riccardi G, Aggett P, Brighenti F, Delzenne N, Frayn K, Nieuwenhuizen A, Pannemans D, Theis S, Truijtelaars S, Vessby B (2004). PASSCLAIM – body weight regulation, insulin sensitivity and diabetes risk. Eur J Nutr Suppl. 2 43 II/7-II/46. Willett W, Manson J, Liu S (2002) Glycemic index, glycemic load, and risk of type 2 diabetes. Am J Clin Nutr (suppl), 274S-280S. Wolever TMS (2000) Dietary carbohydrates and insulin action in humans. British Journal of Nutrition, Vol. 83, Suppl.1, S97-S102. Individual Studies Bouche C, Rizkalla SW, Luo J, Vidal H, Veronese A, Pacer N, Fouquet C, Lang V, Slama G. Five week, low GI diet decreases total fat mass and improves plasma lipid profile in moderately overweight non-diabetic men. 31 January 2008 Page 1,122 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Diabetes Care 2002, 25: 822-828. Gostner A, Schaffer V, Theis S, Menzel T, Luhrs H, Melcher R, Schauber J, Kudlich T, Dusel G, Dorbath D, Kozianowski G, Scheppach W (2005). Effects of isomalt consumption on gastrointestinal and metabolic parameters in healthy volunteers. Brit J Nutrition 94, 575-581. . Wirkung des Zuckeraustauschstoffes Isomalt auf Stoffwechsel- und Risikoparameter bei Patienten mit Diabetes mellitus Typ 2 {Influence of low glycaemic sweetener isomalt on metabolic parameters and vascular risk factors in type 2 diabetics]. Z Gastroenterol 44, 699-941 [abstract P385] 31 January 2008 Page 1,123 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates that induce a reduced glycaemic response Lower impact on blood glucose/ lower glycaemic response; improved blood glucose control 31 January 2008 The glycaemic response induced is reduced {amount of reduction to be consistent with the conditions for making a ‘reduced’ [name of nutrient] nutrition claim as set out in the annex – Nutrition claims and conditions applying to them of Regulation EC 1924/2006} compared with a regular food, without increasing the fat content, assessed from blood glucose response curve (e.g. test food vs traditional food) 1,594 Page 1,124 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Expert reviews, Reviews, Individual studies, Meta-analysis 31 January 2008 References Claim ID Authoritative/Scientific Bodies WHO/FAO (2003). Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series 916, Geneva, 2003, pg 76. FAO/WHO (1998). Carbohydrates in Human Nutrition, FAO Food and Nutrition Paper No. 66, Report of a Joint FAO/WHO Expert Consultation Rome, 14-18 April 1997. Meta-Analyses Brand Miller J. (2003). Low Glycaemic Index diets in the management of diabetes a meta-analysis of randomised control trials. Diabetes Care 26: 2261-2267. Bornet FRJ, Jardy-Gennetier A-E, Jacquet N and Stowell J (2007) Glycaemic response to foods: impact on satiety and long-term weight regulation. Appetite: In press Livesey G, Taylor R, Hulshof T, Howlett J. Glycemic response and helath – a systematic review and meta-analysis: the database, study characteristics and macronutrient intakes. American Journal of Clinical Nutrition, In press. Opperman A, Venter C, Oosthuizen W, Thompson R, Vorster H (2004). Meta-analysis of the health effects of using the glycaemic index in meal planning. Br J Nutr, 92, 367-381 Thomas DE, Elliott EJ, Baur L. Low glycaemic index or low glycaemic load diets for overweight and obesity. Cochrane Database of Systematic Reviews 2007, issue 3: CD005105; DOI: 10.1002/14651858.pub2. Wolever TMS (2003). Carbohydrate and the Regulation of Blood Glucose and Metabolism. Nutrition Reviews, Vol. 61, No. 5, S40-S48. Reviews Augustin, L.S., Franceschi, S., Jenkins, D.J.A., Kendall, C.W.C, La Vecchia, C (2002). Glycemic index in chronic disease - a review. Page 1,125 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Eur J Clin Nutr 56, 1049-1071. Carbohydrates and their glycemic effct]. Praxishandbuch Functional Food (eds. Erbersdobler, Meyer), 22. Akt-Lf 12/2005, Behrs, Hamburg. Brand-Miller J (2003). Glycemic load and chronic disease. Nutr Rev 61, 49-55. Frost G and Dornhurst A. Glycemic Index. Encyclopedia of Human Nutrition, 2nd Edition. Eds Caballero B et al. Elsevier: London, UK, 2005 Howlett J, Ashwell M. Glycemic response and health: summary of a workshop. American Journal of Clinical Nutrition, In press. Jenkins DJA, Kendall CWC, Augustin, LSA, Francheschi S, Hamidi M. Marchie A, Jenkins AL and Axelsen M (2002). Glycemic index: an overview of implications in health and disease. Am J Clin Nutr (suppl), 266S-273S. Livesey, G (2003). Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutr Res Rev 16, 163 -191. Livesey G (2005). Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 105-113. Livesey, G (2006). Glycemic control with unavailable carbohydrates including polyols. Foods Food Ingredients J Jpn 211 (5), 445455. Livesey G. Glycaemic response and health – meta-analyses. Ann Nutr Metab 2007, 51 (suppl 1): 51-52. Ludwig (2002). The glycemic index – physiological mechanisms relating to obesity, diabetes and cardiovascular disease. JAMA 287, 2414-2423. Wolever TMS (2000). Dietary carbohydrates and insulin action in humans. Br J Nutr 83, Suppl. 1, S97-S102. 31 January 2008 Page 1,126 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Wolever TMS (2003). Carbohydrate and the regulation of blood glucose and metabolism. Nutr Rev 61, S.40-S48. 31 January 2008 Page 1,127 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates with a low glycaemic index (GI) Impact on blood glucose / Glycemic control / Glycemic response 31 January 2008 Where low GI = GI score of less than or equal to 55, assessed from the incremental area under the blood glucose response curve of a portion of the food/ product providing 50g available carbohydrate (minumum 10g), measured over 2 hours, and expressed as a percentage of the response to 50g glucose or white bread where GI = 100. Reference: WHO/FAO 1998; Brouns et al 2005. Authoritative/Scientific Bodies FAO. Report of a joint FAO/WHO expert consultation: carbohydrates in human nutrition, in FAO food and nutrition paper Rome, 1998. Authoritative/Scientific Bodies WHO/FAO. Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series 916, Geneva, 2003, pg 76. Textbooks Frost G and Dornhurst A. Glycemic Index. Encyclopedia of Human Nutrition, 2nd Edition. Eds Caballero B et al. Elsevier: London UK, 2005. Textbooks Wolever T. The Glycaemic Index physiological classification of dietary carbohydrate. CABI: Oxfordshire, UK, 2006. Systematic Reviews/Meta-Analysis Brand Miller J. Low GI diets in the management of diabetes a meta- analysis of randomised control trials. Diabetes Care 2003, 26: 2261-2267. Systematic Reviews/Meta-Analysis Opperman AM Venter CS, Oosthuizen W, Thompson RL, Vorster HH. Meta-analysis of the health effects of using the GI in meal planning. Brit J Nutr 2004, 92: 367-381. Reviews -Alfenas RCG, Mattes RD. Influence of glycemic index/load on GI response, appetite, and food intake in healthy humans. Diabetes Care 2005; 28: 2123-2129. Reviews Augustin LS, Franceschi S, Jenkins DJA, Kendall CWC, La Vecchia C. Glycemic index in chronic disease: a review. Eur J Clin Nutr 2002, 56: 1049-1107. 136 Page 1,128 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Brouns F, Bjorck I, Frayn K, Gibbs AL, Lang V, Slama G, Wolever TMS. Glycaemic Index Methodology. Nutrition Research Reviews 2005, 18:145-171. Reviews Foster-Powell K, Holt S, Brand Miller J. International table of GI/GL values 2002. American Journal of Clinical Nutrition 2002, 76: 5-56. Reviews Gray J. (2003). Carbohydrates: Nutritional and Health Aspects. ILSI Monograph (2003) (ISB: 1-57881-146-5). Reviews Henry CJ, Lightowler HJ, Strik CM, Renton H, Hails S. Glycaemic index and glycaemic load values of commercially available products in the UK. Br J Nutr 2005, 94: 922-930. Reviews Unwin N, Shaw J, Zimmet P, Alberti KG. Impaired glucose tolerance and impaired fasting glycaemia: the current status on definition and intervention. Diabet Med. 2002, 19: 708-723. Individual Studies Bouche C, Rizkalla SW, Luo J, Vidal H, Veronese A, Pacer N, Fouquet C, Lang V, Slama G. Five week, low GI diet decreases total fat mass and improves plasma lipid profile in moderately overweight non-diabetic men. Diabetes Care 2002, 25: 822-828. Individual Studies Brynes AE, Edwards MC, Ghatei MA, Dornhorst A, Morgan LM, Bloom SR, Frost GS. A randomised four-intervention crossover study investigating the effect of carbohydrates on daytime profiles of insulin, glucose, non-esterified fatty acids and triacylglycerols in middle-aged men. Br J Nutr 2003, 89: 207-218. Claim ID Page 1,129 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Brynes AE, Lee JL, Brighton RE, Leeds AR, Dornhorst A, Frost GS. A low glycemic diet significantly improves the 24-h blood glucose profile in people with type 2 diabetes, as assessed using the continuous glucose MiniMed monitor. Diabetes Care 2003, 26: 548-549. Individual Studies Brynes AE, Adamson J, Dornhorst A, Frost G. The beneficial effect of a diet with low GI on 24 h glucose profiles in healthy young people as assessed by continuous glucose monitoring. British Journal of Nutrition 2005, 93: 179-182. Individual Studies Liljeberg H, Akerberg AK, Bjorck IM. Effect of the glycemic index and content of indigestible carbohydrates of cereal-based breakfast meals on glucose tolerance at lunch in healthy subjects. Am J Clin Nutr 1999, 69: 647-655. Individual Studies Liljeberg H, Bjorck I. Effects of a low-glycaemic index spaghetti meal on glucose tolerance and lipaemia at a subsequent meal in healthy subjects. Eur J Clin Nutr 2000, 54: 24-28. Individual Studies Henry CJ, Lightowler HJ, Kendall FL, Storey M. The impact of the addition of toppings/fillings on the glycaemic response to commonly consumed carbohydrate foods. Eur J Clin Nutr 2006, 60: 763-769. Epub 2006 Jan 25. Individual Studies Jenkins DJ, Ocana AM, Rao VA, Collier GR. Second-meal effect: low-glycemic-index foods eaten at dinner improve subsequent breakfast glycemic response. Am J Clin Nutr 1988, 48: 1041-1047. Individual Studies Ludwig DS, Majzoub JA, Al-Zahrani A et al. High GI foods, overeating and obesity. Pediatrics, 1999, 103: e26. Claim ID Page 1,130 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Wolever TMS, Vorster HH, Bjork I, Brand-Miller J, Brighenti F, Mann JI, Ramdath DD, Granfeldt Y, Holt S, Perry TL, Venter C, Wu X. Determination of the glycemic index of foods: interlaboratory study. Eur J Clin Nutr 2003, 57: 475-482. Wolever T & Mehling C. Long term effect of varying source or amount of dietary carbohydrate on postprandial plasma glucose, insulin, triacylglycerol, and free fatty acid concentration in subjects with impaired glucose tolerance. American Journal of Clinical Nutrition 2003, 77: 612-621. Henry CJK, Lightowler HJ, tydeman EA, Skeath R. Use of low-glycaemic index bread to reduce 24-hour blood glucose: implications for dietary advice to non-diabetic and diabetic subjects. Int J Food Sc & Nut 2006, 57: 273-278. 31 January 2008 Page 1,131 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative body Review Individual studies Table of GI & GL values References Claim ID Arumugam, V. et al. (2007) A high-glycemic meal pattern elicited increased subjective appetite sensations in overweight and obese women. Appetite. Doi:10.1016/j.appet.2007.07.003. Brand-Miller, J.C. et al. (2003) Physiological Validation of the Concept of Glycemic Load in Lean Young Adults. Journal of Nutrition. 133, pp. 2695-2696. Galgani, J., Aguirre, C. & Díaz, E. (2006) Acute effect of meal glycemic index and glycemic load on blood glucose and insulin responses in humans. Nutrition Journal. 5 (22). Ludwig, D.S. (2002) The Glycaemic Index. Physiological Mechanisms Relating to Obesity, Diabetes and Cardiovascular Disease. Journal of the American Medical Association. 287 (18), pp. 2414-2423. McMillan-Price, J. et al (2006) Comparison of 4 Diets of Varying Glycemic Load on Weight Loss and Cardiovascular Risk Reduction in Overweight and Obese Young Adults: A Randomized Controlled Trial. Archives of Internal Medicine. 166, pp. 1466-1475. Wolever, T.M.S. & Bolognesi, C. (1996) Source and Amount of Carbohydrate Affect Postprandial Glucose and Insulin in Normal Subjects. Journal of Nutrition. 126, pp. 2798-2806. Serum cholesterol 31 January 2008 Where low GI = GI score of less than or equal to 55, assessed from the incremental area under the blood glucose response curve of a Authoritative/Scientific Body FAO. Report of a joint FAO/WHO expert consultation: carbohydrates in human nutrition, in FAO food and nutrition paper Rome, 1998. 137 Page 1,132 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use portion of the food/ product providing 50g available carbohydrate (minumum 10g), measured over 2 hours, and expressed as a percentage of the response to 50g glucose or white bread where GI = 100. Reference: WHO/FAO 1998; Brouns et al 2005. - 31 January 2008 Nature of Evidence References Textbook Frost G and Dornhurst A. Glycemic Index. Encyclopedia of Human Nutrition, 2nd Edition. Eds Caballero B et al. Elsevier: London UK, 2005. Systematic Reviews/Meta-Analysis Kelly S, Frost G, Whittaker V, Summerbell C. Low glycaemic index diets for coronary heart disease (Cochrane Review). The Cochrane Library, Issue 2, 2005. Systematic Reviews/Meta-Analysis Opperman AM, Venter CS, Oosthuizen W, Thompson RL, Vorster HH. Meta-analysis of the health effects of using the GI in meal planning. Brit J Nutr 2004, 92: 367-381. Reviews Augustin LS, Franceschi S, Jenkins DJA, Kendall CWC, La Vecchia C. Glycemic index in chronic disease: a review. Eur J Clin Nutr 2002, 56: 1049-1107. Reviews Brouns F, Bjorck I, Frayn K, Gibbs AL, Lang V, Slama G, Wolever TMS. Glycaemic Index Methodology. Nutrition Research Reviews 2005, 18:145-171. Reviews Gray J. (2003). Carbohydrates: Nutritional and Health Aspects. ILSI Monograph (2003) (ISB: 1-57881-146-5). Reviews Jenkins DJA, Kendall CWC, Augustin LSA et al. GI Overview of Implications of Health and Disease. Am J Clin Nutr 2002, 76: 266s-273s. Reviews Leeds AR. GI and Heart Disease. American Journal of Clinical Nutrition 2002, 76: 286s-289s. Reviews Ludwig DS. The Glycemic Index: Physiological Mechanisms Relating to Obesity, Diabetes and Cardiovascular Disease. JAMA 2002, 287: 2414-2423. Claim ID Page 1,133 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Pawlac DB, Ebbeling CB, Ludwig DS. Should obese patients be counselled to follow a low GI diet? Yes! Obesity Reviews 2002, 3: 235-243. Reviews Pelkman CL.Effect of GI foods on serum concentration of HDL, cholesterol and triglycerides. Current Atherosclerosis Reports 2001, 3: 456-461. Reviews Perlstein RWJ, Hines C, Milsavljevic M. Dietitians’ Association of Australia, review paper. Australian Journal of Nutrition and Dietetics 1997, 54: 57-63.. Individual Studies Bornet FR, Costagliola D, Rizkalla SW et al. Insulinaemic and glycaemic indexes of six starch-rich foods taken alone and in a mixed meal by type 2 diabetics. Am J Clin Nutr 1987, 45: 588-595. Individual Studies Jenkins DJ, Wolever TM, Kalmusky J, Giudici S, Giordano C, Wong GS, Bird JN, Patten R, Hall M, Buckley G, et al. Low glycemic index carbohydrate foods in the management of hyperlipidemia. Am J Clin Nutr 1985, 42: 604-617. Individual Studies Ma Y, Li Y, Chiriboga DE, Olendzki BC, Hebert JR, Li W, Leung K, Hafner AR, Ockene IS. Association between carbohydrate intake and serum lipids. J Am Coll Nutr 2006, 25: 155-163 Individual Studies Rizkalla S, Taghrid L, Laramiguiere M et al. Improved plasma glucose control, whole body glucose utilization and lipid profile on a low glycemic index diet in type 2 diabetic men – a randomized controlled trial. Diabetes Care 2004, 27: 1866-1872. Claim ID Page 1,134 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Sloth B, Krog-Mikkelsen I, Flint A et al. No difference in body weight decrease between a low GI and a high GI diet but reduced LDL-cholesterol after 10-weeks ad libitum intake of the low glycemic index diet. Am J Clin Nut 2004, 80: 337-347. Epidemiological Studies Ford ES, Liu S. GI and serum HDL cholesterol concentration amongst US adults. Arch Intern Med 2001, 161: 572-576. Epidemiological Studies Frost G, Leeds AA, Dore CJ, Madeiros S, Brading S, Dornhorst A. Glycaemic index as a determinant of serum HDL-cholesterol concentration. Lancet 1999, 353: 1045-1048. Claim ID Thomas DE, Elliott EJ, Baur L. Low glycaemic index or low glycaemic load diets for overweight and obesity. Cochrane Dataase of Systematic Reviews 2007, issue 3: CD005105; DOI: 10.1002/14651858. pu b2. Leeds AR. GI and Heart Disease. American Journal of Clinical Nutrition 2002, 76: 286s-289 Jenkins DJ, Wolever TM, Kalmusky J, Giudici S, Giordano C, Wong GS, Bird JN, Patten R, Hall M, Buckley G, et al. Low glycemic index carbohydrate foods in the management of hyperlipidemia. Am J Clin Nutr 1985, 42: 604-617. McMillan Price J, Petocz P, Atkinson F et al. Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults. Arch Int Med 2006, 166: 1466-1475. 31 January 2008 Page 1,135 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative body Cochrane Review Individual studies 31 January 2008 References Claim ID Amano, Y. et al. (2004) Correlation between dietary glycemic index and cardiovascular disease risk factors among Japanese women. European Journal of Clinical Nutrition. 58, pp.1472-1478. Beulens, J.W.J. et al. (2007) High Dietary Glycemic Load and Glycemic Index Risk of Cardiovascular Disease Among Middle-Aged Women: A Population-Based Follow-Up Study. Journal of the American College of Cardiology. 50 (1), pp.14-21. Ebbeling, C.B. et al. (2005) Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults. American Journal of Clinical Nutrition. 71, pp. 976-982. Feher, M.D. & Elkeles, R.S. (1999) Lipid modification and coronary heart disease in type 2 diabetes: different from the general population? Heart. 81, pp. 10-11. Lawes, C.M.M. et al. (2004) High Cholesterol. In Ezzati, M. et al. eds. Comparative Qualification of Health Risks: Global and Regional Burden of Disease Attributable to Selected Major Risk Factors, Volume 1. Geneva, WHO. Liu, S. et al. (2000) A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. American Journal of Clinical Nutrition. 71, pp.1455-1461. Liu, S. et al (2001) Dietary glycemic load assessed by food-frequency questionnaire in relation to plasma high-density-lipoprotein cholesterol and fasting plasma triacylglycerols in postmenopausal women. American Journal of Clinical Nutrition. 73, pp. 560-566. McMillan-Price, J. et al (2006) Comparison of 4 Diets of Varying Glycemic Load on Weight Loss and Cardiovascular Risk Reduction in Page 1,136 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Overweight and Obese Young Adults: A Randomized Controlled Trial. Archives of Internal Medicine. 166, pp. 1466-1475. Satiety 31 January 2008 Where low GI = GI score of less than or equal to 55, assessed from the incremental area under the blood glucose response curve of a portion of the food/ product providing 50g available carbohydrate (minumum 10g), measured over 2 hours, and expressed as a percentage of the response to 50g glucose or white bread where GI = 100. Reference: WHO/FAO 1998; Brouns et al 2005. Authoritative/Scientific Body FAO. Report of a joint FAO/WHO expert consultation: carbohydrates in human nutrition, in FAO food and nutrition paper Rome, 1998. Systematic Review/Meta-Analysis Bornet FRJ, Jardy-Gennetier A-E, Jacquet N and Stowell J (2007) Glycaemic response to foods: impact on satiety and long-term weight regulation. Appetite: In press Reviews Alfenas RCG, Mattes RD. Influence of glycemic index/load on glycemic response, appetite and food intake in healthy humans. Diabetes Care 2005, 28: 2123-2129. Reviews Augustin LS, Franceschi S, Jenkins DJA, Kendall CWC La Vecchia C. Glycemic index in chronic disease: a review. European Journal of Clinical Nutrition 2002, 56: 1049-1107. Reviews Brand Miller J, Holt S, Pawlak DB, McMillan J (2002). Glycemic Index and Obesity. American Journal of Clinical Nutrition 2002, 76: 281s-285s. Reviews Brouns F, Bjorck I, Frayn K, Gibbs AL, Lang V, Slama G, Wolever TMS. Glycaemic Index Methodology. Nutrition Research Reviews 2005, 18:145-171. Reviews Roberts SB. High-glycemic index foods, hunger, and obesity: is there a connection? Nutrition Reviews 2000, 58:163-169. Reviews Eekmekcioglu C. Glycemic Index - A novel opportunity in the dietetic therapy of metabolic diseases? Ernaehrung / Nutrition 2002, 26: 349-356. 138 Page 1,137 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Ludwig DS, Majzoub JA, Al-Zahrani A, et al. High Glycemic Index Foods, Overeating, and Obesity. Pediatrics 1999, 103: e26. Reviews Ludwig DS. Dietary Glycemic Index and Obesity. Journal of Nutrition 2000, 130: 280s-283s. Reviews Pawlac DB, Ebbeling CB, Ludwig DS. Should obese patients be counselled to follow a low GI diet? Yes! Obesity Reviews 2002, 3: 235-243. Reviews Perlstein RWJ, Hines C, Milsavljevic M. Dietitians’ Association of Australia, review paper. Australian Journal of Nutrition and Dietetics 1997, 54: 57-63. Reviews Pi-Sunyer FX. Glycemic index and Disease. American Journal of Clinical Nutrition, 2002, 76: 290s-298s. Reviews Raben A. Should obese patients be counselled to follow a low GI Diet? No. Obesity Review, 2002, 3: 245-256. Individual Studies Anderson GH, Catherine NL, Woodend DM, Wolever TM. Inverse association between the effect of carbohydrates on blood glucose and subsequent short-term food intake in young men. Am J Clin Nutr 2002, 76: 1023-2030. Individual Studies Ball SD, Keller KR, Moyer-Mileur LJ, Ding YW, DonaldsonD, Jackson WD. Prolongation of satiety after low versus moderately high glycemic index meals in obese adolescents. Pediatrics 2003, 111: 488-494. Individual Studies Bornet FR, Costagliola D, Rizkalla SW et al. Insulinaemic and glycaemic indexes of six starch-rich foods taken alone and in a mixed meal by type 2 diabetics. Am J Clin Nutr 1987, 45: 588-595. Claim ID Page 1,138 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Jimenez-Cruz A, Gutierrez-Gonzalez AN, Bacardi-Gascon M. Low glycemic index lunch on satiety in overweight and obese people with type 2 diabetes. Nutr Hosp 2005, 20: 348-350. Individual Studies Liljeberg HG. Effect of the glycemic index and content of indigestible carbohydrates of cereal-based breakfast meals on glucose tolerance at lunch in healthy subjects Am J Clin Nutr 1999,69: 647-655. Individual Studies Pasman WJ, Blokdijk VM, Bertina FM, Hopman WP, Hendriks HF. Effect of 2 breakfasts different in carbohydrate composition on hunger, satiety and mood in healthy men. International Journal of Obesity Related Metabolic Disorders 2003, 27: 663-668. Individual Studies Warren JM, Henry CJK, Simonite V. Low GI breakfast and reduced food intake in pre-adolescent children. Pediatrics 2003,112: e414. Claim ID Page 1,139 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Systematic reviews Individual studies References Claim ID Arumugam, V. et al. (2007) A high-glycemic meal pattern elicited increased subjective appetite sensations in overweight and obese women. Appetite. Doi:10.1016/j.appet.2007.07.003. Bell, S.J. & Sears, B. (2003) Low-Glycemic-Load Diets: Impact on Obesity and Chronic Diseases. Critical Reviews in Food Science and Nutrition. 43 (4), pp. 357-377. Campfield, L. C. et al. (1996) Human Eating: Evidence for a Physiological Basis Using a Modified Paradigm. Neuroscience and Biobehavioural Reviews. 20 (1), pp. 133-137. Dewan, S. et al (2004) Effects of insulin-induced hypoglycaemic on energy intake and food choice at a subsequent test meal. Diabetes/Metabolism Research and Reviews. 20, pp. 405-410. 31 January 2008 Page 1,140 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates with a low glycaemic load Impact on blood glucose Glycaemic control Glycaemic response Where low GL is a GL score of less than 10, using the calculation: 1,683 GL = (GI x grams of carbohydrate per serving size)/100 GI is assessed from the incremental area under the blood glucose response curve of a portion of the food/product providing 50g available carbohydrate (minimum 10g) measured over 2 hours and expressed as a percentage of the response to 50g glucose for which GI equals 100). [See FAO/WHO (1998) and Ludwig, (2002)]. 31 January 2008 Page 1,141 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative body Review Individual studies Table of GI & GL values References Claim ID Arumugam, V. et al. (2007) A high-glycemic meal pattern elicited increased subjective appetite sensations in overweight and obese women. Appetite. Doi:10.1016/j.appet.2007.07.003. Brand-Miller, J.C. et al. (2003) Physiological Validation of the Concept of Glycemic Load in Lean Young Adults. Journal of Nutrition. 133, pp. 2695-2696. FAO/WHO Expert Consultation (1998) Carbohydrates in human nutrition: report of a joint FAO/WHO Expert Consultation, Rome, 14-18 April 1997. FAO Food and Nutrition Paper 66, reprinted 1998. Foster-Powell, K., Holt, S.H.A. & Brand-Miller, J.C. (2002) International table of glycemic index and glycemic load values: 2002. American Journal of Clinical Nutrition. 76, pp. 5-56. Galgani, J., Aguirre, C. & Díaz, E. (2006) Acute effect of meal glycemic index and glycemic load on blood glucose and insulin responses in humans. Nutrition Journal. 5 (22). Ludwig, D.S. (2002) The Glycaemic Index. Physiological Mechanisms Relating to Obesity, Diabetes and Cardiovascular Disease. Journal of the American Medical Association. 287 (18), pp. 2414-2423. McMillan-Price, J. et al (2006) Comparison of 4 Diets of Varying Glycemic Load on Weight Loss and Cardiovascular Risk Reduction in Overweight and Obese Young Adults: A Randomized Controlled Trial. Archives of Internal Medicine. 166, pp. 1466-1475. 31 January 2008 Page 1,142 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Wolever, T.M.S. & Bolognesi, C. (1996) Source and Amount of Carbohydrate Affect Postprandial Glucose and Insulin in Normal Subjects. Journal of Nutrition. 126, pp. 2798-2806. Satiety Where low GL is a GL score of less than 10, using the calculation: GL = (GI x grams of carbohydrate per serving size)/100 GI is assessed from the incremental area under the blood glucose response curve of a portion of the food/product providing 50g available carbohydrate (minimum 10g) measured over 2 hours and expressed as a percentage of the response to 50g glucose for which GI equals 100). [See FAO/WHO (1998) and Ludwig, (2002)]. Maintenance of a healthy weight Where low GL is a GL score of less than 10, using the calculation: Systematic reviews Individual studies Arumugam, V. et al. (2007) A high-glycemic meal pattern elicited increased subjective appetite sensations in overweight and obese women. Appetite. Doi:10.1016/j.appet.2007.07.003. 1,686 Bell, S.J. & Sears, B. (2003) Low-Glycemic-Load Diets: Impact on Obesity and Chronic Diseases. Critical Reviews in Food Science and Nutrition. 43 (4), pp. 357-377. Bornet, F.R.J. et al. (2007) Glycaemic response to foods: Impact on satiety and long-term weight regulation. Appetite. Doi:10.1016/j.appet.2007.04.006. Campfield, L. C. et al. (1996) Human Eating: Evidence for a Physiological Basis Using a Modified Paradigm. Neuroscience and Biobehavioural Reviews. 20 (1), pp. 133-137. Dewan, S. et al (2004) Effects of insulin-induced hypoglycaemic on energy intake and food choice at a subsequent test meal. Diabetes/Metabolism Research and Reviews. 20, pp. 405-410. 1,131 GL = (GI x grams of carbohydrate per serving size)/100 31 January 2008 Page 1,143 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative body GI is assessed from the incremental area under the blood glucose response curve of a portion of the food/product providing 50g available carbohydrate (minimum 10g) measured over 2 hours and expressed as a percentage of the response to 50g glucose for which GI equals 100). [See FAO/WHO (1998) and Ludwig, (2002)]. Cochrane Review Individual studies Review References Claim ID Bornet, F.R.J. et al. (2007) Glycaemic response to foods: Impact on satiety and long-term weight regulation. Appetite. Doi:10.1016/j.appet.2007.04.006. Ebbeling, C.B. et al. (2003) A Reduced-Glycemic Load Diet in the Treatment of Adolescent Obesity. Archives of Pediatrics & Adolescent Medicine. 157, pp.773-779. McMillan-Price, J. et al (2006) Comparison of 4 Diets of Varying Glycemic Load on Weight Loss and Cardiovascular Risk Reduction in Overweight and Obese Young Adults: A Randomized Controlled Trial. Archives of Internal Medicine. 166, pp. 1466-1475. Nielsen, B.M. et al. (2005) dietary glycaemic index and glycaemic load in Danish children in relation to body fatness. British Journal of Nutrition. 94, pp. 992-997. Rigby, N. & James, P. (2003) The obesity campaign view of diabetes prevention. Diabetes Voice. 48, pp. 20-23. Thomas, D.E., Elliott, E.J. & Baur, L. (2007) Low glycaemic index or low glycaemic load diets for overweight and obesity (Review). The Cochrane Library. Issue 3. World Health Organisation (2006) What are overweight and obesity? WHO (Fact sheet N°311). Maintenance of a healthy weight Where low GL is a GL score of less than 10, using the calculation: 1,685 GL = (GI x grams of carbohydrate per serving size)/100 GI is assessed from the incremental area under 31 January 2008 Page 1,144 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use the blood glucose response curve of a portion of the food/product providing 50g available carbohydrate (minimum 10g) measured over 2 hours and expressed as a percentage of the response to 50g glucose for which GI equals 100). [See FAO/WHO (1998) and Ludwig, (2002)]. Nature of Evidence Authoritative body Cochrane Review References Claim ID Bornet, F.R.J. et al. (2007) Glycaemic response to foods: Impact on satiety and long-term weight regulation. Appetite. Doi:10.1016/j.appet.2007.04.006. Individual studies Review Ebbeling, C.B. et al. (2003) A Reduced-Glycemic Load Diet in the Treatment of Adolescent Obesity. Archives of Pediatrics & Adolescent Medicine. 157, pp.773-779. McMillan-Price, J. et al (2006) Comparison of 4 Diets of Varying Glycemic Load on Weight Loss and Cardiovascular Risk Reduction in Overweight and Obese Young Adults: A Randomized Controlled Trial. Archives of Internal Medicine. 166, pp. 1466-1475. Nielsen, B.M. et al. (2005) dietary glycaemic index and glycaemic load in Danish children in relation to body fatness. British Journal of Nutrition. 94, pp. 992-997. Rigby, N. & James, P. (2003) The obesity campaign view of diabetes prevention. Diabetes Voice. 48, pp. 20-23. Thomas, D.E., Elliott, E.J. & Baur, L. (2007) Low glycaemic index or low glycaemic load diets for overweight and obesity (Review). The Cochrane Library. Issue 3. World Health Organisation (2006) What are overweight and obesity? WHO (Fact sheet N°311). Serum cholesterol levels Where low GL is a GL score of less than 10, using the calculation: 1,684 GL = (GI x grams of 31 January 2008 Page 1,145 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use carbohydrate per serving size)/100 GI is assessed from the incremental area under the blood glucose response curve of a portion of the food/product providing 50g available carbohydrate (minimum 10g) measured over 2 hours and expressed as a percentage of the response to 50g glucose for which GI equals 100). [See FAO/WHO (1998) and Ludwig, (2002)]. Nature of Evidence Authoritative body Cochrane Review References Claim ID Amano, Y. et al. (2004) Correlation between dietary glycemic index and cardiovascular disease risk factors among Japanese women. European Journal of Clinical Nutrition. 58, pp.1472-1478. Individual studies Beulens, J.W.J. et al. (2007) High Dietary Glycemic Load and Glycemic Index Risk of Cardiovascular Disease Among Middle-Aged Women: A Population-Based Follow-Up Study. Journal of the American College of Cardiology. 50 (1), pp.14-21. Ebbeling, C.B. et al. (2005) Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults. American Journal of Clinical Nutrition. 71, pp. 976-982. Feher, M.D. & Elkeles, R.S. (1999) Lipid modification and coronary heart disease in type 2 diabetes: different from the general population? Heart. 81, pp. 10-11. Ford, E.S. & Liu, S. (2001) Glycemic Index and Serum High-Density Lipoprotein Cholesterol Concentration Among US Adults. Archives of Internal Medicine. 166, pp. 572-576. Lawes, C.M.M. et al. (2004) High Cholesterol. In Ezzati, M. et al. eds. Comparative Qualification of Health Risks: Global and Regional Burden of Disease Attributable to Selected Major Risk Factors, Volume 1. Geneva, WHO. Liu, S. et al. (2000) A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. American Journal of Clinical Nutrition. 71, 31 January 2008 Page 1,146 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID pp.1455-1461. Liu, S. et al (2001) Dietary glycemic load assessed by food-frequency questionnaire in relation to plasma high-density-lipoprotein cholesterol and fasting plasma triacylglycerols in postmenopausal women. American Journal of Clinical Nutrition. 73, pp. 560-566. McMillan-Price, J. et al (2006) Comparison of 4 Diets of Varying Glycemic Load on Weight Loss and Cardiovascular Risk Reduction in Overweight and Obese Young Adults: A Randomized Controlled Trial. Archives of Internal Medicine. 166, pp. 1466-1475. Thomas, D.E., Elliott, E.J. & Baur, L. (2007) Low glycaemic index or low glycaemic load diets for overweight and obesity (Review). The Cochrane Library. Issue 3. 31 January 2008 Page 1,147 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates with a low glycaemic response Low impact on blood glucose / Low glycemic repsonse / Improved blood glucose control 31 January 2008 The glycemic response is not more than half that of glucose, without increasing the fat content, assessed from blood glucose response curves (e.g. test food vs glucose) either based on a portion of the food providing 50g (minimum 10g) of total carbohydrates and dietary fibre (thus taking into account available carbohydrates and their replacements, e.g. polyols and dietary fibre) or based on the amount of carbohydrates in one serving of the food vs the equivalent amount of glucose. Authoritative/Scientific Bodies WHO/FAO. Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series 916, Geneva, 2003, pg 76. Authoritative/Scientific Bodies FAO/WHO 1998 Carbohydrates in Human Nutrition, FAO Food and Nutrition Paper No. 66, Report of a Joint FAO/WHO Expert Consultation Rome, 14-18 April 1997. Meta-Analysis Anderson J, Randles K, Kendall C, Jenkins D (2004) Carbohydrate and fiber recommendations for individuals with diabetes: A quantitative assessment and meta-analysis of the evidence. Journal of the American College of Nutrition 23, 5-17. Meta-Analysis Brand Miller J (2003) Low-glycemic index diets in the management of diabetes. A meta-analysis of randomised control trials. Diabetes Care 26, 2261-2267. Meta-Analysis Livesey G (2005) Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 1-9. Meta-Analysis Opperman A, Venter C, Oosthuizen W, Thompson R, Vorster H (2004) Meta-analysis of the health effects of using the glycaemic index in meal planning. British Journal of Nutrition, 92, 367-381 Meta-Analysis Wolever TMS (2003) Carbohydrate and the Regulation of Blood Glucose and Metabolism. Nutrition Reviews. 61, S40-S48. Reviews Augustin LS, Franceschi S, Jenkins DJA, Kendall CWC, La Vecchia C (2002) Glycemic index in chronic disease: a review. European Journal of Clinical Nutrition 56, 1049-1107. 139 Page 1,148 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Bjorck I, Liljeberg H, Ostman E (2000) Low glycaemic-index foods. British Journal of Nutrition 83, Suppl. 1, 149-155. Reviews Brand-Miller J (2003) Glycemic load and chronic disease. Nutrition Reviews 61, 49-55. Reviews Jenkins DJA, Kendall CWC, Augustin LSA, Francheschi S, Hamidi M, Marchie A, Jenkins AL, Axelsen M (2002) Glycemic index: an overview of implications in health and disease. American Journal of Clinical Nutrition (suppl), 266S-273S. Reviews Leeds A (2002) Glycemic index and heart disease. American Journal of Clinical Nutrition 76 (suppl.)286S-289S. Reviews Liu S (2002) Intake of refined carbohydrates and whole grain foods in relation to risk of type 2 diabetes mellitus and coronary heart disease. Journal of the American College of Nutrition 21, 298-306. Reviews Liu S, Willet WC (2002) Dietary glycemic load and atherothrombotic risk. Curr. Atheroscler. Rep. 4(6), 454-461. Reviews Livesey G (2003) Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutrition Research Reviews 16, 163-191. Reviews Livesey G (2006) Glycemic control with unavailable carbohydrates including polyols. Foods Food Ingredients J Jpn 211, 445-455 Reviews Livesey G (2005) Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 1-9. Claim ID Page 1,149 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Ludwig DS (2002) The glycemic index physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA 287, 2414-2423. Reviews Ludwig DS (2003) Dietary glycemic index and the regulations of body weight. Lipids 38, 117-121. Reviews Monro J (2005) Expressing the glycaemic potency of foods. Proceedings of the Nutrition Society 64, 115-122. Reviews Riccardi G, Aggett P, Brighenti F, Delzenne N, Frayn K, Nieuwenhuizen A, Pannemans D, Theis S, Truijtelaars S, Vessby B (2004) PASSCLAIM Body weight regulation, insulin sensitivity and diabetes risk. European Journal of Nutrition, Suppl. 2 43 II/7-II/46. Reviews Willett W, Manson J, Liu S (2002) Glycemic index, glycemic load, and risk of type 2 diabetes. American Journal of Clinical Nutrition (suppl), 274S-280S. Reviews Wolever TMS (2000) Dietary carbohydrates and insulin action in humans. British Journal of Nutrition 83, Suppl.1, S97-S102. Reviews Wolever TMS (2003) Carbohydrate and the Regulation of Blood Glucose and Metabolism. Nutrition Reviews 61, S40-S48. Individual Studies Gostner A, Schaffer V, Theis S, Menzel T, Luhrs H, Melcher R, Schauber J, Kudlich T, Dusel G, Dorbath D, Kozianowski G, Scheppach W (2005) Effects of isomalt consumption on gastrointestinal and metabolic parameters in healthy volunteers. British Journal of Nutrition 94, 575-581. Claim ID Page 1,150 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrates with a reduced glycaemic response Lower impact on blood glucose/ lower glycemic response; improved blood glucose control 31 January 2008 The glycemic response is at least 30% reduced compared to a regular food, without increasing the fat content. Assessed from blood glucose response curve (e.g. test food vs traditional food) Authoritative/Scientific Bodies WHO/FAO. Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series 916, Geneva, 2003, pg 76. Authoritative/Scientific Bodies FAO/WHO 1998 Carbohydrates in Human Nutrition, FAO Food and Nutrition Paper No. 66, Report of a Joint FAO/WHO Expert Consultation Rome, 14-18 April 1997. Meta-Analysis Brand Miller J (2003) Low-glycemic index diets in the management of diabetes. A meta-analysis of randomised control trials. Diabetes Care 26, 2261-2267. Meta-Analysis Opperman A, Venter C, Oosthuizen W, Thompson R, Vorster H (2004) Meta-analysis of the health effects of using the glycaemic index in meal planning. Br J Nutr, 92, 367-381 Meta-Analysis Wolever TMS (2003) Carbohydrate and the regulation of blood glucose and metabolism. Nutrition Reviews 61, S40-S48. Reviews Augustin LS, Franceschi S, Jenkins DJA, Kendall CWC, La Vecchia C (2002) Glycemic index in chronic disease: a review. European Journal of Clinical Nutrition 56, 1049-1107. Reviews Brand-Miller J (2003) Glycemic load and chronic disease. Nutrition Reviews 61, 49-55. Reviews Jenkins DJA, Kendall CWC, Augustin LSA, Francheschi S, Hamidi M, Marchie A, Jenkins AL, Axelsen M (2002) Glycemic index: an overview of implications in health and disease. American Journal of Clinical Nutrition (suppl), 266S-273S. 140 Page 1,151 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Livesey G (2006) Glycemic control with unavailable carbohydrates including polyols. Foods Food Ingredients J Jpn 211 (5), 445-455. Reviews Livesey G (2003) Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutrition Research Reviews 16, 163-191. Reviews Ludwig DS (2002) The glycemic index physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA 287, 2414-2423. Reviews Wolever TMS (2000) Dietary carbohydrates and insulin action in humans. British Journal of Nutrition 83, Suppl. 1, S97-S102. Reviews Wolever TMS (2003) Carbohydrate and the regulation of blood glucose and metabolism. Nutrition Reviews 61, S40-S48. Meta-Analysis Anderson J, Randles K, Kendall C, Jenkins D (2004) Carbohydrate and fiber recommendations for individuals with diabetes: A quantitative assessment and meta-analysis of the evidence. Journal of the American College of Nutrition 23, 5-17. Meta-Analysis Livesey G (2005) Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 1-9. Reviews Bjorck I, Liljeberg H, Ostman E (2000) Low glycaemic-index foods. British Journal of Nutrition 83, Suppl. 1, 149-155. Reviews Leeds A (2002) Glycemic index and heart disease. American Journal of Clinical Nutrition 76 (suppl.)286S-289S. Claim ID Page 1,152 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Liu S (2002) Intake of refined carbohydrates and whole grain foods in relation to risk of type 2 diabetes mellitus and coronary heart disease. Journal of the American College of Nutrition 21, 298-306. Reviews Liu S, Willet WC (2002) Dietary glycemic load and atherothrombotic risk. Curr. Atheroscler. Rep. 4(6), 454-461. Reviews Livesey G (2005) Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 1-9. Reviews Ludwig DS (2003) Dietary glycemic index and the regulations of body weight. Lipids 38, 117-121. Reviews Monro J (2005) Expressing the glycaemic potency of foods. Proceedings of the Nutrition Society 64, 115-122. Reviews Riccardi G, Aggett P, Brighenti F, Delzenne N, Frayn K, Nieuwenhuizen A, Pannemans D, Theis S, Truijtelaars S, Vessby B (2004) PASSCLAIM Body weight regulation, insulin sensitivity and diabetes risk. European Journal of Nutrition, Suppl. 2 43 II/7-II/46. Reviews Willett W, Manson J, Liu S (2002) Glycemic index, glycemic load, and risk of type 2 diabetes. American Journal of Clinical Nutrition (suppl), 274S-280S. Individual Studies Gostner A, Schaffer V, Theis S, Menzel T, Luhrs H, Melcher R, Schauber J, Kudlich T, Dusel G, Dorbath D, Kozianowski G, Scheppach W (2005) Effects of isomalt consumption on gastrointestinal and metabolic parameters in healthy volunteers. British Journal of Nutrition 94, 575-581. Claim ID Page 1,153 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Complex carbohydrates Slow release energy 31 January 2008 Textbook Garrow-James-Ralph Human Nutrition and Dietetics. 10th edition, 2000 1,587 Page 1,154 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Glucose and fructose ENDURANCE Enhanced carbohydrate delivery to muscle 31 January 2008 Claim to be only used for Foods for sportpeople under the Dir. 89/398/EEC. Carbohydrates: = 65% of total energy (for foods). Carbohydrates: = 75% of total energy (for beverages). Carbohydrate ratio of glucose to fructose of 2:1. 1,622 Page 1,155 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT References Claim ID Exogenous carbohydrate oxidation rates are elevated after combined ingestion of glucose and fructose during exercise in the heat. Jentjens RLPG, Underwood K, Achten J, Currell K, Mann CH, Jeukendrup AE. J Appl Physiol 100: 807–816, 2006. Oxidation of combined ingestion of glucose and fructose during exercise. Jentjens RL, Moseley L, Waring RH, Harding LK, Jeukendrup AE. J Appl Physiol 96: 1277–1284, 2004. Oxidation of combined ingestion of maltodextrins and fructose during exercise. Wallis GA, Rowlands DS, Shaw C, Jentjens RL, Jeukendrup AE. Med. Sci. Sports Exerc., 37(3): 426–432, 2005. Exogenous carbohydrate oxidation during ultraendurance exercise. Jeukendrup AE, Moseley L, Mainwaring GI, Samuels S, Perry S, Mann CH. J Appl Physiol 100: 1134–1141, 2006. Oxidation of combined ingestion of glucose and sucrose during exercise Jentjens RLPG, Shaw C, Birtles T, Waring RH, Harding RM, Jeukendrup AE Metabolism 54: 610-618 2005. High rates of exogenous carbohydrate oxidation rates from a mixture of glucose and fructose ingested during prolonged cycling exercise Jentjens RLPG, Jeukendrup AE British Journal of Nutrition 93(4): 485-492, 2005. 31 January 2008 Page 1,156 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID High oxidation rates from combined carbohydrates ingested during exercise Jentjens RLPG, Achten J, Jeukendrup AE Med. Sci. Sports Exercise 36(9): 1551-1558, 2004. Oxidation of exogenous glucose, sucrose and maltose during prolonged cycling exercise Jentjens RLPG, Venables MC, Jeukendrup AE J Applied Physiol. 96(4): 1285- 1291, 2004. Respective oxidation of exogenous glucose and fructose given in the same drink during exercise Adopo E, Peronnet F, Massicotte D, Brisson GR, Hillaire-Marcel C J Appl Physiol 76(3):1014-1019 1994. Better/Faster fluid delivery with a combination of carbohydrates than with glucose alone Claim to be only used for Foods for sportpeople under the Dir. 89/398/EEC. Carbohydrates: = 65% of total energy (for foods). Carbohydrates: = 75% of total energy (for beverages). Carbohydrate ratio of glucose to fructose of 2:1. RCT Exogenous carbohydrate oxidation rates are elevated following combined ingestion of glucose and fructose during exercise in the heat Jentjens RLPG, Currell K, Achten J, Mann CH, Jeukendrup AE. J Appl Physiol 100: 807-816, 2006. 1,623 Effect of beverage osmolality on intestinal fluid absorption during exercise Gisolfi CV, Summers RW, Lambert GP, Xia T J Appl Physiol 85(5): 1941-1948, 1998. Effects of carbohydrate type and concentration and solution osmolality on water absorption Shi X, Summers RW, Schedl HP, Flanagan SW, Chang R, Gisolfi CV. Med Sci Sports Exerc. 27(12):1607-1615, 1995. 31 January 2008 Page 1,157 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Isomaltulose (or trademark Palatinose) Reduced speed of digestion and absorption results in lower glycemic response Authoritative/Scientific Bodies German Federal Institute for Risk Assessment (BfR): Initial assessment report on the application made by Sudzucker AG to place on the market the novel food ingredient isomaltulose (Palatinose(TM)) in accordance with Article 6 of Regulation (EC) No 258/97. 24 September 2004. 145 EU Commission 2005 Novel Food Petition evaluation including physiological properties in the initial safety report and in the Standing Committee on Food 31 January 2008 Reviews Irwin WE, Strater PJ (2001) Isomaltulose. In: Handbook of Sweeteners (ed. L. O’Brien Nabors), 3rd ed., Marcel Dekker, New York, 413-421. Reviews Lina BAR, Jonker D, Kozianwoski G (2002) Isomaltulose (Palatinose®): a review of biological and toxicological studies. Food and Chemical Toxicology 40, 1375-1381. Digestion, absorption, blood glucose measurements Kawai K, Okuda Y, Yamashita K (1985) Changes in blood glucose and insulin after an oral Palatinose administration in normal subjects. Endocrinologia Japonica 32, 933-936. Digestion, absorption, blood glucose measurements Kawai K, Yoshikawa H, Muryama Y, Okuda Y, Yamashita K (1989) Usefulness of Palatinose as a caloric sweetener for diabetic patiens. Hormone and Metabolic Research 21, 338-340 Digestion, absorption, blood glucose measurements Liao ZH, Li YB, Yao B, Fan HD, Hu GL, Weng JP (2001). The effects of isomaltulose on blood glucose and lipids for diabetic subjects. Diabetes 50 Suppl., 1530-P, A366. Page 1,158 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Digestion, absorption, blood glucose measurements Macdonald M, Daniel JW (1983) The bio-availability of isomaltulose in man and rat. Nutrition Reports International 28, 1083-1090. In vitro and animal studies Dahlqvist A (1961) Hydrolysis of palatinose (isomaltulose) by pig intestinal glycosidases. Acta Chemica Scandinavica 15, 808-816. In vitro and animal studies Grupp U, Siebert G (1978) Metabolism of hydrogenated palatinose, an equimolar mixture of alpha-Dglucopyranosido- 1,6-sorbitol and alpha-D-glucopyranosido-1,6-mannitol. Research in Experimental Medicine (Berl.) 173, 261-278. In vitro and animal studies Tsuji Y, Yamada K, Hosoya N, Moriuchi S (1986) Digestion and absorption of sugars and sugar substitutes in rat small intestine. J Nutr Sci Vitaminol 32, 93-100. In vitro and animal studies Yamada K, Shinohara H, Hosoya N (1985) Hydrolysis of 1-0-alpha-D-glucopyranosyl-D-fructofuranose (Trehalulose) by rat intestinal sucrase-isomaltase complex. Nutr Rep Int 32, 1211-1220. Claim ID Page 1,159 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Respiratory quotient 31 January 2008 References Claim ID König, Luther, Polland, Theis, Kozianowski, Berg (2007) Metabolic effects of low-glycemic Palatinose™ during long-lasting endurance exercise. Ann Nutr Metab 51 (supp 1), 69. Achten J, Jentjens RL, Brouns F, Jeukendrup AE (2007) Exogenous oxidation of isomaltulose is lower than that of sucrose during exercise in men. J Nutr 137, 1143-1148. Arai, Mizuno, Sakuma, Fukaya, Matsuo, Muto, Sasaki, Matsuura, Okumara, Yamamoto, Taketani, Doi, Takeda (2007) Effects of a palatinose-based liquid diet (Inslow) on glycemic control and the second-meal effect in healthy men. Metabolism Clinical and Experimental 56, 115-121. Suzuki, Tsuyuki, Taihichi, Watanabe, Mizutani (2000) Method for continuing oxidative metabolism accompanying to exercise and food and drink for sport. Patent Publication JP2000300212 Page 1,160 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Lactose Calcium absorption 31 January 2008 -lactose supports calcium absorption. Reviews Allen HL. Calcium bioavailability and absorption: a review. The American Journal of Clinical Nutrition 1982;35:783-808 Reviews Camara-Martos F, Amaro-Lopez MA. Influence of dietary factors on calcium bioavailability: a brief review. Biol Trace Elem Res. 2002;89:43-52. Reviews Gueguen L, Pointillart A. The bioavailability of dietary calcium. J Am Coll Nutr. 2000;19:119S-136S. Reviews Schaafsma G. Bioavailability of calcium and magnesium. Eur J Clin Nutr. 1997 Jan;51 Suppl 1:S13-6. Individual Studies Lee D.B.N, Hu, M-S. , Kayne, L.H. , Nakhoul, F. and Jamgotchian, N. (1991) , The importance of non-vitamin D-mediated calcium absorption. Contributions to Nephrology 91, 14-20. Individual Studies Pansu D., Chapuy MC. Calcium Absorption Enhanced by Lactose and Xylose. Calcified tissue research 1970;4:155-156 Individual Studies Schuette SA, Yasillo NJ, Thompson CM. The effect of carbohydrates in milk on the absorption of calcium by postmenopausal women. J Am Coll Nutr. 1991;10:132-9. Individual Studies Wood RJ, Hanssen DA. Effect of milk and lactose on zinc absorption in lactose-intolerant postmenopausal women. J Nutr. 1988;118:982-6. Individual Studies Zadow JG. Lactose utilisation. Food Research Quarterly, 1991;51:99-106 146 Page 1,161 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Zitterman A, Bock P, Drummer C, Scheld K, Heer M, Stehle P. Lactose does not enhance calcium bioavailability in lactose-tolerant healthy adults. Am J Clin Nutr 2000;71:931-6. Individual Studies on Infants Abrams SA, Griffin IJ, Davila PM. Calcium and zinc absorption from lactose-containing and lactose-free infant formulas. Am J Clin Nutr. 2002 Aug;76(2):442-6. Individual Studies on Infants Kobayashi A, Kawai S, Ohbe Y, Nagashima Y. Effects of dietary lactose and a lactase preparation on the intestinal absorption of calcium and magnesium in normal infants. Am J Clin Nutr 1975;28:681-3. Individual Studies on Infants Moya M, Cortes E, Ballester MI, Vento M, Juste M. Short-term polycose substitution for lactose reduces calcium absorption in healthy term babies. J Pediatr Gastroenterol Nutr 1992;14:57-61. Individual Studies on Infants Moya M, Lifschitz C, Ameen V, Euler AR. A metabolic balance study in term infants fed lactose-containing or lactose-free formula. Acta Paediatr 1999;88:1211-5. Individual Studies on Infants Vento M, Moya M. Lactose hydrolysis and calcium absorption in premature feeding. J Pediatr. 2003;142:737-8. Individual Studies on Infants Wirth FH Jr, Numerof B, Pleban P, Neylan MJ. Effect of lactose on mineral absorption in preterm infants. J Pediatr. 1990;117:283-7. Individual Studies on Infants Ziegler EE, Fomon SJ. Lactose enhances mineral absorption in infancy. J Pediatr Gastroenterol Nutr 1983;2:288-94. Individual Studies on Infants Ziegler EE. Fomon SJ. Methods in infant nutrition research: Balance and growth studies. Acta Paediatr Scan Suppl 1982;299:90 Claim ID Page 1,162 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies on Animals Schaafsma G. , Visser W.J. , Dekker P.R. and van Schaik M. (1988), Effect of dietary calcium supplementation with lactose on bone in vitamin D-deficient rats. Bone 8, 357-362. Individual Studies on Animals Sogabe N, Mizoi L, Asahi K, Ezawa I, Goseki-Sone M. Enhancement by lactose of intestinal alkaline phosphatase expression in rats. Bone. 2004;35:249-55. Textbook Sharp P (2000) Minerals and Trace Elements In: Human Nutrition Eleventh Edition [Geissler C & Powers H, editors] Elsevier Churchill Livingstone, London. Claim ID Strain JJ & Cashman KD (2002) Minerals and Trace Elements In: Introduction to Human Nutrition The Nutrition Society Textbook Series [Gibney MJ, Vorster HH & Kok FJ, editors] Blackwell Publishing, London. Lactose naturally present in dairy products Dental health Lactose the only carbohydrate present in a product, lactose level max. 5 g/100 g Scientific review Scientific investigation Moynihan P. Food and factors that protects against dental caries Nutrition Bulletin 2000 (BNF) 25:281-286 744 Levine RS. Mlik, flavoured milk products and caries. Br. Dent J 2001 Jul 1;191(1):20 Nyvad B The effect of sweetened milk on the pH responce of Dental Plaque Caries Res 29: 321 Thomson ME, Dever JG, Pearce EI Intra-oral testing of flavoured sweetened milk. N Z Dent J 1984 Apr;80(360):44-6 31 January 2008 Page 1,163 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Polydextrose Dental health 31 January 2008 According to US 21CFR §101.80: the food shall not lower plaque pH below 5,7 by bacterial fermentation during consumption and up to 30 min after consumption, as determined by plaque pH telemetry, and other comparable methods. Authoritative Body General Individual Studies Authoritative body Food and Drugs Administration (FDA), Code of Food Regulations 21 CFR Part 101 granting eligibility for oral health claims, after pH telemetry test. 816 Individual studies Kruger, C. (2002) Tooth friendly sweets. Baking and Sweets International 4:26-29 Page 1,164 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Polyols Low glycemic properties 31 January 2008 Authoritative/Scientific Bodies EU Directive 94/35/EC (Sweeteners, Preamble) Authoritative/Scientific Bodies The glycemic properties of polyols were evaluated in several EU Member States (e.g. German DiatV §12) in the 1980th and 1990th in connection with their suitability as sweeteners in foodstuffs for diabetics. Reviews Foster-Powell K, Holt S, Brand.Miller J (2002) International table of GI/GL values 2002. American Journal of Clinical Nutrition 76, 5-56. Reviews Livesey, G. (2003) Health potential of polyols as sugar replacers, with emphasis on low glycaemic properties. Nutrition Research Reviews 16, 163-191. Reviews Livesey, G. (2005) Low glycemic diets and health: implications for obesity. Proceedings of the Nutrition Society 64, 1-9. Individual Studies (example isomalt) Blood glucose measurements Gee JM, Cooke D, Gorick S, Wortley GM, Greenwood RH, Zumbe A, Johnson IT (1991) Effects of conventional sucrose-based, fructose-based and isomalt-based chocolates on postprandial metabolism in non-insulin-dependent diabetics. European Journal of Clinical Nutrition 45, 561-566. Individual Studies (example isomalt) Blood glucose measurements Thiebaud D, Jacot E, Schmitz H, Spengler M, Felber JP (1984) Comparative study of isomalt and sucrose by means of continuous indirect calorimetry. Metabolism 33, 808 - 813. 148 Page 1,165 of 3,931 Category Food Component Health Relationship Remineralisation of teeth 31 January 2008 Suggested Conditions of Use Nature of Evidence References Individual Studies (example isomalt) Human intervention studies (long-term benefits) Gostner A, Schaffer V, Theis S, Menzel T, Luhrs H, Melcher R, Schauber J, Kudlich T, Dusel G, Dorbath D, Kozianowski G, Scheppach W (2005) Effects of isomalt consumption on gastrointestinal and metabolic parameters in healthy volunteers. British Journal of Nutrition 94, 575-581. Individual Studies (example isomalt) Human intervention studies (long-term benefits) Pometta D, Trabichet C, Spengler M (1985) Effects of a 12-week administration of isomalt on metabolic control in type-II-diabetics. Aktuelle Ernahrungsmedizin 10, 174-177. Authoritative Bodies WHO/FAO (2003) Diet, Nutrition and the Prevention of Chronic Diseases. Report of a Joint WHO/FAO Expert Consultation. WHO Technical report Series 916. WHO, Geneva. Reviews Birkhead D (1994) Cariologic aspects of xylitol and its use in chewing gum - a review. Acta Odontol Scand 52, 116-127. Reviews Edgar WM (1990) Saliva and dental health Clinical implications of saliva: Report of a consensus meeting. Br Dent J 25, 96-89. Reviews Edgar WM (1998) Sugar substitutes, chewing gum and dental caries - a review. Br Dent J 10, 184 (1) 29- 32. Reviews Featherstone JDB (2000) The science and practice of caries prevention. Journal of the American Dental Association 131, 887-899. Reviews Imfeld TN (1994) Clinical caries studies with polyalcohols - a literature review. Schweiz Monatsschr. Zahnmed 104 (8) 941-945. Reviews Imfeld TN (1999) Chewing gum - facts and fiction: a review of gum-chewing and oral health. Crit Rev Oral Biol Med 10 (3) 405-419. Claim ID 147 Page 1,166 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Itthagarun A (1997) Chewing gum and saliva in oral health. J Clin Dent 8 (6) 159-162. Reviews Kandelman D (1997) Sugar, alternative sweeteners and meal frequency in relation to caries prevention - new perspectives. Br J Nutr 77 Suppl 1, S121-S128. Reviews Leach SA (1987) Sugar substitutes and remineralization. Dtsch. Zahnartzl. Z. 42, S135-S138. Reviews Lingstrom P, Moynihan P (2003) Nutrition, saliva and oral health. Nutrition 19 (6), 567-569. Reviews Rigmont Barber L, Wilkins EM (2002) Evidence-based prevention, management and monitoring of dental caries. J Dent Hygiene 76, 270-275. Reviews Van Loveren C (2004) Sugar alcohols - what is the evidence for caries-preventive and caries-therapeutic effects? Caries Research 38, 286-293. Individual Studies Dawes C, Macpherson LMD (1992) Effects of nine different chewing-gums and lozenges on salivary flow rate and pH. Caries Res 26, 176-182. Individual Studies Takatsuka T (2000) Influence of Palatinit (isomalt) and xylitol on demineralisation / remineralisation on bovine enamel. Cariology Today 1, 27-40. Individual Studies Takatsuka T (2002) Enamel remineralisation by isomalt toothpaste in situ. J Dent Res 81 (spec iss) ( Seq No 259, Presentation 2815). Claim ID Page 1,167 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Resistant starch- type 2 (RS) from high amylose maize Digestive health benefits 31 January 2008 Each serving of a RS fortified food should provide at least 3g RS. The food must be eaten as part of healthy lifestyle and diet. 2,394 Page 1,168 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Systematic review and meta-analysis of 12 peer reviewed papers (containing 21 clinical outcomes). Assessment of evidence by Passclaim criteria. 31 January 2008 References Claim ID Noakes, M., P. M. Clifton, P. J. Nestel, R. Le Leu, et al. (1996). "Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia." Am J Clin Nutr 64(6): 944-51. Jenkins, D. J., V. Vuksan, C. W. Kendall, P. Wursch, et al. (1998). "Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index." J Am Coll Nutr 17(6): 609-16. Jenkins, D. J., V. Vuksan, A. V. Rao, E. Vidgen, et al. (1999). "Colonic bacterial activity and serum lipid risk factors for cardiovascular disease." Metabolism 48(2): 264-8. Muir, J. G., E. G. Yeow, J. Keogh, C. Pizzey, et al. (2004). "Combining wheat bran with resistant starch has more beneficial effects on fecal indexes than does wheat bran alone." Am J Clin Nutr 79(6): 1020-8. Grubben, M. J., C. C. van den Braak, M. Essenberg, M. Olthof, et al. (2001). "Effect of resistant starch on potential biomarkers for colonic cancer risk in patients with colonic adenomas: a controlled trial." Dig Dis Sci 46(4): 750-6. Behall, K. M., J. C. Howe and R. A. Anderson (2002). "Apparent mineral retention is similar in control and hyperinsulinemic men after consumption of high amylose cornstarch." J Nutr 132(7): 1886-91. Heijnen, M. L., J. M. van Amelsvoort, P. Deurenberg and A. C. Beynen (1996). "Neither raw nor retrograded resistant starch lowers fasting serum cholesterol concentrations in healthy normolipidemic subjects." Am J Clin Nutr 64(3): 312-8. Heijnen, M. L., J. M. van Amelsvoort, P. Deurenberg and A. C. Beynen (1998). "Limited effect of consumption of uncooked (RS2) or Page 1,169 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID retrograded (RS3) resistant starch on putative risk factors for colon cancer in healthy men." Am J Clin Nutr 67(2): 322-31. Silvester, K. R., S. A. Bingham, J. R. Pollock, J. H. Cummings, et al. (1997). "Effect of meat and resistant starch on fecal excretion of apparent N-nitroso compounds and ammonia from the human large bowel." Nutr Cancer 29(1): 13-23. Birkett, A., J. Muir, J. Phillips, G. Jones, et al. (1996). "Resistant starch lowers fecal concentrations of ammonia and phenols in humans." Am J Clin Nutr 63(5): 766-72. Phillips, J., J. G. Muir, A. Birkett, Z. X. Lu, et al. (1995). "Effect of resistant starch on fecal bulk and fermentation-dependent events in humans." Am J Clin Nutr 62(1): 121-30. Hylla, S., A. Gostner, G. Dusel, H. Anger, et al. (1998). "Effects of resistant starch on the colon in healthy volunteers: possible implications for cancer prevention." Am J Clin Nutr 67(1): 136-42. Aggett, P., J.-M. Antoine, N. Asp, F. Bellisle, et al. (2005). "Passclaim: Process for the assessment of scientific support for claims on foods - Consensus on Criteria." Eur J Nutrition 44(supp 1): 1-30. Healthy blood glucose/sugar levels. 31 January 2008 Each serving of a RS fortified food should provide at least 3.4g RS The food must be eaten as part of healthy lifestyle and diet. 2,393 Page 1,170 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence FAO/WHO Expert Report BNF Expert Reviews References Claim ID Authoritative/Scientific Bodies FAO/WHO (1998) Carbohydrates in Human Nutrition, FAO Food and Nutrition Paper No. 66, Report of a Joint FAO/WHO Expert Consultation Rome, 14-18 April 1997 Nugent, A., (2005), Health Properties of Resistant Starch. British Nutrition Foundation Nutrition Bulletin, 30: 27–54 Lunn, J., Buttriss, J. L. (2007) Carbohydrates and Dietary Fibre, British Nutrition Foundation Nutrition Bulletin, 32: 21–64 31 January 2008 Page 1,171 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Systematic review of peer reviewed papers in relation to Hi-maize RS2 and healthy blood glucose/sugar levels Assessment of evidence by Passclaim criteria. References Claim ID Behall, K. M. and J. C. Howe (1995). "Effect of long-term consumption of amylose vs amylopectin starch on metabolic variables in human subjects." Am J Clin Nutr 61(2): 334-340. Behall, K. M. and D. J. Scholfield (2005). "Food amylose content affects postprandial glucose and insulin responses." Cereal Chem 82(6): 654-659. Behall, K. M., D. J. Scholfield and J. Canary (1988). "Effect of starch structure on glucose and insulin responses in adults." Am J Clin Nutr 47(3): 428-432. Behall, K. M., D. J. Scholfield, I. Yuhaniak and J. Canary (1989). " Diets containing high amylose vs amylopectin starch: Effects on metabolic variables in human subjects." Am J Clin Nutr 49(2): 337-344. Behall, K. M. and J. Hallfrisch (2002). "Plasma glucose and insulin reduction after consumption of breads varying in amylose content. ." Eur J Clin Nutr 56(9): 913- 920. Behall, K. M., D. J. Scholfield and J. G. Hallfrisch (2006). "Barley b-glucan reduces plasma glucose and insulin responses compared with resistant starch in men." Nutrition Research 26: 644-650. Behall, K. M., D. J. Scholfield, J. G. Hallfrisch and H. G. Liljeberg-Elmstahl (2006). "Consumption of both resistant starch and beta-glucan improves postprandial plasma glucose and insulin in women." Diabetes Care 29(5): 976-81. 31 January 2008 Page 1,172 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Brighenti, F., L. Benini, D. Del Rio, C. Casiraghi, et al. (2006). "Colonic fermentation of indigestible carbohydrates contributes to the second-meal effect." Am J Clin Nutr 83(4): 817-22. Granfeldt, Y., A. Drews and I. Björck (1995). "Arepas made from high amylose corn flour produce favorably low glucose and insulin responses in healthy humans." J Nutr 125(3): 459-465. Hoebler, C., A. Karinthi, H. Chiron, M. Champ, et al. (1999). "Bioavailability of starch in bread rich in amylose: Metabolic responses in healthy subjects and starch structure." Eur J Clin Nutr 53(5): 360-366. Jenkins, D. J., V. Vuksan, C. W. Kendall, P. Wursch, et al. (1998). "Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index." J Am Coll Nutr 17(6): 609-616. Muir, J., Z. Lu, G. Collier and K. O'Dea (1994). "The Acute Effects of High Resistant Starch Bread (Made from Hi-maize - A High Amylose Maize Starch) on Glucose and Insulin Responses in Non-diabetics." Deakin University, Faculty of Health and Behavioural Sciences, Deakin Institute of Human Nutrition; Victoria, Australia.. Cited in Brown, I.L.; McNaught, K.J.; Andres, D.; Morita, T. 2001. Resistant starch: Plant breedings, applications development and commercial use. In: McCleary, B.V.; Prosky, L. (Eds.). Advanced Dietary Fibre Technology. Blackwell Science Ltd.; Oxford, Engl., pp. 401-412. . Noakes, M., P. M. Clifton, P. J. Nestel, R. Le 31 January 2008 Page 1,173 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Leu, et al. (1996). "Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia." Am J Clin Nutr 64(6): 944-951. Reiser, S., A. S. Powell, D. J. Scholfield, P. Panda, et al. (1989). "Day-long glucose, insulin, and fructose responses of hyperinsulinemic and nonhyperinsulinemic men adapted to diets containing either fructose or high-amylose cornstarch." Am J Clin Nutr 50(5): 1008-1014. Weickert, M. O., M. Mohlig, C. Koebnick, J. J. Holst, et al. (2005). "Impact of cereal fibre on glucose-regulating factors." Diabetologia 48(11): 2343 2353 Aggett, P., J.-M. Antoine, N. Asp, F. Bellisle, et al. (2005). "Passclaim: Process for the assessment of scientific support for claims on foods - Consensus on Criteria." Eur J Nutrition 44(supp 1): 1-30. 31 January 2008 Page 1,174 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Xylitol Plaque reduction 31 January 2008 1-2g/3-5 times/day 817 Page 1,175 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative body Review Human studies Animal studies References Claim ID Authoritative body Scheinin A, Bánóczy J, Szöke J, Esztári I, Pienihäkkinen K, Scheinin U, Tiekso J, Zimmermann P, Hadas E. (1985) Collaborative WHO xylitol field studies in Hungary. I to VII. Acta Odontologica Scandinavica 43(6): 321-387 Food and Drugs Administration (FDA), Code of Food Regulations 21 CFR Part 101 granting eligibility for oral health claims, after pH telemetry test. Review Tanzer J M. (1995) Xylitol chewing gum and dental caries. Int. Dental J. 45:77-92 (Supplement 1) Human studies Aguire-Zero, O., Zero, D., T., Proskin, H., M. (1993) Effect of Chewing Xylitol Chewing Gum on Salivary Flow Rate and the Acidogenic Potential of Dental Plaque. Caries Res. 27:55-59 Cronin, M., Gordon, J., Reardon, R., Balbo, F. (1994) Three clinical trials comparing xylitoland sorbitol-containing chewing gums for their effect on supragingival plaque accumulation?; Journal of Clinical Dentistry (USA), 5/4:106-109 Simons, D., Brailsford, SR., Kidd, EAM., Beighton, D. (2002) The Effect of Medicated Chewing Gums on Oral Health in Frail Older people: A 1- Year Clinical Trail Mäkinen K K, Isokangas P. (1988) Relationship between carbohydrate sweeteners and oral diseases. Prog. Food & Nut. Sci. 12: 73-109 31 January 2008 Page 1,176 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Mäkinen KK, Mäkinen PL, Pape HR, Peldyak J, Hujoel P, Isotupa KP, Soderling E, Isokangas PJ, Allen P, Bennett C. (1996) Conclusion and review of the "Michigan Xylitol Programme" (1986 - 1995) for the prevention of dental caries. Int. Dental J 46:22-34. Mäkinen K K, Mäkinen P-L, Pape HR. (1995) Stabilisation of rampant caries: polyol gums and arrest of dentine caries in two long-term cohort studies in young subjects. Int. Dental J. 45:93-107 (Supplement 1) Simons D., Brailsford S, Kidd EAM., Beighton, D. (2001) The effect of chlorhexidine acetate/Xylitol chewing gum on the plaque and gingival indices of elderly occupants in residential homes. A 1-year clinical trial. J Clin Periodontol 28:1010-1015 Söderling E, Mäkinen KK, Chen CY, Pape HR, Loesche W, Mäkinen PL (1989) Effect of sorbitol, xylitol, and xylitol/sorbitol chewing gums on dental plaque. Caries Res. 23(5): 378-384 Trahan L. (1995) Xylitol: a review of its actions on Streptococci mutans and dental plaque - its clinical significance. Int. Dental J. 45:77-92 (Supplement 1) Animal study Beckers, H., J., A. (1988) Influence of Xylitol on Growth, Establishment, and Cariogenicity of Streptococcus mutans in Dental Plaque of Rats; Caries Res. 22:166-173 Sweetened with xylitol to enhance dental health 31 January 2008 No RDA / RNI 2,414 Page 1,177 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID "Touger-Decker R, van Loveren C. Sugars and dental caries. Am J Clin Nutr. 2003 Oct;78(4):881S-892S. Review. PMID: 14522753 [PubMed - indexed for MEDLINE Honkala S, Honkala E, Tynjälä J, Kannas L. Use of xylitol chewing gum among Finnish schoolchildren. Acta Odontol Scand. 1999 Dec;57(6):306-9. PMID: 10777132 [PubMed - indexed for MEDLINE]" • Gare, Fran (Feb 1, 2003). The Sweet Miracle of Xylitol. Basic Health Publications, Inc.. ISBN 1-59120-038-5. • Tanzer, JM (1995). Xylitol chewing gum and dental caries. International dental journal 45(1 Suppl 1):65-76. (online abstract) • Uhari M, et al. (1998). A novel use of xylitol sugar in preventing acute otitis media. Pediatrics, 102(4): 879–974. • Abu-Elteen, Khaled H. The influence of dietary carbohydrates on in vitro adherence of four Candida species to human buccal epithelial cells. Microbial Ecology in Health and Disease (2005), 17(3), 156-162 Tooth remineralisation 31 January 2008 1-2g/3-5 times/day 818 Page 1,178 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews Human studies Animal studies References Claim ID Authoritative body Food and Drugs Administration (FDA), Code of Food Regulations 21 CFR Part 101 granting eligibility for oral health claims, after pH telemetry test. Reviews Edgar W., M. (1998) Sugar substitutes, chewing gum and dental caries - A review; British Dental J. 184:29-32 Tanzer J M. (1995) Xylitol chewing gum and dental caries. Int. Dental J. 45: 77-92 (Supplement 1) Human studies Gafar A., Blake-Haskins, JC., Sullivan R., Simone A., Schmidt R., Saunders F. (1998) Cariostatic effects of a xylitol/NaF dentifrice in vivo; Int. Dental J. 48:32-39 Mäkinen, K., K., Chiego, D., J., Jr. (1998) Physical chemical and histoloic changes in dentin caries lesions of primary teeth induced by regular use of polyol chewing gums. Acta Odontol Scand. 56:148-156 Mäkinen K K, Mäkinen P-L, Pape H R. (1993) Stabilisation of rampant caries: polyol gums and arrest of dentine caries in two long-term cohort studies in young subjects. Int. Dent. J. 45:93-107 (Supplement 1) Scheinin A., Soderling E., Scheinin U., Glass R., L., Kallio, M-L. (1993) Xylitol-induced changes of enamel microhardness parelleled by microradiographic observations. Acta Odontol Scand 51:241-246 Vissink A., S’Gravenmade E., J., Gelhard T., 31 January 2008 Page 1,179 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID B., F., M., Panders A., K., Franken M., H. (1985) Rehardening Properties of Mucin- or CMC-Containing Saliva Substitutes on Softened Human Enamel. Caries Res. 19: 212-218 Animal study Beckers, H., J., A. (1988) Influence of Xylitol on Growth, Establishment, and Cariogenicity of Streptococcus mutans in Dental Plaque of Rats; Caries Res. 22:166-173 31 January 2008 Page 1,180 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID DIETS Fruit-rich diet 31 January 2008 Heart health Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 328 Weight management via fibre Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 329 Modulation of glycemic response Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 330 Page 1,181 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Low sodium/ salt and/ or increased potassium Heart health Must meet minimum requirements, as per Annex to Regulation 1924/2006. Authoritative Body Scientific Body JHCI – Joint Health Claims Initiative – Final Technical Report – A List of Well Established Nutrient Function Statements http://www.food.gov.uk/multimedia/pdfs/jhci_he althreport.pdf 338 NFA – Terveysvaitteiden valvontaopas, Finnish Food Authority Control guides number 2/2002 http://www.palvelu.fi/evi/evi_material.php NHPD – Health Canada Permitted Health Claims http://laws.justice.gc.ca/en/F-27/C.R.C. -c.870/236932.html#Section-B.01.603 SNF – Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 31 January 2008 Page 1,182 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Meal replacement for weight control (as defined in Directive 96/8/EC energy restricted diets for weight reduction) Safe, effective & healthy weight loss 31 January 2008 For weight loss - Use to replace one or more meals of the daily diet 1,661 Page 1,183 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Analytical Review RCT Cohort study Non-intervention multi-center study Randomised controlled trial (RCT) Systematic review Meta analysis Independent Review References Claim ID Anderson, JW. Combination approaches to weight management. Medscape Diabetes & Endocrinology 6(2), 2004, posted 08/31/2004 Ashley. JM., St Jeor. ST., Schrage. JP, et al. Weight control in the physician’s office. Archives of Internal Medicine. 2001;161;1599-1604 Dhindsa. P., Scott. AR., Donnelly, R. Metabolic and cardiovascular effects of very-low-calorie-diet therapy in obese patients with type 2 diabetes in secondary failure: outcomes after 1 year. Diabetic Medicine. 2003; 20; 319-324 Ditschuneit. HH., Flechtner-Mors. M., Johnson. TD., Adler. G Metabolic and weight loss effects of a long term dietary intervention in obese patients. Am J Clin Nutr. 1999;69;198-204 Flechtner-Mors, M., Ditschuneit, HH., Johnson, TD., Suchard, MA, Adler, G. Metabolic and weight-loss effects of long-term dietary intervention in obese patients: Four-Year results. Obesity Research 2000;8;399-402 Ditschuneit. HH., Frier, HI., Flechtner-Mors, M. Lipoprotein responses to weight loss and weight maintenance in high-risk obese subjects. European Journal of Clinical Nutrition. 2002;56;264-270 Heber, D., Ashley, JM., Wang, HJ., Elashoff, RM. Clinical evaluation of a minimal intervention meal replacement regimen for weight reduction. J.Am.Coll.Nutr. 1994; 13; 608-614 31 January 2008 Page 1,184 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Ryan DH, Espeland MA Foster GD, et al. Look AHEAD (Action for Health in Diabetes) : design and methods for a clinical trial of weight loss for the prevention of cardiac disease in type 2 diabetes. Controlled Clinical Trials (2003); 24: 1–19. Rothacker. DQ., Stniszeweski, BQ., Ellis. PK. Liquid meal replacements vs. traditional food: A potential model for women who cannot maintain eating habit change J.Am.Diet.Assoc. 2001;101;345-347 Yip.i., Go. VlW., DeShields. S., et al. Liquid meal replacements and glycaemic control in obese type 2 diabetes patients Obes.Res. 2001;9;341S-347S O'Reilly, J., Carr, L. and West, P. (2004) Cost effectiveness of meal replacement products in weight control. International Journal of Obesity. Volume 28, Supplement 1, Pages S143 Redmon, JB, Raatz SK, Reck KP, Swanson JE, Kwong CA, Fan Q, Thomas W, Bantle JP One-Year outcome of a Combination of Weight Loss Therapies for Subjects With Type two Diabetes. Diabetes Care (2003);20:2505-2511. Heymsfield, SB., van Mierlo CAJ., van der Knaap, HCM., Heo, M., and Frier, HI (2003) Weight management using a meal replacement strategy: meta and pooling analysis from six studies. International Journal of Obesity 27(5): 537-549 May 2003 American Dietetic Association http://www.adaevidencelibrary.com/template.cf 31 January 2008 Page 1,185 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID m?template=guide_summary&key=625&auth= 1 Greater weight loss than with conventional calorie counting Replace two meals a day Independent Review RCT Meta analysis American Dietetic Association http://www.adaevidencelibrary.com/template.cf m?template=guide_summary&key=625&auth= 1 1,664 Flechtner-Mors, M., Ditschuneit, HH., Johnson, TD., Suchard, MA, Adler, G. Metabolic and weight-loss effects of long-term dietary intervention in obese patients: Four-Year results. Obesity Research 2000;8;399-402 Rothacker. DQ., Stniszeweski, BQ., Ellis. PK. Liquid meal replacements vs. traditional food: A potential model for women who cannot maintain eating habit change J.Am.Diet.Assoc. 2001;101;345-347 Anderson, JW. Combination approaches to weight management. Medscape Diabetes & Endocrinology 6(2), 2004, posted 08/31/2004 Maintenance of weight loss 31 January 2008 Replace one meal a day as a weight maintenance strategy/to keep the weight off 1,665 Page 1,186 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT Observational study with matched controls Editorial Opinion Abstract References Claim ID Ditschuneit. HH., Flechtner-Mors. M., Johnson. TD., Adler. G Metabolic and weight loss effects of a long term dietary intervention in obese patients. Am J Clin Nutr. 1999;69;198-204 Flechtner-Mors, M., Ditschuneit, HH., Johnson, TD., Suchard, MA, Adler, G. Metabolic and weight-loss effects of long-term dietary intervention in obese patients: Four-Year results. Obesity Research 2000;8;399-402 Rothacker, DQ. Five-year self-management of weight using meal replacements: Comparison with matched controls in rural Wisconsin. Nutrition. 2000; 16; 344-348 Hill, JO. Long-Term Weight control with Meal Replacements. Nutrition. 2000; 16; 10 year data – Blackburn, GL. Ten-year self-management of weight using a meal replacement diet plan – comparisons with matched controls Obesity Research 2003; 11; A103 Rothacker. DQ., Staniszeweski, BQ., Ellis. PK. Liquid meal replacements vs. traditional food: A potential model for women who cannot maintain eating habit change . J.Am.Diet.Assoc. 2001;101;345-347 Successful weight loss 31 January 2008 Replace two meals a day as part of a weight loss programme 1,663 Page 1,187 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Randomised controlled trial (RCT) Meta analysis Independent Review References Claim ID Ditschuneit. HH., Flechtner-Mors. M., Johnson. TD., Adler. G Metabolic and weight loss effects of a long term dietary intervention in obese patients. Am J Clin Nutr. 1999;69;198-204 Flechtner-Mors, M., Ditschuneit, HH., Johnson, TD., Suchard, MA, Adler, G. Metabolic and weight-loss effects of long-term dietary intervention in obese patients: Four-Year results. Obesity Research 2000;8;399-402 Heymsfield, SB., van Mierlo CAJ., van der Knaap, HCM., Heo, M., and Frier, HI (2003) Weight management using a meal replacement strategy: meta and pooling analysis from six studies. International Journal of Obesity 27(5): 537-549 May 2003 Anderson, JW. Combination approaches to weight management. Medscape Diabetes & Endocrinology 6(2), 2004, posted 08/31/2004 Rothacker. DQ., Stniszeweski, BQ., Ellis. PK. Liquid meal replacements vs. traditional food: A potential model for women who cannot maintain eating habit change J.Am.Diet.Assoc. 2001;101;345-347 Winick. C., Rothacker. DQ., Norman. RL. Four Worksite Weight Loss Programmes with High-Stress Occupations using Meal Replacement Product. Occup. Med 2002;52;25-30 Ashley. JM., St Jeor. ST., Schrage. JP, et al. Weight control in the physician’s office. Archives of Internal Medicine. 2001;161;1599-1604 31 January 2008 Page 1,188 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Truby, H., deLooy, A., Fox, K.R., Livingstone, B.E. Logan, C.M., Macdonald, I.A., Morgan, L.M., Taylor, M.A., Millward, D.J., BMJ 2006; 332: 1309-1314.Randomised Controlled Trial of Four Commercial Weight Loss Programmes in the UK: Intial Findings from the BBC ”Diet Trials”. Anderson, J.W., Luan, J., Hoie, L.H. Advances in Therapy 2004; 21(2): 61-75.Structured Weight-Loss Programs: Meta-analysis of Weight Loss at 24 Weeks and Assessment of Effects of Intervention Intensity American Dietetic Association http://www.adaevidencelibrary.com/template.cf m?template=guide_summary&key=625&auth= 1 Dietitians in Obesity Management: www.domuk.org?topical update?meal replacements – position and Q&A British Dietetic Association: www.bdaweightwise.com/ ?Options for support?Find the right approach?meal replacements National Obesity Forum: www.nationalobesityforum.org.uk/Files/Content /L/6468/NOF_Adult_Guildelines_Feb_06.pdf 31 January 2008 Page 1,189 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Mediterranean diet Related to cardiovascular health 31 January 2008 See reference section for dietary characteristics 339 Page 1,190 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Epidemiological studies Intervention studies. References Claim ID MEDITERRANEAN DIET Authoritative/Scientific Bodies AHA. http://www.americanheart.org/presenter.jhtml?i dentifier=4655 Reviews de Lorgeril M, Salen P.; The Mediterranean-style diet for the prevention of cardiovascular diseases. Public Health Nutr. 2006 Feb;9(1A):118-23. Review Willett WC, Sacks F, Trichopoulou A, Drescher G, Ferro-Luzzi A, Helsing E, Trichopoulos D. (1995) Mediterranean diet pyramid: a cultural model for healthy eating. Am J Clin Nutr. 1995 Jun;61(6 Suppl): 1402S1406S. Review. Serra-Majem L, Roman B, Estruch R.; Scientific evidence of interventions using the Mediterranean diet: a systematic review; Nutr Rev. 2006 Feb;64(2 Pt 2):S27-47. Clinical Trial Estruch R, Martinez-Gonzalez MA; Effects of a Mediterranean-style diet on cardiovascular risk factors: a randomized trial. Ann Intern Med. 2006 Jul 4;145(1):1-11 Individual Studies Antonelli-Incalzia R, Pedone C; Association between nutrient intake and peripheral artery disease: Results from the InCHIANTI study; Atherosclerosis Volume 186, Issue 1 , May 2006, Pages 200-206 . Demosthenes B. Panagiotakos D, The relationship between adherence to the Mediterranean diet and the severity and short-term prognosis of acute coronary syndromes (ACS): The Greek Study of ACS (The GREECS); Nutrition, Volume 22, Issues 7 31 January 2008 Page 1,191 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID -8, July-August 2006, Pages 722-730 ARTICLE Fidanze F, Alberti A, Lanti M And Menotti A; Mediterranean Adequacy Index: Correlation with 25-year moratlity from coronary heart disease in the seven country study; Nutr. Metab. Cardiovasc. Dis. 2004; Vol14 no. 5, 254 -258 Lapointe A, Couillard C and Lemieux S; Effects of dietary factors on oxidation of low-density lipoprotein particles 2006; Article in press; Online publication: http://dx.doi.org/10.1016/j.jnutbio.2006.01.001 Panagiotakos DB, Chrysohoou C, Pitsavos C, Stefanadis C.; Association between the prevalence of obesity and adherence to the Mediterranean diet: the ATTICA study. Nutrition. 2006 May;22(5):449-56. Epub 2006 Feb 2. Psaltopoulou T, et al; Olive Oil, The mediterranean diet, and arterial blood pressure: The Greek European Prospective Investigation into cancer and nutrition (EPIC) Study; Am. J. Clin. Nutr. 2004; Vol80 no.4:1012-1018 Trichopoulou A, Costacou T, Bamia C, Trichopoulos D. (2003) Adherence to a Mediterranean diet and survival in a Greek population. New England Journal of Medicine 348:2599-2608 Trichopoulou A et al. Modified Mediterranean diet and survival: EPIC-elderly prospective cohort study BMJ, Apr 2005; 330: 991 31 January 2008 Page 1,192 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Reduced or low in energy Body weight management Authoritative Body SNF – Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm 326 Rich in dietary fibre Weight management Must meet minimum requirements for relevant claim in the Annex to Regulation 1924/2006. Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 337 Bowel health and function Must meet minimum requirements for relevant claim in the Annex to Regulation 1924/2006. Authoritative Body NHPD – Health Canada Permitted Health Claims http://laws.justice.gc.ca/en/F-27/C.R.C. -c.870/236932.html#Section-B.01.603 336 SNF – Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm 31 January 2008 Page 1,193 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Rich in whole grain Heart health Authoritative Body FDA Food and Drug Administration of the USA. Code of Federal Regulations; 21 CFR 101 335 JHCI – Joint Health Claims Initiative – Final Technical Report – A List of Well Established Nutrient Function Statements http://www.food.gov.uk/multimedia/pdfs/jhci_he althreport.pdf SNF – Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm 31 January 2008 Page 1,194 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Vegetable-rich diet Modulation of glycemic response Weight management via fibre Heart health 31 January 2008 a diet rich in vegetables helps controlling body weight. Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 333 Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 332 Scientific Body WHO 2003:- Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 331 Page 1,195 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Very low calorie diet (VLCD) Programme Weight loss can reduce snoring Weight management programme Cross-sectional study, cohort study, review Dixon JB, Schachter LM, O’Brien PE. Sleep Disturbance and obesity: changes following surgically induces weight loss. Archives of Internal Medicine. 2001 161(1): 102-6. 481 Braver HM, Block J, Perri MG. Treatment for Snoring Combined Weight Loss, Sleeping on Side and Nasal Spray. Chest. 1995. 107. 5: 1283-1288. Levy P, Pepin JL, Mayer P, Wuyam B, Veale D. Management of simple snoring, upper airway resistance syndrome and moderate sleep apnea syndrome. Sleep. 1996. 19 (suppl 9): S101-10. Kopelman PG. Clinical complications of obesity. Clinics in Endocrinology and Metabolism. 1984. 13(3): 613-34. Banno K, Walld R, Kryger MH. Increasing obesity trends in patients with sleep-related breathing referred to a sleep disorders centre. Journal of Clinical Sleep Medicine.2005. 1(4): 364-6. Madani M. Snoring and obstructive sleep apnea. Archives of Iranian Medicine. 2007. 10(2): 215-26. Long term weight maintenance 31 January 2008 Programme using initial nutritionally complete formula VLCD providing <800kcal/day Weight management Programme providing 468 Page 1,196 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use counsellor support and/or behaviour modification Nature of Evidence Review, cohort study, meta analysis, randomised control trial References Claim ID Astrup A, Rossner S. Lessons from obesity management programmes: greater initial weight loss improves long-term maintenance. Obesity Reviews. 2000. 1. 17-19. Pekkarinen T, Mustajoki P. Comparison of Behaviour Therapy With and Without a Very-Low-Energy Diet in the Treatment of Morbid Obesity. A 5-year outcome. Archives of Internal Medicine. 1997. 157 (14): 1581-5 Saris WHM. Very-Low-Calorie Diets and Sustained Weight Loss. Obesity Research. 2001. 9, supp 4: 295S-301S Anderson JW, Konz EC, Fredrich RC, Wood CL. Long-term weight-loss maintenance: a meta analysis of US studies. American Journal of Clinical Nutrition. 2001. 74:579-584 Jebb SA & Goldberg GR. Efficacy of Very Low Energy Diets and Meal Replacements in the Treatment of Obesity. Journal of Human Nutrition & Dietetics. 1998. 11: 219-225 Anderson JW, Konz EC, Frederich RC, Wood CL.. Long term weight loss maintenance: a meta-analysis of US studies. American Journal of Clinical Nutrition, 2001. 74(5): 579-84 Gilden Tsai A, Wadden TA. The Evolution of Very Low Calorie Diets: An Update and Meta-analysis. Obesity. 2006. 14(8):1283-93 Ryttig KR, Rössner S. Weight maintenance after a very low calorie diet (VLCD) weight reduction period and the effects of VLCD supplementation. A prospective, randomized, 31 January 2008 Page 1,197 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID comparative, controlled long-term trial. Journal of Internal Medicine. 1995. 238(4): 299-306 Quaade F, Astrup A. Initial VLCD improves ultimate weight loss. International Journal of Obesity. 1989. 13, Supp 2, 107-111 Kreitzman S. Factors influencing body composition during VLCD. American Journal Clinical Nutrition.1992. 56: 217S-23S Kreitzman et al. Controlled carbohydrate re-feeding after VLCD improves weight maintenance on low fat diet. International Journal of Obesity.1991 15:suppl 1:P59.30 31 January 2008 Page 1,198 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Systematic review, cohort study References Claim ID C Ayyad and T Anderson. Long term efficacy of dietary treatment of obesity: a systematic review of studies published between 1931 and 1999. Obesity Reviews. 2000. 1(2): 113-9 Holden et al Long-term follow-up of patients attending a combination very-low calorie diet and behaviour therapy weight loss programme. International Journal of Obesity and Related Metabolic Disorders. 1992. 16(8): 605-13 Pekkarinen T, Takala I, Mustajoki P. Two year maintenance of weight loss after VLCD and behavioural therapy for obesity: correlation to the scores of questionnaires measuring eating behaviour. International Journal of Obesity and Related Metabolic Disorders.1996. 20(4): 332-7 Miura J, Arai K, Tsukahara S, Ohno M, Ikeda Y. The long term effectiveness of combined therapy by behaviour modification and very low calorie diet: 2 years follow-up. International Journal of Obesity. 1989. 13 Supp 2: 73-7 Kern PA, Trozzolino L, Wolfe G, Purdy L. Combined use of behaviour modification and very low calorie diet in weight loss and weight maintenance. American Journal of Medical Science. 1994. 307(5):325-8 Kirschner MA, Schneider G, Ertel NH, Gorman J. An 8-year experience with a very low calorie formula diet for control of major obesity. International Journal of Obesity.1988 12 (1): 69-80 Rapid early weight loss and motivation 31 January 2008 Nutritionally complete very low calorie diet formula providing <800kcal/day 479 Page 1,199 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Review, expert opinion/review References Claim ID Astrup and Rossner. Lessons from obesity management programmes: greater initial weight loss improves long-term maintenance. Obesity Reviews. 2000. 1. 17-19. Rossner S. Intermittent vs. continuous VLCD therapy in obesity treatment. International Journal Obesity.1998. 22: 190-192 31 January 2008 Low glycaemic index Nutritionally complete VLCD formula food providing <800kcal/day with GI measured to <55 Safe and effective weight loss Nutritionally complete formula VLCD providing <800 kcal/day Cohort study Henry CJ, Lightowler HJ, Dodwell LM, Wynne JM. Glycaemic index and glycaemic load values of cereal products and weight management meals available in the UK. British Journal of Nutrition. 2007. 98(1): 147-53 484 465 Page 1,200 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Meta analysis,Systematic review,Review, Cohort study.Review,Expert Report,Randomised controlled trial References Claim ID Gilden Tsai A, Wadden TA. The Evolution of Very Low Calorie Diets: An Update and Meta-analysis. Obesity. 2006. 14(8):1283-93 C Ayyad and T Anderson. Long term efficacy of dietary treatment of obesity: a systematic review of studies published between 1931 and 1999. Obesity Reviews. 2000. 1(2): 113-9 Mustajoki P and Pekkarinen T. Very low energy diets in the treatment of obesity. Obesity Reviews 2001 2(1):61-72 Zahouani A, Boulier A, Hespel JP. Short and long-term evaluation of body composition in 1389 obese outpatients following a very low calorie diet (Pro’gram 18 VLCD). Acta Diabetologica 2003. 40 supp 1: S149-50 S. A. Jebb and G. R Goldberg. Efficacy of very low-energy diets and meal replacement in the treatment of obesity. Journal of Human Nutrition and Dietetics (1998), 11, 219-225. Report of experts participating in task 7.3. Report on Tasks for Scientific Cooperation (SCOOP): Collection of data on products intended for use in very-low-calorie-diets. 2002 Doherty JU, Wadden TA, Zuk L, Letizia KA, Foster GD, Day SC. Long term evaluation of cardiac function in obese patients treated with a very low calorie diet: a controlled clinical study of patients without underlying cardiac disease. American Journal Clinical Nutrition. 1991; 53:854-8. Shapiro H, Weinkove C, Coxon A, Kreitzman S, Rodgers M. Three Hospital Experience with control of major obesity by VLCD in medically 31 January 2008 Page 1,201 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID compromised individuals. International Journal of Obesity. 1989. 13 Supp 2: 125-129 Kreitzman SN. Pedersen RD, Budell W, Nichols D, Krissman P, Clements M. Safety and effectiveness of weight reduction using a very-low-calorie formulated food. Archives of Internal Medicine. 1984. 144:747-750. Mustajoki P, Pekkarinen T. Very low energy diets in the treatment of obesity. Obesity Reviews 2001. 2: 61-72. Pekkarinen & Mustajoki. Use of VLCD in preoperative weight loss: efficacy and safety. Obesity Research 1997 Ryde SJS, SaundersNH, Birks JL, Ali PA, Thomas DW, Morgan WD, Evans CJ, Al-Zeibak S, Dutton J, Sivyer A. The effects of VLCD on Body Composition. The Swansea Trial Chapter 3, edited by Kreitzman S & Howard A. Kreizman S. Stability of fat/lean loss demonstrated to relatively low body fat levels by personal fat ratio. The Swansea Trial Chapter 10, edited by Kreitzman S & Howard A. Kreitzman SN, Coxon AY. Independence of body composition from mode, rate or direction of weight change in women as a result of dieting or re-gaining weight. International Journal of Obesity 14: 904 Jebb SA, Goldberg GR, Coward WA, Murgatroyd PR, Prentice AM. Effects of Weight Cycling caused by intermittent dieting on metabolic rate and body composition in obese women. International Journal of Obesity. 31 January 2008 Page 1,202 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 1991.15: 307-374. Appleton and Summerbell The Re-Shape Study: to evaluate the effectiveness of a commercial weight loss programme compared to usual care as delivered in a primary care environment. 2004-5, School of Health & Social Care, University of Teesside Awaiting publication, Cohort study (awaiting study details from Eileen) Cohort study Reduced hunger 31 January 2008 Nutritionally complete, ketogenic VLCD formula providing <800kcal/day 470 Page 1,203 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Double blind randomised controlled trial, randomised control trial, systematic review, review, randomised trial, animal study References Claim ID Krotkiewski. Value of VLCD supplementation with medium chain triglycerides. International Journal of Obesity and Related Metabolic Disorders 2001. 25 (9):1393 - 1400 Pawan and Semple. Effect of 3-hydroxybutyrate in obese subjects on very-low-energy diets and during therapeutic starvation. Lancet. 1983. 1:15-17 Astrup A, Meinert Larsen T, Harper A. Atkins and other low-carbohydrate diets: hoax or an effective tool for weight loss. 2004. Lancet. 2004. 364(9437): 897-9 Erlanson-Albertsson C and Mei J. The Effect of low carbohydrate on energy metabolism. International Journal of Obesity. 2005. 29: S26-S30 Adam-Perrot A, Clifton P, Brouns F. Low-carbohydrate diets: nutritional and physiological aspects. Obesity Reviews. 2006. 7(1): 49-58 McClernon FJ, Yancy WS, Eberstein JA, Atkins RC, Westman EC. The effects of a low carbohydrate ketogenic diet and a low-fat diet on mood, hunger, and other self reported symptoms. Obesity. 2007. 15 (1): 182-7 Boden et al. Effect of a Low-Carbohydrate Diet on Appetite, Blood Glucose Levels and Insulin Resistance in Obese Patients with Type 2 Diabetes. 2005. Rich and Chambers. Are Ketone Bodies an Appetite Suppressant? Journal of Parenteral and Enteral Nutrition. 1988. 13(7S) 31 January 2008 Page 1,204 of 3,931 Category Food Component Health Relationship Rapid weight loss Suggested Conditions of Use Nutritionally complete formula VLCD providing <800 kcal/day Nature of Evidence Review, cohort study, meta analysis References Jebb SA, Goldberg GR . Efficacy of very low-energy diets and meal replacement in the treatment of obesity. Journal of Human Nutrition and Dietetics (1998), 11, 219-225. Claim ID 467 Mustajoki P, Pekkarinen T. Very low energy diets in the treatment of obesity. Obesity Reviews 2001. 2: 61-72. Zahouani A, Boulier A, Hespel JP. Short and long-term evaluation of body composition in 1389 obese outpatients following a very low calorie diet (Pro’gram 18 VLCD). Acta Diabetologica 2003. 40 supp 1: S149-50 Gilden Tsai A, Wadden TA. The Evolution of Very Low Calorie Diets: An Update and Meta-analysis. Obesity. 2006. 14(8):1283-93 Anderson JW, Luan J, Høie LH. Structured Weight Loss Programs: meta analysis of weight loss at 24 weeks and assessment of effects of intervention intensity. Advances in Therapy. 2004. 21(2):61-75 Saris WH. VLCD and sustained weight loss. Obesity Research 9: 295S-301S (2001 VLCD/low carbohydrate diets Improve blood lipid profile 31 January 2008 Nutritionally complete VLCD formula <800kcal 476 Page 1,205 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Cohort study, meta analysis, randomised trial References Claim ID Pekkarinen T, Takala I, Mustajoki P. Weight loss with very-low-calorie diet and cardiovascular risk factors in moderately obese women: One-year follow-up study including ambulatory blood pressure monitoring. International journal of Obesity and Related Metabolic disorders. 1998. 22(7):661-6 Nordmann AJ, Nordmann A, Briel M, Keller U, Yancy WS, Brehm BJ, Bucher HC. Effects of Low Carbohydrate vs Low-Fat Diets on Weight Loss and Cardiovascular Risk Factors: meta analysis of randomised controlled trials Westman EC, Yancy WS, Olsen MK, Dudley T, Guyton JR. Effect of a low carbohydrate , ketogenic diet program compared to a low-fat diet on fasting lipoprotein subclasses. International Journal of Cardiology. 2006. 110 (2): 212-6 Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish Weight Watchers, and Zone Diets for Weight Loss and Heart Disease Risk Reduction: a randomized trial. The Journal of the American Medical Association. 2005. 293(1): 43-53. higher/faster weight loss in men compared to women 31 January 2008 Nutritionally complete very low calorie diet formula providing <800kcal/day 480 Page 1,206 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Review, cohort study, retrospective data References Claim ID Anderson JW, Hamilton CC, Brinkman-Kaplan V. Benefits and Risks of an Intensive Very-Low-Calorie Diet Program for Severe Obesity. The American Journal of Gastroenterology. 1992. 87(1): 6-15 Burgess NS. Effect of a very-low-calorie diet on body composition and resting metabolic rate in obese men and women. Journal of the American Dietetic Association. 1991. 91(4): 430-434 Shapiro H, Weinkove C, Coxon A, Kreitzman S, Rodgers M. Three Hospital Experience with control of major obesity by VLCD in medically compromised individuals. International Journal of Obesity. 1989. 13 Supp 2: 125-129 Holt J, Horsnell T, Cox J, du Plessis J, Mullins G, Hewlett B. Obese men are at higher risk than obese women. Following a small trial, a long term observational study will report over the next 10 years on weight loss and weight maintenance on a group of self-referred obese men. Poster presented at ECO 2007, Budapest. International Journal of Obesity. 2007. 31(suppl 1): s169. Holt J, Horsnell T, du Plessis J, Hewlett B. Reporting on the mean weight loss and reduction in BMI for 11511 females who completed 14 weeks on the LighterLife Programme between 1998 and 2005. Poster presented at ECO 2007, Budapest. International journal of Obesity. 2007. 31(suppl 1): s 172. Burning fat for energy, preserving lean tissue 31 January 2008 Nutritionally complete very low calorie diet formula providing 478 Page 1,207 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use <800kcal/day Nature of Evidence Expert report, cohort study References Claim ID Report of experts participating in task 7.3. Report on Tasks for Scientific Cooperation (SCOOP): Collection of data on products intended for use in very-low-calorie-diets. 2002 Kreitzman SM. Factors influencing body composition during very-low-calorie diets. American Journal of Clinical Nutrition. 1992. 56 supp 1: 217S-223S Hoie LH, Bruusgaard D, Thom E. Reduction of body mass and change in body composition on a very low calorie diet. International Journal of Obesity and Related Metabolic Disorders. 1993 17(1): 17-20 Burgess NS. Effect of a VLCD on body composition and resting metabolic rate on obese men and women. Journal of the American Dietetic Association. 1991. 91(4): 430-4 Coxon A, Kreitzman S, Brodie D, Howard A. Rapid weight loss and lean tissue: evidence for comparable body composition and metabolic rate in differing rates of weight loss. International Journal of Obesity. 1989. 13 supp 2: 179-181 31 January 2008 Page 1,208 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID FATS 31 January 2008 Page 1,209 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Cholesterol Blood cholesterol and heart health 31 January 2008 Textbook Encyclopedia of Human Nutrition 1999 page 1039 Authoritative/Scientific Body AHA Scientific statement - Diet and lifestyle recommendations revision 2006 - A scientific statement from the American Heart Association Nutrition Committee Circulation 2006;114:82-96 Authoritative/Scientific Body European guidelines on cardiovascular disease prevention in clinical practice - Third Joint Task force of European and other Societies on Cardiovascular disease prevention in clinical practice. European Heart Journal 2003; 24,1601-1610 Authoritative/Scientific Body Hoge Gezondheidsraad Voedingsaanbevelingen voor Belgie Herziening november 2006 HGR dossiernummer 7145-2 Authoritative/Scientific Body Belgische Voedingsmiddelentabel - NUBEL vierde uitgave, vijfde druk september 2006 Authoritative/Scientific Body WHO - Report of the Joint WHO/FAO Expert Consultation on Diet, Nutrition and the Prevention of Chronic Disease (2002: Geneva, Switzerland). WHO Technical Report Series 916. WHO Geneva, 2003. Authoritative/Scientific Body ATP III Final Report V. Adopting Healthful Lifestyle Habits to Lower LDL Cholesterol and Reduce CHD Risk http://circ.ahajournals.org/cgi/content/full/106/2 5/3253#TBL4 173 Page 1,210 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Authoritative/Scientific Body NCEP Report Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines http://circ.ahajournals.org/cgi/content/full/110/2/ 227 Meta-Analysis Weggemans-Zock-Katan meta-analysis, American Journal of Clinical Nutrition 2001/73:885-91 Individual Studies Denke M.A. et al. Individual Cholesterol Variation in Response to a Margarine or Butter Based Diet. JAMA, 2000; 284: 2740-2747. Individual Studies Muller et al. Serum Cholesterol Predictive Equations with Special Emphasis on Trans and Saturated Fatty Acids. An Analysis from Designed Controlled Studies Lipids, 2001; 36: 783-791. Claim ID Page 1,211 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID CLA (conjugated linoleic acid) Reduces body fat mass 31 January 2008 The product must contain at least 1.5 gram CLA per serving Claim to be used for foods for active individuals 1,678 Page 1,212 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Peer-reviewed scientific research articles Peer-reviewed scientific research review Peer-reviewed scientific research meta-analysis References Claim ID Blankson H, Stakkestad JA, Fagertun H, et al. (2000) Conjugated linoleic acid reduces body fat mass in overweight and obese humans. J Nutr; 130: 2943-2948. Gaullier JM, Halse J, Hoye K, et al (2004) Conjugated linoleic acid supplementation for 1 y reduces body fat mass in healthy overweight humans. Am J Clin Nutr 79: 1118-1125. Gaullier JM, Halse J, Hoivik HO, et al (2007) Six-month supplementation with conjugated linoleic acid induces regional-specific fat mass decreases in overweight and obese. Brit J Nutr 97: 550-560. Pinkoski C, Chilibeck PD, Candow DG, et al (2006) The effects of conjugated linoleic acid supplementation during resistance training. Med Sci Sports Exerc; 38(2): 339-348. Riserus U, Berglund L, and Vessby B (2001) Conjugated linoleic acid (CLA) reduced abdominal adipose tissue in obese middle-aged men with signs of the metabolic syndrome: a randomized controlled trial. Int J Obes 25: 1129-1135. Smedman A and Vessby B (2001) Conjugated linoleic acid supplementation in humans-metabolic effects. Lipids 36: 773-781. Thom E, Wadstein J, and Gudmundsen O (2001) Conjugated linoleic acid reduces body fat in healthy exercising humans. J Int Med Res; 29: 392-396. Watras AC, Buchholz AC, Close RN, et al (2007) The role of conjugated linoleic acid in reducing body fat and preventing holiday weight 31 January 2008 Page 1,213 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID gain. Int J Obes 31:481-487. Belury MA (2002) Dietary Conjugated Linoleic Acid In Health: Physiological Effects and Mechanisms of Action (Review Article). Annu Rev Nutr 22: 505-531. Whigham LD, Watras AC, and Schoeller DA (2007) Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr 85: 1203-1211. Supports lean body mass The product must contain at least 1.5 gram CLA per serving Claim to be used for foods for active individuals Peer-reviewed scientific research articles Pinkoski C, Chilibeck PD, Candow DG, et al (2006) The effects of conjugated linoleic acid supplementation during resistance training. Med Sci Sports Exerc; 38(2): 339-348. 1,675 Antioxidant capability The product must contain at least 1.5 gram CLA per serving Claim to be used for foods for active individuals Peer-reviewed scientific research article Yu L (2001) Free radical scavenging properties of conjugated linoleic acids. J Agric Food Chem 49: 3452-3456. 1,677 Skin health Nut 0.5-10g/day Clinical Trial Agero AL, Verallo-Rowell VM. A randomized double-blind controlled trial comparing extra virgin coconut oil with mineral oil as a moisturizer for mild to moderate xerosis. Dermatitis. 2004 Sep;15(3):109-16. 2,544 Coconut Oil 31 January 2008 Page 1,214 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Conjugated linoleic acid (CLA) Weight management 31 January 2008 1.5-3.4 g CLA/day, CLA is a commercial mixture of 50:50 c10t12 and t9c11 isomers 385 Page 1,215 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Clinical Studies References Claim ID Reviews/Meta Analyses Berven G, Bye A, Hals O, Blankson H, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Safety of conjugated linoleic acid (CLA) in overweight or obese human volunteers. European J. Lipid Sci. Technol. 2000; 102: 455–462. Kreider RB, Ferreira MP, Greenwood M, Wilson M, Almada AL. Effects of conjugated linoleic acid supplementation during resistance-training on body composition. Bone density, strength, and selected hematological markers. J Strength Cond Res 2002; 3: 325-34. Smedman A, Vessby, B. Conjugated linoleic acid supplementation in humans Metabolic effects. Lipids 2001;36:773–781. Wang et al. (2004): Conjugated linoleic acid and obesity control: efficacy and mechanism. Int.J.Obes.Relat.Metab.Disord. 28(8): 941-55 Watras AC, Buchholz AC, Close RN, Zhang Z, Schoeller DA (2006) The role of conjugated linoleic acid in reducing body fat and preventing holiday weight gain. Int J Obes (Lond) Whigham LD, Watras AC, Schoeller DA (2007) Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr. 2007 May;85(5):1203-11. Human Intervention Studies Blankson H, Stakkestad JA, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Conjugated Linoleic Acid reduces body fat mass in overweight and obese humans. Journal of Nutrition 2000;130:2943-48 Gaullier JM, Halse J, Hoivik HO, Hoye K, Syvertsen C, Nurminiemi M, Hassfeld C, Einerhand A, O'Shea M, Gudmundsen O (2007) Six months supplementation with 31 January 2008 Page 1,216 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID conjugated linoleic acid (CLA) induces regional-specific fat mass decreases in overweight and obese. Br J Nutr, Volume 97, No. 3, on pages 550 to 560. Gaullier JM, Hasle J, Hoye K, Kristiansen K, Halse, J, Fagertun H, Vik H, and Gudmundsen O. Conjugated linoleic acid supplementation for 1 year reduces body fat mass in healthy overweight humans. Am J Clin Nutr 2004; 79: 1118-25 Gaullier JM, Hasle J, Hoye K, Kristiansen K, Halse, J, Fagertun H, Vik H, and Gudmundsen O. Supplementation with Conjugated Linoleic Acid for 24 Months Is Well Tolerated by and Reduces Body Fat Mass in Healthy, Overweight Humans, J. Nutr 2005; 135, 778-784. Gaullier JM, Berven G, Blankson H, Gudmonson O. Clinical trial results support a preference for using CLA preparations enriched with two isomers rather than four isomers in human studies. Lipids. 2002; 37: 1019-25. Jean-Michel G et al Conjugated linoleic acid supplementation for 1 y reduces body fat mass in healthy overweight humans; Am J Clin Nutr 2004;79:1118 –25. Kamphuis MMJW, Lejeune MPGM, Saris WHM, Westerterp-Plantinga MS. The effect of conjugated linoleic acid supplementation after weight loss on body weight regain, body composition, and resting metabolic rate in overweight subjects. Int J Obesity 2003; 27: 840-847. Kamphuis MMJW, Lejeune MPGM, Saris WHM, Westerterp-Plantinga MS. Effect of conjugated linoleic acid supplementation after weight loss on appetite and food intake in overweight subjects, Eur J Clin Nutr 2003; 57; 1268-74 Larsen TM, Toubro S, Gudmundsen O, 31 January 2008 Page 1,217 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Astrup A. Conjugated linoleic acid supplementation for 1 y does not prevent weight or body fat regain. Am J Clin Nutr 2006;83:606-12. Mougios V, Matsakas A, Petridou A, Ring S, Sagredos A, Melissopoulou A, Tsigilis N, Nikolaidis M. Effect of supplementation with conjugated inoleic acid on human serum lipids and body fat. J Nutr Biochem 2001; 12: 585-94. Pinkoski C, Chilibeck PD, Candow DG, Esliger D, Ewaschuk JB, Facci M, Farthing JP, Zello GA. The effects of conjugated linoleic acid supplementation during resistance training.GA. Med Sci Sports Exerc. 2006;38:339-48. Riserus U, Berglund L, Vessby B. Conjugated linoleic acid (CLA) reduced abdominal adipose tissue in obese middle-aged men with signs of metabolic syndrome: a randomised controlled trial. International Journal of Obesity 2001: 25; 11291135. Thom E. Wadstein J. Gudmundsen O. Conjugated linoleic acid reduces body fat in healthy exercising humans.[erratum appears in J Int Med Res 2001 Mar-Apr;30(2):210 Note: Correction of dosage error in abstract.]. [Clinical Trial. Journal Article. Randomized Controlled Trial] Journal of International Medical Research. 29(5):392-6, 2001 Sep-Oct. Whigham LD, O'Shea M, Mohede IC, Walaski HP, Atkinson R L, Safety profile of conjugated linoleic acid in a 12-month trial in obese humans, Food Chem Toxicol. 2004; 42: 1701-9. Zambell KL, Keim NL, Van Loan MD, Gale B, Benito P, Kelley DS, Nelson GJ. Conjugated linoleic acid supplementation in humans: 31 January 2008 Page 1,218 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Effects on body composition and energy expenditure. Lipids 2000; 35: 777–82 Zambell KL. Horn WF. Keim NL. Conjugated linoleic acid supplementation in humans: effects on fatty acid and glycerol kinetics. Lipids. 2001: 36(8):767-72, Peer-reviewed scientific research article Immune health 31 January 2008 Up to 3,4 g CLA per day Watras AC, Buchholz AC, Close RN, et al (2007) The role of conjugated linoleic acid in reducing body fat and preventing holiday weight gain. Int J Obes 31:481-487. 387 Page 1,219 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence clinical studies References Claim ID Clinical studies Albers R, van der Wielen RPJ, Brink EJ, Hendriks HFJ, Dorovska-Taran VN, Mohede ICM. Effects of cis-9, trans-11 and trans-10, cis-12 conjugated linoleic acid (CLA) isomers on immune function in healthy man. European Journal of Clinical Nutrition 2003; 57: 595-603 Kelley DS, Tayler PC, Rudolph IL, Benito P, Nelson GJ, Mackey BE, Erickson KL. Dietary Conjugated Linoleic Acid Did Not Alter Immune Status in Young Health Women. Lipids 2000; 35: 1065-1071 Song H-J, Grant I, Rotondo D, Mohede I, Sattar N, Heys SD and Wahle KWJ. Effect of CLA supplementation on immune function in young healthy volunteers. European Journal of Clinical Nutrition 2005:1-10 In vivo studies Bassaganya-Riera J, Pogranichniy RM, Jobgen SC, Halbur PG, Yoon K-J, O’Shea M, Mohede I, Hontecillas R. Conjugated linoleic acid ameliorates viral infectivity in a pig model of virally induced immunosuppression. Journal of Nutritional 2003; 133:3204-3214 Bassaganya-Riera J, Hontecillas-Magarzo R, Bregendahl K, Wannemuehler MJ, Zimmerman DR. Effects of dietary conjugated linoleic acid in nursery pigs of dirty and clean environments on growth, empty body composition, and immune competence. American society of animal science 2001;79:714-721 Bassaganya-Riera J, Reynolds K, Martino-Catt S, Cui Y, Hennighausen L, Gonzalez F, Rohrer J, Benninghoff AU, Hontecillas R. Activation of PPAR y and b by Conjugated Linoleic Acid 31 January 2008 Page 1,220 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Mediates Protection From Experimental Inflammatory Bowel Disease. Gastroenterology 2004; 127: 777-791 Body fat/muscle composition 31 January 2008 492 Page 1,221 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published meta-analysis Published Clinical Trial Published Review Published Research Study References Claim ID Whigham LD, Watras AC, Schoeller Da (2007) Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr; 85(5): 1203-1211. Gaullier JM, Halse J, Hoivik HO et al (2007) Six months supplementation with conjugated linoleic acid induces regional-specific fat mass decreases in overweight and obese. Br J Nutr; 97(3): 550-560. Bhattacharya A, Banu J, Rahman M et al (2006) Biological effects of conjugated linoleic acids in health and disease. J Nutr Biochem; 17(12): 789-810. Badinga L, Greene ES (2006) Physiological properties of conjugated linoleic acid and implications for human health. Nutr Clin Pract; 21(4): 367-373. AM, Artacho R Haro, Cabrera C (2006) Linoleic conjugated acid: current interest in human nutrition. Med Clin; 127(13): 508-515. Nagao K, Yanagita T (2005) Conjugated fatty acids in food and their health benefits. J Biosci Bioeng; 100(2): 152-157. Thijssen MA, Malpeuch C, Gregoire S et al (2005) Effects of specific CLA isomers on plasma fatty acid profile and expression of desaturases in humans. Lipids; 40(2): 137-145. Gaullier JM, Halse J, Hoye K et al (2005) Supplementation with conjugated linoleic acid for 24 months is well tolerated by and reduces body fat mass in healthy, overweight humans. J Nutr; 135(4): 778-784. 31 January 2008 Page 1,222 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Rainer L, Heiss CJ (2004) Conjugated linoleic acid: health implications and effects on body composition. J Am Diet Assoc; 104(6): 963-968. Wang Y, Jones PJ (2004) Dietary conjugated linoleic acid and body composition. Am J Clin Nutr; 79(6S): 1153-1158. Brown JM, McIntosh MK (2003) Conjugated linoleic acid in humans: regulation of adiposity and insulin sensitivity. J Nutr; 133(10): 3041-3046. Kamphuis MM, Lejeune MP, Saris WH et al (2003) Effect of conjugated linoleic acid supplementation after weight loss on appetite and food intake in overweight subjects. Eur J Clin Nutr; 57(10): 1268-1274. Kamphuis MM, Lejeune MP, Saris WH (2003) The effect of conjugated linoleic acid supplementation after weight loss on body weight regain, body composition and resting metabolic rate in overweight subjects. Int J Obes Relat Metab Disord; 27(7): 840-847. Ntambi JM, Choi Y, Park Y et al (2002) Effects of conjugated linoleic acid on immune responses, body composition and stearoyl-CoA desaturase. Can J Appl Physiol; 27(6): 617-628. Noone EJ, Roche HM, Nugent AP et al (2002) The effect of dietary supplementation using isomeric blends of conjugated linoleic acid on lipid metabolism in healthy human subjects. Br J Nutr; 88(3): 243-251. DeLaney JP, West DB (2000) Changes in body 31 January 2008 Page 1,223 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID composition with conjugated linoleic acid. J Am Coll Nutr; 19(4): 487-493. Pariza MW, Park Y, Cook ME (2000) Mechanisms of action of conjugated linoleic acid: evidence and speculation. Proc Soc Exp Biol Med; 223(1): 8-13. Normal immune function 31 January 2008 493 Page 1,224 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review Published Clinical Trial References Claim ID Bhattacharya A, Banu J, Rahman M et al (2006) Biological effects of conjugated linoleic acids in health and disease. J Nutr Biochem; 17(12): 789-810. Badinga L, Greene ES (2006) Physiological properties of conjugated linoleic acid and implications for human health. Nutr Clin Pract; 21(4): 367-373. Nugent AP, Roche HM, Noone EJ et al (2005) The effects of conjugated linoleic acid supplementation on immune function in healthy volunteers. Eur J Clin Nutr; 59(6): 742-750. Nagao K, Yanagita T (2005) Conjugated fatty acids in food and their health benefits. J Biosci bioeng; 100(2): 152-157 Rainer L, Heiss CJ (2004) Conjugated linoleic acid: health implications and effects on body composition. J Am Diet Assoc; 104(6): 963-968. O’Shea M, Bassaganya J, Mohede IC (2004) Immunomodulatory properties of conjugated inoleic acid. Am J Clin Nutr; 79(6S): 1199-1206. Tricon S, Burdge GC, Kew S et al (2004) Effects of cis-9, trans-11 and trans-10, cis-12 conjugated linoleic acid on immune cell function in healthy humans. Am J Clin Nutr; 80(6): 1626-1633. Albers R, van der Wielen RP, Brink EJ et al (2003) Effects of cis-9, trans-11 and trans-10, cis-12 conjugated linoleic acid isomers on immune function in healthy men. Eur J Clin Nutr; 57(4): 595-603. 31 January 2008 Page 1,225 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Ntambi JM, Choi Y, Park Y et al (2002) Effects of conjugated linoleic acid on immune responses, body composition and stearoyl-CoA desaturase. Can J Appl Physiol; 27(6): 617-628. Banni S (2002) Conjugated linoleic acid metabolism. Curr Opin Lipidol; 13(3): 261-266. Pariza MW, Park Y, Cook ME (2000) Mechanisms of action of conjugated linoleic acid: evidence and speculation. Proc Soc Exp Biol Med; 223(1): 8-13. 31 January 2008 Page 1,226 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Conjugated linoleic acid (CLA) ((cis-9, trans-11 conjugated linoleic acid, and trans-10, cis-12 conjugated linoleic acid (50:50) triglycerides) weight management, fat metabolism enhancement Body weight management 31 January 2008 Product-specific claim: 3.4 g CLA per day or intake 1.7 - 3.4 g /day 388 Page 1,227 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence meta-analysis, human studies References Claim ID Whigham LD, Watras AC, Schoeller DA (2007) Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr. 2007 May;85(5):1203-11. Individual Studies Berven G, Bye A, Hals O, Blankson H, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Safety of conjugated linoleic acid (CLA) in overweight or obese human volunteers. European J. Lipid Sci. Technol. 2000; 102: 455–462. Blankson H, Stakkestad JA, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Conjugated linoleic acid (CLA) reduces body fat mass in overweight and obese humans. J Nutr 2000; 130: 2943-8. Gaullier JM, Berven G, Blankson H, Gudmonson O. Clinical trial results support a preference for using CLA preparations enriched with two isomers rather than four isomers in human studies. Lipids. 2002; 37: 1019-25. Gaullier JM, Halse J, Hoivik HO, Hoye K, Syvertsen C, Nurminiemi M, Hassfeld C, Einerhand A, O'Shea M, Gudmundsen O (2007) Six months supplementation with conjugated linoleic acid (CLA) induces regional-specific fat mass decreases in overweight and obese. Br J Nutr, Volume 97, No. 3, on pages 550 to 560. Gaullier JM, Hasle J, Hoye K, Kristiansen K, Halse, J, Fagertun H, Vik H, and Gudmundsen O. Conjugated linoleic acid supplementation for 1 y reduces body fat mass in healthy overweight humans. Am J Clin Nutr 2004; 79: 1118-25 68 Gaullier JM, Hasle J, Hoye K, Kristiansen K, 31 January 2008 Page 1,228 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Halse, J, Fagertun H, Vik H, and Gudmundsen O. Supplementation with Conjugated Linoleic Acid for 24 Months Is Well Tolerated by and Reduces Body Fat Mass in Healthy, Overweight Humans, J. Nutr 2005; 135, 778-784. Kamphuis MMJW, Lejeune MPGM, Saris WHM, Westerterp-Plantinga MS. The effect of conjugated linoleic acid supplementation after weight loss on body weight regain, body composition, and resting metabolic rate in overweight subjects. Int J Obesity 2003; 27: 840-847. Kamphuis MMJW, Lejeune MPGM, Saris WHM, Westerterp-Plantinga MS. Effect of conjugated linoleic acid supplementation after weight loss on appetite and food intake in overweight subjects, Eur J Clin Nutr 2003; 57; 1268-74 Kreider RB, Ferreira MP, Greenwood M, Wilson M, Almada AL. Effects of conjugated linoleic acid supplementation during resistance-training on body composition. Bone density, strength, and selected hematological markers. J Strength Cond Res 2002; 3: 325-34. Larsen TM, Toubro S, Gudmundsen O, Astrup A. Conjugated linoleic acid supplementation for 1 y does not prevent weight or body fat regain. Am J Clin Nutr 2006;83:606-12. Mougios V, Matsakas A, Petridou A, Ring S, Sagredos A, Melissopoulou A, Tsigilis N, Nikolaidis M. Effect of supplementation with conjugated inoleic acid on human serum lipids and body fat. J Nutr Biochem 2001; 12: 585-94. Pinkoski C, Chilibeck PD, Candow DG, Esliger D, Ewaschuk JB, Facci M, Farthing JP, Zello GA. The effects of conjugated linoleic acid supplementation during resistance training.GA. Med Sci Sports Exerc. 31 January 2008 Page 1,229 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 2006;38:339-48. Riserus U, Berglund L, Vessby B. Conjugated linoleic acid (CLA) reduced abdominal adipose tissue in obese middle-aged men with signs of the metabolic syndrome: a randomised controlled trial. Int J Obes Relat. Metab Disord 2001; 25: 1129-35 Smedman A, Vessby, B. Conjugated linoleic acid supplementation in humans Metabolic effects. Lipids 2001;36:773–8. Taylor JS, Williams SR, Rhys R, James P, Frenneaux MP. Conjugated Linoleic Acid Impairs Endothelial Function. Arterioscler Thromb Vasc Biol 2006;26:307-12. Thom E, Wadstein J, Gudmundson O. Conjugated linoleic acid reduces body fat in healthy exercising humans. J Int Med Res 2001; 29: 392-6. Watras AC, Buchholz AC, Close RN, Zhang Z, Schoeller DA (2006) The role of conjugated linoleic acid in reducing body fat and preventing holiday weight gain. Int J Obes (Lond) Whigham LD, O'Shea M, Mohede IC, Walaski HP, Atkinson R L, Safety profile of conjugated linoleic acid in a 12-month trial in obese humans, Food Chem Toxicol. 2004; 42: 1701-9. Zambell KL, Keim NL, Van Loan MD, Gale B, Benito P, Kelley DS, Nelson GJ. Conjugated linoleic acid supplementation in humans: Effects on body composition and energy expenditure. Lipids 2000; 35: 777–82 31 January 2008 Page 1,230 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence human studies; meta-analysis References Claim ID Atkinson R. International meeting: LIPID FORUM, Denmark june 1999. Abstract: Clinical implications for conjugated linoleic acid (CLA) in the treatment of obesity Berven G, Bye A, Hals O, Blankson H, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Safety of conjugated linoleic acid (CLA) in overweight or obese human volunteers. European J. Lipid Sci. Technol. 2000; 102: 455–462. Blankson H, Stakkestad JA, Fagertun H, Thom E, Wadstein J, Gudmundsen O. Conjugated linoleic acid (CLA) reduces body fat mass in overweight and obese humans. J Nutr 2000; 130: 2943-8. Gaullier JM, Berven G, Blankson H, Gudmonson O. Clinical trial results support a preference for using CLA preparations enriched with two isomers rather than four isomers in human studies. Lipids. 2002; 37: 1019-25. Gaullier JM, Halse J, Høivik HO, Høye K, Syvertsen C, Nurminiemi M, Hassfeld C, Einerhand A, O'Shea M, Gudmundsen O (2007) Six months supplementation with conjugated linoleic acid (CLA) induces regional-specific fat mass decreases in overweight and obese. Br J Whigham LD, Watras AC, Schoeller DA (2007) Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr. 2007 May;85(5):1203-11 31 January 2008 Page 1,231 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID DHA omega-3 fatty acid Pregnancy and nursing Daily consumption from single or multiple sources of at least 200 mg of DHA Authoritative Body WHO/FAO Expert Committee on Fats and Oils in Human Nutrition (1994). Report of a Joint FAO/WHO Expert Consultation. FAO Food and Nutrition Paper 57. Rome: Food and Agriculture Organization, 1994. PERILIP European Union Supported Consensus Conference on Dietary Fat Intake During the Perinatal Period (2006). Brenna JT. Meeting Report: European consensus conference on recommendations for long chain polyunsaturate consumption for pregnant and lactating women (PERILIP). ISSFAL Newsletter 2005;12:4-6. Agence Français de Sécurité Sanitaire des Aliments (AFSSA), Centre National d’Etudes et de Recommandations sur la Nutrition et l’ Alimentation and Centre National de la Recherche Scientifique, 2000. International Society for the Study of Fatty Acids and Lipids (ISSFAL, 1999b), Workshop on the Essentiality of and Dietary Reference Intakes (DRIs) for Omega-6 and Omega Fatty Acids. National Institutes of Health. April 7-9, 1999. ISSFAL website at www.issfal.org.uk/PUFA20%Intakes.htm 954 Scientific Advisory Committee on Nutrition (SACN) (UK) (2004). Advice on fish consumption. ISBN 0 11 243083. The Stationary Office. London. Monograph 31 January 2008 Cunnane SC and Griffin BA Nutrition and Metabolism of Lipids pp 81-115. In: Introduction to Human Nutrition Gibney MJ, Vorster HH and Kok FJ (eds) Blackwell, Oxford, 2002. Page 1,232 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Critical Review of Human Clinical Data References Claim ID Critical References DHA Supplementation During Pregnancy Studies Assessing Maternal Blood DHA Levels Human Intervention Studies Randomised Controlled Trials Barden, A.E.; Mori, T.A.; Dunstan, J.A.; Taylor, A.L.; Thornton, C.A.; Croft, K.D.; Beilin, L.J.; Prescott, S.L. 2004. Fish oil supplementation in pregnancy lowers F2-isoprostanes in neonates at high risk of atopy. Free Radic Res 38(3):233-239. Borod, E.; Atkinson, R.; Barclay, W.R.; Carlson, S.E. 1999. Effects of third trimester consumption of eggs high in docosahexaenoic acid on docosahexaenoic acid status and pregnancy. Lipids 34 (Suppl.):S231. Decsi, T.; Campoy, C.; Koletzko, B. 2005. Effect of N-3 polyunsaturated fatty acid supplementation in pregnancy: The Nuheal trial. In: Koletzko, B.; Dodds, P.; Akerblom, H.; Ashwell, M. (Eds.). Early Nutrition and Its Later Consequences: New Opportunities: Perinatal Programming of Adult Health - EC Supported Research. Danone Institute. Springer; New York, Advances in Experimental Medicine and Biology, Vol. 569, pp. 109 113. Denburg, J.A.; Hatfield, H.M.; Cyr, M.M.; Hayes, L.; Holt, P.G.; Sehmi, R.; Dunstan, J.A.; Prescott, S.L. 2005. Fish oil supplementation in pregnancy modifies neonatal progenitors at birth in infants at risk of atopy. Pediatr Res 57(2):276-281. Dunstan, J.A.; Mori, T.A.; Barden, A.; Beilin, L, J.; Taylor, A.L.; Holt, P.G.; Prescott, S.L. 31 January 2008 Page 1,233 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 2003a. 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Eur J Clin Nutr 58(3):429-437. Knudsen, V.K.; Hansen, H.S.; Osterdal, M.L.; Mikkelsen, T.B.; Mu, H.; Olsen, S.F. 2006. Fish oil in various doses or flax oil in pregnancy and timing of spontaneous delivery: a randomised controlled trial. Br J Obstet Gynaecol 113(5):536-543. Larqué, E.; Krauss-Etschmann, S.; Campoy, C.; Hartl, D.; Linde, J.; Klingler, M.; Demmelmair, H.; Cano, A.; Gil, A.; Bondy, B.; Koletzko, B. 2006. Docosahexaenoic acid 31 January 2008 Page 1,234 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID supply in pregnancy affects placental expression of fatty acid transport proteins. Am J Clin Nutr 84(4):853-861. Malcolm, C.A.; Mcculloch, D.L.; Montgomery, C.; Shepherd, A.; Weaver, L.T. 2003a. Maternal docosahexaenoic acid supplementation during pregnancy and visual evoked potential development in term infants: a double blind, prospective, randomised trial. Arch Dis Child Fetal Neonatal Ed 88(5):F383-F390. Malcolm, C.A.; Hamilton, R.; Mcculloch, D.L.; Montgomery, C.; Weaver, L.T. 2003b. Scotopic electroretinogram in term infants born of mothers supplemented with docosahexaenoic acid during pregnancy. Invest Ophthalmol Vis Sci 44(8):3685 3691. Montgomery, C.; Speake, B.K.; Cameron, A.; Sattar, N.; Weaver, L.T. 2003. Maternal docosahexaenoic acid supplementation and fetal accretion. Br J Nutr 90(1):135 145. Otto, S.J.; van Houwelingen, A.C.; Hornstra, G. 2000. The effect of supplementation with docosahexaenoic and arachidonic acid derived from single cell oils on plasma and erythrocyte fatty acids of pregnant women in the second trimester. Prostaglandins Leukot Essent Fatty Acids 63(5):323-328. Sanjurjo, P.; Ruiz-Sanz, J.I.; Jimeno, P.; Aldámiz-Echevarría, L.; Aquino, L.; Matorras, R.; Esteban, J.; Banque, M. 2004. Supplementation with docosahexaenoic acid in the last trimester of pregnancy: maternal-fetal biochemical findings. J Perinat Med 32(2):132-136. 31 January 2008 Page 1,235 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Smuts, C.M.; Borod, E.; Peeples, J.M.; Carlson, S.E. 2003a. High-DHA eggs: Feasibility as a means to enhance circulating DHA in mother and infant. Lipids 38(4):407 414. Smuts, C.M.; Huang, M.; Mundy, D.; Plasse, T.; Major, S.; Carlson, S.E. 2003b. A randomized trial of docosahexaenoic acid supplementation during the third trimester of pregnancy. Obstet Gynecol 101(3):469-479. Van Houwelingen, A.C.; Sørensen, J.D.; Hornstra, G.; Simonis, M.M.G.; Boris, J.; Olsen, S.F.; Secher, N.J. 1995. Essential fatty acid status in neonates after fish-oil supplementation during late pregnancy. Br J Nutr 74(5):723-731. Studies Assessing Maternal Breast Milk DHA Levels Human Intervention Studies Randomised Controlled Trials Barden, A.E.; Mori, T.A.; Dunstan, J.A.; Taylor, A.L.; Thornton, C.A.; Croft, K.D.; Beilin, L.J.; Prescott, S.L. 2004. Fish oil supplementation in pregnancy lowers F2-isoprostanes in neonates at high risk of atopy. Free Radic Res 38(3):233-239. Denburg, J.A.; Hatfield, H.M.; Cyr, M.M.; Hayes, L.; Holt, P.G.; Sehmi, R.; Dunstan, J.A.; Prescott, S.L. 2005. Fish oil supplementation in pregnancy modifies neonatal progenitors at birth in infants at risk of atopy. Pediatr Res 57(2):276-281. Dunstan, J.A.; Mori, T.A.; Barden, A.; Beilin, L, 31 January 2008 Page 1,236 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID J.; Taylor, A.L.; Holt, P.G.; Prescott, S.L. 2003a. Maternal fish oil supplementation in pregnancy reduces interleukin-13 levels in cord blood of infants at high risk of atopy. Clin Exp Allergy 33(4):442 448. Dunstan, JA.; Mori, T.A.; Barden, A.; Beilin, L.J.; Taylor, A.L.; Holt, P.G.; Prescott, S.L. 2003b. Fish oil supplementation in pregnancy modifies neonatal allergen-specific immune responses and clinical outcomes in infants at high risk of atopy: a randomized, controlled trial. J Allergy Clin Immunol 112(6):1178-1184. Dunstan, J.A.; Roper, J.; Mitoulas, L.; Hartmann, P.E.; Simmer, K.; Prescott, S.L.. 2004a. The effect of supplementation with fish oil during pregnancy on breast milk immunoglobulin A, soluble CD14, cytokine levels and fatty acid composition. Clin Exp Allergy 34(8):1237-1242. Dunstan, J.A.; Mori, T.A.; Barden, A.; Beilin, L.J.; Holt, P.G.; Calder, P.C.; Taylor, A.L.; Prescott, S.L. 2004b. Effects of n-3 polyunsaturated fatty acid supplementation in pregnancy on maternal and fetal erythrocyte fatty acid composition. Eur J Clin Nutr 58(3):429-437. DHA Supplementation During Pregnancy and Lactation Studies Assessing Maternal Blood DHA Levels Human Intervention Studies Randomised Controlled Trials Helland, I.B.; Saugstad, O.D.; Smith, L.; Saarem, K.; Solvoll, K.; Ganes, T.; Drevon, C.A. 2001. Similar effects on infants of n-3 and n-6 fatty acids supplementation to pregnant 31 January 2008 Page 1,237 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID and lactating women. Pediatrics 108(5):E82 [1-10]. Helland, I.B.; Smith, L.; Saarem, K.; Saugstad, O.D.; Drevon, C.A. 2003. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics 111(1):e39-e44. Helland, I.B.; Saugstad, O.D.; Saarem, K.; Van Houwelingen, A.C.; Nylander, G.; Drevon, C.A. 2006. Supplementation of n-3 fatty acids during pregnancy and lactation reduces maternal plasma lipid levels and provides DHA to the infants. J Matern Fetal Neonatal Med 19(7):397-406. Studies Assessing Maternal Breast Milk DHA Levels Human Intervention Studies Randomised Controlled Trials Boris, J.; Jensen, B.; Salvig, J.D.; Secher, N.J.; Olsen, S.F. 2004. A randomized controlled trial of the effect of fish oil supplementation in late pregnancy and early lactation on the n-3 fatty acid content in human breast milk. Lipids 39(12):1191 1196. Helland, I.B.; Saugstad, O.D.; Smith, L.; Saarem, K.; Solvoll, K.; Ganes, T.; Drevon, C.A. 2001. Similar effects on infants of n-3 and n-6 fatty acids supplementation to pregnant and lactating women. Pediatrics 108(5):E82 [1-10]. Helland, I.B.; Smith, L.; Saarem, K.; Saugstad, O.D.; Drevon, C.A. 2003. Maternal supplementation with very-long-chain n-3 fatty 31 January 2008 Page 1,238 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics 111(1):e39-e44. Helland, I.B.; Saugstad, O.D.; Saarem, K.; Van Houwelingen, A.C.; Nylander, G.; Drevon, C.A. 2006. Supplementation of n-3 fatty acids during pregnancy and lactation reduces maternal plasma lipid levels and provides DHA to the infants. J Matern Fetal Neonatal Med 19(7):397-406. DHA Supplementation During Lactation Studies Assessing Maternal Blood DHA Levels Human Intervention Studies Randomised Controlled Trials Gibson, R.A.; Neumann, M.A.; Makrides, M. 1997. Effect of increasing breast milk docosahexaenoic acid on plasma and erythrocyte phospholipid fatty acids and neural indices of exclusively breast fed infants. Eur J Clin Nutr 51(9):578-584. Hawkes, J.S.; Bryan, D.-L.; Makrides, M.; Neumann, M.A.; Gibson, R.A. 2002. A randomized trial of supplementation with docosahexaenoic acid-rich tuna oil and its effects on the human milk cytokines interleukin 1ß, interleukin 6, and tumor necrosis factor a. Am J Clin Nutr 75(4):754-760. 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Willatts, P.; Forsyth, J.S.; DiModugno, M.K.; 31 January 2008 Page 1,254 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Varma, S.; Colvin, M. 1998a. Influence of long-chain polyunsaturated fatty acids on infant cognitive function. Lipids 33(10):973-780. Willatts, P.; Forsyth, J.S, DiModugno, M.K.; Varma, S.; Colvin, M. 1998b. Effect of long-chain polyunsaturated fatty acids in infant formula on problem solving at 10 months of age. Lancet 352(9129):688-691. Studies Assessing Cognitive Outcomes in Pre-Term Infants Human Intervention Studies Randomised Controlled Trials O'Connor, D.L.; Hall, R.; Adamkin, D.; Auestad, N.; Castillo, M.; Connor, W.E.; Connor, S.L.; Fitzgerald, K.; Groh-Wargo, S.; Hartmann, E.E.; Jacobs, J.; Janowsky, J.; Lucas, A.; Margeson, D.; Mena, P.; Neuringer, M.; Nesin, M.; Singer, L.; Stephenson, T.; Szabo, J.; Zemon, V. 2001. Growth and development in preterm infants fed long-chain polyunsaturated fatty acids: a prospective, randomized controlled trial. Pediatrics 108(2):359-371. Werkman, S.H.; Carlson, S.E. 1996. A randomized trial of visual attention of preterm infants fed docosahexaenoic acid until nine months. Lipids 31(1):91-97. Studies Assessing Cognitive Outcomes in Healthy Adults Human Intervention Studies Randomised Controlled Trials Fontani, G.; Corradeschi, F.; Felici, A.; Alfatti, F.; Migliorini, S.; Lodi, L. 2005. Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in 31 January 2008 Page 1,255 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID healthy subjects. Eur J Clin Invest 35(11):691-699. Observational Studies Case-control Conquer, J.A.; Tierney, M.C.; Zecevic, J.; Bettger, W.J.; Fisher, R.H. 2000. Fatty acid analysis of blood plasma of patients with Alzheimer's disease, other types of dementia, and cognitive impairment. Lipids 35(12):1305-1312. Whalley, L.J.; Fox, H.C.; Wahle, K.W.; Starr, J.M.; Deary, I.J. 2004. Cognitive aging, childhood intelligence, and the use of food supplements: possible involvement of n-3 fatty acids. Am J Clin Nutr 80(6):1650-1657. Longitudinal Heude, B.; Ducimetiere, P.; Berr, C.; EVA Study. 2003. Cognitive decline and fatty acid composition of erythrocyte membranes--The EVA Study. Am J Clin Nutr 77(4):803-808. DHA+EPA - long chain omega 3 fatty acids Eye, brain and heart health 31 January 2008 Minimum 0.3 g per 100g (15% of the 2 g RDI suggested by SCF) Authoritative guidelines Nordic Nutrition Recommendations 2004 Integrating nutrition and physical activity, 4th edition, NORD 2004:13 747 Page 1,256 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Docosahexaenoic acid Cardiovascular health Reviews Mori TA, Woodman RJ, The independent effects of eicosapentaenoic acid and docosahexaenoic acid on cardiovascular risk factors in humans, Curr Opin Clin Nutr Metab Care, 2006, 9(2), 95-104 855 von Schacky C; A review of omega-3 ethyl esters for the cardiovascular prevention and treatment of increased blood triglyceride levels, Vascular Health and Risk Management, 2006, 2(3), 251-262 Human studies Theobald HE, Goodall AH, Sattar N, Talbot DC, Chowienczyk PJ, Sanders TA, Low-dose docosahexaenoic acid lowers diastolic blood pressure in middle-aged men and women, J. 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Perinatal supply and metabolism of long-chain polyunsaturated fatty acids. Importance for the early development of the nervous system. Ann NY Acad Sci 967 : 299-310 Jeffrey, B.G. et al (2001). The role of docosahexaenoic acid in retinal function. Lipids 36 : 859-871 Human studies: Colombo, J. et al (2004). Maternal DHA and the development of attention in infancy and toddlerhood. Child Development 75 : 12541267 Birch, E.E. et al (2002). A randomised controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr 75 : 570-580 Makrides, M. et al (1994). Fatty acid composition of brain, retina and erythrocytes in breast-and formula-fed infants. Am J Clin Nutr 60 : 189-194 Innis, S.M. et al (1994). Development of visual acuity in relation to plasma and erythrocyte omega-6 and omega-3 fatty acids in healthy, term gestation infants. Am J Clin Nutr 60 : 347-352 Animal studies: 31 January 2008 Page 1,262 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Anderson, G.J. et al (1990). Docosahexaenoic acid is the preferred dietary n-3 fatty acid for the development of the brain and retina. Pediatric Res 27 : 89-97 Mechanistic studies: Fliesler, S.J. and Anderson, R.E. (1983). Chemistry and metabolism of lipids in the vertebrate retina. Prog Lipid Res 22 : 79-131 Rojas, C.V. et al (2003). Gene expression analysis in human fetal retinal explants treated with docosahexaenoic acid. Invest Ophthalmol Vis Sci 44 : 3170-3177 Cognitive function in the elderly 31 January 2008 720 - 1720 mg of DHA per day. 393 Page 1,263 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence epidemiological studies, individual clinical studies References Claim ID Human Intervention Studies Fontani G, Corradeschi F, Felici A, Alfatti F, Migliorini S et al. Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects. Eur J Clin Invest 2005;35(11):691-9. Freund-Levi Y, Eriksdotter M, Cederholm T, Basun H, Faxen-Irving G, Garlind A, Vedin I, Vessby B, Wahlund L, Palmblad J. Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer Disease: OmegAD Study. Arch Neurol 2006;63:1402-1408. Terano T, Fujishiro S, Ban t et al. Docosahexaenoic acid supplementation improves the moderately severe dementia from thrombotic cerebrovascular diseases. Lipids 1999;34 (supp):S345-S346 Epidemiological Studies Conquer JA, Tierney MC, Zecevic J, Bettger WJ, Fisher RH Fatty acid analysis of blood plasma of patients with Alzheimer’s disease, other types of dementia, and cognitive impairment. Lipids. 2000;35(12):1305-12. Corrigan FM, Van Rhijn A, Horrobin DF. Essential fatty acids in Alzheimer’s disease Ann NY Acad Sci 1991;640:250-2. Heude B, Ducimetiere P, Berr C. Cognitive decline and fatty acid composition of erythrocyte membranes – the EVA study. Am J Clin Nutr 2003;77:803-8. Kalmijn S, van Boxtel MP, Ocke M, Verschuren WM, Kromhout D, Launer LJ. Dietary intake of fatty acids and fish in relation to cognitive performance at middle age. Neurology 2004 62(2):275-80. Kyle DJ et al. Low serum docosahexaenoic acid is a significant risk factor for Alzeimer’s dementia. Lipids 1999; 34:S245. Morris MC, Evans DA, Bienias JL, Tangney 31 January 2008 Page 1,264 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID CC, Bennett DA, et al. Consumption of fish and n-3 fatty acids and risk of incident of Alzheimer disease. Arch Neurol 2003;60(7):940-6. Morris CM, Evans DA, Tangney CC, Bienias JL, Wilson RS. Fish consumption and cognitive decline with age in a large community study. Arch Neurol 2005;62:1-5. Tully AM, Roche HM, Doyle R, Fallon C, Bruce I et al. Low serum cholesteryl ester¬docosahexaenoic acid levels in Alzheimer’s disease: a case-control study. British Journal of Nutrition 2003;89:483-489. Whalley LJ, Fox HC, Wahle KW, Starr JM, Deary IJ. Cognitive aging, childhood intelligence, and the use of food supplements: possible involvement of n-3 fatty acids. Am J Clin Nutr 2004;80:1650-7. Human Neurodevelopment 31 January 2008 160 - 300 mg per day for pregnant and lactating women 391 Page 1,265 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence authoritative bodies/scientific committees, textbooks, critical reviews References Claim ID Authoritative bodies and international and national scientific committees acknowledging the importance of DHA for neurodevelopment, brain and visual functions Canadian Food Inspection Agency. Guide to Food Advertising and Labeling (2003). Approved Biological Role Claims http://www.inspection.gc.ca/english/fssa/labeti/ guide/ch8e.shtml#8.5 Institute of Medicine, National Academy of Science (2005). Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids (Macronutrients). The National Academy of Sciences Press, Washington DC. Agency for Health Care Research and Quality (AHRQ) (2005a). Hodge W, Barnes D, Schachter H, Pan Y, Lowcock E, Zhang L, Sampson M, Morrison A, Tran K, Miguelez M, Lewin G. Effects of Omega -3 Fatty Acids on Eye Health. Evidence Report/Technology Assessment No. 117 (Prepared by University of Ottawa Evidence-based Practice Center under Contract No. 290-02-0021.) AHRQ Publication No. 05-E008-2. Rockville, MD: Agency for Healthcare Research and Quality. February 2005. Agency for Health Care Research and Quality (AHRQ) (2005b). Hodge W, Barnes D, Schachter H, Pan Y, Lowcock E, Zhang L, Sampson M, Morrison A, Tran K, Miguelez M, Lewin G. Effects of Omega -3 Fatty Acids on Eye Health. Evidence Report/Technology Assessment No. 117 (Prepared by University of Ottawa Evidence-based Practice Center under Contract No. 73 290-02-0021.) AHRQ Publication No. 05-E008-2. 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Scientific organizations and government agencies having established nutrient reference values for DHA Wootton SA, Jackson AA. DHA requirements in pregnancy and lactation. In: Advice on fish consumption: benefits & risks. Scientific Advisory Committee on Nutrition. HMSO, Norwich. 2004, pp 107-119. Agence Frangaise de Securite Sanitaire des Aliments, Centre National d’Etudes et de Recommandations sur la Nutrition et l’ Alimentation et Centre National de la Recherche Scientifique, 2000. (Martin A. Coordonnateur. Apports nutritionnels conseilles pour la population frangaise. 3e edition. Editions Tec & Doc, Lavoisier, Paris, 2001). Evidence from recognized text books and monographs British Nutrition Foundation's Task Force. Unsaturated fatty acids: Nutritional and physiological significance. Chapman and Hall, London. 1992. Evidence from critical reviews Hibbeln JR, Ferguson TA, Blasbalg TL. Omega-3 fatty acid deficiencies in neurodevelopment, aggression and autonomic dysregulation: opportunities for intervention. Int Rev Psychiatry 2006;18:107-118. 74 Fleith M, Clandinin MT. Dietary PUFA for preterm and term infants: review of clinical studies. Crit Rev Food Sci Nutr 2005;45(3):205 -29. Innis SM. Polyunsaturated fatty acids in 31 January 2008 Page 1,268 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID human milk: an essential role in infant development. Adv Exp Med Biol 2004;554:2743. Jensen CL. Effects of n-3 fatty acids during pregnancy and lactation. Am J Clin Nutr 2006;83(6 Suppl):1452S-1457S. McNamara RK, Carlson SE. Role of omega-3 fatty acids in brain development and function: potential implications for the pathogenesis and prevention of psychopathology. Prostaglandins Leukot Essent Fatty Acids 2006;75:329-349. McCann JC, Ames BN. 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Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids (Macronutrients). The National Academy of Sciences Press, Washington DC, Chapter 8. http://www.nap.edu/openbook.php?isbn=03090 85373. Accessed 8/17/07. (US, 2005). Agency for Health Care Research and Quality. MacLean CH, Issa AM, Newberry SJ, et al. Effects of Omega-3 Fatty Acids on Cognitive Function with Aging, Dementia, and Neurological Diseases. Evidence Report/Tech Assessment No. 114. http://www.ahrq.gov/downloads/pub/evidence/p df/o3cogn/o3cogn.pdf Accessed 9/5/07. (US, 2005). Agency for Health Care Research and Quality. Lewin GA, Schachter HM, Yuen D, et al. Effects of Omega-3 fatty acids on child and maternal health. Evidence Report/Technology Assessment No. l18. http://www.ahrq.gov/clinic/epcsums/o3mchsum. htm Accessed 9/5/07. 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Seafood Choices: Balancing Benefits and Risks. Committee on Nutrient Relationships in Seafood: Selections to Balance Benefits and Risks. MC Nesheim and AL Yakitine, eds. The National Academies Press, Washington DC. http://www.nap.edu/catalog.php?record_id=117 62#toc Accessed 8/17/07. (US, 2003). American Dietetic Association. Position of the American Dietetic Association and Dietitians of Canada: Vegetarian Diets, JADA 103:748-65. Optimization of brain maturation 31 January 2008 55 - 160 mg per day 392 Page 1,280 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence authoriative bodies/scientific committees, textbooks, critical reviews, individual studies 31 January 2008 References Claim ID Authoritative bodies and international and national scientific committees acknowledging the importance of DHA for proper brain development and maturation Canadian Food Inspection Agency. Guide to Food Advertising and Labeling (2003). , Approved Biological Role Claims http://www.inspection.gc.ca/english/fssa/labeti/ guide/ch8e.shtml#8.5 Institute of Medicine, National Academy of Science (2005). Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids (Macronutrients). The National Academy of Sciences Press, Washington DC. Agency for Health Care Research and Quality (AHRQ) (2005b). Hodge W, Barnes D, Schachter H, Pan Y, Lowcock E, Zhang L, Sampson M, Morrison A, Tran K, Miguelez M, Lewin G. Effects of Omega -3 Fatty Acids on Eye Health. Evidence Report/Technology Assessment No. 117 (Prepared by University of Ottawa Evidence-based Practice Center under Contract No. 290-02-0021.) AHRQ Publication No. 05-E008-2. Rockville, MD: Agency for Healthcare Research and Quality. February 2005. Agency for Health Care Research and Quality (AHRQ) (2005c). 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References as to cognitive function and mental balance Evidence from recognized text books and monographs Burgess JR, Stevens LJ. Essential fatty acids in relation to attention deficit hyperactivity 31 January 2008 Page 1,282 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID disorder. In: Peet M, Glen I, Horrobin DF, eds. Phospholipid spectrum disorders in psychiatry and neurology. Carnforth: Marius Press. 2003:511–519. Evidence from critical reviews Hibbeln JR, Ferguson TA, Blasbalg TL. Omega-3 fatty acid deficiencies in neurodevelopment, aggression and autonomic dysregulation: opportunities for intervention. Int Rev Psychiatry 2006;18:107-118. McNamara RK, Carlson SE. Role of omega-3 fatty acids in brain development and function: potential implications for the pathogenesis and prevention of psychopathology. Prostaglandins Leukot Essent Fatty Acids 2006;75:329-349. Burgess JR, Stevens L, Zhang W, Peck L. Long-chain polyunsaturated fatty acids in children with attention-deficit hyperactivity disorder. Am J Clin Nutr 2000;71 (suppl):327S330S. Richardson AJ. Omega-3 fatty acids in ADHD and related neurodevelopmental disorders. Int Rev of Psychiatry 2006;18(2):155 -172. Richardson AJ. Clinical trials of fatty acid treatment in ADHD, dyslexia, dyspraxia and the autistic spectrum. Prostaglandins Leukotrienes Essential Fatty Acids 2004a;70:383-390. Richardson AJ. Long-chain polyunsaturated fatty acids in childhood developmental and psychiatric disorders. Lipids 2004b;39:1215-1222. Solfrizzi V, D’Introno A, Colacicco AM, et al. Dietary fatty acids intake: possible role in cognitive decline and dementia. Exp Gerontol 2005;40:257-270. Uauy R, Dangour AD. Nutrition in brain 31 January 2008 Page 1,283 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID development and aging: role of essential fatty acids. Nutr Rev 2006;64:S24-S33; discussion S72-S91. Evidence from individual studies: Richardson AJ, Montgomery P. The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics. 2005 May;115(5):1360-6. Richardson AJ, Puri BK. A randomized double-blind, placebo-controlled study on the effects of supplementation with highly unsaturated fatty acids on ADHD-related symptoms in children with specific learning difficulties. Prog Neuropsychopharmacol Biol Psychiatry 2002;26:233-239. 76 Stevens L, Zhang W, Peck L, Kuczek T, Grevstad N, Mahon A, Zentall SS, Arnold LE, Burgess JR. EFA supplementation in children with inattention, hyperactivity, and other disruptive behaviours. Lipids 2003;38:1007-1021. Human Intervention Studies Fontani G, Corradeschi F, Felici A, Alfatti F, Migliorini S et al. Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects. Eur J Clin Invest 2005;35(11):691-9. 31 January 2008 Page 1,284 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Echium oil Regulation of metabolic function 31 January 2008 Oil extracted from Seeds of Echium Plantagineum 849 Page 1,285 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Arterburn LM, Bailey E, Oken H; Distribution, interconversion, and dose response of n-3 fatty acids in human, Am J Clin Nutr, 2006, 83, 1467S-76S Das UN, Essential fatty acids: biochemistry, physiology and phatology, BiotechnoL J., 2006, 1, 420-439 Mesa-Garcia M, Aguilera-Garcia C, Gil-Hernandez A, Importance of lipids in the nutritional treatment of inflammatory diseases, Nutr. Hosp., 2006, 21, 28-41. Ruxton CHS, Calder PC, Reed SC, Simpson MJA; The impact of long-chain n-3 polyunsaturated fatty acids on human health; Nutrition Research Reviews, 2005, 18, 113-129 Vasquez A; Reducing pain and inflammation naturally. Part II: New insights into fatty acid supplementation and its effects on eicosanoid production and genetic expression, Journal of the Council on Nutrition of the American Chiropractic Association, 2005, 28(1), 5-16 Kapoor R, Huang YS, Gamma linolenic acid; an anti-inflammatory omega-6 fatty acid, Current Pharmaceutical Biotechnology, 2006, 7, 531-534. Gamma-linolenic acid (GLA), Alternative Medicine Reviews, 2004, 9, 70-78 Fan Y, Chapkin RS, Importance of dietary y-linolenic acid in human health and nutrition, J. Nutr., 1998, 128, 1411-14 31 January 2008 Page 1,286 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies References Claim ID Surette M, Edens M, Chilton F, Tramposch K, Dietary Echium oil increases plasma and neutrophil long-chain (n-3) fatty acids and lowers serum triacylglycerols in hypertriglyceridemic humans, Journal of Nutrition, 2004, 134, 1406-1411 Miles EA, Banerjee T, Calder P, The influence of different combinations of y-linolenic acid, stearidonic acid and EPA on the fatty acid composition of blood lipids and mononuclear cells in human volunteers, Prostaglandins Leukot Essential Fatty Acids, 2004, 70(6), 529-38. Miles EA, Banerjee T, Dooper MMBW, M'Rabet L, Graus YMF, Calder P, The influence of different combinations of y-linolenic acid, stearidonic acid and EPA on immune function in healthy young male subjects, 2004, 91, 893-903. James M, Ursin V, Cleland L, Metabolism of stearidonic acid in human subjects: comparison with the methabolism of other n-3 fatty acids, Am J Clin Nutr, 2003, 77, 1140-45 31 January 2008 Page 1,287 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Animal studies References Claim ID Harris WS, DiRienzo MA, Sands SA, George C, Jones PG, Eapen AK, Stearidonic acid increases the reed blood cell and heart eicosapentaenoic acid content in dogs, Lipids, 2007, 40(10), 995-998 Kelavar UP, Hutzley J, Dhir R, Kim P, Allen KGD, McHugh K, Prostate tumor growth and recurrence can be modulated by the (0-6:(0-3 ratio in diet: athymic mouse xenograft model simulating radical prostatectomy, Neoplasia, 2006, 8, 112-124 Cleland L, Gibson R, Pedler J,James M , Paradoxical Effect on n-3-containing vegetals oils on long chain n-3 fatty acids in Rat Heart, Lipids, 2005, 42, 325-333 Phipps JE, Enderson BL, Jones L, Whelan J, Karlstad MD, Enteral nutrition with stearidonic acid increases incorporation of anti-inflammatory N-3 fatty acids in liver phospholipids in the rat, Journal of Surgical Research, 2004, 121 (2), 330-331 In-vitro studies Molecule precursors regulating cell functions (prostaglandins, leucotrienes) 31 January 2008 Oil extracted from Seeds of Echium Plantagineum Horia E, Watkins BA, Comparison of stearidonic acid and a-linolenic acid on PGE2 production and COX-2 protein levels in MDA-MB-231 breast cancer cell cultures, The Journal of Nutritional Biochemistry, 2005, 16 (3), 184-192. 850 Page 1,288 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Kapoor R, Huang YS, Gamma linolenic acid; an anti-inflammatory omega-6 fatty acid, Current Pharmaceutical Biotechnology, 2006, 7, 531-534. Arterburn LM, Bailey E, Oken H; Distribution, interconversion, and dose response of n-3 fatty acids in human, Am J Clin Nutr, 2006, 83, 1467S-76S Das UN, Essential fatty acids: biochemistry, physiology and phatology, BiotechnoL J., 2006, 1, 420-439 Mesa-Garcia M, Aguilera-Garcia C, Gil-Hernandez A, Importance of lipids in the nutritional treatment of inflammatory diseases, Nutr. Hosp., 2006, 21, 28-41. Ruxton CHS, Calder PC, Reed SC, Simpson MJA; The impact of long-chain n-3 polyunsaturated fatty acids on human health; Nutrition Research Reviews, 2005, 18, 113-129 Vasquez A; Reducing pain and inflammation naturally. Part II: New insights into fatty acid supplementation and its effects on eicosanoid production and genetic expression, Journal of the Council on Nutrition of the American Chiropractic Association, 2005, 28(1), 5-16 Gamma-linolenic acid (GLA), Alternative Medicine Reviews, 2004, 9, 70-78 Fan Y, Chapkin RS, Importance of dietary y-linolenic acid in human health and nutrition, J. Nutr., 1998, 128, 1411-14 31 January 2008 Page 1,289 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies References Claim ID Barabino S, Rolando M, Camicione P et al., Systemic linoleic and gamma linolenic acid therapy in dry eye sindrome with an inflammatory component, Cornea, 2003, 22, 97-101 Aragona P, Bucolo C, Spinella R, Giuffrida S, Ferreri G, Systemic omega-6 essential fatty acid treatment and PGE1 tear content in Sj6gren's Syndrome patients, Investigative Ophtalmology & Visual Science, 2005, 46, 4474-9 Miles EA, Banerjee T, Dooper MMBW, M'Rabet L, Graus YMF, Calder P, The influence of different combinations of y-linolenic acid, stearidonic acid and EPA on immune function in healthy young male subjects, 2004, 91, 893-903 Barham JB, Edens MB, Fonteh AN, Johnson MM, Easter L, Chilton F, Addition of Eicosapentaenoic to y-linolenic acid-supplemented diets prevents serum arachidonic acid accumulation in humans, J Nutr, 2000, 130, 1925-1931 Chilton-Lopez, Surette ME, Swan DD, Fonteh AN, Johnson MM, Chilton F, Metabolism of gammalinolenic acid in human neutrophils, The Journal of Immunology, 1996, 156, 2941¬2947 Guivernau M, Meza N, Barja P, Roman 0; Clinical and experimental study on the long-term effect of dietary gamma-linolenic acid on plasma lipids, platelet aggregation, thromboxane formation, and prostacyclin production, Prostaglandins Leukot Essent Fatty Acids, 1994, 51(5), 311-6 31 January 2008 Page 1,290 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Animal studies References Claim ID Kelavar UP, Hutzley J, Dhir R, Kim P, Allen KGD, McHugh K, Prostate tumor growth and recurrence can be modulated by the (0-6:(0-3 ratio in diet: athymic mouse xenograft model simulating radical prostatectomy, Neoplasia, 2006, 8, 112-124 Petrik MBH, McEntee, MF, Johnson BJ, Obukowicz MG, Whelan J, Highly unsaturated n-3 fatty acids, but not a-I inolenic, conjugated linoleic or y-linolenic acids, reduce tumorigenesis in Apcmlni+ mice, J. Nutr, 2000, 130, 2434-2443 In vitro evidence Horia E, Watkins BA, Comparison of stearidonic acid and a-linolenic acid on PGE2 production and COX-2 protein levels in MDA-MB-231 breast cancer cell cultures, The Journal of Nutritional Biochemistry, 2005, 16 (3), 184-192. Kockmann V, Spielmann D, Traitler H, Lagarde M, Inhibitory effect of stearidonic acid (18:4 n-3) on platelet aggregation and arachidonate oxygenation, Lipids, 1989, 24, 1004-1007. Guichardant M, Traitler H, Spielmann D, Sprecher H, Finot PA, Stearidonic acid, an inhibitor of the 5-lipoxygenase pathway. A comparison with timnodonic acid and dihomo-y¬linoleic acid. Lipids, 1993, 28(4), 321-4 Lowering of blood triglycerides 31 January 2008 Oil extracted from Seeds of Echium Plantagineum Human studies Surette M, Edens M, Chilton F, Tramposch K, Dietary Echium oil increases plasma and neutrophil long-chain (n-3) fatty acids and lowers serum triacylglycerols in hypertriglyceridemic humans, Journal of Nutrition, 2004, 134, 1406-1411 851 Page 1,291 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Eicosapentaenoic acid Helps enhance mood Reviews Freeman MP et al, Omega-3 fatty acids: evidence basis for treatment and future research in Psychiatry, J Clin Psychiatry, 2006, 67, 1954-1967 Human studies Frangou S, Lewis M, McCrone P, Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: randomised double-blind pacebo-controlled study, British J. Psychiatry, 2006, 188, 46-50 854 Osher Y, Bersudsky Y, Belmaker RH, Omega-3 eicosapentaenoic acid in bipolar depression: report of a small open-label study, J. Clin Psychiatry, 2005, 66, 726-9 Peet M, Horrobin DF; A dose-ranging study of the effects of ethyl-eicosapentaenoate in patients with ongoing depression despite apparently adequate treatment with standard drugs, Arch Gen Psychiatry, 2002, 59, 913-919 Nemets B, Stahl Z, Belmaker RH, Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder, Am J Psychiatry, 2002, 159, 477-479 Crowe FL, Skeaff CM, Green TJ, Gray AR, Serum phospholipids n-3 long chain polyunsaturated fatty acids and physical and mental health in a population-based survey of New Zealand adolescents and adults, Am. J. Clin. Nutr., 2007, 86, 1278-85 Cardiovascular health 31 January 2008 853 Page 1,292 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Mori TA, Woodman RJ, The independent effects of eicosapentaenoic acid and docosahexaenoic acid on cardiovascular risk factors in humans, Curr Opin Clin Nutr Metab Care, 2006, 9(2), 95-104 von Schacky C; A review of omega-3 ethyl esters for the cardiovascular prevention and treatment of increased blood triglyceride levels, Vascular Health and Risk Management, 2006, 2(3), 251-262 Human studies Yokoyama M et aL; Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis, Lancet, 2007, 369, 1090-98 Authoritative Bodies Authoritative Bodies Eicosapentaenoic acid (EPA; C20:5 n-3) + docosahexaenoic acid (DHA; C22:6 n-3) or long-chain n-3 (omega 3) polyunsaturated fatty acids (LC n-3 PUFA, LC omega 3 PUFA) Cardiovascular System : maintenance and promotion of heart health and healthy circulation Providing no less than 0.2g LC n-3 PUFA per serving 489 Department of Health (1994). Nutritional Aspects of Cardiovascular Disease. Report of the Cardiovascular Review Group Committee on Medical Aspects of Food Policy. Report on Health and Social Subjects No. 46. London : HMSO Food Standards Agency (2004). Advice on Fish Consumption : benefits and risks. London : TSO Authoritative Opinion www.jhci.co.uk 31 January 2008 Page 1,293 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Emulsified Cod Liver Oil Intake of emulsified Cod Liver Oil improves the digestion and absorption of Omega-3 Fatty Acids 5-10ml per day Human Intervention Studies Garaiova I et al. A randomised cross-over trial in healthy adults indicating improved absorption of omega-3 fatty acids by pre-emulsification. Nutrition Journal 6:4 (2007). 991 5-10ml per day Human Intervention Studies Garaiova I et al. A randomised cross-over trial in healthy adults indicating improved absorption of omega-3 fatty acids by pre-emulsification. Nutrition Journal 6:4 (2007). 990 Emulsified Fish Oil Intake of emulsified Fish Oil improves the digestion and absorption of Omega-3 Fatty Acids 31 January 2008 Page 1,294 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Enova ™ Oil (diacylglycerol oil of plant origin – Min 80% diacylglycerols) Weight maintenance 31 January 2008 For total or partial replacement of traditional edible oils, or for use in a variety of foods and beverages (EFSA Opinion EFSA-Q2004-089) 650 Page 1,295 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body, Texbook, Human Intervention Studies 31 January 2008 References Claim ID 1. Japanese Ministry of Health, Foods for Special Health Use (FOSHU) system, May 1998 approved claim for Econa® Healthy Cooking Oil*. 2. Japanese Ministry of Health, Foods for Special Health Use (FOSHU) system, September 2003, approved claim for mayonnaise-type dressing with Econa® Healthy Cooking Oil* (*Econa® Healthy Cooking Oil is the brand name used in Japan for Enova ™ Oil) 3. Diacylglycerol Oil. AOCS Press 2004. Editors: Katsuragi, Y., Yasukawa, T., Matsuo, N., Flickinger, B.D., Tokimitsu, I., Matlock, M.G. 4. Kamphuis, M.M., Mela, D.J., Westerterp-Plantenga, M.S. Diacylglycerols affect substrate oxidation and appetite in humans. Am J Clin Nutr, 2003, 77(5), 1133-9. 5. Saito, S., Tomonobu, K., Hase, T., Tokimitsu, I. Effects of diacylglycerol on postprandial energy expenditure and respiratory quotient in healthy subjects. Nutrition, 2006, 22(1), 30-5. 6. Nagao, T., Watanabe, H., Goto, N., Onizawa, K., Taguchi, H., Matsuo, N., Yasukawa, T., Tsushima, R., Shimasaki,H., Itakura, H. Dietary diacylglycerol suppresses accumulation of body fat compared to triacylglycerol in men in a double-blind controlled trial. J Nutr, 2000, 130(4), 792-7. 7. Maki, K.C., Davidson, M.H., Tsushima, R., Matsuo, N., Tokimitsu, I., Umporowicz, D.M., Dicklin, M.R., Foster, G.S., Ingram, K.A., Anderson, B.D., Frost, S.D., Bell, M. Consumption of diacylglycerol oil as part of a reduced Page 1,296 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID energy diet enhances loss of body weight and fat in comparison with consumption of a triacylglycerol control oil. Am J Clin Nutr, 2002, 76(6), 1230-6. 8. Takei, A., Toi, T., Takahashi, H, Takeda, Y., Moriwaki, J., Takase, H., Katsuragi, Y. Effects of diacylglycerol containing mayonnaise on lipid metabolism and body fat in humans. J Nutr Food, 2001, 4, 89-101. 9. Teramoto, T., Watanabe, H., Ito, K., Furukawa, T., Shimoda, K., Hoshino, M., Nagao, T, Naito, S. Significant effects of diacylglycerol on body fat and lipid metabolism in patients on hemodialysis. Clin Nutr, 2004, 23(5), 1122-6. 10. Katsuragi, T., Toi, T., Yasukawa, T. Effects of dietary diacylglycerol on obesity and hyperlipidemia. Jap Soc Human Dry Dock, 1999, 14, 12-16. 31 January 2008 Page 1,297 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID EnovaTM Oil (diacylglycerol oil of plant origin – Min 80% diacylglycerols) Postprandial serum triglyceride 31 January 2008 For total or partial replacement of traditional edible oils, or for use in a variety of foods and beverages (EFSA Opinion EFSA-Q2004-089) 649 Page 1,298 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body, Textbook, Human Intervention Studies 31 January 2008 References Claim ID 1. Japanese Ministry of Health, Foods for Special Health Use (FOSHU) system, May 1998 approved claim for Econa® Healthy Cooking Oil*. (*Econa® Healthy Cooking Oil is the brand name used in Japan for EnovaTM Oil) 2. Diacylglycerol Oil. AOCS Press 2004. Editors: Katsuragi, Y., Yasukawa, T., Matsuo, N., Flickinger, B.D., Tokimitsu, I., Matlock, M.G 3. Taguchi, H., Watanabe, H., Onizawa, K., Nagao, T., Gotoh, N., Yasukawa, T., Tsushima, R., Shimasaki, H., Itakura, H. Double-blind controlled study on the effects of dietary diacylglycerol on postprandial serum and chylomicron triacylglycerol responses in healthy humans. J Am Coll Nutr, 2000, 19(6), 789-96. 4. Takase, H., Shoji, K., Hase, T., Tokimitsu, I. Effect of diacylglycerol on postprandial lipid metabolism in non-diabetic subjects with and without insulin resistance. Atherosclerosis, 2005, 180(1), 197-204. 5. Tada, N., Shoji, K., Takeshita, M., Watanabe, H., Yoshida, H., Hase, T., Matsuo, N., Tokimitsu, I. Effects of diacylglycerol ingestion on postprandial hyperlipidemia in diabetes. Clin Chim Acta, 2005, 353, 87-94. 6. Yamamoto, K., Asakawa, H., Tokunaga, K., Meguro, S., Watanabe, H., Tokimitsu, I., Yagi, N. Effects of diaclyglcyerol administration on serum triacylglycerol in a patient homozygous for complete lipoprotein lipase deletion. Metabolism, 2005, 54(1), 67-71. 7. Tada, N., et al., Dynamics of postprandial remnant-like lipoprotein particles in serum after loading of diacylglycerols. Cli n Ch i m Acta, 2001, Page 1,299 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 311, 109-17. 8. Tomonobu, K., Hase, T., Tokimitsu, I. Dietary diaclyglycerol in a typical meal suppresses postprandial increases in serum lipid levels compared with dietary triacylglcyerol. Nutrition, 2006, 22(2), 12835. 31 January 2008 Page 1,300 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID EPA and DHA Omega-3 fatty acids Joint health General Population. Authoritative Body; Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day) Expert and Scientific Organisations; Health Canada, Natural Health Products Directorate, Fish Oil Monograph, 2006. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hp fb-dgpsa/pdf/prodnatur/mono_fish_oil_huile_po isson_e.pdf 2,436 Published research Expert Workshop of the European Academy of Nutritional Sciences (1998). de Deckere EA, Korver O, Verschuren PM, Katan MB. Health aspects of fish and n-3 polyunsaturated fatty acids from plant and marine origin. Eur J Clin Nutr 1998 Oct; 52(10): 749-753. Agency for Health Care Research and Quality (US) (2004). Shekelle PG et al. Effects of Omega-3 Fatty Acids on Lipids and Glycaemic Control in Type II Diabetes and the Metabolic Syndrome and on Inflammatory Bowel Disease, Rheumatoid Arthritis, Renal Disease, Systemic Lupus Erythematosus, and Osteoporosis. Evidence Report/Tech Assessment No. 89. http://www.ahrq.gov/downloads/pub/evidence/p df/o3lipid/o3lipid.pdf. Calder PC, Am J Clin Nutr 2006; 83 (suppl), 1505S-1519S. n-3 Polyunsaturated fatty acids, inflammation, and inflammatory diseases. Fortin PR et al, J Clin Epidemiol 1995, 48, 1379-90. Validation of a meta-analysis: The effects of fish oil in rheumatoid arthritis. Mood General Population. 2,435 Minimum 15% RDI per 100g or 100kcal. 31 January 2008 Page 1,301 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use (RDI for EPA+DHA assumed as 200mg/day) Nature of Evidence Published research References Claim ID Fontani G et al: Eur J Clin Invest 2005; 35 (11), 691-9. Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects. Timonen M et al: J Affect Disord 2004; 82(3), 447-52. Fish consumption and depression: the Northern Finland 1966 birth cohort study. Otto SJ et al: Prostaglandins Leukot Essent Fatty Acids 2003; 69(4), 237-43. Increased risk of post-partum depressive symptoms is associated with slower normalization after pregnancy of the functional docosahexaenoic acid status Tiemeier H et al: Am J Clin Nutr 2003; 78 (1), 40-6. Plasma fatty acid composition and depression are associated in the elderly: the Rotterdam study. Makrides M et al: Asia Pac J Clin Nutr 2003; 12 Supple S37. Docosahexanaenoic acid and post-partum depression – is there a link? Mamalakis G et al: Prostaglandins Leukot Essent Fatty Acids 2002; 67 (5), 311-8. Depression and adipose essential polyunsaturated fatty acids. Hibbeln JR: J Affect Disord 2002; 69 (1-3), 15-29. Seafood consumption, the DHA content of mother’s milk and prevalence rates of postpartum depression: a cross-national, ecological analysis. Tanskanen A et al: Psychiatr Serv 2001; 52 (4), 529-31. Fish consumption and depressive symptoms in the general population in Finland. 31 January 2008 Page 1,302 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Edwards R et al: J Affect Disord 1998; 48 (2-3), 149-55. Omega-3 polyunsaturated fatty acid levels in the diet and in red blood cell membranes of depressed patients. Yehuda S et al: Nutr Neurosci 2005; 8 (4), 265-7. Mixture of essential fatty acids lowers test anxiety. Silvers KM and Scott KM: Public Health Nutr 2002; 5 (3), 427-31. Fish consumption and self-reported physical and mental health status. 31 January 2008 Page 1,303 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Essential fatty acid Alpha-linolenic acid (LNA - omega 3) Blood cholesterol 31 January 2008 Scientific Body WHO 2003. Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 08537 164 Page 1,304 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative/Scientific Bodies Meta-Analysis Reviews Individual Studies References Claim ID Authoritative/Scientific Bodies EFSA 2005. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to nutrition claims concerning omega-3 fatty acids, monounsaturated fat, polyunsaturated fat and unsaturated fat Request N° EFSA-Q2004-107)(adopted on 6 July 2005) FDA. FDA USA Authoritative Statement on MUFA from olive oil and CHD. Meta-Analysis Mensink RP et al., Effects of dietary fatty acids and carbohydrates on the ratio of serum total to HDL cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am J Clin Nutr. 2003;77:114655. Brouwer IA, Katan MB, Zock PL. Dietary alpha-linolenic acid is associated with reduced risk of fatal coronary heart disease, but increased prostate cancer risk: a meta-analysis. J Nutr. 2004;134:919-22. Reviews De Lorgeril M, Salen P. Dietary prevention of coronary heart disease: the Lyon diet heart study and after.World Rev Nutr Diet. 2005;95:103-14. Review. British Nutrition Foundation 2005. Stanner S (ed) Cardiovascular Diease: Diet, Nutrition and Emerging Risk Factors Individual Studies Finnegan YE, Minihane AM, Leigh-Firbank EC et al. Plant- and marine-derived polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid concentrations and on the susceptibility of LDL to oxidative modification in moderately 31 January 2008 Page 1,305 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID hyperlipidemic subjects. Am J Clin Nutr 2003;77:783-95. Petra L. L. Goyens and Ronald P. MensinkThe Dietary alpha-Linolenic Acid to Linoleic Acid Ratio Does Not Affect the Serum Lipoprotein Profile in Humans.J. Nutr. 135: 2799–2804, 2005 Artery/Heart health 31 January 2008 Scientific Body WHO 2003. Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 08537 165 Page 1,306 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Scientific Body Reviews References Claim ID Authoritative/Scientific Bodies EFSA 2005. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to nutrition claims concerning omega-3 fatty acids, monounsaturated fat, polyunsaturated fat and unsaturated fat Request N° EFSA-Q2004-107)(adopted on 6 July 2005) FDA. FDA USA Authoritative Statement on MUFA from olive oil and CHD. Meta-Analysis Mensink RP et al., Effects of dietary fatty acids and carbohydrates on the ratio of serum total to HDL cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am J Clin Nutr. 2003;77:114655. Brouwer IA, Katan MB, Zock PL. Dietary alpha-linolenic acid is associated with reduced risk of fatal coronary heart disease, but increased prostate cancer risk: a meta-analysis. J Nutr. 2004;134:919-22. Reviews De Lorgeril M, Salen P. Dietary prevention of coronary heart disease: the Lyon diet heart study and after.World Rev Nutr Diet. 2005;95:103-14. Review. British Nutrition Foundation 2005. Stanner S (ed) Cardiovascular Diease: Diet, Nutrition and Emerging Risk Factors Individual Studies Finnegan YE, Minihane AM, Leigh-Firbank EC et al. Plant- and marine-derived polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid concentrations and on the susceptibility of LDL to oxidative modification in moderately 31 January 2008 Page 1,307 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID hyperlipidemic subjects. Am J Clin Nutr 2003;77:783-95. Petra L. L. Goyens and Ronald P. MensinkThe Dietary alpha-Linolenic Acid to Linoleic Acid Ratio Does Not Affect the Serum Lipoprotein Profile in Humans.J. Nutr. 135: 2799–2804, 2005 31 January 2008 Page 1,308 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Expert Review National Cholesterol Education Program. Third report of the expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. http://www.nhlbi.nih.gov/guidelines/cholesterol/ atp3_rpt.htm. Bethesda, MD, National Heart, Lung and Blood Institute Review Hutter CM, Austin MA, Humphries SE. Familial hypercholesterolemia, peripheral arterial disease, and stroke: a HuGE minireview. Am J Epidemiol. 2004; 160(5): 430435 Clinical Trials Arntzenius AC et al Diet, lipoproteins, and the progression of coronary atherosclerosis. The Leiden Intervention Trial. N Engl J Med. 1985;312:805-11. Dayton S, Pearce ML, Hashimoto S, Dixon WJ, Tomiyasu U. A controlled clinical trial of a diet high in unsaturated fat in preventing complications of atherosclerosis. Circulation 1969;40 (suppl 2):1-63. Individual Studies Agmon Y, Khandheria BK, Meissner I, Schwartz GL, Petterson TM, O'Fallon WM, Whisnant JP, Wiebers DO, Seward JB. Relation of coronary artery disease and cerebrovascular disease with atherosclerosis of the thoracic aorta in the general population. Am J Cardiol. 2002: 89(3): 262-267. Brown AA and Hu F B (2001) Dietary Modulation of Endothelial Function: Implications for Cardiovascular Disease. Am J Clin Nutr 73:673-686. Frantz ID, Jr., Dawson EA, Ashman PL et al. Test of effect of lipid lowering by diet on cardiovascular risk. The Minnesota Coronary 31 January 2008 Page 1,309 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Survey. Arteriosclerosis 1989;9:129-35. Law MR, Wald NJ, & Thompson SG By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? 1994 BMJ. 308, 367372. Leren P. The Oslo diet-heart study. Eleven-year report. Circulation 1970;42:935-42. Matsushima Y, Kawano H, Koide Y, Baba T, Toda G, Seto S, Yano K. Relationship of carotid intima-media thickness, pulse wave velocity, and ankle brachial index to the severity of coronary artery atherosclerosis. Clin Cardiol. 2004: 27(11): 629-634. Nicolosi RJ, Wilson TA, Rogers EJ, Kritchevsky D. Effects of specific fatty acids (8:0, 14:0, cis-18:1, trans-18:1) on plasma lipoproteins, early atherogenic potential, and LDL oxidative properties in the hamster. J Lipid Res. 1998;39:1972-80. Nicolosi RJ. Experimental mechanism: formation of atheroma. Am J Clin.Nutr. 1995;62:689S-92S. Taniguchi H, Momiyama Y, Fayad ZA, Ohmori R, Ashida K, Kihara T, Hara A, Arakawa K, Kameyama A, Noya K, Nagata M, Nakamura H, Ohsuzu F. In vivo magnetic resonance evaluation of associations between aortic atherosclerosis and both risk factors and coronary artery disease in patients referred for coronary angiography.Am Heart J. 2004: 148(1): 137-143. Turpeinen O, Karvonen MJ, Pekkarinen M, Miettinen M, Elosuo R, Paavilainen E. Dietary prevention of coronary heart disease: the Finnish Mental Hospital Study. Int.J Epidemiol. 1979;8:99-118. Watts GF, Jackson P, Burke V, Lewis B. Dietary fatty acids and progression of coronary artery disease in men. Am J Clin.Nutr 31 January 2008 Page 1,310 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 1996;64:202-9. Brain development and maturation of neurosensorial functions Molecule precursors regulating cell functions (prostaglandins, leucotrienes) 31 January 2008 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 08537 Expert Reviews WHO/FAO Fats and oils in human nutrition Report of a joint expert consultation. Rome, 19-26 October 1993 Expert Reviews British Nutrition Foundation (1999) Briefing Paper: n-3 Faty Acids and Health. Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. 162 163 Page 1,311 of 3,931 Category Food Component Health Relationship Growth and development and maintenance 31 January 2008 Suggested Conditions of Use Nature of Evidence References Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Claim ID 161 Page 1,312 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Essential fatty acid Linoleic Acid (LA - omega 6) Artery/ Heart health 31 January 2008 Scientific Body WHO 2003. Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 08537 160 Page 1,313 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Scientific Body Reviews References Claim ID Authoritative/Scientific Bodies EFSA 2005. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to nutrition claims concerning omega-3 fatty acids, monounsaturated fat, polyunsaturated fat and unsaturated fat Request N° EFSA-Q2004-107)(adopted on 6 July 2005) FDA. FDA USA Authoritative Statement on MUFA from olive oil and CHD. Meta-Analysis Mensink RP et al., Effects of dietary fatty acids and carbohydrates on the ratio of serum total to HDL cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am J Clin Nutr. 2003;77:114655. Brouwer IA, Katan MB, Zock PL. Dietary alpha-linolenic acid is associated with reduced risk of fatal coronary heart disease, but increased prostate cancer risk: a meta-analysis. J Nutr. 2004;134:919-22. Reviews De Lorgeril M, Salen P. Dietary prevention of coronary heart disease: the Lyon diet heart study and after.World Rev Nutr Diet. 2005;95:103-14. Review. British Nutrition Foundation 2005. Stanner S (ed) Cardiovascular Diease: Diet, Nutrition and Emerging Risk Factors Individual Studies Finnegan YE, Minihane AM, Leigh-Firbank EC et al. Plant- and marine-derived polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid concentrations and on the susceptibility of LDL to oxidative modification in moderately 31 January 2008 Page 1,314 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID hyperlipidemic subjects. Am J Clin Nutr 2003;77:783-95. Petra L. L. Goyens and Ronald P. MensinkThe Dietary alpha-Linolenic Acid to Linoleic Acid Ratio Does Not Affect the Serum Lipoprotein Profile in Humans.J. Nutr. 135: 2799–2804, 2005 31 January 2008 Page 1,315 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Expert Review National Cholesterol Education Program. Third report of the expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. http://www.nhlbi.nih.gov/guidelines/cholesterol/ atp3_rpt.htm. Bethesda, MD, National Heart, Lung and Blood Institute Review Hutter CM, Austin MA, Humphries SE. Familial hypercholesterolemia, peripheral arterial disease, and stroke: a HuGE minireview. Am J Epidemiol. 2004; 160(5): 430435 Clinical Trials Arntzenius AC et al Diet, lipoproteins, and the progression of coronary atherosclerosis. The Leiden Intervention Trial. N Engl J Med. 1985;312:805-11. Dayton S, Pearce ML, Hashimoto S, Dixon WJ, Tomiyasu U. A controlled clinical trial of a diet high in unsaturated fat in preventing complications of atherosclerosis. Circulation 1969;40 (suppl 2):1-63. Individual Studies Agmon Y, Khandheria BK, Meissner I, Schwartz GL, Petterson TM, O'Fallon WM, Whisnant JP, Wiebers DO, Seward JB. Relation of coronary artery disease and cerebrovascular disease with atherosclerosis of the thoracic aorta in the general population. Am J Cardiol. 2002: 89(3): 262-267. Brown AA and Hu F B (2001) Dietary Modulation of Endothelial Function: Implications for Cardiovascular Disease. Am J Clin Nutr 73:673-686. Frantz ID, Jr., Dawson EA, Ashman PL et al. Test of effect of lipid lowering by diet on cardiovascular risk. The Minnesota Coronary 31 January 2008 Page 1,316 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Survey. Arteriosclerosis 1989;9:129-35. Law MR, Wald NJ, & Thompson SG By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease? 1994 BMJ. 308, 367372. Leren P. The Oslo diet-heart study. Eleven-year report. Circulation 1970;42:935-42. Matsushima Y, Kawano H, Koide Y, Baba T, Toda G, Seto S, Yano K. Relationship of carotid intima-media thickness, pulse wave velocity, and ankle brachial index to the severity of coronary artery atherosclerosis. Clin Cardiol. 2004: 27(11): 629-634. Nicolosi RJ, Wilson TA, Rogers EJ, Kritchevsky D. Effects of specific fatty acids (8:0, 14:0, cis-18:1, trans-18:1) on plasma lipoproteins, early atherogenic potential, and LDL oxidative properties in the hamster. J Lipid Res. 1998;39:1972-80. Nicolosi RJ. Experimental mechanism: formation of atheroma. Am J Clin.Nutr. 1995;62:689S-92S. Taniguchi H, Momiyama Y, Fayad ZA, Ohmori R, Ashida K, Kihara T, Hara A, Arakawa K, Kameyama A, Noya K, Nagata M, Nakamura H, Ohsuzu F. In vivo magnetic resonance evaluation of associations between aortic atherosclerosis and both risk factors and coronary artery disease in patients referred for coronary angiography.Am Heart J. 2004: 148(1): 137-143. Turpeinen O, Karvonen MJ, Pekkarinen M, Miettinen M, Elosuo R, Paavilainen E. Dietary prevention of coronary heart disease: the Finnish Mental Hospital Study. Int.J Epidemiol. 1979;8:99-118. Watts GF, Jackson P, Burke V, Lewis B. Dietary fatty acids and progression of coronary artery disease in men. Am J Clin.Nutr 31 January 2008 Page 1,317 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 1996;64:202-9. Growth and development and maintenance of body functions Brain development and maturation of neurosensorial functions Blood cholesterol 31 January 2008 Linoleic acid (omega 6) lowers blood cholesterol. Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. 156 157 159 Page 1,318 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Scientific Body WHO 2003. Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Claim ID Page 1,319 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Scientific Body Reviews References Claim ID Authoritative/Scientific Bodies EFSA 2005. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to nutrition claims concerning omega-3 fatty acids, monounsaturated fat, polyunsaturated fat and unsaturated fat Request N° EFSA-Q2004-107)(adopted on 6 July 2005) FDA. FDA USA Authoritative Statement on MUFA from olive oil and CHD. WHO 2003 Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series, no. 916 (TRS 916). Meta-Analysis Mensink RP et al., Effects of dietary fatty acids and carbohydrates on the ratio of serum total to HDL cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am J Clin Nutr. 2003;77:114655. Brouwer IA, Katan MB, Zock PL. Dietary alpha-linolenic acid is associated with reduced risk of fatal coronary heart disease, but increased prostate cancer risk: a meta-analysis. J Nutr. 2004;134:919-22. Reviews De Lorgeril M, Salen P. Dietary prevention of coronary heart disease: the Lyon diet heart study and after.World Rev Nutr Diet. 2005;95:103-14. Review. British Nutrition Foundation 2005. Stanner S (ed) Cardiovascular Diease: Diet, Nutrition and Emerging Risk Factors Individual Studies Finnegan YE, Minihane AM, Leigh-Firbank EC et al. Plant- and marine-derived polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid 31 January 2008 Page 1,320 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID concentrations and on the susceptibility of LDL to oxidative modification in moderately hyperlipidemic subjects. Am J Clin Nutr 2003;77:783-95. Petra L. L. Goyens and Ronald P. MensinkThe Dietary alpha-Linolenic Acid to Linoleic Acid Ratio Does Not Affect the Serum Lipoprotein Profile in Humans.J. Nutr. 135: 2799–2804, 2005 Molecule precursors regulating cell functions (prostaglandins, leucotrienes) 31 January 2008 Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2002. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Expert Reviews WHO/FAO Fats and oils in human nutrition Report of a joint expert consultation. Rome, 19-26 October 1993 Expert Reviews British Nutrition Foundation (1999) Briefing Paper: n-3 Faty Acids and Health. 158 Page 1,321 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Essential Fatty Acids Essential fatty acids to aid in digestive tract function. 31 January 2008 No RDA / RNI 2,406 Page 1,322 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID "Wild GE, Drozdowski L, Tartaglia C, Clandinin MT, Thomson AB. Nutritional modulation of the inflammatory response in inflammatory bowel disease--from the molecular to the integrative to the clinical. World J Gastroenterol. 2007 Jan 7;13(1):1-7. Full-text available at: <http://www.wjgnet.com/1007-9327/13/1.asp>. Meister D, Ghosh S. Effect of fish oil enriched enteral diet on inflammatory bowel disease tissues in organ culture: differential effects on ulcerative colitis and Crohn's disease. World J Gastroenterol. 2005 Dec 21;11(47):7466-72. Full-text available at <http://www.wjgnet.com/1007-9327/11/7466.as p>. Senkal M, Haaker R, Linseisen J, Wolfram G, Homann HH, Stehle P. Preoperative oral supplementation with long-chain Omega-3 fatty acids beneficially alters phospholipid fatty acid patterns in liver, gut mucosa, and tumor tissue. JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4):236-40. Abstract available at <http://jpen.aspenjournals.org/cgi/content/abstr act/29/4/236>. " 1. Natural Medicines Comprehensive Database 2000 2. The Complete German Commission E Monographs Therapeutic Guide to Herbal Medicines 1998 American Botanical Council 3. PDR for Herbal Medicines 2nd Edition 2000 Medical Economics Co. Inc. 31 January 2008 Page 1,323 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 4. The Review of Natural Products Facts and Comparisons Wolters Kluwer Health Inc. 2003 5. A Dictionary of Natural Products George MacDonald Hawking, 1997 Plexus Publishing 6. The Natural Pharmacy 2nd Edition Prima Health 1999 Healthnotes Inc. 7. Pharmacognosy and Pharmacobiotechnology Robbers, Speedie and Tyler. 1996 Williams and Wilkins 8. Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetics 2nd Ed. Albert Leung and Steven Foster 1996 John Wiley & Sons, Inc. 10. J Agric Food Chem. 2006 Jun 14;54(12):4162-7 Total oxidant scavenging capacity of Euterpe oleracea Mart. (açaí) seeds and identification of their polyphenolic compounds. 11. J Ethnopharmacol. 2006 Sep 19;107(2):291-6. Epub 2006 Mar 22. Inhibitory effects of Euterpe oleracea Mart. on nitric oxide production and iNOS expression. 12. J Agric Food Chem. 2006 Feb 22;54(4):1222-9. Açai (Euterpe oleracea Mart.) polyphenolics in their glycoside and aglycone forms induce apoptosis of HL-60 leukemia cells. 13. Int J Food Sci Nutr. 2005 Feb;56(1):53-64. Total oxidant scavenging capacities of Euterpe oleracea Mart. (Açaí) fruits. 14. J Agric Food Chem. 2004 Mar 31 January 2008 Page 1,324 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 24;52(6):1539-45 Phytochemical composition and pigment stability of Açai (Euterpe oleracea Mart.). • Kong J. M., Chia L. S., Goh N. K., Chia T. F., Brouillard R. (2003). "Analysis and biological activities of anthocyanins.". Phytochemistry 64 (5): 923-33. DOI:10.1016/S0031-9422(03)00438-2. • Wada L, Ou B (2002). Antioxidant activity and phenolic content of Oregon caneberries.. J Agric Food Chem. Jun 5;50(12):3495-500. • Stoner GD, Wang LS, Zikri N, Chen T, Hecht SS, Huang C, Sardo C, Lechner JF (2007). Cancer prevention with freeze-dried berries and berry components.. 1: Semin Cancer Biol. May 10; • Andersen, O.M. Flavonoids: Chemistry, Biochemistry and Applications. CRC Press, Boca Raton FL 2006. • G. M. Robinson, Robert Robinson (1931). "A survey of anthocyanins. I". Biochem J. 25 (5): 1687–1705. 31 January 2008 Page 1,325 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Evening primrose oil Menstrual health Product-specific claim: 3000 mg capsules per day individual clinical studies Human Intervention Studies Collins A, Cerin A, Colemen G, Mandgren B. Essential fatty acids in the treatment of Premenstrual Syndrome (PMS). Obstet Gynecol 1993;81:93-8. Puolakka J, Makarainen L, Viinikka L and Ylikorkala O. Biochemical and clinical effects of treating the premenstrual syndrome with prostaglandin synthesis precursors. The Journal of Reproductive Medicine. 1985, Vol 30, No. 3; pp149-153. Ockerman PA, Bachrack I, Glans S, Rassner S. Evening primrose oil as a treatment of the premenstrual syndrome Recent Advances in Clinical Nutrition. 1986, Vol 2, pp 404-405. 400 Hormonal Health Ref 1: Twelve 500 mg capsules per day of EPO daily. Human Intervention Studies Ref 1 - Collins A, Cerin A, Colemen G, Mandgren B. Essential fatty acids in the treatment of Premenstrual Syndrome (PMS). Obstet Gynecol 1993;81:93-8. 704 Ref 2 : Eight 500 mg capsules per day of EPO daily. Ref 3: Six 500 mg capsules of EPO daily. Product-specific claim/ 3000 mg capsules per day. Skin health 31 January 2008 Product-specific claim: Ref 2- Puolakka J, Mäkäräinen L, Viinikka L and Ylikorkala O. Biochemical and clinical effects of treating the premenstrual syndrome with prostaglandin synthesis precursors. The Journal of Reproductive Medicine. 1985, Vol 30, No. 3; pp149-153 Ref 3 - Ockerman PA, Bachrack I, Glans S, Rassner S. Evening primrose oil as a treatment of the premenstrual syndrome. Recent Advances in Clinical Nutrition. 1986, Vol 2, pp 404-405 399 Page 1,326 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use 3000-6000 mg capsules per day 31 January 2008 Nature of Evidence meta-analyses and individual study References Claim ID Morse NL and Clough PM. A meta-analysis of randomized, placebo-controlled clinical trials of Efamol evening primrose oil in atopic eczema. Where do we go from here in light of more recent discoveries? Current Pharmaceutical Biotechnology 2006, 7: (6) pp 503-24 Morse PF, Horrobin DF, Manku MS, Stewart JCM, Allen R, Littlewood S, Wright S, Burton J, Gould DJ, Holts PJ,Jansen CT, Mattila L, Meigel W, Dettke TH, Wexler D, Guenther L, Bordoni A and Patrizi A.Meta-analysis of placebo-controlled studies of the efficacy of Epogam in The treatment of atopic eczema. Relationship between plasma essential fatty acid changes and clinical response. British Journal of Dermatology 1989, 121:75-90. Human Intervention Studies Muggli R Systemic evening primrose oil improves the biophysical skin parameters of healthy adults. International Journal of Cosmetic Science. 2005; 27:243-249. Page 1,327 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Evening Primrose Oil (EPO), Oenothera spp. and Fish Oil (FO) providing long chain omega 6 and omega 3 fatty acids [gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA)] Joint Health Ref 7 - 240 mg eicosapentaenoic acid from Fish Oil and 450 mg gamma-linolenic acid from Evening Primrose Oil per day (Note: This is 6 g of a mixture of 80% evening primrose oil and 20% fish oil by weight) Meta-Analyses of Human Clinical Trials and Systematic Reviews Ref 1 - Goldberg RJ, Katz J. A meta-analysis of the analgesic effects of omega-3 polyunsaturated fatty acid supplementation for inflammatory joint pain. Pain. 2007 May;129(1-2):210-23. 705 Ref 2- Fortin PR, Lew RA, Liang MH, Wright EA, Beckett LA, Chalmers TC, Sperling RI. Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. J Clin Epidemiol. 1995 Nov;48(11):1379-90. Ref 3 - Little CV & Parsons T. Herbal therapy for treating rheumatoid arthritis. The Cochrane Database of Systematic Reviews 2000, Issue 4, Art. No. CD002948. DOI:10.1002/14651858.CD002948. Ref 4 - Soeken KL, Miller SA, Ernst E. Herbal medicines for the treatment of rheumatoid arthritis: a systematic review. Rheumatology 2003, 42:652-659. Ref 5 - Ernst E and Chrubasik S. Phyto-anti-inflammatories. A systematic review of randomized, placebo-controlled, double-blind trials. Rheumatic Diseases Clinics of North America 26(1):13-27. Feb 2000. 31 January 2008 Page 1,328 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human Clinical Studies References Claim ID Ref 6 - Brzeski M, Madhok R, Capell HA. Evening primrose oil in patients with rheumatoid arthritis and side-effects of non-steroidal anti-inflammatory drugs. Br J Rheumatol 1991 Oct;30(5):370-2 Ref 7 - Belch JJF et al. Effects of altering dietary essential fatty acids on requirements for non-steroidal anti-inflammatory drugs in patients with rheumatoid arthritis: a double-blind placebo controlled study. Annals of the Rheumatic Disease 1988:47:96-104. Ref 8 - Veale DJ, Torley HI, Richards IM, O'Dowd A, Fitzsimons C, Belch JJ, Sturrock RD. A double-blind placebo controlled trial of Efamol Marine on skin and joint symptoms of psoriatic arthritis. Br J Rheumatol. 1994 Oct;33(10):954-8. Ref 9 - Jantti J, Seppala E, Vapaatalo H, Isomaki H. Evening primrose oil and olive oil in treatment of rheumatoid arthritis. Clin Rheumatol. 1989 Jun;8(2):238-44. Epidemiological Studies Ref 10 - Navarro E, Esteve M, Olive A, Klaassen J, Cabre E, Tena X, Fernandez-Banares F, Pastor C, Gassull MA. Abnormal fatty acid pattern in rheumatoid arthritis. A rationale for treatment with marine and botanical lipids. J Rheumatol. 2000 Feb;27(2):298-303. Ref 11 - Barham JB, Edens MB, Fonteh AN, Johnson MM, Easter L, Chilton FH. Addition of eicosapentaenoic acid to gamma-linolenic acid-supplemented diets prevents serum arachidonic acid accumulation in humans. J Nutr. 2000 Aug;130(8):1925-31. 31 January 2008 Page 1,329 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Review Articles Ref 12 - Belch JJ, Muir A. n-6 and n-3 essential fatty acids in rheumatoid arthritis and other rheumatic conditions. Proc Nutr Soc. 1998 Nov;57(4):563-9. Text Books Ref 13 - Belch JJ. Essential Fatty Acids and Rheumatoid Arthritis. In: Omega 6 Essential Fatty Acid, Pathophysiology and role in clinical medicine. DF Horrobin (ed.) Wiley-Liss, New York. 1990, pp. 223-237. Claim ID Page 1,330 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Evening primrose oil and fish oil Bone health 31 January 2008 Product-specific claim: 4-6 g of 80% EPO and 20% FO per day 401 Page 1,331 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence individual clinical human studies, animal studies References Claim ID Human Intervention Studies Bassey EJ, Littlewood JJ, Rothwell MC, Pye DW Lack of effect of supplementation with essential fatty acids on bone mineral density in healthy pre-and postmenopausal women: two randomized controlled trials of Efacal v calcium alone. Br J Nutr 2000 Jun;83(6):629 35. Belch J Ansell D, Madhok R, O’Dowd A, Sturrock R Effects of altering dietary essential fatty acids on requirements for non-steroidal anti-inflammatory drugs in patients with rheumatoid arthritis: A double-blind, placebo-controlled study. Annals of Rheumatic Diseases. 1988;47:96-104 Buck AC, Smellie WS, Jenkins A, Meddins R, James A and Horrobin DF. The treatment of idiopathic recurrent urolithiasis with fish oil and evening primrose oil - A double-blind study. Urolithiasis 2, Ed. Ryall R et al. Plenum Press, New York, 1994: 575-579. Kruger MC, Coetzer H, DeWinter R, Gericke G and van Papendorp DH Calcium, gamma¬linolenic acid and eicosapentaenoic supplementation in senile osteoporosis Aging 1998;10(5):385-94. van Papendorp DH, Coetzer H and Kruger MC. Biochemical profile of osteoporotic patients on essential fatty acid Supplementation Nutrition Research 1995; 15 (3): 325-334. Animal Studies Buck AC, Jackson R, Lingan K and Horrobin D. The prevention of experimental nephrocalcinosis with eicosapentaenoic acid and evening primrose oil. J Urology 1993;149:499A. Claassen N, Coetzer H, Steinmann CML and Kruger MC The effect of different n6/n3 EFA ratios on calcium balance and bone in 31 January 2008 Page 1,332 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID rats. Prostaglandin Leukot Essent Fatty Acids 1995;53(1):13-9. Claassen N, Potgieter HC, Seppa M, Vermaak WJH, Coetzer H, van Papendorp DH andd Kruger MC Supplemented gamma-linolenic acid and eicosapentaenoic acid influence bone status in young male rats: Effects on free urinary collagen crosslinks, total urinary hydroxyproline and bone calcium content. Bone 1995; 16(4):385S-392S. Coetzer H, Claassen N, van Papendorp DH and Kruger MC. Calcium transport by isolated brush border and basolateral membrane vesicles: role of essential fatty acid supplementation Prostaglandins, Leukot Essent Fatty Acids. 1994; 50 : 257-266. Sakaguchi K, Murita I, Murota S Eicosapentaenoic acid inhibits bone loss due to ovariectomy in rats. Prostaglandins Leukot Essent Fatty Acids 1994;50(2):81-4. Sun D, Krishnan A, Zaman K, Lawrence R, Bhattacharya A, Fernandes G Dietary n-3 fatty acids decrease osteoclastogenesis and loss of bone mass in ovariectomized mice. J Bone Miner Res 2003;18(7):1206-16 Fat Satiety 31 January 2008 Textbook Biesalski et al. ‘Nutrition medicine’, 2005. 1,588 Page 1,333 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fats Supply of metabolic energy Cell growth/cell functioning and structure 31 January 2008 Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. 149 150 Page 1,334 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Claim ID Fats (containing EFA) Essential fatty acids (EFA) supply 31 January 2008 152 Page 1,335 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fats (fatty acids higher than c-10) Absorption of fat soluble vitamins 31 January 2008 Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. 151 Page 1,336 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fish oil Brain / cognitive function 1.5g daily of EPA/DHA is recommended 1,064 Do not use if taking anti-coagulant medication (e.g. warfarin or asprin) 31 January 2008 Page 1,337 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human study RCT Reviews Peer reviewed journal References Claim ID Beydoun MA, Kaufman JS, Satia JA, Rosamond W et al. Plasma n-3 fatty acids and the risk of cognitive decline in older adults: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 2007 Apr;85(4):1103-11 Amminger GP, Berger GE, Schafer MR, Klier C et al. Omega-3 fatty acids supplementation in children with autism: a double-blind, randomised, placebo-controlled pilot study. Biol Psychiatry. 2007 Feb 15;61(4):551-3 Freund-Levi Y, Eriksdotter-Jonhagen M, Cederholm T, Basum H et al. Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer’s disease: OmegaAD study: a randomised, double-blind trial. Arch Neurol. 2006 Oct; 63(10):1402-8 Bourre JM. Dietary omega-3 fatty acids for women. Biomed Pharmacother. 2007 Feb-Apr;61(2-3):105-12. Epub 2007 Jan 2. Review. Lim WS, Gammack JK, Van Niekerk J, Dangour AD. Omega-3 fatty acids for the prevention of dementia. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005379 Richardson AJ, Montgomery P. The Oxford-Durham study: a randomised, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics 2005 May;115(5):1360-6 Kalmijn S, van Boxtel MP, Ocke M, Verschuren WM et al . Dietary intake of fatty acids and fish in relation to cognitive performance at middle age. Neurology. 2004 Jan 27;62(2):275-80 31 January 2008 Page 1,338 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Morris MC, Evans DA, Bienias JL, Tangney CC et al. Consumption of fish and n-3 fatty acids and risk of incident Alzheimer’s disease. Arch Neurol. 2003 Jul;60(7):940-6 Su KP, Huang SY, Chiu CC, Shen WW. Omega-3 fatty acids in major depressive disorder. A preliminary double-blind, placebo-controlled trial. Eur Neuropsychopharmacol. 2003 Aug; 13(4):267-71 Heude B, Ducimetiere P, Berr C; EVA study. Cognitive decline and fatty acid composition of erythrocyte membranes- the EVA study. Am J Clin Nutr. 2003 Apr; 77(4):803-8. 31 January 2008 Page 1,339 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fish oil 1 N-3 (EPA, DHA) n-3 are essential fatty acids and have critical roles in the membrane structure and as precursors of eicosanoids 31 January 2008 Minimum 1g fish oil equal to on average 320 EPA and 220 DHA 1,781 Page 1,340 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Expert Review Textbook RCT Meta analyses Cohort Animal study References Claim ID Fats and oils in human nutrition. 1994. Food and Agriculture Organization and World Health Organization. Ref Type: Report Innis SM. Dietary (n-3) Fatty Acids and Brain Development. J Nutr 2007;137:855-9. Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Churchill Livingstone, 2000. Kotani S, Sakaguchi E, Warashina S et al. Dietary supplementation of arachidonic and docosahexaenoic acids improves cognitive dysfunction. Neurosci Res 2006;56:159-64. Fontani G, Corradeschi F, Felici A, Alfatti F, Migliorini S, Lodi L. Cognitive and physiological effects of Omega-3 polyunsaturated fatty acid supplementation in healthy subjects. Eur J Clin Invest 2005;35:691-9. Appleton KM, Hayward RC, Gunnell D et al. Effects of n-3 long-chain polyunsaturated fatty acids on depressed mood: systematic review of published trials. Am J Clin Nutr 2006;84:1308-16. Behan PO, Behan WM, Horrobin D. Effect of high doses of essential fatty acids on the postviral fatigue syndrome. Acta Neurol Scand 1990;82:209-16. Kalmijn S, van Boxtel MP, Ocke M, Verschuren WM, Kromhout D, Launer LJ. Dietary intake of fatty acids and fish in relation to cognitive performance at middle age. Neurology 2004;62:275-80. 31 January 2008 Page 1,341 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Freeman MP, Hibbeln JR, Wisner KL et al. Omega-3 fatty acids: evidence basis for treatment and future research in psychiatry. J Clin Psychiatry 2006;67:1954-67. Issa AM, Mojica WA, Morton SC et al. The efficacy of omega-3 fatty acids on cognitive function in aging and dementia: a systematic review. Dement Geriatr Cogn Disord 2006;21:88-96. Assisi A, Banzi R, Buonocore C et al. Fish oil and mental health: the role of n-3 long-chain polyunsaturated fatty acids in cognitive development and neurological disorders. Int Clin Psychopharmacol 2006;21:319-36. Whalley LJ, Fox HC, Wahle KW, Starr JM, Deary IJ. Cognitive aging, childhood intelligence, and the use of food supplements: possible involvement of n-3 fatty acids. Am J Clin Nutr 2004;80:1650-7. Heude B, Ducimetiere P, Berr C. Cognitive decline and fatty acid composition of erythrocyte membranes--The EVA Study. Am J Clin Nutr 2003;77:803-8. Hashimoto M, Hossain S, Shimada T, Shido O. Docosahexaenoic acid-induced protective effect against impaired learning in amyloid beta-infused rats is associated with increased synaptosomal membrane fluidity. Clin Exp Pharmacol Physiol 2006;33:934-9. Chen CC, Chaung HC, Chung MY, Huang LT. Menhaden fish oil improves spatial memory in rat pups following recurrent pentylenetetrazole-induced seizures. Epilepsy Behav 2006;8:516-21. 31 January 2008 Page 1,342 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Champeil-Potokar G, Chaumontet C, Guesnet P, Lavialle M, Denis I. Docosahexaenoic acid (22:6n-3) enrichment of membrane phospholipids increases gap junction coupling capacity in cultured astrocytes. Eur J Neurosci 2006;24:3084-90. Freund-Levi Y, Eriksdotter-Jonhagen M, Cederholm T et al. Omega-3 fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD study: a randomized double-blind trial. Arch Neurol 2006;63:1402-8. Fenton WS, Dickerson F, Boronow J, Hibbeln JR, Knable M. A placebo-controlled trial of omega-3 fatty acid (ethyl eicosapentaenoic acid) supplementation for residual symptoms and cognitive impairment in schizophrenia. Am J Psychiatry 2001;158:2071-4. 31 January 2008 Page 1,343 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fish oil 2 N-3 (EPA, DHA) n-3 are essential fatty acids and have critical roles in the membrane structure and as precursors of eicosanoids 31 January 2008 Minimum 3g fish oil/day equal to on average 960 mg EPA and 660 mg DHA/day 1,782 Page 1,344 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Expert Textbook Review Meta analyses RCT Clinical trial Cohort In vitro References Claim ID Fats and oils in human nutrition. 1994. Food and Agriculture Organization and World Health Organization. Ref Type: Report Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Churchill Livingstone, 2000. Innis SM. Dietary (n-3) Fatty Acids and Brain Development. J Nutr 2007;137:855-9. Fortin PR, Lew RA, Liang MH et al. Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. J Clin Epidemiol 1995;48:1379-90. Adam O, Beringer C, Kless T et al. Anti-inflammatory effects of a low arachidonic acid diet and fish oil in patients with rheumatoid arthritis. Rheumatol Int 2003;23:27-36. Albertazzi P, Coupland K. Polyunsaturated fatty acids. Is there a role in postmenopausal osteoporosis prevention? Maturitas 2002;42:13-22. Kremer JM. Effects of modulation of inflammatory and immune parameters in patients with rheumatic and inflammatory disease receiving dietary supplementation of n-3 and n-6 fatty acids. Lipids 1996;31 Suppl:S243-S247. Covington MB. Omega-3 fatty acids. Am Fam Physician 2004;70:133-40. Kremer JM, Lawrence DA, Jubiz W et al. Dietary fish oil and olive oil supplementation in patients with rheumatoid arthritis. Clinical and 31 January 2008 Page 1,345 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID immunologic effects. Arthritis Rheum 1990;33:810-20. Berbert AA, Kondo CR, Almendra CL, Matsuo T, Dichi I. Supplementation of fish oil and olive oil in patients with rheumatoid arthritis. Nutrition 2005;21:131-6. Kjeldsen-Kragh J, Lund JA, Riise T et al. Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. J Rheumatol 1992;19:1531-6. Kremer JM, Lawrence DA, Petrillo GF et al. Effects of high-dose fish oil on rheumatoid arthritis after stopping nonsteroidal antiinflammatory drugs. Clinical and immune correlates. Arthritis Rheum 1995;38:1107-14. Kremer JM, Jubiz W, Michalek A et al. Fish-oil fatty acid supplementation in active rheumatoid arthritis. A double-blinded, controlled, crossover study. Ann Intern Med 1987;106:497-503. Pritchett JW. Statins and Dietary Fish Oils Improve Lipid Composition in Bone Marrow and Joints. Clin Orthop Relat Res 2006. Navarro E, Esteve M, Olive A et al. Abnormal fatty acid pattern in rheumatoid arthritis. A rationale for treatment with marine and botanical lipids. J Rheumatol 2000;27:298-303. Curtis CL, Rees SG, Cramp J et al. Effects of n-3 fatty acids on cartilage metabolism. Proc Nutr Soc 2002;61:381-9. 31 January 2008 Page 1,346 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fish oil 3 n-3 (EPA, DHA) n-3 are essential fatty acids and have critical roles in the membrane structure and as precursors of eicosanoids 31 January 2008 Minimum 1g fish oil equal to on average 320 EPA and 220 DHA 1,783 Page 1,347 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Expert report Meta analyses Review RCT Negative Review RCT negative References Claim ID SACN Scientific advisory commitee on nutrition. Advice on fish consumption: benefits & risks. 2004. Commitee on toxicity. Morris MC, Sacks F, Rosner B. Does fish oil lower blood pressure? A meta-analysis of controlled trials. Circulation 1993;88:523-33. Bucher HC, Hengstler P, Schindler C, Meier G. N-3 polyunsaturated fatty acids in coronary heart disease: a meta-analysis of randomized controlled trials. Am J Med 2002;112:298-304. He K, Song Y, Daviglus ML et al. Accumulated evidence on fish consumption and coronary heart disease mortality: a meta-analysis of cohort studies. Circulation 2004;109:2705-11. Whelton SP, He J, Whelton PK, Muntner P. Meta-analysis of observational studies on fish intake and coronary heart disease. Am J Cardiol 2004;93:1119-23. Leaf A. Omega-3 fatty acids and prevention of arrhythmias. Curr Opin Lipidol 2007;18:31-4. Lee S, Gura KM, Kim S, Arsenault DA, Bistrian BR, Puder M. Current clinical applications of omega-6 and omega-3 fatty acids. Nutr Clin Pract 2006;21:323-41. Wang C, Harris WS, Chung M et al. n-3 Fatty acids from fish or fish-oil supplements, but not alpha-linolenic acid, benefit cardiovascular disease outcomes in primary- and secondary-prevention studies: a systematic review. Am J Clin Nutr 2006;84:5-17. Balk EM, Lichtenstein AH, Chung M, Kupelnick B, Chew P, Lau J. Effects of omega-3 fatty 31 January 2008 Page 1,348 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID acids on serum markers of cardiovascular disease risk: a systematic review. Atherosclerosis 2006;189:19-30. Marchioli R, Levantesi G, Macchia A et al. Antiarrhythmic mechanisms of n-3 PUFA and the results of the GISSI-Prevenzione trial. J Membr Biol 2005;206:117-28. Leaf A, Xiao YF, Kang JX, Billman GE. Prevention of sudden cardiac death by n-3 polyunsaturated fatty acids. Pharmacol Ther 2003;98:355-77. Brouwer IA, Geelen A, Katan MB. n-3 Fatty acids, cardiac arrhythmia and fatal coronary heart disease. Prog Lipid Res 2006;45:357-67. Hooper L, Thompson RL, Harrison RA et al. Risks and benefits of omega 3 fats for mortality, cardiovascular disease, and cancer: systematic review. BMJ 2006;332:752-60. Burr ML, shfield-Watt PA, Dunstan FD et al. Lack of benefit of dietary advice to men with angina: results of a controlled trial. Eur J Clin Nutr 2003;57:193-200. 31 January 2008 Page 1,349 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fish oil, omega 3 fatty acids Joint health Min. 2 g DHA and/or EPA daily Min. 2.6 g fish oil daily Scientific body,Accepted by National Institute of Health (US-NIH), Meta-analysis 1MedlinePlus, a service of the US National Library of Medicine and the National Institutes of Health (http://www.nlm.nih.gov/medlineplus/druginfo/n atural/patient-fishoil.html) 507 2 Fortin PR, Lew RA, Liang MH, Wright EA, Beckett LA, Chalmers TC, Sperling RI.: Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. J Clin Epidemiol 1995; 48:1379-1390 Review, Randomized placebo-controlled parallel design, Randomized double-blind, placebo-controlled clinical trial, Randomized double-blind, placebo-controlled clinical trial 3 Stamp LK, James MJ, Cleland LG.: Diet and Rheumatoid. Arthritis: A review of the literature. Seminars in Arthritis and Rheumatism (2005): 77 94. Elsevier Inc. 4 Berbert AA, Kondo CR, Almendra CL, Almendra, CL, Matsuo T, Dichi I: Supplementation of fish oil and olive oil in patients with rheumatoid arthritis. Nutrition 2005;21:131-136 5 Volker D, Fitzgerald P, Major G,Garg M: Efficacy of fish oil concentrate in the treatment of rheumatoid arthritis. J. Rheumatol. 2000; 27: 2343-2436 6 Remans PHJ, Sont JK, Wagenaar LW, Woutres-Wesseling W, Zuijderduin WM, JongmaA, Breedveld FC, van Laar JM: Nutrient supplementation with polyunsaturated fatty acids and micronutrients in rheumatoid arthritis: clinical and biochemical effects. Eur. J. Clin. Nutr. 2004; 58: 839-845. (Results contradictive with other evidence presented) 31 January 2008 Page 1,350 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fish oils / Omega 3 fatty acids Blood lipids 31 January 2008 Adults: typical dosage should be 300-500 mg of fish-derived Omega-3 oils daily (as per WHO recommendations), typically comprised of around an approximate 60:40 ratio EPA:DHA. Dosages of up to 2 g Omega-3 may be used, although long-term use of high doses is not recommended. Long-term intake of fish oils may reduce vitamin E absorption, so fish oil products should include vitamin E (preferably natural, full spectrum forms containing mixed tocopherols/tocotrienols) . Oily fish which naturally contain high levels of Omega-3 fatty acids include anchovy, black cod, bluefish, halibut, kipper, mackerel, mehaden, mullet, herring, pilchard, sable fish, salmon, sardine, seal blubber, sturgeon, trout, tuna, and whale blubber. Therefore on days when whole fish is consumed, fish oil RCTs Harris WS. n-3 fatty acids and serum lipoproteins: human studies. Am J Clin Nutr 1997;65(5 Suppl):1645S-1654S. Sanders TA, Oakley FR, Miller GJ, et al. Influence of n-6 versus n-3 polyunsaturated fatty acids in diets low in saturated fatty acids on plasma lipoproteins and hemostatic factors. Arterioscler Thromb Vasc Biol 1997;17(12):3449-3460. Harris WS, Dujovne CA, Zucker M, et al. Effects of a low saturated fat, low cholesterol fish oil supplement in hypertriglyceridemic patients. A placebo-controlled trial. Ann Intern Med 1988;109(6):465-470. Roche HM, Gibney MJ. Postprandial triacylglycerolaemia: the effect of low-fat dietary treatment with and without fish oil supplementation. Eur J Clin Nutr 1996;50(9):617-624. Grimsgaard S, Bonaa KH, Hansen JB, et al. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am J Clin Nutr 1997;66(3):649-659. 1,092 Page 1,351 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID supplementation is not necessary. Precautions: Do not exceed recommended dosage; total intakes of EPA and DHA in excess of 3000 mg daily may lead to internal bleeding. GAMMA LINOLENIC ACID GLA reduces regaining weight in overweight individuals 31 January 2008 890 mg/d of GLA in the form of borage oil (5 g/d) for 1 year Human RCTs Marie A. Schirmer and Stephen D. Phinney. Y-Linolenate Reduces Weight Regain in Formerly Obese Humans. J. Nutr. 137:1430-1435, June 2007. 1,053 Page 1,352 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Gamma-linolenic acid (GLA; C18: 3n-6/C18: 3?6) provided by evening primrose oil and/or borage (starflower) oil Skin health 31 January 2008 Minimum 33mg GLA/d 487 Page 1,353 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies Reviews Animal studies References Claim ID Human Studies Morse, P.F., Horrobin, D.F., Manku, M.S., Stewart, J.C.M. et al (1989). Meta-analysis of placebo-controlled studies of the efficacy of Epogam in the treatment of atopic eczema. Relationship between plasma essential fatty acid changes and clinical response. Br J Dermatol 121: 75-90 Schalin-Karrila, M., Mattila, L. & Jansen, C.T. (1987). Evening primrose oil in the treatment of atopic eczema: effect on clinical status, plasma phospholipids fatty acids and circulating blood prostaglandins. Br J Dermatol 117: 11-19 Hederos, C.A. & Berg, A. (1996). Epogam evening primrose oil treatment in atopic dermatitis and asthma. Arch Dis Child 75: 494-497 Van Gool, C.J., Thijs, C., Henquet, C.J., Van Houwelingen, A.C., Dagnelie, P.C. et al (2003). Gamma-linolenic acid supplementation for prophylaxis of atopic dermatitis: a randomised, controlled trial in infants at high familial risk. Am J Clin Nutr 77: 943-951 Wright, S. and Burton, J.L. (1982). Oral evening primrose oil improves atopic eczema. Lancet 2: 1120-1122 Andreassi, M., Forleo, P., Di Lorio, A., Masci, A., Abate, G. & Amerio, P. (1997). Efficacy of gamma-linolenic acid in the treatment of patients with atopic dermatitis. J Intern Med Res 25: 266-274 Lovell, C.R., Burton, J.L. & Horrobin, D.F. 31 January 2008 Page 1,354 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID (1981). Treatment of atopic eczema with evening primrose oil. Lancet 1: 278 Nissen, H.P., Wehrmann, W., Kreysel, J.W., Morse, P.F. & Horrobin, D.F. (1988). Objective assessment of the effects of Epogam on skin smoothness as assessed by prolifometry in both normal controls and patients with atopic eczema. Fat Sci Technol 7: 268-271 Reviews Horrobin, D.F. (2000). Essential fatty acid metabolism and its modification in atopic eczema. Am J Clin Nutr 71 (suppl): 367S-372S Ziboh, V.A., Miller, C.C. & Cho, Y. (2000). Metabolism of polyunsaturated fatty acids by skin epidermal enzymes: generation of anti-inflammatory and antiproliferative metabolites. Am J Clin Nutr 71 (suppl): 361S-366S Kerscher, M.J. and Korting, H.C. (1992). Treatment of atopic eczema with evening primrose oil: rationale and clinical results. Clin Invest 70: 167-171 Wright, S. (1991). Essential fatty acids and the skin. Br J Dermatol 125: 503-515 Animal Study Miller, C.C. and Ziboh, V.A. (1988). Gamma-linolenic acid-enriched diet alters 31 January 2008 Page 1,355 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID cutaneous eicosanoids. Bioch Bioph Res Com 154: 967-974 General Fan, Y. – Y. & Chapkin, R.S. (1998). Importance of dietary ?-linolenic acid in human health and nutrition. J Nutr 128: 1411-1414 Horrobin, D.F. (1992). Nutritional and medical importance of gamma-linolenic acid. Progr Lipd Res 31: 163-194 Horrobin, D.F. (1993). Fatty acid metabolism in health and disease: the role of delta-6-desaturase. Am J Clin Nutr 57: 732S-737S Barre, D. E. (2001). Potential of evening primrose, borage, blackcurrant and fungal oil in human health. Ann Nutr Metab 45: 47-57 Joint health 31 January 2008 Minimum 33mg GLA/d 485 Page 1,356 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies Reviews Mechanisms References Claim ID Gamma-linolenic acid (GLA) and joint health Human Studies Belch, J.J.F., Ansell, D., Madhok, R., O’Dowd, A & Sturrock, R.D. (1988). The effects of altering dietary essential fatty acids on requirements for non-steroidal anti-inflammatory drugs in patients with rheumatoid arthritis. Ann Rheum Dis 47: 96-104 Hansen, T.M., Lerche, A., Kassis, V. et al (1983). Treatment of rheumatoid arthritis with prostaglandin E1 precursors cis-linoleic acid and gamma-linolenic acid. Scand J Rheumatol 12: 85-88 Janntti, J., Seppala, E. & Vapaatalo, H. (1989). Evening primrose oil and olive oil in the treatment of rheumatoid arthritis. Clin Rheumatol 8: 238-244 Leventhall, L.J., Boyce, E.G., Zurier, R.B. (1994). Treatment of rheumatoid arthritis with blackcurrant seed oil. Br J Rheumatol 33: 847-852 Leventhall, L.J., Boyce, E.G., Zurier, R.B. (1993). Treatment of rheumatoid arthritis with gamma-linolenic acid. Ann Intern Med 119: 867-873 Brzeski, M., Madhok, R., Capell, H.A. (1991). Evening primrose oil in patients with rheumatoid arthritis and side effects of non-steroidal anti-inflammatory drugs. Br J Rheumatol 30: 370-372 Tate, G., Mandell, B.F., Laposta, M., Ohliger, 31 January 2008 Page 1,357 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID D. et al (1989). Suppression of acute and chronic inflammation by dietary gamma-linolenic acid. J Rheumatol 16: 729-734 Zurier, R.B., Rossetti, R.G., Jacobson, E.W., Demarco, D.M. et al (1996). Gamma-linolenic acid treatment of rheumatoid arthritis. Arthritis Rheumatism 39: 1808-1817 Reviews Belch, J.J.F. & Hill, A. (2000). Evening primrose oil and borage oil in rheumatologic conditions. Am J Clin Nutr 71 (suppl): 352S-356S Calder, P.C. & Zurier, R.B. (2001). Polyunsaturated fatty acids and rheumatoid arthritis Curr Opinion Clin Nutr Metab Care 4: 115-121 Setty, A.R. & Sigal, L.H. (2005). Herbal medications commonly used in the practice of rheumatology: mechanisms of action, efficacy and side effects. Seminars Arthritis Rheum 34: 773-784 Mechanisms/General Pullman-Mooar, S., Laposta, M., Lem, D., Holman, R.T. et al (1990). Alterations of the cellular fatty acid profile and the production of eicosanoids in human monocytes by gamma-linolenic acid. Arthritis Rheumatism 33: 1526-1533 Zurier, R.B. (1991). Essential fatty acids and inflammation. Annals Rheum Dis 50: 745-746 31 January 2008 Page 1,358 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Furse, R.K., Rossetti, R.G., Zurier, R.B. (2001). Gammalinolenic acid, an unsaturated fatty acid with anti-inflammatory properties, blocks amplification of IL-I? production by human monocytes. J Immumol 167: 480-496 Fan, Y.-Y. & Chapkin, R.S. (1998). Importance of dietary ?-linolenic acid in human health and nutrition. J Nutr 128: 1411-1414 Horrobin, D.F. (1992). Nutritional and medical importance of gamma-linolenic acid. Progr Lipid Res 31: 163-194 Horrobin, D.F. (1993). Fatty acid metabolism in health and disease: the role of delta-6-desaturase. Am J Clin Nutr 57: 732S-737S Barre, D.E. (2001). Potential of evening primrose, borage, blackcurrant and fungal oils in human health. Ann Nutr Metab 45: 47-57 31 January 2008 Page 1,359 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Gamma-linolenic acid (GLA; C18: 3n-6/C18: 3?-6) provided by evening primrose oil and/or borage (starflower) oil. Menstrual health 31 January 2008 Minimum 33mg GLA/d 486 Page 1,360 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies Reviews Meta-analysis Mechanisms References Claim ID Human Studies Puolakka, J., Makarainen, L., Viinikka, L. & Ylikorkala, O. (1985). Biochemical and clinical effects of treating the premenstrual syndrome with prostaglandin synthesis precursors. J Reprod Med 30: 149-153 Ockerman, P.A., Bachrack, I., Glans, S. & Rassner, S. (1986). Evening primrose oil as treatment of the premenstrual syndrome. Recent Adv Clin Nutr 2: 404-405 Brush, M.G., Watson, S.J., Horrobin, D.F. & Manku, M.S. (1984) Abnormal essential fatty acid levels in plasma of women with premenstrual syndrome. Am J Obstet Gynecol 150: 363-366 Larsson, B., Jonasson, A. & Fianu, S. (1989). Evening primrose oil in the treatment of pre-menstrual syndrome: a pilot study. Curr Ther Res 46: 58-63 Collins, A., Cerin, A., Coleman, G. & Landgren, B.M. (1993). Essential fatty acids in the treatment of premenstrual syndrome. Obstet Gynecol 81: 93-98 Cerin, A., Collins, A., Landgren, B.M. & Eneroth, P. (1993). Hormonal and biochemical profiles of premenstrual syndrome. Treatment with essential fatty acids. Acta Obstet Gynecol Scand 72: 337-343 Khoo, S.K., Munro, C. & Battistutta, D. (1990). Evening primrose oil and treatment of premenstrual syndrome. Med J Aust 153: 630-631 31 January 2008 Page 1,361 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Steinbrunn, B.S., Zera, R.T. & Rodriguez, J.L. (1997). Mastalgia-tailoring treatment to type of breast pain. Postgrad Med 102: 183-188 Meta-analysis Budeiri, D., Li Wan Po, A. & Dornan, J.C. (1996). Is evening primrose oil of value in the treatment of premenstrual syndrome? Control Clin Trials 17: 60-68 Reviews Horrobin, D.F. (1983). The role of essential fatty acids and prostaglandins in the premenstrual syndrome. J Reprod Med 28: 465-468 Horrobin, D.F. & Manku, M.S. (1989). Premenstrual syndrome and premenstrual breast pain (cyclical mastalgia): disorders of essential fatty acid metabolism. Prostaglandins Leukotrienes EFA 37: 255-261 Horrobin, D.F. (1990). Evening primrose oil and premenstrual syndrome. Med J Aust 153: 630-631 Kleijnen, J. (1994). Evening primrose oil. Br Med J 309: 824-825 Fan, Y.-Y. & Chapkin, R.S. (1998). Importance of dietary ?-linolenic acid in human health and nutrition. J Nutr 128: 1411-1414 Dickerson, L.M., Mazyck, P.J. & Hunter, M.H. (2003). Premenstrual syndrome – practical therapeutics. Am Family Physician 67: 1743-1752 31 January 2008 Page 1,362 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Horrobin, D.F. (1992). Nutritional and medical importance of gamma-linolenic acid Progr Lipid Res 31: 163-194 Horrobin, D.F. (1993). Fatty acid metabolism in health and disease: the role of delta-6-desaturase. Am J Clin Nutr 57: 732S-737S Mechanisms & General Horrobin, D.F., Manku, M.S. & Huang, Y.S. (1984). Effects of essential fatty acids on prostaglandin biosynthesis. Biomed Biochim Acta 43: S114-120 Barre, D.E. (2001). Potential of evening primrose, borage, blackcurrant, and fungal oils in human health. Ann Nutr Metab 45: 47-57 Ziboh, V.A. & Fletcher, M.P. (1992). Dose-response effect of dietary gamma-linolenic acid enriched oils on human polymorphonuclear neutrophil biosynthesis of leukotriene B4. Am J Clin Nutr 55: 39-45 Miller, C.C. & Ziboh, V.A. (1988). Gamma-linolenic acid-enriched diet alters cutaneous eicosanoids Biochem Biophys Res Comm 154: 967-974 Barham, J.B., Edens, M.B., Fonteh, A.N., Johnson, M.M. et al (2000). Additions of eicosapentaenoic acid to ?-linolenic acid supplemented diets prevents serum arachidonic acid accumulation in humans. J Nutr 130: 1925-1931 31 January 2008 Page 1,363 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hemp seed oil Beautifies the skin from inside and out 31 January 2008 Seed 0.5-10g/day Report Deferne, J.L. and D. W. Pate, 1996. Hemp seed oil: A source of valuable essential fatty acids. Journal of the International Hemp Association 3(1): 1, 4-7. 2,543 Page 1,364 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long Chain Fatty Acids (EPA/DHA) Immune Function 5-10ml per day Human Intervention Studies Calder PC, Polyunsaturated Fatty Acids and Inflammation. Biochem Soc Trans. 33(2), 423-427 (Apr 2005) 988 Calder PC, Polyunsaturated Fatty Acids and Immunity. World Rev Nutr Diet. 88, 109-116 (2201) Calder PC, Dietary Modification of Inflammation with Lipids. Proc Nutr Soc. 61(3), 345-358 (Aug 2002) Schubert R et al., Influence of low dose polyunsaturated fatty acid supplementation on the inflammatory response of healthy adults. Nutition. 23, 724-730 (2007) Brain Function 5-10ml per day Human Intervention Studies Kendall-Tackett K. A new paradigm for depression in new mothers: the central role of inflammation and how breastfeeding and anti-inflammatory treatments protect maternal mental health. Int Breastfeed J. 30,2:6 (Mar 2007) 989 Hibbeln JR et al: Maternal seafood consumption in pregnancy and neurodevelopmental outcomes in childhood (ALSPAC study): an observational cohort study. Lancet 369, 578-85 (2007). Eilander A et al. Effects of n-3 long chain polyunsaturated fatty acid supplementation on visual and cognitive development throughout childhood: a review of human studies. Brain and Eye 31 January 2008 5-10ml per day 986 Page 1,365 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Function Nature of Evidence Human Intervention Studies References Claim ID Bazan NG. Omega-3 fatty acids, pro-inflammatory signaling and neuroprotection. Curr Opin Clin Nutr Matab Care. 10(2),136-141 (2007) Alan DD et al. A randomised controlled trial investigating the effect of n-3 long-chain polyunsaturated fatty acid supplementation on cognitive and retinal function in cognitively healthy older people: the Older People and n-3 long-chain polyunsaturated fatty acids (OPAL) study protocol. Nutr J. 31,5:20 (2006) Joint Mobility 5-10ml per day Human Intervention Study; Double- Blind RCT Moyad MA. An introduction to dietary/supplemental omega-3 fatty acids for general health and prevention: part II. Urol Oncol. 23(1), 36-48 (2005) 985 Kremer JL et al. Dietary fish oil and olive oil supplementation in patients with rheumatoid arthritis. Clinical and immunologic effects. Arthritis Rheum. 33(6), 810-820 (1990) Goldberg RJ, Katz J. A meta-analysis of the analgesic effects of omega-3 polyunsaturated fatty acid supplementation for inflammatory joint pain. Pain. 129, 210-223 (2007) 31 January 2008 Page 1,366 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long Chain n-3 poly unsaturated fatty acids Brain development in the foetus Each serving must contain no less than 0.2g Long Chain n-3 PUFA. DoH DRV report Nutrition text book BNF briefing paper Department of Health. (1991) Report on Health and Social Subjects. Dietary reference values for food, energy and nutrients in the United Kingdom. 2,513 Human Nutrition and Dietetics. 10th edition. JS Garrow, WPT James, A Ralph. Churchill Livingstone 2000. British Nutrition Foundation (1999) Briefing paper. 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Oxford University Press, 2001. 31 January 2008 Page 1,368 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative/Scientific Bodies Individual Studies References Claim ID Authoritative/Scientific Bodies Voedingsnormen. Energie, eiwitten, vetten en verteerbare koolhydraten. The Netherlands, 2001. SACN 2004. Scientific Advisory Committee on Nutrition .Advice on Fish Consumption. Benefits and Risks http://www.sacn.gov.uk/reports/# Individual Studies Bakker EC, Ghys AJA, Kester ADM et al. Long-chain plyunsaturated fatty acids at birth and cognitive function at 7 y of age. European Journal of Clinical Nutrition 2003;57:89-95. Brenna JT. Efficiency of conversion of alpha-linolenic acid to long chaing n-3 fatty acids in man. Current Opinion in Clinical Nutrition and Metabolic Care 2002;5:127-32. Hirayama S, Hamazaki T, Terasawa K. 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Nutrition and behaviour: The role of n-3 fatty acids in cognitive function. Br J Nutr 2000;83:337-9. Lowering of both fasting and postprandial levels of blood triglycerides 31 January 2008 >1.5g per day (BNF CVD 2005 p.217) Reviews British Nutrition Foundation 2005. Stanner S (ed) Cardiovascular Diease: Diet, Nutrition and Emerging Risk Factors Reviews Wijendran V, Hayes KC.Dietary n-6 and n-3 fatty acid balance and cardiovascular health. Annu Rev Nutr. 2004;24:597-615 170 Page 1,370 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Baro L, Fonolla J, Pena JL, Martinez-Ferez A, Lucena A, Jimenez J, Boza JJ, Lopez-Huertas E.n-3 Fatty acids plus oleic acid and vitamin supplemented milk consumption reduces total and LDL cholesterol, homocysteine and levels of endothelial adhesion molecules in healthy humans.Clin Nutr. 2003 Apr;22(2):175-82. Individual Studies Carrero JJ, Lopez-Huertas E, Salmeron LM, Baro L, Ros EDaily supplementation with (n-3) PUFAs, oleic acid, folic acid, and vitamins B-6 and E increases pain-free walking distance and improves risk factors in men with peripheral vascular disease. J Nutr. 2005 Jun;135(6):1393-9 Individual Studies Carrero JJ, Baro L, Fonolla J, Gonzalez-Santiago M, Martinez-Ferez A, Castillo R, Jimenez J, Boza JJ, Lopez-Huertas E.Cardiovascular effects of milk enriched with omega-3 polyunsaturated fatty acids, oleic acid, folic acid, and vitamins E and B6 in volunteers with mild hyperlipidemia. Nutrition. 2004 Jun;20(6):521-7 Individual Studies Harris WS : n-3 fatty acids and serum lipoproteins: human studies. Am J Clin Nutr, 1997, 65: 1645S-1654S Individual Studies Visioli F, et al Very low intakes of n-3 fatty acids incorporated into bovine milk reduce plasma triacylglycerol and increase HDL-cholesterol concentrations in healthy subjects. Pharmacol Res, 2000, 41: 571-576 Individual Studies Zampelas A, et al. : Polyunsaturated fatty acids of the n-6 and n-3 series : effects on postprandial lipid and apoprotein levels in healthy men. Eur J Clin Nutr, 1994, 48: 842-848 Claim ID Page 1,371 of 3,931 Category Food Component Health Relationship Endothelial function/arterial function 31 January 2008 Suggested Conditions of Use >1.5g per day (BNF CVD 2005 p.217) Nature of Evidence References Individual Studies Zampelas A, Roche H, Knapper JM et al.: Differences in postprandial lipemic response between Northern and Southern Europeans. Atherosclerosis, 1998, 139: 83-93 Authoritative/Scientific Bodies Health Council of the Netherlands. Guidelines for a healthy diet 2006. The Hague: Health Council of the Netherlands, 2006; publication no. 2006/21. http://www.gr.nl/pdf.php?ID=1479 or http://www.gr.nl/referentie.php?ID=1481 Authoritative/Scientific Bodies Lichtenstein AH, Appel LJ, Brands M, et al. Diet and lifestyle recommendations revision 2006. A scientific statement from the American Heart Association Nutrition Committee. Circulation 2006;114:82-96. http://circ.ahajournals.org/cgi/reprint/114/1/82.p df Authoritative/Scientific Bodies Scientific Advisory Committee on Nutrition (SACN). Advice on fish consumption: benefits & risks. London, TSO, 2004. http://www.sacn.gov.uk/reports/# Authoritative/Scientific Bodies World Health Organization. Diet, nutrition and the prevention of chronic diseases. WHO Technical Report Series 916. Geneva, 2003. http://www.who.int/hpr/NPH/docs/who_fao_exp ert_report.pdf Reviews Brown AA, Hu FB; Am J Clin Nutr 2001; 73:673 Dietary modulation of endothelial function: implications for cardiovascular disease. Am J Clin Nutr. 2001 Apr;73(4):673-86. Reviews Mozaffarian D, Rimm B: Fish intake, contaminants, and human health: evaluating the risks and the benefits. JAMA. 2006 Oct 18;296(15):1885-99. (Erratum in: JAMA. 2007 Feb 14; 297(6):590 JAMA. 2006; 296(15):1885.) Claim ID 171 Page 1,372 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies Engler MM, Engler MB, Malloy M, Chiu E, Besio D, Paul S, Stuehlinger M, Morrow J, Ridker P, Rifai N, Mietus-Snyder M; Docosahexaenoic acid restores endothelial function in children with hyperlipidemia: results from the EARLY study. Int J Clin Pharmacol Ther. 2004 Dec;42(12):672-9. Human Intervention Studies Fleischhauer FJ, Yan WD, Fischell TA.; Fish oil improves endothelium-dependent coronary vasodilation in heart transplant recipients; J Am Coll Cardiol. 1993 Mar 15;21(4):982-9. Human Intervention Studies Goodfellow J, Goodfellow J, Bellamy MF, Ramsey MW, Jones CJ, Lewis MJ.; Dietary supplementation with marine omega-3 fatty acids improve systemic large artery endothelial function in subjects with hypercholesterolemia: J Am Coll Cardiol. 2000 Feb;35(2):265-70. Human Intervention Studies Khan F, Elherik K, Bolton-Smith C, Barr R, Hill A, Murrie I, Belch JJ. The effects of dietary fatty acid supplementation on endothelial function and vascular tone in healthy subjects; Cardiovasc Res. 2003 Oct 1;59(4):955-62 Human Intervention Studies McVeigh GE, Brennan GM, Johnston GD, McDermott BJ, McGrath LT, Henry WR, Andrews JW, Hayes JR.;Dietary fish oil augments nitric oxide production or release in patients with type 2 (non¬insulin-dependent) diabetes mellitus.; Diabetologia. 1993 Jan;36(1):33-8 Human Intervention Studies Mita T, Watada H, Ogihara T, Nomiyama T, Ogawa O, Kinoshita J, Shimizu T, Hirose T, Tanaka Y, Kawamori R.; Eicosapentaenoic acid reduces the progression of carotid intima-media thickness in patients with type 2 diabetes.; Atherosclerosis. 2007 Mar;191(1):162-7. Epub 2006 Apr 17 Claim ID Page 1,373 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies Mori TA, Watts GF, Burke V, Hilme E, Puddey IB, Beilin LJ. Differential effects of eicosapentaenoic acid and docosahexaenoic acid on vascular reactivity of the forearm microcirculation in hyperlipidemic, overweight men; Circulation. 2000 Sep 12;102(11):1264-9. Human Intervention Studies Woodman RJ, Mori TA, Burke V, Puddey IB, Barden A, Watts GF, Beilin LJ. Effects of purified eicosapentaenoic acid and docosahexaenoic acid on platelet, fibrinolytic and vascular function in hypertensive type 2 diabetic patients.; Atherosclerosis. 2003 Jan;166(1):85-93. Observational Studies Nishizawa H, Hamazaki K, Hamazaki T, Fujioka S, Sawazaki S. The relationship between tissue RBC n-3 fatty acids and pulse wave velocity. In Vivo. 2006 Mar-Apr;20(2):307-10. Observational Studies Sondergaard E, Moller JE, Egstrup K.; Effect of dietary intervention and lipid-lowering treatment on brachial vasoreactivity in patients with ischemic heart disease and hypercholesterolemia.; Am Heart J. 2003 May;145(5):E19. Claim ID Page 1,374 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long chain Omega 3 fatty acids (EPA/DPA/DHA) Joint health 31 January 2008 Authoritative bodies Health Canada. Fish oil monograph (August 2006) www.hc-sc.qc.ca/dhp-mps/prodnatur/applicatio ns/licen prod/monoqraph/mono fish oil huile Poisson e.html Claim for products providing 2800-3000 mg EPA+DHA in a daily dose and containing a ratio of EPA:DHA between 0.5:1 and 2:1. In conjunction with conventional therapy, helps reduce the pain of rheumatoid arthritis Meta-analyses Goldberg RJ, Katz J, A meta-analysis of the analgesic effects of omega-3 polyunsaturated fatty acid supplementation for inflammatory joint pain, Pain, 2007, 129, 210-223 - Fortin PR, Lew RA, Liang MH, Wright EA, Beckett LA, Chalmers TC et al., Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis, Journal of Clinical Epidemiology, 1995, 48, 1379-90 852 Page 1,375 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Ramsbottom H, Lockwood B, Nutraceuticals for healthy joints, The Pharmaceutical Journal, 2006, 277, 740-746 Desai S, Lockwood B„ Nutraceuticals in joint health. Mode of action, Nutrafoods, 2006, 5, 20-33. Cleland LG, James MJ, Proudman SM, The role of fish oils in the treatment of rheumatoid arthritis, Drugs, 2003, 63, 845-53 Calder PC, Zurier RB, Polyunsaturated fatty acids and rheumatoid arthritis. Curr Opin Clin Nutr Metab Care, 2001, 4, 115-21 Kremer JM, n-3 fatty acid supplements in rheumatoid arthritis, Am J Clin Nutr, 2000, 71(suppl), 349S-51S. 31 January 2008 Page 1,376 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies References Claim ID Proudman SM, Keen HI, Stamp LK, Lee AT, Goldblatt F, Ayres OC, Rischmueller M, James MJ, Hill CL, Caughey GE, Cleland LG, Response-driven combination therapy with conventional Disease-Modifying Antirheumatic Drugs can achieve high responses rates in early Rheumatoid Arthritis with minimal Glucocorticoid and Nonsteroidal anti-inflammatory drugs use, Semin, Arhtritis Rheum, 2007, in press. Cleland LG, Caughey GE, James MJ, Proudman SM, Reduction of cardiovascular risk factor with longterm fish oil treatment in early rheumatoid arthritis, J Rheumatol, 2006, 33, 1973-9 Bebert AA, Kondo CRM, Almendra CL, Matsuo T, Dichi I, Supplementation of fish oil and olive oil in patients with rheumatoid arthritis, Nutrition, 2005, 21, 131-136 Volker D, Fitzgerald P, Major G, Garg M, Efficacy of fish oil concentrate in the treatment of rheumatoid arthritis, J Rheumatol, 2000, 27, 2343-2346. Lau CS, Morley KD, Belch JJ, Effect of fish oil supplementation on non-steroidal anti-inflammatory drug requirement in patients with mild rheumatoid arthritis – a double-blind placebo controlled study, Br J Rheumatol, 1993, 32, 982-9. Kremer JM, Jubiz W, Michalek A, Rynes RI, Bartholomew LE, Bigaouette J, Timchalk M, Beeler D, lininger L, Fish-oil fatty acid supplementation in active rheumatoid arthritis. A double-blinded, controlled, crossover study, Ann Intern Med, 1987, 106, 497-503 31 January 2008 Page 1,377 of 3,931 Category Food Component Health Relationship Cardiovascular/ heart health Suggested Conditions of Use 0.43g per day (serving 1/3 to 1/4 of this) 3g weekly or .45g daily 31 January 2008 Nature of Evidence Meta-analysis dossier of evidence submitted for previous national approval of an identical claim. References Baldwin N, Rice R, A Generic Health Claim Submission by Omega-3 health claim consortium to the JHCI, May 2004 http://www.jhci.org.uk/approv/omega.htm Claim ID 168 Page 1,378 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative bodies References Claim ID Opinion of the scientific panel on contaminants in the food chain on a request from the European Parliament related to the safety assessment of wild and farmed fish, the EFSA Journal (2005), 236, 1-118. Question N° EFSA-Q-2004-22 adopted on 22 June 2005 Agency for Health Care Research and Quality AHRQ; Effects of Omega-3 Fatty acids on Cardiovascular Disease, Evidence Report /Technology Assessment No. 94, 2004 http://www.ahrq.gov/downloads/pub/evidence/p df/o3cardio/o3cardio.pdf US FDA Heart Health Claim: Omega-3 fatty acids and Reduced Risk of Coronary Hearth Disease. Docket No 2003Q-0401 (9/8/2004) UK NICE report 2007 Post MI: secondary prevention in primary and secondary care for patients following a myocardial infarction. http://guidance.nice.org.uk/page.aspx?o=43101 9 UK Nutrition Intake Recommendation: Scientific Advisory Committee on Nutrition. Advise of fish consumption: benefits and risk. 2004 (www.food.pov.uk/multimedia/pdfs/fishreport20 0401.pdf) General/CHD 450 mg n-3 LCPUFA (EPA, DHA, DPAn-3) per day from two servings of fish per week UK JHCI Heart Health Claim (2005). See references in Generic Health Claim Submission by the Omega-3 Health Claim Consortium to the JHCI for Consideration of the JHCI Expert Committee, http://www.ihci.orp.uk/approv/omepa.htm 31 January 2008 Page 1,379 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Eating 3g weekly, or 0.45g daily, long chain omega-3 polyunsaturated fatty acids, as part of a healthy lifestyle, helps maintain heart health The claim relates only to very long chain polyunsaturated fatty acids (of chain length 20 carbons or above) including EPA, DPA and DHA (i.e. 20:3n-3, 20:4n-3, 20:5n-3, 22:5n-3 and 22:6n-3), and not all long chain polyunsaturated fatty acids, such as alpha-linolenic acid (i.e. 18:3n-3 and 18:4n-3) AFSSA The omega 3 fatty acids and the cardiovascular system: nutritional benefits and claims www.afssa.fr/ftp/afssa/39490-39491.pdf Approved claim: "Omega-3 fatty acids contribute to or support healthy cardiovascular function" WHO/FAO Joint Expert Consultation on Diet, Nutrition and the Prevention of Chronic Disease (2003). Report of a Joint FAO/WHO Expert Consultation. Technical Report Series 916. Convincing associations for reduced risk of CVD include consumption of ... fish and fish oils (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)... Meta-analyses 31 January 2008 Bucher, H.C., Hengstler, P., Schindler, C., and Meier, G., n-3 Polyunsaturated Fatty Acids in Coronary Heart Disease: A Meta-Analysis of Randomized Controlled Trials, Am. J. Med., 2002, 112,298-304. Page 1,380 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Schmier J K, Rachman N J, Halpern M T, The cost-effectiveness of omega-3 supplements for prevention of secondary coronary events, Managed Care, 2006; 15(4), 43-50 - Block R, Pearson TA; The cardiovascular implications of omega-3 fatty acids, Folia Cardiol., 2006, 13, 557-569 Wang C, Harris WS, Chung M, Lichtenstein AH, Balk EM, Kupelnick B, Jordan HS, Lau J; n-3 fatty acids from fish oil or fish-oil supplements, but not a-linolenic acid, benefit cardiovascular disease outcomes in primaryand secondary-prevention studies: a systematic review, Am J Clin Nutr, 2006, 84, 5-17 von Schacky C; A review of omega-3 ethyl esters for the cardiovascular prevention and treatment of increased blood triglyceride levels, Vascular Health and Risk Management, 2006, 2(3), 251-262 Calder PC, n-3 fatty acids and cardiovascular disease: evidence explained and mechanisms explored, Clinical Science, 2004, 107, 1-11. Din JH, Newby DE, Flapan AD, Omega-3 fatty acids and cardiovascular disease-fishing for a natural treatment, British Med J, 2004, 328, 30-35. Harris WS, Von Schacky C, The omega-3 index: a new risk factor for death from coronary hearth disease ?, Prey. Med., 2004, 39, 212-20. Weisman D, Motro M, Schwammenthal E, Fisman EZ, Tenenbaum A, Tanne D, Adler Y; Efficacy of Omega-3 fatty acid supplementation in primary and secondary prevention of Coronary Hearth Disease, lsr Med Assoc J, 31 January 2008 Page 1,381 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 2004, 6, 227-232 Holub B; Clinical nutrition: 4. Omega-3 fatty acids in cardiovascular care; Canadian Medical Association Journal, 2002, 166(5), 608-15 Kris-Etherton PM, Harris W, Appel, L; Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease, Circulation, 2002, 106, 2747-2757 31 January 2008 Page 1,382 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies References Claim ID Yokoyama M et aL; Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis, Lancet, 2007, 369, 1090-98 Rissanen T, Voutilainen S, NyyssOnen K, Lakka TA, Salonen JT, Fish-oil derived fatty acids, docosahexaenoic acid and docosapentaenoic acid and the risk of acute coronary events. The Kuopio Ischaemic Heart Disease Risk Factor Study, Circulation, 2000, 102, 2677-2679. von Schacky C, Angerer P, Kothny W, Theisen K, Mudra H; The effect of dietary n-3 fatty acids on coronary atherosclerosis. A randomized, double-blinded, placebo-controlled trial, Ann. Intern. Med., 1999, 130, 554-562. GISSI investigators; Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Soprawivenza nell'Infarto miocardico, Lancet , 1999, 354, 447-455. Burr ML, Fehily AM, Gilbert JF, Rogers S, Holliday RM, Sweetnam PM, et al., Effects on changes in fat, fish, and fibre intakes on death and myocardial reinfarction: diet and reinfarction trial (DART), Lancet , 1989, 334, 757-61. 31 January 2008 Page 1,383 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long chain omega-3 fatty acids EPA and DHA Healthy triglyceride levels The effective dose required to maintain healthy triglyceride levels is estimated to be 500 mg n-3 LC-PUFAs per day. To carry the claim, a product should contain =30 mg n-3 LC-PUFAs per 100 g or 100 kcal, in accordance with the Update of the ANNEX of the Regulation 1924/2006 (e.g., 1% or 2% DHA milk provides ?40 mg DHA per 100 g and 77 mg DHA per 100 kcal, and so would qualify to carry the claim). General Population. 901 Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day) 31 January 2008 Page 1,384 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Bodies; Expert and Scientific Organisations; Published research References Claim ID Agency for Healthcare Research Quality (US) (2004). Balk E, Chung M, Lichtenstein A, et al. Effects of omega-3 fatty acids on cardiovascular risk factors and intermediate markers of cardiovascular disease. Evidence report No. 93. http://www.ahrq.gov/clinic/epcsums/o3cardrisks um.htm Accessed 8/22/07. Grimsgaard et al, Am J Clin Nutr 1997; 66, 649-59. Highly purified eicosapentaenoic acid docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. http://www.ajcn.org/cgi/reprint/66/3/649.pdf Harris WS, Am J Clin Nutr, 1997; 65 (Suppl): 1645S-54S. n-3 Fatty acids and serum lipoproteins: human studies. http://www.ajcn.org/cgi/reprint/65/5/1645S.pdf Balk, E.M.et al. 2006. Effects of omega-3 fatty acids on serum markers of cardiovascular disease risk: A systematic review. Atherosclerosis 189:19-30. Hu, F.B.; Willett, W.C. 2002. Optimal diets for prevention of coronary heart disease. Journal of the American Medical Association 288:2569-2578. http://jama.ama-assn.org/cgi/content/full/288/2 0/2569 British Nutrition Foundation (2000). Briefing paper ‘n-3 Fatty Acids and Health’. http://www.nutrition.org.uk/home.asp?siteId=43 &sectionId=686&subSectionId=341&parentSect ion=303&which=6#1171. Accessed 9/10/2007. Health Canada, Natural Health Products 31 January 2008 Page 1,385 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Directorate, Fish Oil Monograph, 2006. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hp fb-dgpsa/pdf/prodnatur/mono_fish_oil_huile_po isson_e.pdf 31 January 2008 Page 1,386 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body – Recommended Intakes References Claim ID International Society for the Study of Fatty Acids and Lipids, 2004 ISSFAL. 2004. Recommendations for Intake of Polyunsaturated Fatty Acids in Healthy Adults (Report of the Sub-Committee). International Society for Study of Fatty Acids and Lipids (ISSFAL); Tiverton, Devon, Engl. ISSFAL Policy Statement No. 3. Available from: http://www.issfal.org.uk/lipid-matters/issfal-polic y-statements/issfal-policy-statement-3.html. Scientific Advisory Committee on Nutrition, 2004 SACN. 2004. Advice on Fish Consumption: Benefits and Risks. U.K. Food Standards Agency (FSA) & U.K. Department of Health, Committee on Toxicity (COT), Scientific Advisory Committee on Nutrition (SACN); London, Engl. Available from: http://www.food.gov.uk/multimedia/pdfs/fishrep ort2004full.pdf. FAO/WHO Expert Committee on Fats and Oils in Human Nutrition, 2003 FAO/WHO. 2003. Diet, Nutrition and the Prevention of Chronic Diseases. Report of a Joint WHO/FAO Expert Consultation, Jan. 28-Feb. 1, 2002, Geneva, Switz. World Health Organization (WHO); Geneva, Switz. WHO Technical Report Series, No. 916. Available from: http://whqlibdoc.who.int/trs/WHO_TRS_916.pdf . European Society of Cardiology, 2003 European Society of Cardiology. 2003. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute 31 January 2008 Page 1,387 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Myocardial Infarction of the European Society of Cardiology. Eur Heart J 24(1):28-66. Available from: http://eurheartj.oxfordjournals.org/cgi/content/fu ll/24/1/28. American Heart Association, 2002 Kris-Etherton, P.M.; Harris, W.S.; Appel, L.J.; (for the American Heart Association Nutrition Committee). 2002. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 106(21):2747-2757 & [Erratum, 107(3):512]. Available from: http://circ.ahajournals.org/cgi/content/full/106/2 1/2747. American Heart Association, 2006 Lichtenstein, A.H.; Appel, L.J.; Brands, M.; Carnethon, M.; Daniels, S.; Franch, H.A.; Franklin, B.; Kris-Etherton, P.; Harris, W.S.; Howard, B.; Karanja, N.; Lefevre, M.; Rudel, L.; Sacks, F.; Van Horn, L.; Winston, M.; Wylie-Rosett, J. 2006. Summary of American Heart Association Diet and Lifestyle Recommendations revision 2006. Arterioscler Thromb Vasc Biol 26(10):2186-2191. Available from: http://atvb.ahajournals.org/cgi/content/full/26/10 /2186. US National Academies of Science, Institute of Medicine, 2005 IOM. 2005. Macronutrients and healthful diets. In: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Institute of Medicine (IOM) of the National Academies / The National Academy Press (NAP); Washington, DC. 31 January 2008 Page 1,388 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Available from: http://books.nap.edu/openbook.php?record_id= 10490&page=769. Health Council of the Netherlands, 2001 Spaaij, C.J.; Pijls, L.T. 2004. New dietary reference intakes in the Netherlands for energy, proteins, fats and digestible carbohydrates. Eur J Clin Nutr 58(1):191-194. Available from: http://www.nature.com/ejcn/journal/v58/n1/full/1 601788a.html. Eurodiet – Nutrition and Diet for Healthy Lifestyles, 2000 Eurodiet. 2000. EURODIET Core Report. University of Crete, Eurodiet Project; Crete, Greece (Sponsored by the European Commission, Directorate General for Health & Consumer Protection (Unit F/3), and the Greek Ministry of Health). Available from: http://eurodiet.med.uoc.gr/. UK Committee on Medical Aspects of Food Policy, 1994 Stockley, L. 1996. Nutritional Aspects of Cardiovascular Disease (Nutrition Briefing Paper based on the 1994 Report of the Cardiovascular Review Group, Committee on Medical Aspects of Food Policy [COMA]). Prepared for the U.K. Health Education Authority (HEA); London, Engl. Available from: http://www.nice.org.uk/page.aspx?o=502129. British Nutrition Foundation Task Force on Unsaturated Fatty Acids, 1992 BNF. 1999. n-3 Fatty Acids and Health. British Nutrition Foundation (BNF); London, Engl. 31 January 2008 Page 1,389 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Meta-Analyses/Critical Review3 References Claim ID McKenny, J.M.; Sica, D. 2007. Prescription omega-3 fatty acids for the treatment of hypertriglyceridemia. American Journal of Health-System Pharmacists 64:595-605. Undeland, I.; Ellegård, L.; Sandberg, A-S. 2004. Fish and cardiovascular health. Scandinavian Journal of Nutrition 48(3):119-130. 31 January 2008 Page 1,390 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Randomized Controlled Trials – Favourable Effects on Triglycerides3 References Claim ID Browning, L.M.; Krebs, J.D.; Moore, C.S.; Mishra, G.D.; O’Connell, M.A.; Jebb, S.A. 2007. The impact of long chain n-3 polyunsaturated fatty acid supplementation on inflammation, insulin sensitivity and CVD risk in a group of overweight women with an inflammatory phenotype. Diabetes, Obesity and Metabolism 9:70-80. Bryhn, M.; Hansteen, H.; Schanche, T.; Aakre, S.E. 2006. The bioavailability and pharmacodynamics of different concentrations of omega-3 acid ethyl esters. Prostaglandins, Leukotrienes and Essential Fatty Acids 75:19-24. Buckley, R.; Shewring, B.; Turner, R.; Yaqoob, P.; Minihane, A.M. 2004. Circulating triacylglycerol and apoE levels in response to EPA and docosahexaenoic acid supplementation in adult human subjects. British Journal of Nutrition 92:477-483. Chan, D.C.; Watts, G.F.; Mori, T.A.; Barrett, P.H.R.; Beilin, L.J.; Redgrave, T.G. 2002. Factorial study of the effects of atorvastatin and fish oil on dyslipidaemia in visceral obesity. European Journal of Clinical Investigation 32:429-436. Dyerberg, J.; Eskesen, D.C.; Andersen, P.W.; Astrup, A.; Buemann, B.; Christensen, J.H.; Clausen, P.; Rasmussen, B.F.; Schmidt, E.B.; Tholstrup, T.; Toft, E.; Toubro, S.; Stender, S. 2004. Effects of trans and n-3 unsaturated fatty acids on cardiovascular risk markers in healthy males. An 8 weeks dietary intervention study. European Journal of Clinical Nutrition 58:1062-1070. 31 January 2008 Page 1,391 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hamazaki, K.; Itomura, M.; Huan, M.; Nishizawa, H.; Watanabe, S.; Hamazaki, T.; Sawazaki, S.; Terasawa, K.; Nakajima, S.; Terano, T.; Hata, Y.; Fujishiro, S. 2003. n-3 long chain FA decrease serum levels of TG and remnant-like particle-cholesterol in humans. Lipids 38(4):353-358. Hill, A.M.; Buckley, J.D.; Murphy, K.J.; Howe, P.R.C. 2007. Combining fish-oil supplements with regular aerobic exercise improves body composition and cardiovascular disease risk factors. American Journal of Clinical Nutrition 85:1267-1274. Krebs, J.D.; Browning, L.M.; McLean, N.K.; Rothwell, J.L.; Mishra, G.D.; Moore, C.S.; Jebb, S.A. 2006. Additive benefits of long-chain n-3 polyunsaturated fatty acids and weight-loss in the management of cardiovascular disease risk in overweight hyperinsulinaemic women. International Journal of Obesity 30:1535-1544. Lara, J.J.; Economou, M.; Wallace, A.M.; Rumley, A.; Lowe, G.; Slater, C.; Caslake, M.; Sattar, N.; Lean, M.E.J. 2007. Benefits of salmon eating on traditional and novel vascular risk factors in young, non-obese healthy subjects. Atherosclerosis 193:213-221. Leigh-Firbank, E.C.; Minihane, A.M.; Leake, D.S.; Wright, J.W.; Murphy, M.C.; Griffin, B.A.; Williams, C.M. 2002. Eicosapentaenoic acid and docosahexaenoic acid from fish oils: differential associations with lipid responses. British Journal of Nutrition 87:435-445. Liu, M.; Wallmon, A.; Wallin, R.; Saldeen, T. 2003. Effects of stable fish oil and simvastatin on plasma lipoproteins in patients with 31 January 2008 Page 1,392 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID hyperlipidemia. Nutrition Research 23:1027-1034. Lovegrove, J.A.; Lovegrove, S.S.; Lesauvage, S.V.M.; Brady, L.M.; Saini, N.; Minihane, A.M.; Williams, C.M. 2004. Moderate fish-oil supplementation reverses low-platelet, long-chain n-3 polyunsaturated fatty acid status and reduces plasma triacylglycerol concentrations in British Indo-Asians. American Journal of Clinical Nutrition 79:974-982. Maki, K.C.; Van Elswyk, M.E.; McCarthy, D.; Seeley, M.A.; Veith, P.E.; Hess, S.P.; Ingram, K.A.; Halvorson, J.J.; Calaguas, E.M.; Davidson, M.H. 2003. Lipid responses in mildly hypertriglyceridemic men and women to consumption of docosahexaenoic acid-enriched eggs. International Journal for Vitamin and Nutrition Research 73(5):357-368. Maki, K.C.; Van Elswyk, M.E.; McCarthy, D.; Hess, S.P.; Veith, P.E.; Bell, M.; Subbaiah, P.; Davidson, M.H. 2005. Lipid responses to a dietary docosahexaenoic acid supplement in men and women with below average levels of high density lipoprotein cholesterol. Journal of the American College of Nutrition 24(3):189-199. Stark, K.D.; Holub, B.J. 2004. Differential eicosapentaenoic acid elevations and altered cardiovascular disease risk factor responses after supplementation with docosahexaenoic acid in postmenopausal women receiving and not receiving hormone replacement therapy. American Journal of Clinical Nutrition 79:765-773. Woodman, R.J.; Mori, T.A.; Burke, V.; Puddey, 31 January 2008 Page 1,393 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID I.B.; Watts, G.F.; Beilin, L.J. 2002. Effects of purified eicosapentaenoic and docosahexaenoic acids on glycemic control, blood pressure, and serum lipids in type 2 diabetic patients with treated hypertension. American Journal of Clinical Nutrition 76:1007-1015. Wu, W.H.; Lu, S.C.; Wang, T.F.; Jou, H.J.; Wang, T.A. 2006. Effects of docosahexaenoic acid supplementation on blood lipids, estrogen metabolism, and in vivo oxidative stress in postmenopausal vegetarian women. European Journal of Clinical Nutrition 60:386-392. Observational Studies – Cross-Sectional3 Okuda, N.; Ueshima, H.; Okayama, A.; Saitoh, S.; Nakagawa, H.; Rodriguez, B.L.; Sakata, K.; Choudhury, S.R.; Curb, J.D.; Stamler, J. (for the INTERLIPID Research Group) 2005. Relation of long-chain n-3 polyunsaturated fatty acid intake to serum high density lipoprotein cholesterol among Japanese men in Japan and Japanese-American men in Hawaii: the INTERLIPID study. Atherosclerosis 178:371-379. Panagiotakos, D.B.; Zeimbekis, A.; Boutziouka, V.; Economou, M.; Kourlaba, G.; Toutouzas, P.; Polychronopoulos, E.. 2007. Long-term fish intake is associated with better lipid profile, arterial blood pressure, and blood glucose in elderly people from Mediterranean islands (MEDIS epidemiological study). Medical Science Monitor 13(7):307-312. Heart Health 31 January 2008 The effective dose required to maintain heart health is estimated to be 500 mg n-3 LC-PUFAs per day. To carry the claim, a 900 Page 1,394 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use product should contain =30 mg n-3 LC-PUFAs per 100 g or 100 kcal, in accordance with the Update of the ANNEX of the Regulation 1924/2006 (eg., 1% or 2% DHA milk provides ?40 mg DHA per 100 g and 77 mg DHA per 100 kcal, and so would qualify to carry the claim). 5-10ml per day General Population. Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day) Nature of Evidence Authoritative Bodies; Expert and Scientific Organisations; References Claim ID ISSFAL (1999). Simopoulos AP, Leaf A, Salem N. Workshop on the Essentiality of and Recommended Dietary Intakes for Omega-6 and Omega-3 Fatty Acids. J Am Coll Nutr 1999;18:487-489. Published research Committee on Medical Aspects of Food Policy (UK), 1996. Stockley, L. 1996. Nutritional Aspects of Cardiovascular Disease (Nutrition Briefing Paper based on the 1994 Report of the Cardiovascular Review Group, Committee on Medical Aspects of Food Policy [COMA]). Prepared for the U.K. Health Education Authority (HEA); London, Engl. Available from: http://www.nice.org.uk/page.aspx?o=502129. Agence Français de Sécurité Sanitaire des Aliments, [The omega-3 Fatty Acids and the Cardiovascular System :Nutritional benefits and claims]. (FR) (2003). http://www.afssa.fr/ftp/afssa/basedoc/rapporto mega3.pdf Accessed 8/15/07. National Health and Medical Research Council (Australia and New Zealand) (2005). Nutrient reference values for Australia and New Zealand including recommended dietary intakes. www.nhmrc.gov.au/publications/synopses/_file s/n35.pdf National Heart Foundation of Australia (2005). Position Statement on Lipid Management-2005. Heart Lung and Circulation 2005;14:275-291. British Nutrition Foundation (2000). Briefing paper ‘n-3 Fatty Acids and Health’. http://www.nutrition.org.uk/home.asp?siteId=43 &sectionId=686&subSectionId=341&parentSect 31 January 2008 Page 1,395 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID ion=303&which=6#1171. Accessed 9/10/2007. Expert Workshop of the European Academy of Nutritional Sciences (1998). de Deckere EA, Korver O, Verschuren PM, Katan MB. Health aspects of fish and n-3 polyunsaturated fatty acids from plant and marine origin. Eur J Clin Nutr 1998 Oct; 52(10): 749-753. UK NICE (National Institute of Clinical Excellence, Clinical Guideline number 48 (2007). Secondary prevention in primary and secondary care for patients following a myocardial infarction. http://guidance.nice.org.uk/CG48/?c=91497 Health Canada, Natural Health Products Directorate, Fish Oil Monograph, 2006. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hp fb-dgpsa/pdf/prodnatur/mono_fish_oil_huile_po isson_e.pdf 31 January 2008 Page 1,396 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body – Recommended Intakes References Claim ID International Society for the Study of Fatty Acids and Lipids, 2004 ISSFAL. 2004. Recommendations for Intake of Polyunsaturated Fatty Acids in Healthy Adults (Report of the Sub-Committee). International Society for Study of Fatty Acids and Lipids (ISSFAL); Tiverton, Devon, Engl. ISSFAL Policy Statement No. 3. Available from: http://www.issfal.org.uk/lipid-matters/issfal-polic y-statements/issfal-policy-statement-3.html. Scientific Advisory Committee on Nutrition, 2004 SACN. 2004. Advice on Fish Consumption: Benefits and Risks. U.K. Food Standards Agency (FSA) & U.K. Department of Health, Committee on Toxicity (COT), Scientific Advisory Committee on Nutrition (SACN); London, Engl. Available from: http://www.food.gov.uk/multimedia/pdfs/fishrep ort2004full.pdf. FAO/WHO Expert Committee on Fats and Oils in Human Nutrition, 2003 FAO/WHO. 2003. Diet, Nutrition and the Prevention of Chronic Diseases. Report of a Joint WHO/FAO Expert Consultation, Jan. 28-Feb. 1, 2002, Geneva, Switz. World Health Organization (WHO); Geneva, Switz. WHO Technical Report Series, No. 916. Available from: http://whqlibdoc.who.int/trs/WHO_TRS_916.pdf . European Society of Cardiology, 2003 European Society of Cardiology. 2003. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute 31 January 2008 Page 1,397 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Myocardial Infarction of the European Society of Cardiology. Eur Heart J 24(1):28-66. Available from: http://eurheartj.oxfordjournals.org/cgi/content/fu ll/24/1/28. American Heart Association, 2002 Kris-Etherton, P.M.; Harris, W.S.; Appel, L.J.; (for the American Heart Association Nutrition Committee). 2002. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 106(21):2747-2757 & [Erratum, 107(3):512]. Available from: http://circ.ahajournals.org/cgi/content/full/106/2 1/2747. American Heart Association, 2006 Lichtenstein, A.H.; Appel, L.J.; Brands, M.; Carnethon, M.; Daniels, S.; Franch, H.A.; Franklin, B.; Kris-Etherton, P.; Harris, W.S.; Howard, B.; Karanja, N.; Lefevre, M.; Rudel, L.; Sacks, F.; Van Horn, L.; Winston, M.; Wylie-Rosett, J. 2006. Summary of American Heart Association Diet and Lifestyle Recommendations revision 2006. Arterioscler Thromb Vasc Biol 26(10):2186-2191. Available from: http://atvb.ahajournals.org/cgi/content/full/26/10 /2186. US National Academies of Science, Institute of Medicine, 2005 IOM. 2005. Macronutrients and healthful diets. In: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Institute of Medicine (IOM) of the National Academies / The National Academy Press (NAP); Washington, DC. 31 January 2008 Page 1,398 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Available from: http://books.nap.edu/openbook.php?record_id= 10490&page=769. Health Council of the Netherlands, 2001 Spaaij, C.J.; Pijls, L.T. 2004. New dietary reference intakes in the Netherlands for energy, proteins, fats and digestible carbohydrates. Eur J Clin Nutr 58(1):191-194. Available from: http://www.nature.com/ejcn/journal/v58/n1/full/1 601788a.html. Eurodiet – Nutrition and Diet for Healthy Lifestyles, 2000 Eurodiet. 2000. EURODIET Core Report. University of Crete, Eurodiet Project; Crete, Greece (Sponsored by the European Commission, Directorate General for Health & Consumer Protection (Unit F/3), and the Greek Ministry of Health). Available from: http://eurodiet.med.uoc.gr/. UK Committee on Medical Aspects of Food Policy, 1994 Stockley, L. 1996. Nutritional Aspects of Cardiovascular Disease (Nutrition Briefing Paper based on the 1994 Report of the Cardiovascular Review Group, Committee on Medical Aspects of Food Policy [COMA]). Prepared for the U.K. Health Education Authority (HEA); London, Engl. Available from: http://www.nice.org.uk/page.aspx?o=502129. British Nutrition Foundation Task Force on Unsaturated Fatty Acids, 1992 BNF. 1999. n-3 Fatty Acids and Health. British Nutrition Foundation (BNF); London, Engl. 31 January 2008 Page 1,399 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body – Approved Claims References Claim ID Joint Health Claims Initiative, 2005 JHCI. 2005. [Final Report - Generic Health Claim for LC n-3 PUFA and Heart Health]. Joint Health Claims Initiative (JHCI); Tiverton, Devon, Engl. Available from: http://www.jhci.org.uk/approv/omega.htm. Swedish Nutrition Foundation, 2004 SNF. 2004. 4. Cardiovascular disease/atherosclerosis/hardening of the arteries - Omega-3 fatty acids. In: Health Claims in the Labelling and Marketing of Food Products: The Food Sector’s Code of Practice (Includes all claims related to health, performance and well-being). Swedish Nutrition Foundation (SNF); Lund, Sweden, p. 20. Available from: http://www.hp-info.nu/SweCode_2004_1.pdf. U.S. Food and Drug Administration, 2004 (for food) FDA. 2004. Letter Responding to Health Claim Petition dated November 3, 2003 (Martek Petition): Omega-3 Fatty Acids and Reduced Risk of Coronary Heart Disease (Docket No. 2003Q-0401) dated Sep. 8, 2004. Food and Drug Administration, U.S. (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Nutritional Products, Labeling, and Dietary Supplements; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~dms/ds-ltr37.html. U.S. Food and Drug Administration, 2002 (for supplements) FDA. 2002. Letter Responding to a Request to Reconsider the Qualified Claim for a Dietary Supplement Health Claim for Omega-3 Fatty Acids and Coronary Heart Disease (Docket No. 91N-0103) dated February 8, 2002. Food and 31 January 2008 Page 1,400 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Drug Administration, U.S. (FDA), Center for Food Safety and Applied Nutrition (CFSAN), Office of Nutritional Products, Labeling, and Dietary Supplements; College Park, Maryland. Available from: http://www.cfsan.fda.gov/~dms/ds-ltr28.html. 31 January 2008 Page 1,401 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Meta-Analyses/Critical Review3 References Claim ID Balk, E.M.; Lichtenstein, A.H.; Chung, M.; Kupelnick, B.; Chew, P.; Lau, J. 2006. Effects of omega-3 fatty acids on serum markers of cardiovascular disease risk: A systematic review. Atherosclerosis 189:19-30. Calder, P.; 2004. n-3 fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clinical Science 107:1-11. Dickinson, H.O.; Mason, J.M.; Nicolson, D.J.; Campbell, F.; Beyer, F.R.; Cook, J.V.; Williams, B.; Ford, G.A. 2006. Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials. Journal of Hypertension 24:215-233. Geleijnse, J.M.; Giltay, E.J.; Grobbee, D.E.; Donders, A.R.T.; Kok, F.J. 2002. Blood pressure response to fish oil supplementation: metaregression analysis of randomized trials. Journal of Hypertension 20:1493-1499. Geleijnse, J.M.; Grobbee, D.E.; Kok, F.J. 2005. Impact of dietary and lifestyle factors on the prevalence of hypertension in Western populations. Journal of Human Hypertension 19:S1-S4. He, K.; Song, Y.; Daviglus, M.L.; Liu, K.; Van Horn, L.; Dyer, A.R.; Greenland, P. 2004. Accumulated evidence on fish consumption and coronary heart disease mortality: A meta-analysis of cohort studies. Circulation 109:2705-2711. Hu, F.B.; Willett, W.C. 2002. Optimal diets for prevention of coronary heart disease. Journal of the American Medical Association 31 January 2008 Page 1,402 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 288:2568-2578. McKenny, J.M.; Sica, D. 2007. Prescription omega-3 fatty acids for the treatment of hypertriglyceridemia. American Journal of Health-System Pharmacists 64:595-605. Undeland, I.; Ellegård, L.; Sandberg, A-S. 2004. Fish and cardiovascular health. Scandinavian Journal of Nutrition 48(3):119-130. Whelton, S.P.; He, J.; Whelton, P.K.; Muntner, P. 2004. Meta-analysis of observational studies on fish intake and coronary heart disease. American Journal of Cardiology 93:1119-1123. 31 January 2008 Page 1,403 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Randomized Controlled Trials – Favourable Effects on Blood Lipids3 References Claim ID Browning, L.M.; Krebs, J.D.; Moore, C.S.; Mishra, G.D.; O’Connell, M.A.; Jebb, S.A. 2007. The impact of long chain n-3 polyunsaturated fatty acid supplementation on inflammation, insulin sensitivity and CVD risk in a group of overweight women with an inflammatory phenotype. Diabetes, Obesity and Metabolism 9:70-80. Bryhn, M.; Hansteen, H.; Schanche, T.; Aakre, S.E. 2006. The bioavailability and pharmacodynamics of different concentrations of omega-3 acid ethyl esters. Prostaglandins, Leukotrienes and Essential Fatty Acids 75:19-24. Buckley, R.; Shewring, B.; Turner, R.; Yaqoob, P.; Minihane, A.M. 2004. Circulating triacylglycerol and apoE levels in response to EPA and docosahexaenoic acid supplementation in adult human subjects. British Journal of Nutrition 92:477-483. Chan, D.C.; Watts, G.F.; Mori, T.A.; Barrett, P.H.R.; Beilin, L.J.; Redgrave, T.G. 2002. Factorial study of the effects of atorvastatin and fish oil on dyslipidaemia in visceral obesity. European Journal of Clinical Investigation 32:429-436. Dyerberg, J.; Eskesen, D.C.; Andersen, P.W.; Astrup, A.; Buemann, B.; Christensen, J.H.; Clausen, P.; Rasmussen, B.F.; Schmidt, E.B.; Tholstrup, T.; Toft, E.; Toubro, S.; Stender, S. 2004. Effects of trans and n-3 unsaturated fatty acids on cardiovascular risk markers in healthy males. An 8 weeks dietary intervention study. European Journal of Clinical Nutrition 58:1062-1070. 31 January 2008 Page 1,404 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hamazaki, K.; Itomura, M.; Huan, M.; Nishizawa, H.; Watanabe, S.; Hamazaki, T.; Sawazaki, S.; Terasawa, K.; Nakajima, S.; Terano, T.; Hata, Y.; Fujishiro, S. 2003. n-3 long chain FA decrease serum levels of TG and remnant-like particle-cholesterol in humans. Lipids 38(4):353-358. Hill, A.M.; Buckley, J.D.; Murphy, K.J.; Howe, P.R.C. 2007. Combining fish-oil supplements with regular aerobic exercise improves body composition and cardiovascular disease risk factors. American Journal of Clinical Nutrition 85:1267-1274. Krebs, J.D.; Browning, L.M.; McLean, N.K.; Rothwell, J.L.; Mishra, G.D.; Moore, C.S.; Jebb, S.A. 2006. Additive benefits of long-chain n-3 polyunsaturated fatty acids and weight-loss in the management of cardiovascular disease risk in overweight hyperinsulinaemic women. International Journal of Obesity 30:1535-1544. Lara, J.J.; Economou, M.; Wallace, A.M.; Rumley, A.; Lowe, G.; Slater, C.; Caslake, M.; Sattar, N.; Lean, M.E.J. 2007. Benefits of salmon eating on traditional and novel vascular risk factors in young, non-obese healthy subjects. Atherosclerosis 193:213-221. Leigh-Firbank, E.C.; Minihane, A.M.; Leake, D.S.; Wright, J.W.; Murphy, M.C.; Griffin, B.A.; Williams, C.M. 2002. Eicosapentaenoic acid and docosahexaenoic acid from fish oils: differential associations with lipid responses. British Journal of Nutrition 87:435-445. Liu, M.; Wallmon, A.; Wallin, R.; Saldeen, T. 2003. Effects of stable fish oil and simvastatin on plasma lipoproteins in patients with 31 January 2008 Page 1,405 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID hyperlipidemia. Nutrition Research 23:1027-1034. Lovegrove, J.A.; Lovegrove, S.S.; Lesauvage, S.V.M.; Brady, L.M.; Saini, N.; Minihane, A.M.; Williams, C.M. 2004. Moderate fish-oil supplementation reverses low-platelet, long-chain n-3 polyunsaturated fatty acid status and reduces plasma triacylglycerol concentrations in British Indo-Asians. American Journal of Clinical Nutrition 79:974-982. Maki, K.C.; Van Elswyk, M.E.; McCarthy, D.; Seeley, M.A.; Veith, P.E.; Hess, S.P.; Ingram, K.A.; Halvorson, J.J.; Calaguas, E.M.; Davidson, M.H. 2003. Lipid responses in mildly hypertriglyceridemic men and women to consumption of docosahexaenoic acid-enriched eggs. International Journal for Vitamin and Nutrition Research 73(5):357-368. Maki, K.C.; Van Elswyk, M.E.; McCarthy, D.; Hess, S.P.; Veith, P.E.; Bell, M.; Subbaiah, P.; Davidson, M.H. 2005. Lipid responses to a dietary docosahexaenoic acid supplement in men and women with below average levels of high density lipoprotein cholesterol. Journal of the American College of Nutrition 24(3):189-199. Stark, K.D.; Holub, B.J. 2004. Differential eicosapentaenoic acid elevations and altered cardiovascular disease risk factor responses after supplementation with docosahexaenoic acid in postmenopausal women receiving and not receiving hormone replacement therapy. American Journal of Clinical Nutrition 79:765-773. Woodman, R.J.; Mori, T.A.; Burke, V.; Puddey, 31 January 2008 Page 1,406 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID I.B.; Watts, G.F.; Beilin, L.J. 2002. Effects of purified eicosapentaenoic and docosahexaenoic acids on glycemic control, blood pressure, and serum lipids in type 2 diabetic patients with treated hypertension. American Journal of Clinical Nutrition 76:1007-1015. Wu, W.H.; Lu, S.C.; Wang, T.F.; Jou, H.J.; Wang, T.A. 2006. Effects of docosahexaenoic acid supplementation on blood lipids, estrogen metabolism, and in vivo oxidative stress in postmenopausal vegetarian women. European Journal of Clinical Nutrition 60:386-392. Randomized Controlled Trials – Favourable Effects on Blood Pressure3 Dyerberg, J.; Eskesen, D.C.; Andersen, P.W.; Astrup, A.; Buemann, B.; Christensen, J.H.; Clausen, P.; Rasmussen, B.F.; Schmidt, E.B.; Tholstrup, T.; Toft, E.; Toubro, S.; Stender, S. 2004. Effects of trans and n-3 unsaturated fatty acids on cardiovascular risk markers in healthy males. An 8 weeks dietary intervention study. European Journal of Clinical Nutrition 58:1062-1070. Theobald, H.E.; Goodall, A.H.; Sattar, N.; Talbot, D.C.S.; Chowienczyk, P.J.; Sanders, T.A.B. 2007. Low-dose docosahexaenoic acid lowers diastolic blood pressure in middle-aged men and women. The Journal of Nutrition 137:973-978. Lara, J.J.; Economou, M.; Wallace, A.M.; Rumley, A.; Lowe, G.; Slater, C.; Caslake, M.; Sattar, N.; Lean, M.E.J. 2007. Benefits of salmon eating on traditional and novel vascular risk factors in young, non-obese healthy subjects. Atherosclerosis 193:213-221. 31 January 2008 Page 1,407 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Observational Studies – Prospective Cohort Studies3 References Claim ID Albert, C.M.; Campos, H.; Stampfer, M.J.; Ridker, P.M.; Manson, J.E.; Willett, W.C.; Ma, J. 2002. Blood levels of n-3 fatty acids and the risk of sudden death. New England Journal of Medicine 346(15):1113-1118. He, K.; Rimm, E.B.; Merchant, A.; Rosner, B.A.; Stampfer, M.J.; Willett, W.C.; Ascherio, A. 2002. Fish consumption and risk of stroke in men. American Medical Association 288:3130-3136. Hu, F.B.; Bronner, L.; Willett, W.C.; Stampfer, M.J.; Rexrode, K.M.; Albert, C.M.; Hunter, D.; Manson, J.E. 2002. Fish and omega-3 fatty acid intake and risk of coronary heart disease in women. Journal of the American Medical Association 287(14):1815-1821. Iso, H.; Kobayashi, M.; Ishihara, J.; Sasaki, S.; Okada, K.; Kita, Y.; Kokubo, Y.; Tsugane, S.; for the JPHC Study Group. 2006. Intake of fish and n3 fatty acids and risk of coronary heart disease among Japanese: The Japanese Public Health Center-Based (JHPC) Study Cohort I. Circulation 113:195-202. Mozaffarian, D.; Ascherio, A.; Hu, F.B.; Stampfer, M.J.; Willett, W.C.; Siscovick, D.S.; Rimm, E.B. 2005. Interplay between different polyunsaturated fatty acids and risk of coronary heart disease in men. Circulation 111:157-164. Mozaffarian, D.; Lemaitre, R.N.; Kuller, L.H.; Burke, G.L.; Tracy, R.P.; Siscovick, D.S. 2003. Cardiac benefits of fish consumption may depend on the type of fish consumed: The cardiovascular health study. Circulation 107:1372-1377. 31 January 2008 Page 1,408 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Observational Studies – Cross-Sectional3 References Claim ID Chrysohoou, C.; Panagiotakos, D.B.; Pitsavos, C.; Skoumas, J.; Krinos, X.; Chloptsios, Y.; Nikolaou, V.; Stefanadis, C. 2007. Long-term fish consumption is associated with protection against arrhythmia in healthy persons in a Mediterranean region – the ATTICA study. American Journal of Clinical Nutrition 85:1385-1391. Mozaffarian, D.; Prineas, R.J.; Stein, P.K.; Siscovick, D.S. 2006. Dietary fish and n-3 fatty acid intake and cardiac electrocardiographic parameters in humans. Journal of the American College of Cardiology 48:478-484. Okuda, N.; Ueshima, H.; Okayama, A.; Saitoh, S.; Nakagawa, H.; Rodriguez, B.L.; Sakata, K.; Choudhury, S.R.; Curb, J.D.; Stamler, J. (for the INTERLIPID Research Group) 2005. Relation of long-chain n-3 polyunsaturated fatty acid intake to serum high density lipoprotein cholesterol among Japanese men in Japan and Japanese-American men in Hawaii: the INTERLIPID study. Atherosclerosis 178:371-379. Panagiotakos, D.B.; Zeimbekis, A.; Boutziouka, V.; Economou, M.; Kourlaba, G.; Toutouzas, P.; Polychronopoulos, E.. 2007. Long-term fish intake is associated with better lipid profile, arterial blood pressure, and blood glucose in elderly people from Mediterranean islands (MEDIS epidemiological study). Medical Science Monitor 13(7):307-312. Ueshima, H.; Stamler, J.; Elliott, P.; Chan, Q.; Brown, I.J.; Carnethon, M.R.; Daviglus, M.L.; He, K.; Moag-Stahlberg, A.; Rodriguez, B.L.; Steffen, L.M.; Van Horn, L.; Yarnell, J.; Zhou, B. (INTERMAP Research Group). 2007. 31 January 2008 Page 1,409 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Food omega-3 fatty acid intake of individuals (total, linolenic acid, long-chain) and their blood pressure: INTERMAP study. Hypertension 50(2):313-319. Observational Studies – Case-Control3 Guallar, E.; Sanz-Gallardo, I.; van’t Veer, P.; Bode, P.; Aro, A.; Gómez-Aracena, J.; Kara, J.D.; Riemersma, R.A.; Martin-Moreno, J.M.; Kok, F.J. (For the Heavy Metals and Myocardial Infarction Study Group). 2002. Mercury, fish oils, and the risk of myocardial infarction. New England Journal of Medicine 347:1747-1754. Lemaitre, R; King, I; Mozaffarian, D; Kuller, L; Tracy, R; Siscovick, D. 2003. n-3 polyunsaturated fatty acids, fatal ischemic heart disease, and nonfatal myocardial infarction in older adults: the Cardiovascular Health Study. American Journal of Clinical Nutrition 77:319-325. Rozenn, N.L.; King, I.B.; Mozaffarian, D.; Kuller, L.H.; Tracy, R.P.; Siscovick, D.S. 2003. n-3 polyunsaturated fatty acids, fatal ischemic heart disease, and nonfatal myocardial infarction in older adults: The Cardiovascular Health Study. American Journal of Clinical Nutrition 77:319-325. Tavani, A.; Bertuzzi, M.; Gallus. S.; Negri, E.; La Vecchia, C. 2004. Risk factors for non-fatal myocardial infarction in Italian women. Preventative Medicine 39:128-134. 31 January 2008 Page 1,410 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human Intervention Studies References Claim ID Jacobson TA. Beyond lipids: the role of omega-3 fatty acids from fish oil in the prevention of coronary heart disease. Curr Artheroscler Rep. 9(2), 145-153 (2007) De Lorgeril M. Essential polyunsaturated fatty acids, inflammation, atherosclerosis and cardiovascular diseases. Subcell Biochem. 42, 283-297 (2007) Lamotte M et al. A multi-country health-economic evaluation of highly concentrated n-3 polyunsaturated fatty acids in the secondary prevention after myocardial infarction. Herz. 31, 3,74-82 (Dec 2006) HDL (good) cholesterol 31 January 2008 The effective dose required to maintain healthy HDL cholesterol levels is estimated to be 500 mg n-3 LC-PUFAs per day. To carry the claim, a product should contain =30 mg n-3 LC-PUFAs per 100 g or 100 kcal, in accordance with the Update of the ANNEX of the Regulation 1924/2006 (eg., 1% or 2% DHA milk provides ?40 mg DHA per 100 g and 77 mg DHA per 100 kcal, and so would qualify to carry the claim). 899 Page 1,411 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body – Recommended Intakes References Claim ID International Society for the Study of Fatty Acids and Lipids, 2004 ISSFAL. 2004. Recommendations for Intake of Polyunsaturated Fatty Acids in Healthy Adults (Report of the Sub-Committee). International Society for Study of Fatty Acids and Lipids (ISSFAL); Tiverton, Devon, Engl. ISSFAL Policy Statement No. 3. Available from: http://www.issfal.org.uk/lipid-matters/issfal-polic y-statements/issfal-policy-statement-3.html. Scientific Advisory Committee on Nutrition, 2004 SACN. 2004. Advice on Fish Consumption: Benefits and Risks. U.K. Food Standards Agency (FSA) & U.K. Department of Health, Committee on Toxicity (COT), Scientific Advisory Committee on Nutrition (SACN); London, Engl. Available from: http://www.food.gov.uk/multimedia/pdfs/fishrep ort2004full.pdf. FAO/WHO Expert Committee on Fats and Oils in Human Nutrition, 2003 FAO/WHO. 2003. Diet, Nutrition and the Prevention of Chronic Diseases. Report of a Joint WHO/FAO Expert Consultation, Jan. 28-Feb. 1, 2002, Geneva, Switz. World Health Organization (WHO); Geneva, Switz. WHO Technical Report Series, No. 916. Available from: http://whqlibdoc.who.int/trs/WHO_TRS_916.pdf . European Society of Cardiology, 2003 European Society of Cardiology. 2003. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute 31 January 2008 Page 1,412 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Myocardial Infarction of the European Society of Cardiology. Eur Heart J 24(1):28-66. Available from: http://eurheartj.oxfordjournals.org/cgi/content/fu ll/24/1/28. American Heart Association, 2002 Kris-Etherton, P.M.; Harris, W.S.; Appel, L.J.; (for the American Heart Association Nutrition Committee). 2002. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 106(21):2747-2757 & [Erratum, 107(3):512]. Available from: http://circ.ahajournals.org/cgi/content/full/106/2 1/2747. American Heart Association, 2006 Lichtenstein, A.H.; Appel, L.J.; Brands, M.; Carnethon, M.; Daniels, S.; Franch, H.A.; Franklin, B.; Kris-Etherton, P.; Harris, W.S.; Howard, B.; Karanja, N.; Lefevre, M.; Rudel, L.; Sacks, F.; Van Horn, L.; Winston, M.; Wylie-Rosett, J. 2006. Summary of American Heart Association Diet and Lifestyle Recommendations revision 2006. Arterioscler Thromb Vasc Biol 26(10):2186-2191. Available from: http://atvb.ahajournals.org/cgi/content/full/26/10 /2186. US National Academies of Science, Institute of Medicine, 2005 IOM. 2005. Macronutrients and healthful diets. In: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients). Institute of Medicine (IOM) of the National Academies / The National Academy Press (NAP); Washington, DC. 31 January 2008 Page 1,413 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Available from: http://books.nap.edu/openbook.php?record_id= 10490&page=769. Health Council of the Netherlands, 2001 Spaaij, C.J.; Pijls, L.T. 2004. New dietary reference intakes in the Netherlands for energy, proteins, fats and digestible carbohydrates. Eur J Clin Nutr 58(1):191-194. Available from: http://www.nature.com/ejcn/journal/v58/n1/full/1 601788a.html. Eurodiet – Nutrition and Diet for Healthy Lifestyles, 2000 Eurodiet. 2000. EURODIET Core Report. University of Crete, Eurodiet Project; Crete, Greece (Sponsored by the European Commission, Directorate General for Health & Consumer Protection (Unit F/3), and the Greek Ministry of Health). Available from: http://eurodiet.med.uoc.gr/. UK Committee on Medical Aspects of Food Policy, 1994 Stockley, L. 1996. Nutritional Aspects of Cardiovascular Disease (Nutrition Briefing Paper based on the 1994 Report of the Cardiovascular Review Group, Committee on Medical Aspects of Food Policy [COMA]). Prepared for the U.K. Health Education Authority (HEA); London, Engl. Available from: http://www.nice.org.uk/page.aspx?o=502129. British Nutrition Foundation Task Force on Unsaturated Fatty Acids, 1992 BNF. 1999. n-3 Fatty Acids and Health. British Nutrition Foundation (BNF); London, Engl. 31 January 2008 Page 1,414 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Randomized Controlled Trials – Favourable Effects on HDL-C3 References Claim ID Chan, D.C.; Watts, G.F.; Mori, T.A.; Barrett, P.H.R.; Beilin, L.J.; Redgrave, T.G. 2002. Factorial study of the effects of atorvastatin and fish oil on dyslipidaemia in visceral obesity. European Journal of Clinical Investigation 32:429-436. Hill, A.M.; Buckley, J.D.; Murphy, K.J.; Howe, P.R.C. 2007. Combining fish-oil supplements with regular aerobic exercise improves body composition and cardiovascular disease risk factors. American Journal of Clinical Nutrition 85:1267-1274. Krebs, J.D.; Browning, L.M.; McLean, N.K.; Rothwell, J.L.; Mishra, G.D.; Moore, C.S.; Jebb, S.A. 2006. Additive benefits of long-chain n-3 polyunsaturated fatty acids and weight-loss in the management of cardiovascular disease risk in overweight hyperinsulinaemic women. International Journal of Obesity 30:1535-1544. Lara, J.J.; Economou, M.; Wallace, A.M.; Rumley, A.; Lowe, G.; Slater, C.; Caslake, M.; Sattar, N.; Lean, M.E.J. 2007. Benefits of salmon eating on traditional and novel vascular risk factors in young, non-obese healthy subjects. Atherosclerosis 193:213-221. Lovegrove, J.A.; Lovegrove, S.S.; Lesauvage, S.V.M.; Brady, L.M.; Saini, N.; Minihane, A.M.; Williams, C.M. 2004. Moderate fish-oil supplementation reverses low-platelet, long-chain n-3 polyunsaturated fatty acid status and reduces plasma triacylglycerol concentrations in British Indo-Asians. American Journal of Clinical Nutrition 79:974-982. 31 January 2008 Page 1,415 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Observational Studies – Cross-Sectional3 31 January 2008 References Claim ID Okuda, N.; Ueshima, H.; Okayama, A.; Saitoh, S.; Nakagawa, H.; Rodriguez, B.L.; Sakata, K.; Choudhury, S.R.; Curb, J.D.; Stamler, J. (for the INTERLIPID Research Group) 2005. Relation of long-chain n-3 polyunsaturated fatty acid intake to serum high density lipoprotein cholesterol among Japanese men in Japan and Japanese-American men in Hawaii: the INTERLIPID study. Atherosclerosis 178:371-379. Page 1,416 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long chain omega-3 polyunsaturated fatty acids Heart health 31 January 2008 The claim relates only to very long chain polyunsaturated fatty acids (of chain length 20 carbons or above) including EPA, DPA and DHA (i.e. 20:3n-3, 20:4n-3, 20:5n-3, 22:5n-3 and 22:6n-3), and not all long chain polyunsaturated fatty acids, such as alpha-linolenic acid (i.e. 18:3n-3 and 18:4n-3). The ratio of EPA and DHA should reflect that which occurs naturally in oily fish. Must be accompanied by a statement to the effect that 3g must be consumed weekly, or 0.45g daily, as part of a healthy lifestyle. When a product is presented as a stand alone serving, then each serving must contain no less than 0.2g LC n-3 PUFA. When a product carries a recommendation for a number of portions per day or week then the total LC n-3 PUFA content of the daily JHCI Joint Health Claims Initiative, 2004 (http://www.jhci.org.uk/approv/JHCIDossier.pdf) 2,351 Page 1,417 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID recommendation (daily serving) must be greater than 0.2g. Not personalise the claim to the individual, e.g. "provides half your daily needs". State the proportion (i.e. a ‘quarter’, ‘third’, ‘half’ etc) of the 0.45g daily intake, or 3g weekly intake, in each serving or portion. Clarify to consumers when products have been fortified with LC n-3 PUFA and make clear to consumers the origin of the oil. Products containing significant amounts of contaminants (identified by the SACN/COT Inter-Committee Subgroup to be marlin, swordfish, shark and, to a lesser extent, tuna) carrying the claim should also carry a warning for pregnant women and children 31 January 2008 Page 1,418 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long-chain omega 3 (n-3) polyunsaturated fatty acids (LC omega 3 PUFA, LCn-3 PUFA) or EPA and DHA or docosahexaenoic acid (DHA; C22-6n-3) or omega 3 fish oils Brain development and function 55 mg/day minimum 488 Applicable to adults and children 31 January 2008 Page 1,419 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Textbooks Reviews Randomised trials epidemiology References Claim ID Consensus Statement Koletzko, B., Cetin, I., Brenna, J. T. for the Perinatal Lipid Intake Working Group (2007). Dietary fat intakes for pregnant and lactating women. Br J Nutr doi: 10.1017/S0007114507764747 Human Studies Farquharson, J., Jamieson, E.C., Abbasi, A.K., Patrick, W.J.A., Logan, R.W. & Cockburn, F. (1995). Effect of diet on the fatty acid composition of the major phospholipids of infant cerebral cortex. Arch Dis Child 72 : 198-203 Olsen, S.F., Sorensen, J.D., Secher, N.J., Hedegaard, M., Henriksen, T.B., Hansen, A.S. & Grant, A. (1992). Randomised, controlled trial of the effect of fish oil supplementation on pregnancy duration. Lancet 339 : 1003-1007 Voigt, R.G., Jensen, C.L., Fraley, J.K., Rozelle, J.C., Brown III, F.R. & Heird, W.C. (2002). Relationship between ?3 long-chain polyunsaturated fatty acid status during early infancy and neurodevelopmental status at 1 year of age. J Hum Nutr Diet 15 : 111-120 Willatts, P., Forsyth, J.S., DiModugno, M.K., Varma, S. & Colvin, M. (1998). Effect of long-chain polyunsaturated fatty acids in infant formula on problem solving at 10 months of age. Lancet 352 : 688-691 Birch, E.E., Hoffman, D.R., Castaneda, Y.S., 31 January 2008 Page 1,420 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fawcett, S.L., Birch, D.G. & Uauy, R. (2002). A randomised controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age Am J Clin Nutr 75 : 570-580 Bouwstra, H., Dijck-Brouwer, D.A.J., Wildeman, J.A.L., Tjoonk, H.M., van der Heide, J.C., Boersma, E.R. et al (2003). Long-chain polyunsaturated fatty acids have a positive effect on the quality of general movements of healthy term infants. Am J Clin Nutr 78 : 313-318 Makrides M., Neuman, M.A., Byard, R.W., Simmer, K. & Gibson, R.A. (1994). Fatty acid composition of brain, retina and erythrocytes in breast- and formula-fed infants. Am J Clin Nutr 60 : 189-194 Helland, I.B., Smith, L., Saarem, K., Saugstad, O.D. & Drevon, C.A. (2003). Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children’s IQ at 4 years of age. Pediatrics 111 : e39-e44 Colombo, J., Kannass, K.N., Shaddy, D.J., Kundurthi, S., Maikranz, J.M., Anderson, C.J. et al (2004). Maternal DHA and the development of attention in infancy and toddlerhood. Child Development 75: 1254-1267 Auestad, N., Scott, D.T., Janowsky, J.S., Jacobsen, C., Carroll, R.E., Montalto, M.B., Halter, R. et al (2003). Visual, cognitive and language assessment at 39 months: a follow-up study of children fed formulas containing long-chain polyunsaturated fatty 31 January 2008 Page 1,421 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID acids to 1 year of age. Pediatrics 112: e177-e183 Morris, M. C., Evans, D.A., Tangney, C.C., Bienias, J.L. & Wilson, R.S. (2005). Fish consumption and cognitive decline with age in a large community study. Arch Neurol 62: 1849-1853 Freund-Levi, Y. Eriksdotter-Jönhagen, M., Cederholm, T., Basun, H., Faxèn-Irving, G., Garlind, A., Vedin, I., Vessby, B. et al (2006). ?3 Fatty acid treatment in 174 patients with mild to moderate Alzheimer disease: OmegAD Study. Arch Neurol 63: 1402-1408 Schaefer, E. J., Bongard, V., Beiser, A.S., Lamon-Fava, S., Robins, S.J., Au, R., Tucker, K.L., Kyle, D.J. et al (2006). Plasma phosphatidylcholine docosahexaenoic acid content and risk of dementia and Alzheimer disease. Arch Neurol 63: 1545-1550 Van Gelder, B. M., Tijhuis, M., Kalmijn, S. & Kromhout, D. (2007). Fish consumption, n-3 fatty acids and subsequent 5-y cognitive decline in elderly men: the Zutphen Elderly Study. Am J Clin Nutr 85: 1142-1147 Jensen, C. L., Voigt, T.C., Prager, T.C., Zou, Y.L., Fraley, J.K., Rozelle, J.C. et al (2005). Effects of maternal docosahexaenoic acid intake on visual function and neurodevelopment in breastfed term infants. Am J Clin Nutr 82: 125-132 Birch, E. E., Garfield, S., Castaneda, Y., 31 January 2008 Page 1,422 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hughbanks-Wheaton, D., Uauy, R. & Hoffman, D. (2007). Visual acuity and cognitive outcomes at 4 years of age in a double-blind, randomised trial of long-chain polyunsaturated fatty acid-supplemented infant formula. Early Human Development 83: 279-284 Lauritzen, L., Jargensen, M.H., Olsen, S.F., Straarup, E.M. & Michaelsen, K.F. (2005). Maternal fish oil supplementation in lactation: effect on developmental outcome in breast-fed infants. Reprod Nutr Dev 45: 535-547 Freemantle, E., Vandal, M., Tremblay-Mercier, J., Tremblay, S., Blachere, J.-C., Begin, M.E., Brenna, J.T. et al. (2006). Maternal fish oil supplementation in lactation: effect on developmental outcome in breast-fed infants. Prostaglandins Leukotrienes EFA 75: 213-220 Dunstan, J. A., Simmer, K., Dixon, G. & Prescott, S.L. (2006). Cognitive assessment at 2½ years following fish oil supplementation in pregnancy: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. Published on-line doi: 10.11.36/adc.2006.099085 Judge, M. P.Harel, O. & Lammi-Keefe, C.J. (2007). Maternal consumption of a docosahexaenoic acid-containing functional food during pregnancy: benefit for infant performance on problem solving but not on recognition memory tasks at age 9 mo. Am J Clin Nutr 85: 1572-1577 Whalley, L.F., Fox, H.C., Wahle, K.W., Starr, J.M. & Deary, I.J. (2004). Cognitive aging, childhood intelligence, and the use of food supplements: possible involvement of n-3 fatty 31 January 2008 Page 1,423 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID acids. Am J Clin Nutr 80: 1650-1657 Richardson, A.J. & Montgomery, P. (2005). The Oxford-Durham Study: a randomised, controlled trial of dietary supplementation with fatty acids in children with development coordination disorder. Pediatrics 115: 1360-1366 Sinn, N. & Bryan, J. (2007). Effect of supplementation with polyunsaturated fatty acids and micronutrients on learning and behaviour problems associated with child ADHD. J Development Behavioral Pediatrics 28: 82-91 Montgomery, C., Speake, B.K., Cameron, A., Sattar, N. & Weaver, L.T. (2003). Maternal docosahexaenoic acid supplementation and fetal accretion. Br J Nutr 90: 135-145 Epidemiological Studies Hibbeln, J.R., Davis, J.M., Steer, C., Emmett, P., Rogers, I., Williams, C. & Golding J. (2007). Maternal seafood consumption in pregnancy and neurodevelopmental outcomes in childhood (ALSPAC Study) : an observational cohort study. Lancet 369 : 578-585 Ghys, A., Bakker, E., Hornstra, G. & van den Hout, M. (2002). Red blood cell and plasma phospholipid arachidonic and docosahexaenoic acid levels at birth and cognitive development at 4 years of age. Early Human Development 69 : 83-90 31 January 2008 Page 1,424 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Daniels, J.L., Longnecker, M.P., Rowland, A.S., Golding, J. (2004). Fish intake during pregnancy and early cognitive development of offspring. Epidemiol 15 : 394-402 Kalmijn, S., van Boxtel, M.P.J., Ocké, M., Verschuren, W.M.M., Kromhout, D. & Launer, L.J. (2004). Dietary intake of fatty acids and fish in relation to cognitive performance at middle age. Neurology 62: 275-280 Cheruku, S. R., Montgomery-Downs, H.E., Farkas, S.L., Thoman, E.B. & Lammi-Keefe, C.J. (2002). Higher maternal plasma docosahexaenoic acid during pregnancy is associated with more mature neonatal sleep-state patterning. Am J Clin Nutr 76: 608-613 Engelhart, M. J., Geerlings, M.I., Ruitenberg, A., van Swieten, J.C., Hofman, A., Witteman, J.M.C. & Breteler, M.M.B. (2002). Diet and risk of dementia: does fat matter? The Rotterdam Study. Neurology 59: 1915-1921 Morris, M. C., Evans, D.A., Bienias, J.L., Tangney, C.C., Bennett, D.A., Willon, R.S. et al (2003). Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol 60: 940-946 Conklin, S. M., Gianaros, P.J., Brown, S.M., Yao, J.K., Hariri, A.R., Manuck, S.B., Muldoon, M.F. (2007). Long-chain omega-3 fatty acid intake is associated positively with corticolimbic gray matter volume in healthy adults. Neurosci Lett 421: 209-212 31 January 2008 Page 1,425 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Reviews Salem N. Jr., Litman, B., Kim, H.-Y. & Gawrisch, K. (2001). Mechanisms of action of docosahexaenoic acid in the nervous system. Lipids 36 : 945-959 FAO/WHO (1994). FAO Food Nutr Pap 57 : 1-147 Simopoulos, A.P., Leaf, A. & Salem Jr., N (1999). Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr 18 : 487-489 Larque, E., Demmelmair, H. & Koletzko, B. (2002). Perinatal supply and metabolism of long-chain polyunsaturated fatty acids. Importance for the early development of the nervous system. Ann NY Acad Sci 967 : 299-310 Muskiet, F. A. J., Fokkema, M.R., Schaafsma, A., Boersma, E.R. & Crawford, M.A. (2004). Is docosahexaenoic acid (DHA) essential? Lessons from DHA status regulation, our ancient diet, epidemiology and randomised, controlled trials. J Nutr 134: 183-186 Connor, W. E. and Connor, S. L. (2007). The importance of fish and docosahexaenoic acid in Alzheimer disease. Am J Clin Nutr 85: 929-930 Muskiet, F. A. J., van Goor, S.A., Kuipers, R.S., Velzing-Aarts, F.V., Smit, E.N., Bouwstra, H. et al (2006). Long-chain polyunsaturated fatty 31 January 2008 Page 1,426 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID acids in maternal and infant nutrition. Prostaglandins Leukotrienes EFA 75: 135-144 Koletzko, B., Agostoni, C., Carlson, S.E., Clandinin, T., Hornstra, G. et al (2001). Long-chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Pediatrica 90: 460-464 Cheatham, C. L., Colombo, J. & Carlson, S.E. (2006). n-3 Fatty acids and cognitive function and visual acuity development: methodologic and conceptual considerations. Am J Clin Nutr 83(suppl): 1458S-1466S Johnson, E. J. and Schaefer, E. J. (2006). Potential role of dietary n-3 fatty acids in the prevention of dementia and macular degeneration. Am J Clin Nutr 83(suppl): 1494S-1498S Animal Studies Calderon, F. and Kim, H.Y. (2004). Docosahexaenoic acid promotes neurite growth in hippocampal neurons J Neurochem 90 : 979-988 (erratum : J Neurochem 2004 ; 90 : 1540) Dyall, S. C., Michael, G.J., Whelpton, R., Scott, A.G. & Michael-Titus, A.T. (2007). Dietary enrichment with omega-3 polyunsaturated fatty acids reverses age-related decreases in the GluR2 and NR2B glutamate receptor subunits in rat forebrain. Neurobiol of Aging 28: 424-439 31 January 2008 Page 1,427 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long-chain omega-3 (n-3) polyunsaturated fatty acids (LC omega-3 PUFA, LC n-3 PUFA) or docosahexaenoic acid or eicosapentaenoic acid or omega-3 fish oils Building block for lipids in the retina’s photoreceptors; Eye Health 31 January 2008 Applicable to adults and children 491 Page 1,428 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCTs Human studies Animal studies Mechanisms References Claim ID Human Studies Birch, E.E., Hoffman, D.R., Castaneda, Y.S., Fawcett, S.L., Birch, D.G. & Uauy, R. (2002). A randomised controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr 75 : 570-580 Makrides, M., Neuman, M.A., Byard, R.W., Simmer, K. & Gibson, R.A. (1994). Fatty acid composition of brain, retina and erythrocytes in breast- and formula-fed infants. Am J Clin Nutr 60 : 189-194 Montgomery, C. et al (2003). Br J Nutr 90: 135-145 Innis, S.M., Nelson, C.M., Rioux, M.F. & King, D.J. (1994). Development of visual acuity in relation to plasma and erythrocyte omega-6 and omega-3 fatty acids in healthy, term gestation infants. Am J Clin Nutr 60 : 347-352 Auestad, N., Scott, D.T., Janowsky, J.S., Jacobsen, C., Carroll, R.E., Montalto, M.B., Halter, R. et al (2003). Visual, cognitive and language assessment at 39 months: a follow-up study of children fed formulas containing long-chain polyunsaturated fatty acids to 1 year of age. Pediatrics 112: e117-e183 Williams, C., Birch, E.E., Emmett, P.M. & Northstone, K. (2001). Stereoacuity at age 3.5 y in children born full-term is associated with prenatal and postnatal dietary factors: a report from a population-based cohort study. 31 January 2008 Page 1,429 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Am J Clin Nutr 73: 316-322 Judge, M. P., Harel, O., Lammi-keefe, C.J. (2007). A docosahexaenoic acid-functional food during pregnancy benefits infant visual acuity at four but not six months of age. Lipids 42: 117-122 Jensen, C. L., Voigt, T.C., Prager, T.C., Zou, Y.L., Fraley, J.K., Rozelle, J.C. et al. (2005). Effect on maternal docosahexaenoic acid intake on visual function and neurodevelopment in breastfed term infants. Am J Clin Nutr 82: 125-132 Birch, E. E., Garfield, S., Castaneda, Y.S., Hughbanks-Wheaton, D., Uauy, R. & Hoffman, D.R. (2007). Visual acuity and cognitive outcomes at 4 years of age in a double-blind, randomised trial of long-chain polyunsaturated fatty acid-supplemented infant formula. Early Human Development 83: 279-284 Lauritzen, L., Jørgensen, M.H., Mikkelsen, T.B., Skovgaard, I.M., Straarup, E.M., Olsen, S.F. et al (2004). Maternal fish oil supplementation in lactation: effect on visual acuity and n-3 fatty acid content of infant erythrocytes. Lipids 39: 195-206 Malcolm, C. A., Hamilton, R., McCulloch, D.L., Montgomery, C. & Weaver, L.T. (2003). Scotopic electroretinogram in term infants born of mothers supplemented with docosahexaenoic acid during pregnancy. Invest Ophthalmol Vis Sci 44: 3685-3691 Consensus Statement 31 January 2008 Page 1,430 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Koletzko, B., Cetin, I., Brenna, J. T. for the Perinatal Lipid Intake Working Group (2007). Dietary fat intakes for pregnant and lactating women. Br J Nutr doi: 10.1017/S0007114507764747 Reviews Uauy, R., Hoffman, D.R., Peirano, P., Birch, D.G. & Birch, E.E. (2001). Essential fatty acids in visual and brain development. Lipids 36 : 885-895 Innis, S.M. (1993). Essential fatty acid requirements in human nutrition. Can J Physiol Pharmacol 71 : 699-706 Larque, E., Demmelmair, H. & Koletzko, B. (2002). Perinatal supply and metabolism of long-chain polyunsaturated fatty acids. Importance for the early development of the nervous system. Ann NY Acad Sci 967 : 299-310 Jeffrey, B.G., Weisinger, H.S., Neuringer, M. & Mitchell, D.C. (2001). The role of docosahexaenoic acid in retinal function. Lipids 36 : 859-871 Cheatham, C. L., Colombo, J. & Carlson, S.E. (2006). n-3 Fatty acids and cognitive function and visual acuity development: methodologic and conceptual considerations. Am J Clin Nutr 83(suppl): 1458S-1466S Johnson, E. J. and Schaefer, E. J. (2006). Potential role of dietary n-3 fatty acids in the prevention of dementia and macular degeneration. Am J Clin Nutr 83(suppl): 1494S-1498S 31 January 2008 Page 1,431 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID SanGiovanni, J. P and Chew, E. Y. (2005). The role of omega-3 polyunsaturated fatty acids in health and disease of the retina. Progr Retin Eye Res 24: 87-138 Animal/Ex-Vivo Studies Anderson, G.J. et al (1990). Docosahexaenoic acid is the preferred dietary n-3 fatty acid for the development of the brain and retina. Pediatric Res 27 : 89-97 Diau, G.-Y., Loew, E.R., Wijendran, V., Sarkadi-Nagy, E., Nathanielsz, P.W. & Brenna, J.T. (2003). Docosahexaenoic and arachidonic acid influence on preterm baboon retinal composition and function. Invest Ophthalmol Vis Sci 44: 4559-4566 Connor, K. M., SanGiovanni, J.P., Lofqvist, C., Aderman, C.M., Chen, J., Higuchi, A., Hong, S. et al (2007). Increased dietary intake of ?-3 polyunsaturated fatty acids reduces pathological retinal angiogenesis. Nature Medicine 13: 868-873 Rojas, C.V., Martinez, J.I., Flores, I., Hoffman, D.R. & Uauy, R. (2003). Gene expression analysis in human fetal retinal explants treated with docosahexaenoic acid. Invest Ophthalmol Vis Sci 44 : 3170-3177 Mechanisms Fliesler, S.J. and Anderson, R.E. (1983). Chemistry and metabolism of lipids in the vertebrate retina. Prog Lipid Res 22 : 79-131 31 January 2008 Page 1,432 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Long-chain omega-3 fatty acids EPA and DHA Brain, eye and nerve development and function 31 January 2008 General population 896 Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day) Page 1,433 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Bodies; Expert and Scientific Organizations; References Claim ID Scientific Advisory Committee on Nutrition (UK) (2004). Advice on fish consumption, paragraph 5.18. ISBN 0 11 243083. The Stationary Office. London. http://www.sacn.gov.uk/pdfs/fics_sacn_advice_ fish.pdf Accessed 8/22/07. Ministero della Salute (Italy) http://www.ministerosalute.it/alimenti/resources /documenti/nutrizione/gravidanza_e_allattamen to.pdf Accessed 8/17/07. Guide to Food Advertising and Labeling (CA) (2003). Health Canada, Approved Biological Role Claims http://www.inspection.gc.ca/english/fssa/labeti/ guide/ch8e.shtml#8.5, accessed October 17, 2006. • Approved biological role claim: “DHA, an omega-3 fatty acid, supports the normal development of the brain, eyes and nerves” Institute of Medicine, National Academy of Science (US) (2005). Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein, and amino acids (Macronutrients). The National Academy of Sciences Press, Washington DC, Chapter 8. http://www.nap.edu/openbook.php?isbn=03090 85373, Accessed 8/17/07. WHO/FAO Expert Committee on Fats and Oils in Human Nutrition (1994). Report of a Joint FAO/WHO Expert Consultation. FAO Food and Nutrition Paper 57. Rome: Food and Agriculture Organization. http://www.fao.org/docrep/V4700E/V4700E00.h tm Accessed 8/17/07. National Health and Medical Research Council 31 January 2008 Page 1,434 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID (Australia and New Zealand) (2005). Nutrient reference values for Australia and New Zealand including recommended dietary intakes. www.nhmrc.gov.au/publications/synopses/_file s/n35.pdf Agency for Health Care Research and Quality (US) (2005). MacLean CH, Issa AM, Newberry SJ, et al. Effects of Omega-3 Fatty Acids on Cognitive Function with Aging, Dementia, and Neurological Diseases. Evidence Report/Tech Assessment No. 114. http://www.ahrq.gov/downloads/pub/evidence/p df/o3cogn/o3cogn.pdf Agency for Health Care Research and Quality (US) (2005) Lewin GA, Schachter HM, Yuen D, et al. Effects of Omega-3 fatty acids on child and maternal health. Evidence Report/Technology Assessment No. l18. http://www.ahrq.gov/clinic/epcsums/o3mchsum. htm Health Canada, Natural Health Products Directorate, Fish Oil Monograph, 2006. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hp fb-dgpsa/pdf/prodnatur/mono_fish_oil_huile_po isson_e.pdf, accessed September 14, 2007. International Society for the Study of Fatty Acids and Lipids (ISSFAL, 1999). Simopoulos AP, Leaf A, Salem N. Workshop on the Essentiality of and Recommended Dietary Intakes for Omega-6 and Omega-3 Fatty Acids. J Am Coll Nutr 1999;18:487-489. Perinatal Lipid Intake Working Group Consensus Statement: Dietary fat intakes for pregnant and lactating women. (EU) (2007). 31 January 2008 Page 1,435 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Brit J Nutr, in press. See also http://www.perilip.org/PeriLipRecommendations .html - recommendations Accessed 8/17/07. Agency for Health Care Research and Quality (AHRQ) (2005b). Hodge W, Barnes D, Schachter H, Pan Y, Lowcock E, Zhang L, Sampson M, Morrison A, Tran K, Miguelez M, Lewin G. Effects of Omega-3 Fatty Acids on Eye Health. Evidence Report/Technology Assessment No. 117 (Prepared by University of Ottawa Evidence-based Practice Center under Contract No. 290-02-0021.) AHRQ Publication No. 05-E008-2. Rockville, MD: Agency for Healthcare Research and Quality. July 2005. http://www.ahrq.gov/downloads/pub/evidence/p df/o3eye/o3eye.pdf Maternal Health; Pregnancy and nursing Minimum 15% RNI per 100g or 100kcal or Or amount to provide minimum 200 mg DHA/d 300-400mg DHA, 36-60mg EPA per day 897 General Population. Minimum 15% RDI per 100g or 100kcal. (RDI for EPA+DHA assumed as 200mg/day) 31 January 2008 Page 1,436 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Bodies; Expert and Scientific Organizations; References Claim ID Apports nutritionnels conseilles pour la population francaise (FR) (2001). 3rd edition, coordonnateur Ambroise Martin. CNERNA-CNRS, Paris, Technique & documentation. [Nutritional recommendations for the French population]. http://www.lavoisier.fr/notice/gb2743005350.ht ml Accessed 8/17/07. Agence Français de Sécurité Sanitaire des Aliments, [The omega-3 Fatty Acids and the Cardiovascular System :Nutritional benefits and claims]. 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See also http://www.perilip.org/PeriLipRecommendations .html#recommendations Accessed 8/17/07. 31 January 2008 Page 1,437 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Scientific Advisory Committee on Nutrition (UK) (2004). Advice on fish consumption. ISBN 0 11 243083. The Stationary Office. London. http://www.sacn.gov.uk/pdfs/fics_sacn_advice_ fish.pdf Accessed 8/22/07. WHO/FAO Expert Committee on Fats and Oils in Human Nutrition (1994). Report of a Joint FAO/WHO Expert Consultation. FAO Food and Nutrition Paper 57. Rome: Food and Agriculture Organization. http://www.fao.org/docrep/V4700E/V4700E00.h tm Accessed 8/17/07. Ministero della Salute (Italy) http://www.ministerosalute.it/alimenti/resources /documenti/nutrizione/gravidanza_e_allattamen to.pdf Accessed 8/17/07. National Health and Medical Research Council (Australia and New Zealand) (2005). Nutrient reference values for Australia and New Zealand including recommended dietary intakes. www.nhmrc.gov.au/publications/synopses/_file s/n35.pdf American Dietetic Association (US) (2003). Position of the American Dietetic Association and Dietitians of Canada: Vegetarian Diets, JADA 103:748-65. ISSFAL (2004). Simopoulos AP, Leaf A, Salem N. Workshop on the Essentiality of and Recommended Dietary Intakes for Omega-6 and Omega-3 Fatty Acids. J Am Coll Nutr 1999;18:487-489. Institute of Medicine, National Academy of Sciences (US) (2007). Seafood Choices: 31 January 2008 Page 1,438 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Balancing Benefits and Risks. Committee on Nutrient Relationships in Seafood: Selections to Balance Benefits and Risks. MC Nesheim and AL Yakitine, eds. The National Academies Press, Washington DC. http://www.nap.edu/catalog.php?record_id=117 62#toc. Accessed 8/17/07. Hoge Gezondheidsraad (BE), 2007. “Sense and nonsense of Omega-3 acids” found at http://www.gezondheid.be/index.cfm?fuseactio n=art&art_id=3264 Accessed 8/17/07. 31 January 2008 Page 1,439 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT CS Cohort Study Scientific Review References Claim ID Helland et al. 2006: Supplementation of n-3 fatty acids during pregnancy and laCSation reduces maternal plasma lipid levels and provides DHA to the infants. J Matern Fetal Neonatal Med 19: 397 Fidler et al., 2000: Docosahexaenoic acid transfer into human milk after dietary supplementation: a randomized clinical trial. J Lipid Res 41: 1376 http://www.jlr.org/cgi/content/full/41/9/1376 Helland et al. 2003: Maternal supplementation with very long chain n-3 fatty acids during pregnancy and lactation augments children´s IQ at 4 years of age. Pediatrics 111: e39 http://pediatrics.aappublications.org/cgi/content/ full/111/1/e39 Lauritzen et al., 2005: Maternal fish oil supplementation in lactation and growth during the first 2.5 years of life. Ped Res 58: 235 Jorgensen et al., 2001: Is there a relation between docohexaenoic acid concentration in mothers milk and visual development in term infants? J Pediatr Gastroenterol Nutr 32: 293 Agostoni, C., F. Marangoni, et al. (2001). "Prolonged breast-feeding (six months or more) and milk fat content at six months are associated with higher developmental scores at one year of age within a breast-fed population." Adv Exp Med Biol 501: 137-41. Auestad, N., R. Halter, et al. (2001). "Growth and development in term infants fed long-chain polyunsaturated fatty acids: a double-masked, randomized, parallel, prospective, multivariate study." Pediatrics 108(2): 372-81. 31 January 2008 Page 1,440 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Birch, E. E., S. Garfield, et al. (2007). "Visual acuity and cognitive outcomes at 4 years of age in a double-blind, randomized trial of long-chain polyunsaturated fatty acid-supplemented infant formula." Early Hum Dev 83(5): 279-84. Boris, J., B. Jensen, et al. (2004). "A randomized controlled trial of the effect of fish oil supplementation in late pregnancy and early lactation on the n-3 fatty acid content in human breast milk." Lipids 39(12): 1191-6. Fidler, N., T. Sauerwald, et al. (2000). "Docosahexaenoic acid transfer into human milk after dietary supplementation: a randomized clinical trial." J Lipid Res 41(9): 1376-83. Brenna, J. T., B. Varamini, et al. (2007). "Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide." Am J Clin Nutr 85(6): 1457-64. Decsi, T. and B. Koletzko (2005). "N-3 fatty acids and pregnancy outcomes." Curr Opin Clin Nutr Metab Care 8(2): 161-6. Arterburn, L. M., E. B. Hall, et al. (2006). "Distribution, interconversion, and dose response of n-3 fatty acids in humans." Am J Clin Nutr 83(6 Suppl): 1467S-1476S. Helland, I. B., O. D. Saugstad, et al. (2006). "Supplementation of n-3 fatty acids during pregnancy and lactation reduces maternal plasma lipid levels and provides DHA to the infants." J Matern Fetal Neonatal Med 19(7): 397-406. 31 January 2008 Page 1,441 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Helland, I. B., O. D. Saugstad, et al. (2001). "Similar effects on infants of n-3 and n-6 fatty acids supplementation to pregnant and lactating women." Pediatrics 108(5): E82. Hibbeln, J. R. (2002). "Seafood consumption, the DHA content of mothers' milk and prevalence rates of postpartum depression: a cross-national, ecological analysis." J Affect Disord 69(1-3): 15-29. Hoppu, U., M. Rinne, et al. (2005). "Breast milk fatty acid composition is associated with development of atopic dermatitis in the infant." J Pediatr Gastroenterol Nutr 41(3): 335-8. Innis, S. M. (2000). "Essential fatty acids in infant nutrition: lessons and limitations from animal studies in relation to studies on infant fatty acid requirements." Am J Clin Nutr 71(1 Suppl): 238S-44S. Innis, S. M. (2003). "Perinatal biochemistry and physiology of long-chain polyunsaturated fatty acids." J Pediatr 143(4 Suppl): S1-8. Innis, S. M. (2004). "Polyunsaturated fatty acids in human milk: an essential role in infant development." Adv Exp Med Biol 554: 27-43. Jorgensen, M. H., P. K. Nielsen, et al. (2006). "The composition of polyunsaturated fatty acids in erythrocytes of lactating mothers and their infants." Matern Child Nutr 2(1): 29-39. Marangoni, F., C. Agostoni, et al. (2000). "Polyunsaturated fatty acid concentrations in human hindmilk are stable throughout 12-months of lactation and provide a sustained intake to the infant during exclusive 31 January 2008 Page 1,442 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID breastfeeding: an Italian study." Br J Nutr 84(1): 103-9. O'Connor, D. L., R. Hall, et al. (2001). "Growth and development in preterm infants fed long-chain polyunsaturated fatty acids: a prospective, randomized controlled trial." Pediatrics 108(2): 359-71. Smit, E. N., M. Koopmann, et al. (2000). "Effect of supplementation of arachidonic acid (AA) or a combination of AA plus docosahexaenoic acid on breastmilk fatty acid composition." Prostaglandins Leukot Essent Fatty Acids 62(6): 335-40. Smit, E. N., E. A. Oelen, et al. (2000). "Breast milk docosahexaenoic acid (DHA) correlates with DHA status of malnourished infants." Arch Dis Child 82(6): 493-4. Willatts, P. (2002). "Long chain polyunsaturated fatty acids improve cognitive development." J Fam Health Care 12(6 Suppl): 5. Xiang, M., L. S. Harbige, et al. (2005). "Long-chain polyunsaturated fatty acids in Chinese and Swedish mothers: diet, breast milk and infant growth." Acta Paediatr 94(11): 1543-9. Yuhas, R., K. Pramuk, et al. (2006). "Human milk fatty acid composition from nine countries varies most in DHA." Lipids 41(9): 851-8. Innis, S.M., (2007). “Dietary (n-3) Fatty Acids and Brian Development.” American Society for Nutrition. J. Nutr. 137: 855–859, 2007. 31 January 2008 Page 1,443 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Low or reduced saturated fat (hard fat) or replacement of saturated fat with MUFA PUFA (soft fat) low cholesterol Lowers LDL cholesterol Arterial/ heart Health Must meet minimum requirements, as per Annex to Regulation 1924/2006. Authoritative Body Scientific Boday JHCI – Joint Health Claims Initiative – Final Technical Report – A List of Well Established Nutrient Function Statements http://www.food.gov.uk/multimedia/pdfs/jhci_he althreport.pdf 327 NFA – Terveysvaitteiden valvontaopas, Finnish Food Authority Control guides number 2/2002 http://www.palvelu.fi/evi/evi_material.php SNF – Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm 31 January 2008 Page 1,444 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Marine oils such as cod liver oil and fish oil containing eicosapentaenoic acid (EPA : C20:5 n-3) + docosahexaenoic acid (DHA; C22:6 n-3) or long-chain n-3 (omega 3) polyunsaturated fatty acids (LC n-3 PUFA, LC omega 3 PUFA) or ‘Omega 3’ Joint health 31 January 2008 Up to 2800 mg LC omega-3 PUFA/day 490 Page 1,445 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Meta-analysis, randomised controlled trials, reviews, mechanistic research, medical expert opinion. References Claim ID Human Studies Kjeldsen-Kragh, J., Lund, J.A., Riise, T., Finnanger, B. et al (1992). Dietary omega 3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis. J Rheumatol 19: 1531-1536 Skoldstam, L., Borjesson, O., Kjallman, A., Seiving, B. & Akesson, B. (1992). Effects of six months of fish oil supplementation in stable rheumatoid arthritis. A double-blind, controlled study. Scand J Rheumatol 21: 178-185 Van der Tempel, H., Tulleken, J.E., Linburg, J.C., Muskiet, A.J. & Van Rijswijk, M.H. (1990). Effects of fish oil supplementation in rheumatoid arthritis. Ann Rheum Dis 49: 76-80 Geusens, P., Wouters, D., Nijs, J., Jiang, Y. & Dequeker, J. (1994). Long-term effect of omega 3 fatty acid supplementation in active rheumatoid arthritis. Arthritis Rheumatism 37: 824-829 Lau, D.S., Morley, K.D. & Belch, J.J.F. (1993). Effects of fish oil supplementation on non-steroidal anti-inflammatory drug requirement in patients with mild rheumatoid arthritis – a double-blind placebo study. Br J Rheumatol 32: 982-989 Kremer, J.M., Jubiz, W., Michalek, A.V., Rynes, R.I. et al (1987). Fish oil supplementation in active rheumatoid arthritis: a double blinded, controlled cross-over study. Ann Intern Med 106: 497-503 31 January 2008 Page 1,446 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Gruenwald, J., Graubaum, H.J. & Harde, A. (2002). Effect of cod liver oil on symptoms of rheumatoid arthritis. Advances in Therapy 19: 101-107 Eriksen, W., Sandvik, L. & Bruusgaard, D. (1996). Does dietary supplementation of cod liver oil mitigate musculoskeletal pain? Eur J Clin Nutr 50: 689-693 Volker, D., Fitzgerald, P., Major, G & Garg, M. (2000). Efficacy of fish oil concentrate in the treatment of rheumatoid arthritis. J Rheumatol 27: 2343-2346 Kremer, J.M., Lawrence, D.A., Jubiz, W., Digiacomo, R. et al (1990). Dietary fish oil and olive oil supplementation in patients with rheumatoid arthritis. Arthritis Rheumatism 33: 810-820 Cleland, L.G., French, J.K., Betts, W.H., Murphy, G.A. & Elliott, M.J. ((1988). Clinical and biochemical effects of dietary fish oil supplements in rheumatoid arthritis. J Rheumatol 15: 1471-1475 Nielsen, G.L., Faarvang, K.L., Thomsen, B.S., Telglbjaerg, K.L. et al (1992). The effects of dietary supplementation with n-3 polyunsaturated fatty acids in patients with rheumatoid arthritis: a randomised, double-blind trial. Eur J Clin Invest 22: 687-691 Kremer, J.M., Malamood, H., Maliakkal, B., Rodgers, J.B. et al (1996). Fish oil dietary supplementation for prevention of indomethacin-induced gastric and small bowel toxicity in healthy volunteers 31 January 2008 Page 1,447 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID J Rheumatol 23: 1770-1773 Remans, P.H.J., Sont, J.K., Wagenaar, L.W., Wouters-Wesseling, W. et al. (2004). Nutrient supplementation with polyunsaturated fatty acids and micro-nutrients in rheumatoid arthritis: clinical and biochemical effects. Eur J Clin Nutr 58: 839-845 Meta-Analyses Fortin, P.R., Lew, R.A., Liang, M.H., Sperling, R.I. et al (1995). Validation of a meta-analysis: the effects of fish oil in rheumatoid arthritis. J Clin Epidemiol 48: 1379-1390 Goldberg, R.J. & Katz, J. (2007). A meta-analysis of the analgesic effects of omega-3 polyunsaturated fatty acid supplementation for inflammatory joint pain. Pain 129: 210-223 Reviews Calder, P.C. The scientific basis for fish oil supplementation in rheumatoid arthritis. In Food and Nutritional Supplements – Their role in health and disease, pp 175-197. J.K. Ransley, J.K. Donnelly, N.W. Read, Editors. Berlin: Springer (2000). Calder, P.C. & Field, C.J. Fatty acids, inflammation and immunity. In Nutrition and Immune Function, pp 57-92. P.C. Calder, C.J. Fields and H.S. Gill, Editors. Wallingford: CABI Publishing (2002). Watkins, B.A., Li, Y., Lippman, H.E. & Seifert, M.F. (2001). Omega 3 polyunsaturated fatty acids and skeletal health. Exp. Biol Med 226: 485-497 31 January 2008 Page 1,448 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Rennie, K.L., Hughes, J., Lang, R. & Jebb, S.A. (2003). Nutritional management of rheumatoid arthritis: a review of the evidence J Hum Nutr Dietet 16: 97-109 Ariza-Ariza, R., Mestanza-Peralta, M. & Cardiel, H.H. (1998). Omega 3 fatty acids in rheumatoid arthritis: an overview Semin Arhtritis Rheum 27: 366-370 Adam, O. (1995). Anti-inflammatory diet in rheumatic diseases. Eur J Clin Nutr 49: 703-717 Calder, P.C. (2006). N-3 Polyunsaturated fatty acids, inflammation and inflammatory diseases. Am J Clin Nutr 83(suppl): 1505S-1519S Mechanisms/General Arita, M., Bianchini, F., Aliberti, J., Sher, A. et al (2005). Stereochemical assignment, anti-inflammatory properties and receptor for omega-3 lipid mediator resolvin E1. J Exp Med 201: 713-722 James, M.J. & Cleland, L.G. (1997). Dietary n-3 fatty acids and therapy for rheumatoid arthritis. Semin Arthritis Rheum 27: 85-97 Stulnig, T.M. (2003). Immunomodulation by polyunsaturated fatty acids: mechanisms and effects. Int Arch Allergy Immunol 132: 310-321 Sperling, R.I., Benincaso, A.I., Knoell, C.T. & Larkin, J.K. (1993). Dietary n-3 polyunsaturated fatty acids inhibit 31 January 2008 Page 1,449 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID phosphoinositide formation and chemotaxis in neutrophils. J Clin Invest 91: 651-660 Cleland, L.G., James, M.J., Neumann, M.A., D’ Angelo, M. & Gibson, R.A. (1992). Linoleate inhibits EPA in corporation from dietary fish oil supplements in human subjects. Am J Clin Nutr 55: 395-399 Ferrucci, L., Cherubini, A., Bandinelli, S., Bartali, B., Corsi, A. et al (2006). Relationship of plasma polyunsaturated fatty acids to circulating inflammatory markers. J Clin Endocrinol Metab 91: 439-446 31 January 2008 Page 1,450 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Monounsaturated fatty acids from tallow (cetyl myristate, cetyl myristoleate, cetyl palmitoleate, cetyl laurate, cetyl palmitate, cetyl oleate) [Celadrin TM] Joint health and mobility 31 January 2008 Minimum of 832mg cetylated fatty acids (as Celadrin TM) per day 567 Page 1,451 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human intervention studies (oral) Human studies (topical application) Animal studies References Claim ID Hesslink R, Armstrong D, Nagendran MV, Sreevatsan S, Barathur R. Cetylated fatty acids improve knee function in patients with osteoarthritis. J Rheumatology 2002, 29: 1708-1712 (Summary 2). http://www.celadrininfo.com/studies/EfficacyRh eumatol.pdf Kraemer WJ, Ratamess NA, Anderson JM, Maresh CM, Tiberio DP, Joyce ME et al. Effect of a cetylated fatty acid topical cream on functional mobility and quality of life of patients with osteoarthritis. J Rheumatol 2004; 31: 767-774. (Summary 3). http://www.celadrininfo.com/studies/EfficacyRh eumatolCream.pdf Kraemer WJ, Ratamess NA, Maresh CM, Anderson JA, Tiberio DP, Joyce ME et al. Effects of treatment with a cetylated fatty acid topical cream on static postural stability and plantar pressure distribution in patients with knee osteoarthritis. J Strength Cond Res 2005a; 19: 115-121. (Summary 4). http://www.celadrininfo.com/studies/2005-Krae meretal.pdf Kraemer WJ, Ratamess NA, Maresh CM, Anderson JA, Volek JS, Tiberio DP et al. A cetylated fatty acid topical cream with menthol reduces pain and improves functional performance in individuals with arthritis. J Strength Cond Res 2005b; 19: 475-480. (Summary 5). http://www.celadrininfo.com/studies/2005Mar-K raemeretal.pdf Diehl, H. W. and E. L. May. Cetyl myristoleate isolated from Swiss albino mice: an apparent 31 January 2008 Page 1,452 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID protective agent against adjuvant arthritis in rats. J Pharm Sci 1994, 83: 296-299. (Summary 6). Hunter, K. W., Jr., R. A. Gault, et al. Synthesis of cetyl myristoleate and evaluation of its therapeutic efficacy in a murine model of collagen-induced arthritis. Pharmacol Res 2003, 47: 43-47. (Summary 7). Omega Heart health 31 January 2008 Minimum 0.3 g per 100g (15% of the 2 g RDI suggested by SCF) Authoritative guidelines Nordic Nutrition Recommendations 2004 Integrating nutrition and physical activity, 4th edition, NORD 2004:13 746 Page 1,453 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Omega 3 fatty acids Anti-angiogenic properties Normal brain development and function 31 January 2008 Survey articles * SanGiovanni JP et al., Retinal and Eye Research 2487–138 (2005) :The role of omega-3 long chain polyunsaturated fatty acids in health and disease of the retina ; Connor W.E. Am J Clin Nutr 71 (1 Suppl) 171S-5S (2000):The importance of n3 fatty acids in health and disease; 514 496 Page 1,454 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review References Claim ID Crawford MA (2006) Docosahexaenoic acid in neural signaling systems. Nutr Health; 18(3): 263-276. Koletzko B, Larque E, Demmelmair H (2007) Placental transfer of long chain polyunsaturated fatty acids. J Perinatal Med; 35: 5-11. Bourre JM(2006) Effects of nutrients in food on the structure and function of the nervous system: update on dietary requirements for brain. J Nutr Health Aging; 1(5); 386-399. Assisi A, Banzi R, Buonocore C et al (2006) Fish oil and mental health: the role of n-3 long chain fatty acids in cognitinve development. Int Clin Psychopharmacol; 21(6); 319-336. McNamara RK, Carlson SE (2006) Role of omega 3 fatty acids in brain development and function. Prostaglandins Leuk Essent Fatty Acids; 75(4): 329-349. Uauy R, Dangour AD (2006) Nutrition in brain development and aging: role of essential fatty acids. Nutr Rev; 64(5): 24-33. DHA, fatty acid interacting proteins and neuronal function: breast milk and fish are good for you. Ann Rev Cell Dev Biol; 21: 633-657. Is DHA required for development of normal brain function? An overview of evidence from cognitive and behavioral tests in humans and animals. Am J Clin Nutr; 82(2): 281-295. Heird WC, Lapillonne A (2005) The role of essential fatty acids in development. Ann Rev Nutr; 25: 549-571. 31 January 2008 Page 1,455 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Singh M (2005) Essential fatty acids, DHA and human brain. Indian J Pediatr; 72(30: 239-242. Haag M (2003) Essential fatty acids and the brain. Can J Psychiatry; 48(3): 195-203. Eye health 31 January 2008 125 - 500 mg Studies *Cho E et al. Am J Clin Nutr. 73/2):209-18 (2001):no title; *Seddon JM et al. Arch Ophthalmol 119 (8) 1191-9 (2001):Dietry fat and risk for advanced age related macular degeneratoion; *Smith W et al. (2000): Dietry fat and fish intake and age related maculopathy * Ouchi M et al. Ophthalmologica 216 (5) 363-7 (2002):A novel relation of fatty acid with age related macular degeneration; * Bazan N.G.; Brain Pathol 15 (2) 159-66 (2005) A DHA derived mediator that protects brain and retina against cell injury induced oxidative stress * Busik, J. V., W. Chen, SO Iovs. 46(Suppl. S) 1097 (2005); * SanGiovanni JP et al., Retinal and Eye Research 2487–138 (2005) :The role of omega-3 long chain polyunsaturated fatty acids in health and disease of the retina ; * Rotstein et al., Investigative Ophthalmology and Visual Science.44:2252-2259 (2003):Protective effect of docosahexaenoic acid on oxidative stress induced apoptosis of retina photoreceptors; * Bazan et al. Trends in Neurosciences 29(5):263-71 (2006): Cell survival matters:docosahexaenoic acid signalling, neuroprotection and photoreceptors; Rotstein N.P. et al., Lipids 34 (Suppl) S115 (1999):Essentiallity of docosahexaenoic acid in retina photoreceptor cell development Lipids; 512 Page 1,456 of 3,931 Category Food Component Health Relationship Normal immune function 31 January 2008 Suggested Conditions of Use Nature of Evidence References Survey articles Textbook Connor W.E. Am J Clin Nutr 71 (1 Suppl) 171S-5S (2000) :The importance of n3 fatty acids in health and disease; Authoratives bodies, Scientific committees, textbooks ISSFAL-International Society for the Study of Fatty Acids and Lipids - Dosage recommendations 2004 Simopoulos AP., et al. Workshop on the essentiality of and recommended dietary intakes for Omega-6 and Omega-3 fatty acids. J Am Coll Nutr 1999;18(5):487-489 Claim ID 495 Page 1,457 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review References Claim ID Blumer N, Renz H (2007) Consumption of omega 3 fatty acids during perinatal life: role in immuno-modulation and allergy prevention. J Perinat Med; 35(1S): 12-18. Kontogianni MD, Zampelas A, Tsigos C (2006) Nutrition and inflammatory load. Ann NY Acad Sci; 1083: 214-238. Fritsche K (2006) Fatty acids as modulators of the immune response. Ann Rev Nut; 26: 45-73. LaGuardia M, Giammanco S, DiMajo D et al (2005) Omega 3 fatty acids: biological activity and effects on human health. Panminerva Med; 47(4): 245-257. Grimble RF (2005) Immunonutrition. Curr Opin Gastroenterol; 21(20: 216-222. Bansal V, Syres KM, Makarenkova V et al (2005) Interactions between fatty acids and arginine metabolism: implications for the design of immune-enhancing diets. J Parenter Enteral Nutr; 29(10: 75-80. 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Retinal and Eye Research 24 87-138 (2005) :The role of omega-3 long chain polyunsaturated fatty acids in health and disease of the retina; Page 1,461 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Omega 3 fatty acids (DHA/EPA) Eye health 31 January 2008 150-350mg DHA, 36-100mg EPA per day 1,149 Page 1,462 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT Animal Study Scientific Paper Systematic Review Cohort Study References Claim ID Cangemi, F. E. (2007). "TOZAL Study: an open case control study of an oral antioxidant and omega-3 supplement for dry AMD." BMC Ophthalmol 7: 3. Suh, M. and M. T. Clandinin (2005). "20:5n-3 but not 22:6n-3 is a preferred substrate for synthesis of n-3 very-long- chain fatty acids (C24-C36) in retina." Curr Eye Res 30(11): 959-68. German, O. L., M. F. Insua, et al. (2006). "Docosahexaenoic acid prevents apoptosis of retina photoreceptors by activating the ERK/MAPK pathway." J Neurochem 98(5): 1507-20. Connor et al.; 1992: Essential fatty acids: the importance of n-3 fatty acids in the retina and brain. Nutr Rev 50: 21. Hodge et al. 2007: Evidence for the effect of ?-3 fatty acids on progression of age-related macular degeneration. RETINA 27: 216 – 221 Hodge et al. 2006: The evidence for efficacy of omega-3 fatty acids in preventing or slowing progression of renitis pigmentosa. Can J Ophtal 41:481 http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pu bmed&Cmd=ShowDetailView&TermToSearch= 16883366&ordinalpos=2&itool=EntrezSystem2. PEntrez.Pubmed.Pubmed_ResultsPanel.Pubm ed_RVDocSum Cho et al. 2001: Prospective study of dietary fat and the risk of age-related macular degeneration. Am J Clin Nutr 73: 209 http://www.ajcn.org/cgi/content/full/73/2/209 31 January 2008 Page 1,463 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Ngyen et al. 2007: Dietary omega 3 fatty acids decrease intraocular pressure with age by increasing aqueous outflow. Invest Ophtal Vis Sci 48: 756. Heinemann, K. M., M. K. Waldron, et al. (2005). "Long-chain (n-3) polyunsaturated fatty acids are more efficient than alpha-linolenic acid in improving electroretinogram responses of puppies exposed during gestation, lactation, and weaning." J Nutr 135(8): 1960-6. Jump, D. B. (2002). "The biochemistry of n-3 polyunsaturated fatty acids." J Biol Chem 277(11): 8755-8. Moriguchi, T., S. Y. Lim, et al. (2004). "Effects of an n-3-deficient diet on brain, retina, and liver fatty acyl composition in artificially reared rats." J Lipid Res 45(8): 1437-45. Nishizawa, C., J. Y. Wang, et al. (2003). "Effect of dietary DHA on DHA levels in retinal rod outer segments in young versus mature rats." Int J Vitam Nutr Res 73(4): 259-65. Uauy, R. and A. D. Dangour (2006). "Nutrition in brain development and aging: role of essential fatty acids." Nutr Rev 64(5 Pt 2): S24-33; discussion S72-91. 31 January 2008 Page 1,464 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Omega 6 fatty acids Normal immune function 31 January 2008 509 Page 1,465 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review References Claim ID Kapoor R, Huang YS (2006) Gamma linolenic acid: an anti-inflammatory omega 6 fatty acid. Curr Pharm Biotechnol; 7(6): 531-534. Shaikh SR, Edidin M (2006) Polyunsaturated fatty acids, membrane organization, T cells and antigen presentation. Am J Clin Nutr; 84(6): 1277-1289. 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Semin Arthritis Rheum; 25(2): 87-96. 31 January 2008 Page 1,466 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Horrobin DF (1992) Nutritional and medical importance of gamma linolenic acid. Prog Lipid Res; 31(2): 163-194. Tear production Published Research Study Macri A, Giuffrida S, Amico V et al (2003) Effect of linoleic acid and gamma linoleic acid on tear production, tear clearance and on ocular surface after photorefractive keratectomy. Graefes Arch Clin Exp Ophthalmol; 241(7): 561-566. 498 Aragona P, Bucolo C, Spinella R et al (2005) Systemic omega 6 essential fatty acid treatment and PGE 1 tear content in Sjogren’s syndrome patients. Invest Ophthalmol Vis Sci; 46(12): 4474-4479. Barabino S, Rolando M, Camicione P et al (2003) Systemic linoleic and gamma linolenic acid therapy in dry eye syndrome with an inflammatory component. Cornea; 22(2): 97-101. Normal skin 31 January 2008 499 Page 1,467 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review References Claim ID Ziboh VA, Cho Y, Mani I (2002) Biological significance of essential fatty acids/ prostanoids/lipoxygenase-derived monohydroxy fatty acids in skin. Arch Pharm Res; 26(6): 747-758. Horrobin DF (2000) Essential fatty acid metabolism and its modification in atopic eczema. Am J Clin Nutr; 71(1S): 367-372. Ziboh VA, Miller CC, Cho Y (2000) Metabolism of polyunsaturated fatty acids by skin epidermal enzymes: generation of anti-inflammatory and antiproliferative metabolites. Am J Clin Nutr; 71(1S): 361-366. Horrobin DF (1993) Fatty acid metabolism in health and disease: the role of delta 6 desaturase. Am J Clin Nutr; 57(5S): 732-736. Normal central nervous system function Published Monograph Published Review Gamma linolenic acid. Altern Med Rev; 9(1): 70-78. 497 Uauy R, Dangour AD (2006) Nutrition in brain development and aging: role of essential fatty acids. Nutr Rev; 64(5): 24-33. Bourre JM (2006) Effects of nutrients on the structure and function of the nervous system: update on dietary requirements for brain. J Nutr Health Aging; 10(5): 386-399. Singh M (2005) Essential fatty acids, DHA and human brain. Indian J Pediatr; 72(3): 239-242. Haag M (2003) Essential fatty acids and the brain. Can J Psychiatry; 48(3): 195-203. 31 January 2008 Page 1,468 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Omega-3 and Omega-6 fatty acids (GLA) Women´s health 31 January 2008 400 – 1000mg DHA + EPA 1-3g EPO per day corresponds to 90-330mg GLA per day 1,153 Page 1,469 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Scientific Review RCT Cohort study CS References Claim ID Saldeen P, Saldeen T, 2004: Women and omega-3 fatty acids. Obstet Gynecol Surv. 59: 722. Harel Z, et al., 1996: Supplementaton with polyunsaturated fatty acids in the management of dysmenorrhea in adolescents. Am J Obstet Gynecol 174: 1335. Comparative Study Campagnoli C et al., 2005: Polyunsaturated (PUFAs) might reduce hot flushes: an indication from two controlled trials on soy isoflavones alone and with a PUFA supplement. Maturitas, 51: 127. 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BMJ 308: 501. 31 January 2008 Page 1,470 of 3,931 Category Food Component Health Relationship Brain Function (Adult & Children) Suggested Conditions of Use 100-3000mg EPA+DHA per day Nature of Evidence RCT Scientific Review Animal Study References Auestad, N. et. al. (2003) “Visual, Cognitive, and Language Assessments at 39 Months: A Follow-up Study of Children Fed Formulas Containing Long-Chain Polyunsaturated Fatty Acids to 1 Year of Age.” PEDIATRICS Vol. 112 No. 3 September 2003 Claim ID 1,154 Scientific Review CS Connor et al.; 1992: Essential fatty acids: the importance of n-3 fatty acids in the retina and brain. Nutr Rev 50: 21. Moriguchi, T., S. Y. Lim, et al. (2004). "Effects of an n-3-deficient diet on brain, retina, and liver fatty acyl composition in artificially reared rats." J Lipid Res 45(8): 1437-45. Uauy, R. and A. D. Dangour (2006). "Nutrition in brain development and aging: role of essential fatty acids." Nutr Rev 64(5 Pt 2): S24-33; Innis, S.M., (2007). “Dietary (n-3) Fatty Acids and Brain Development.” American Society for Nutrition. J. Nutr. 137: 855–859, 2007. Haag, M. (2003). “Essential fatty acids and the brain.” Canadian Journal of Psychiatry 48:195-203; 2003. Morris, M. C., et. Al. (2003). “Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Archives of Neurology 60:940-946; 2003. Yehuda, S. Rabinovitz, S. Mostofsky, D. (2005). Essential fatty acids and the brain: From infancy to aging. Neurobiology of Aging, 26S, S98–S102 Lauritzen, L., Hansen, H. S., Jorgensen, M. H. 31 January 2008 Page 1,471 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID & Michaelsen, K. F. (2001). The essentiality of long chain n-3 fatty acids in relation to development and function of the brain and retina. Progress in Lipid Research, 40, 1-94. Salem N Jr, Moriguchi T, Greiner RS, McBride K, Ahmad A, Catalan JN, Slotnick B. (2001). Alterations in brain function after loss of docosahexaenoate due to dietary restriction of n-3 fatty acids. Journal of Molecular Neuroscience, 16, 209-307 Omega-3 fatty acids 31 January 2008 Brain development, and maturation of neurosensorial functions Review Reference book SanGiovanni JP And Chew EY (2005) The role of omega-3 long chain polyunsaturated fatty acids in health and disease of the retina. Progr Ret Eye Res 24, 87 -138 505 Retinal structure and function Review Reference book SanGiovanni JP And Chew EY (2005) The role of omega-3 long chain polyunsaturated fatty acids in health and disease of the retina. Progr Ret Eye Res 24, 87 -138 506 Growth and development and maintenance Review Reference book SanGiovanni JP And Chew EY (2005) The role of omega-3 long chain polyunsaturated fatty acids in health and disease of the retina. Progr Ret Eye Res 24, 87 -138 504 Page 1,472 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Omega-3 fatty acids (incl. DHA) For cardiovascular system, metabolism (cholesterin, triglycerides) 31 January 2008 75-150 mg 125 - 500 mg 2,486 Page 1,473 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoratives bodies, Scientific committees, textbooks References Claim ID ISSFAL - International Society for the Study of Fatty Acids and Lipids - Dosage recommendations 2004 Simopoulos AP., et al. Workshop on the essentiality of and recommended dietary intakes for Omega-6 and Omega-3 fatty acids. J Am Coll Nutr 1999;18(5):487-489 1. Unknown: Docosahexaenoic Acid (DHA). In: PDR for Nutritional Supplements. 1st Ed. Montvale, Medical Economics Company, Inc. 2001; 136-138 2. Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol 2000;42:174-181. 3. Montgomery C, Speake BK, Cameron A, Sattar N, Weaver LT. Maternal docosahexaenoic acid supplementation and foetal accretion. British Journal of Nutrition 2003;90:135:145. 4. Sanjurjo P, Ruiz-Sanz JI, Jimeno P, Aldamiz-Echevarria L, Aquino L, Matorras R, Esteban J, Banque M. Supplementation with docosahexaenoic acid in the last trimester of pregnancy: maternal-fetal biochemical findings. J Perinat Med 2004;32(2): 132-136. 5. Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics 2003;111(1): 39-44. 31 January 2008 Page 1,474 of 3,931 Category Food Component Health Relationship Support of human neurodevelopment Suggested Conditions of Use 125 - 500 mg Nature of Evidence Authoratives bodies, Scientific committees, textbooks References ISSFAL - International Society for the Study of Fatty Acids and Lipids - Dosage recommendations 2004 Simopoulos AP., et al. Workshop on the essentiality of and recommended dietary intakes for Omega-6 and Omega-3 fatty acids. J Am Coll Nutr 1999;18(5):487-489 Claim ID 2,488 1. Unknown: Docosahexaenoic Acid (DHA). In: PDR for Nutritional Supplements. 1st Ed. Montvale, Medical Economics Company, Inc. 2001; 136-138 2. Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol 2000;42:174-181. 3. Montgomery C, Speake BK, Cameron A, Sattar N, Weaver LT. Maternal docosahexaenoic acid supplementation and foetal accretion. British Journal of Nutrition 2003;90:135:145. 4. Sanjurjo P, Ruiz-Sanz JI, Jimeno P, Aldamiz-Echevarria L, Aquino L, Matorras R, Esteban J, Banque M. Supplementation with docosahexaenoic acid in the last trimester of pregnancy: maternal-fetal biochemical findings. J Perinat Med 2004;32(2): 132-136. 5. Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics 2003;111(1): 39-44. 31 January 2008 Page 1,475 of 3,931 Category Food Component Health Relationship Optimisation of brain maturation Suggested Conditions of Use 125 - 500 mg Nature of Evidence Authoratives bodies, Scientific committees, textbooks References ISSFAL - International Society for the Study of Fatty Acids and Lipids - Dosage recommendations 2004 Simopoulos AP., et al. Workshop on the essentiality of and recommended dietary intakes for Omega-6 and Omega-3 fatty acids. J Am Coll Nutr 1999;18(5):487-489 Claim ID 2,489 1. Unknown: Docosahexaenoic Acid (DHA). In: PDR for Nutritional Supplements. 1st Ed. Montvale, Medical Economics Company, Inc. 2001; 136-138 2. Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol 2000;42:174-181. 3. Montgomery C, Speake BK, Cameron A, Sattar N, Weaver LT. Maternal docosahexaenoic acid supplementation and foetal accretion. British Journal of Nutrition 2003;90:135:145. 4. Sanjurjo P, Ruiz-Sanz JI, Jimeno P, Aldamiz-Echevarria L, Aquino L, Matorras R, Esteban J, Banque M. Supplementation with docosahexaenoic acid in the last trimester of pregnancy: maternal-fetal biochemical findings. J Perinat Med 2004;32(2): 132-136. 5. Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics 2003;111(1): 39-44. 31 January 2008 Page 1,476 of 3,931 Category Food Component Health Relationship To fulfil increased omega-3 fatty acids need during pregnancy Suggested Conditions of Use 125 - 500 mg Nature of Evidence Authoratives bodies, Scientific committees, textbooks References ISSFAL - International Society for the Study of Fatty Acids and Lipids - Dosage recommendations 2004 Simopoulos AP., et al. Workshop on the essentiality of and recommended dietary intakes for Omega-6 and Omega-3 fatty acids. J Am Coll Nutr 1999;18(5):487-489 Claim ID 2,487 1. Unknown: Docosahexaenoic Acid (DHA). In: PDR for Nutritional Supplements. 1st Ed. Montvale, Medical Economics Company, Inc. 2001; 136-138 2. Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol 2000;42:174-181. 3. Montgomery C, Speake BK, Cameron A, Sattar N, Weaver LT. Maternal docosahexaenoic acid supplementation and foetal accretion. British Journal of Nutrition 2003;90:135:145. 4. Sanjurjo P, Ruiz-Sanz JI, Jimeno P, Aldamiz-Echevarria L, Aquino L, Matorras R, Esteban J, Banque M. Supplementation with docosahexaenoic acid in the last trimester of pregnancy: maternal-fetal biochemical findings. J Perinat Med 2004;32(2): 132-136. 5. Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. 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Dietarv reference intakes For folate, thiamine, riboflavin, niacin, vitamin B12, panthothenic acid, biotin, and choline. Washington D.C., National Academy Press. Jenike, M. A., Albert, M. S., Heller, H., LoCastro, S. and Gunther, J. (1986). "Combination therapy with lecithin and ergoloid mesylates fur Alzheimer's disease." J Clin Psvchiatrv 47(5): 249-51. Jones, J. P., Meck, W., Williarns, C. L., Wilson, W. A. and Swartzwelder, H. S. (1999). 31 January 2008 Page 1,506 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID "Choline availability to the developing rat fetus alters adult hippocampallong-term potentiation." Brain Res Dev Brain Res 118(12): 159-67. Kaye, W. H., Sitaram, N., Weingartner, H., Ebert, M. H., Smallberg, S. and Gillin, J. C. (1982). "Modest facilitation on memory in dementia with combined lecithin and anticholinerestase treatment." Biol Psychiatry 17(2): 275-80. 127 Ladd, S. L., Sommer, S. A., LaBerge, S. and Toscano, W. (1993). "Effect of phosphatidylcholine on explicit memory." Clin NeuropharmacoI 16(6): 540-9. Levin, H. S. (1991). "Treatment of postconcussional symptoms with CDP-choline." J Neurol Sci 103 Suppl: S39-42. Levy, R. (1982). "Lecithin in Alzheimer's disease [letter]." Lancet 2(8299): 671-2. Little, A., Levy, R., Chuaqui-Kidd, P.and Hand, D. (1985). "A double-blind, placebo controlled trial of high-dose lecithin in Alzheimer's disease." J Neurol Neurosurg Psvchiatry 48(8): 736-42. Loy, R., Heyer, D., Williams, C. L. and Meck, W. H. (1991). "Choline-induced spatial memory facilitation correlates with altered distribution and morphology of septal neurons." Adv. ExQ. Med. Biol. 295: 373-382. Marcus, R. and Coulston, A.M. (1996) Water-soluble vitamins. In: Hardman, J.G.; Limbird, L.E.; Molinoff, P.B.; Ruddon, R.W. and Goodman Gilman, A. eds. Goodman and Gilman’s: The pharmacological basis of therapeutics, ninth edition. McGraw-Hill Inc., pp 1555-1572. Markakis, E. A. and Gage, F. H. (1999). "Adult-generated neurons in the dentate gyrus 31 January 2008 Page 1,507 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID send axonal projections to field CA3 and are surrounded by synaptic vesicles." J Comp Neurol 406(4): 449-60. Meck, W. and Williams, C. (1997). "Perinatal choline supplementation increases the threshold fur chunking in spatial memory." Neuroreport 8: 3053-3059. Meck, W. and Williams, C. (1997). "Simultaneous temporal processing is sensitive to prenatal choline availability in mature and aged rats." Neuroreport 8: 3045-51. Meck, W. H., Smith, R. A. and Williams, C. L. (1988). "Pre- and postnatal choline supplementation produces long-term facilitation of spatial memory." Dev. Psvchobiol. 21(4): 339 -353. Meck, W. H. and Williams, C. L. (1999). "Choline supplementation during prenatal development reduces proactive interference in spatial memory." Brain Res Dev Brain Res 118(1-2): 51-9. Mervis, R. F. (1982). "Chronic dietary choline represses age-related loss of dendritic spines in mouse neocortical pyramidal cells." J. Neuropathol. EXD. Neurol. 41: 363. Mohs, R. C. and Davis, K. L. (1980). "Choline chloride effects on memory: correlation with the effects of physostigmine." Psvchiatrv Research 2(2): 149-56. Mohs, R. C. and Davis, K. L. (1985). "Interaction of choline and scopolamine in human memory." Life Sciences 37(2): 193-7. Mohs, R. C., Davis, K. L., Tinklenberg, J. R. and Hollister, L. E. (1980). "Choline chloride effects on memory in the elderly." Neurobiology of Aging 1(1): 21-5. Mohs, R. C., Davis, K. L., Tinklenberg, J. R., Hollister, L. E., Yesavage, J. A. and Kopell, B. S. (1979). "Choline chloride treatment ofmemory deficits in the elderly." American 31 January 2008 Page 1,508 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Journal of Psvchiatrv 136(10): 1275-7. Peters, B. H. and Levin, H. S. (1979). "Effects of physostigmine and lecithin on memory in Alzheimer disease." Ann NeuroI 6(3): 219-21. Poirier, J. (1994). "Apolipoprotein E in animal models of CNS injury and in Alzheimer's disease." Trends Neurosci 17(12): 525-30. Pomara, N., Domino, E. F., Yoon, H., Brinkman, S., Tamminga, C. A. and Gershon, S. (1983). "Failure of single-dose lecithin to alter aspects of central cholinergic activity in Alzheimer's disease." Journal of Clinical Psvchiatry 44(8): 293-5. Pyapali, G., Turner, D., Williams, C., Meck, W. and Swartzwelder, H. S. (1998). "Prenatal choline supplementation decreases the threshold for induction of long-term potentiation in young adult rats." J. Neurophysiol. 79: 17901796. 128 Schenk, F. and Brandner, C. (1995). "lndirect effects of peri- and postnatal choline treatment on place-learning abilities in rat." Psychobiology 23: 302-313. Sitaram, N., Weingartner, H., Caine, E. D. and Gillin, J. C. (1978). "Choline: Selective enhancement of serial learning and encoding of low imagery words in man." Life Sci. 22(17): 1555-60. Sitaram, N., Weingartner, H. and Gillin, J. C. (1978). "Human serial learning: enhancement with arecholine and choline impairment with scopolamine." Science 201(4352): 274-6. Spiers, P., Myers, D., Hochanadel, G., Liebeffilan, H. and Wurtman, R. (1996). "Citicoline improves verbal memory in aging." Arch. Neurol. 53(5): 441-8. 31 January 2008 Page 1,509 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Tees, R. C. (1999). "The influences of rearing environment and neonatal choline dietary supplementation on spatial learning and memory in adult rats." Behav Brain Res 105(2): 173-88. Tees, R. C. (1999). "The influences of sex, rearing environment, and neonatal choline dietary supplementation on spatial and nonspatial learning and memory in adult rats." Dev PsvchobioI35(4): 328-42. Trommer, B. A., Schmidt, D. E. and Wecker, L. (1982). "Exogenous choline enhances the synthesis of acetylcholine only under conditions of increased cholinergic neuronal activity ." J. Neurochem. 39(6): 17041709. Ulus, I. H., Wurtman, R. J., Mauron, C. and Blusztajn, J. K. (1989). "Choline increases acetylcholine release and protects against the stimulation-induced decrease in phosphatide levels within membranes of rat corpus striatum." Brain Res. 484(1-2): 217-27. van Praag, H., Kempeffilann, G. and Gage, F. H. (1999). "Running increases cell proliferation and neurogenesis in the adult mouse dentate gyrus [see comments]." Nat Neurosci 2(3): 266-70. Weinstein, H. C., Teunisse, S. and van Gool, W. A. (1991). "Tetrahydroaminoacridine and lecithin in the treatment of Alzheimer's disease. Effect on cognition, functioning in daily life, behavioural disturbances and burden experienced by the carers." J NeuroI 238(1): 34 -8. Weisgraber, K. H. and Mahley, R. W. (1996). "Human apolipoprotein E: the Alzheimer's disease connection." FASEB J.10: 1485-1494. Wettstein, A. (1983). "No effect from double-blind trial of physostigmine and lecithin 31 January 2008 Page 1,510 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID in Alzheimer disease." Ann NeuroI 13(2): 2102. Williarns, C. L., Meck, W. H., Heyer, D. D. and Loy, R. (1998). "Hypertrophy of basal forebrain neurons and enhanced visuospatial memory in perinatally choline-supplemented rats." Brain Res 794(2): 225-38. Zeisel, S. H. and Blusztajn, J. K. (1994). "Choline and human nutrition." Ann. Rev. Nutr.14:269-296. Zeisel, S.H. (1999) Choline and phosphatidylcholine in Modern Nutrition in Health and Disease, pp. 513-523, 9th edition, Shils et al., Williams and Wilkins eds. Baltimore. Zeisel, S.H. and Holmes-McNary, M. (2001) Handbook of vitamins; 3rd ed, revised and expanded. Marcel Dekker Inc, New York, chapter 14, pp 513-528. 31 January 2008 Page 1,511 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Phosphatidyl serine Mental health / Cognitive function 31 January 2008 300-400 mg per day 429 Page 1,512 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCTs, endorsement by national experts, clinical reviews, individual human clinical studies References Claim ID Review Kidd, Parris M; A Review of Nutrients and Botanicals in the Integrative Management of Cognitive Dysfunction. Altern Med Rev, Vol. 4, Iss. 3, 144:161, 1999 Text Books Endorsement by National Expert http://www.cfsan.fda.gov/~dms/ds-ltr36.html. This link provides the full FDA review of claim substantiation including all published human clinical studies. Review articles McDaniel, M.A., S.F. Maier, and G.O. Einstein, "Brain-specific" nutrients: a memory cure? Nutrition, 2003. 19(11-12): p. 957-75. Filburn, C., Dietary supplementation with phospholipids and docohexaenoic acid for age-related cognitive impairment. JANA, 2000. 3(3): p. 45-55. Kidd, P.M., A review of nutrients and botanicals in the integrative management of cognitive dysfunction. Altern Med Rev, 1999. 4(3): p. 144-61. FDA: http://www.cfsan.fda.gov/~dms/ds-ltr36.html. This link provides the full FDA review of claim substantiation including all published human clinical studies. Human Intervention Studies Hellhammer, J., E. Fries, C. Buss, et al., Effects of soy lecithin phosphatidic acid and phosphatidylserine complex (PAS) on the endocrine and psychological responses to mental stress. Stress, 2004. 7(2): p. 119-26. Benton, D., R.T. Donohoe, B. Sillance, et al., The influence of phosphatidylserine 31 January 2008 Page 1,513 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID supplementation on mood and heart rate when faced with an acute stressor. Nutr Neurosci, 2001. 4(3): p. 169-78. Monteleone, P., M. Maj, L. Beinat, et al., Blunting by chronic phosphatidylserine administration of the stress-induced activation of the hypothalamo-pituitary-adrenal axis in healthy men. Eur J Clin Pharmacol, 1992. 42(4): p. 385-8. Monteleone, P., L. Beinat, C. Tanzillo, et al., Effects of phosphatidylserine on the neuroendocrine response to physical stress in humans. Neuroendocrinology, 1990. 52(3): p. 243-8. Jorissen, B.L., F. Brouns, M.P. Van Boxtel, et al., The influence of soy-derived phosphatidylserine on cognition in age-associated memory impairment. Nutr Neurosci, 2001. 4(2): p. 121-34. Heiss, W.D., J. Kessler, R. Mielke, et al., Long-term effects of phosphatidylserine, pyritinol, and cognitive training in Alzheimer's disease. A neuropsychological, EEG, and PET investigation. Dementia, 1994. 5(2): p. 88-98. Cenacchi, T., T. Bertoldin, C. Farina, et al., Cognitive decline in the elderly: a double-blind, placebo-controlled multicenter study on efficacy of phosphatidylserine administration. Aging (Milano), 1993. 5(2): p. 123-33. Engel, R.R., W. Satzger, W. Gunther, et al., Double-blind cross-over study of phosphatidylserine vs. placebo in patients with early dementia of the Alzheimer type. Eur Neuropsychopharmacol, 1992. 2(2): p. 149-55. Crook, T., W. Petrie, C. Wells, et al., Effects of phosphatidylserine in Alzheimer's disease. Psychopharmacol Bull, 1992. 28(1): p. 61-6. 31 January 2008 Page 1,514 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Crook, T.H., J. Tinklenberg, J. Yesavage, et al., Effects of phosphatidylserine in age-associated memory impairment. Neurology, 1991. 41(5): p. 644-9. Maggioni, M., G.B. Picotti, G.P. Bondiolotti, et al., Effects of phosphatidylserine therapy in geriatric patients with depressive disorders. Acta Psychiatr Scand, 1990. 81(3): p.265-70. Individual Studies Amaducci, Crook Lippi Bracco Baldereschi Latorraca Piersanti Tesco; Use of Phosphatidylserine in Alzheimeris disease. Annals N Y Academy of Sciences, Vol. 640, 1991 Bracco, L.; Clinical studies on the activity of phosphatidylserine (PS). Aging Brain and Dementia: New Trends in Diagnosis and Therapy591:602, 1990 Carol Paton, Dip. Clin. Pharm. MRPharmS; Advances in the treatment of Alzheimer's disease. The Pharmaceutical Journal, Vol 259, pp 693-697 Pharmaceutical:697, 1997 Cenacchi, T.; Cognitive decline in the elderly: A double-blind, placebo-controlled multicenter study on efficiacy of phosphatidylserine administration. Aging Clin Exp Res, Vol. 5123:133, 1993 Cohen, S. A.; Age-related alteration of NMDA-receptor properties in the mouse forebrain: partial restoration by chronic phosphatidylserine treatment. Brain Research, 584, pp 174-180Research, 584, pp:Research, 584,180, 1992 Crook, T. H.; Effects of phosphatidylserine in age-associated memory impairment. Neurology 41, pp 644-64941, pp:41,649, 1991 Crook, T. H.; Treatment of Age-Related Cognitive Decline: Effects of Phosphatidylserine. Anti-Aging Medical 31 January 2008 Page 1,515 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Therapeutics Vol II, (Eds ) Klatz, Goldman, Iss. Eds., Klatz, Goldmann, 1998 Funfgeld, E. W.; Double-blind study with phosphatidylserine (PS) in Parkinsonian patients with senile dementia of Alzheimer's disease Alzheimer's Disease and Related Disorders1235:1246, 1989 Gelbmann, C. M. and Mueller, W. E.; Chronic treatment with phosphatidylserine restores muscarinic cholinergic receptor deficits in the aged mouse brain. Neurobiol Aging, Vol. 13(1)45:50, 1992 Guido Rosadini, Walter G. S.; Phosphatidylserine: Quantitative EEG effects in healthy volunteers. Neuropsychobiology, 24, pp 42-4824, pp:48, 1990 Heiss, Kessler Mielke Szelies Herholz; Long-Term Effects of Phosphatidylserine, Pyritinol, and Cognitive Training in Alzheimeris Disease. Dementia, 55, 1994 Hershkowitz, Diver; Long-Term Traetment of Dementia Alzheimer Type with Phosphatidylserine: Effect on Receptors and Microviscosity of Lymphocyte and Trombocyte Membrane. Phospholipids and Nervous System: Biochemical and Molecular Pathologyand, 1989 Jorissen, B. L, Brouns, F, Van Boxtel, MPJ, and Riedel, WJ; Safety of soy-derived phosphatidylserine in elderly people. Nutritional Neuroscience, Vol. 5, Iss. 5, 337:343, 2002 - Kidd, Parris M. Phosphatidylserine (PS) A. remarkable brain cell nutrient Bibliography. Lucas Meyer Brochure, 1996 Kidd, Parris M.; Phosphatidylserine: The remarkable brain cell nutrient. Nutritional News, Vol 11, No 6News, Vol, 1997 Luigi Amaducci, M. D.; Phosphatidylserine in the treatment of Alzheimer's disease: Results of a Multicenter study. 31 January 2008 Page 1,516 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Psychopharmacology Bulletin, Vol 24, No 1, pp 130-134Bulletin, Vol:134, 1988 Monteleone, P.; Blunting by chronic phosphatidylserine administration of the stress-induced activation of the hypothalamo-pituitary-adrenal axis in healthy men. Eur J Clin Pharmacol , 41:385-388J:388, 1992 Palmiero Monteleone, Lucia Beinat Carla Tanzillo Mario Maj Dargut Kemali; Effects of phosphatidylserine on the neuroendocrine response to physical stress in humans. Neuroendocrinology, 52, pp 243-24852, pp:52,248, 1990 Rabboni, Maggioni; Neuroendocrine and behavioural effects of phosphatidylserine in elderly patients with abiotrophic or vascular dementia or mild depression. Clinical Trials Journal Vol 27, No 3Trials, 1990 Rolf, R. Engel; Double-blind cross-over study of phosphatidylserine vs. placebo in patients with early dementia of the Alzheimer type.European Neuropsychopharmacology, Vol. 2149:155, 1992 Sakai, Masashi, Yamatoya, Hideyuki, and Kudo, Satoshi; Pharmacological effects of phosphatidylserine enzymatically synthesized from soybean lecithin on brain functions in rodents. J Nutr Sci Vitaminol, Vol. 42, Iss. 1, 47:54, 1996 Thomas Crook, PhD. William Petrie; Effects of phosphatidylserine in Alzheimer's disease. Psychopharmacology Bulletin, Vol 28, No 1, pp 61-66Bulletin, Vol:66, 1992 31 January 2008 Page 1,517 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Phosphatidylserine Memory and cognitive functioning in the elderly The product should contain at least 15% of the minimum effective dose, which is 300 mg/day. Thus, products containing =45 mg phosphatidyl-serine per 100 g or 100 mL would qualify to carry the proposed claims. Studies demonstrating efficacy ranged in duration from 6 weeks to 6 months. While, in some studies, efficacy, improvements were noted after 3 weeks, the majority of studies reported improvement after 6 weeks; thus, an intake of 300 mg/day phosphatidyl-serine for a minimum of 6 weeks is recommended. Authoritative Body – Approved Claims Federal Ministry of Social Safety and Generations, Austria 1,100 FDA, 2003. Phosphatidylserine and Cognitive Dysfunction and Dementia (Qualified Health Claim: Final Decision Letter). U.S. Food and Drug Administration (FDA), CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements; Bethesda, Maryland, May 13, 2003. Available from http://vm.cfsan.fda.gov/~dms/ds-ltr36.html. No adverse effects are associated with phosphatidyl-serine 31 January 2008 Page 1,518 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Clinical Studies: Randomized, controlled, double-blinded trials (pivotal supporting data, as cited in Independent Critical Scientific Review) References Claim ID Cenacchi, T.; Bertoldin, T.; Farina, C.; Fiori, M.G.; Crepaldi, G. 1993. Cognitive decline in the elderly: a double-blind, placebo-controlled multicenter study on efficacy of phosphatidylserine administration. Aging (Milano) 5(2):123-133. Crook, T.H.; Tinklenberg, J.; Yesavage, J.; Petrie, W.; Nunzi, M.G.; Massari, D.C. 1991. Effects of phosphatidylserine in age-associated memory impairment. Neurology 41(5):644-649. Delwaide, P.J.; Gyselynck-Mambourg, A.M.; Hurlet, A.; Ylieff, M. 1986. Double-blind randomized controlled study of phosphatidylserine in senile demented patients. Acta Neurol Scand 73(2):136-140. Palmieri, G.; Palmieri, R.; Inzoli, M.R.; Lombardi, G.; Sottini, C.; Tavolato, B.; Giometto, G. 1987. Double-blind controlled trial of phosphatidylserine in patients with senile mental deterioration. Clin Trials J 24(1):73-83. Villardita, C.; Grioli, S.; Salmeri, G.; Nicoletti, F.; Pennisi, G. 1987. Multicentre clinical trial of brain PS in elderly patients with intellectual deterioration. Clin Trials J 24(1):84-93. 31 January 2008 Page 1,519 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Clinical Studies: Open label trials (supporting data, as cited in Independent Critical Scientific Review) References Claim ID Allegro, L.; Favaretto, V.; Ziiliotto, G. 1987. Oral phosphatidylserine in elderly patients with cognitive deterioration: an open study. Clin Trials J 24(1):104-108. Caffarra, P.; Santamaria, V. 1987. The effects of phosphatidylserine in patients with mild cognitive decline: an open trial. Clin Trials J 24(1):109-114. Crook, T.H. 1998. Treatment of age-related cognitive decline: effects of phosphatidylserine. In: Klatz, R.M.; Goldman, R. (Eds.). Anti-Aging Medical Therapeutics, Vol II. Health Quest Publications; Marina del Rey, California, pp. 20-28. Granata, Q.; Di Michele, J.D. 1987. Phosphatidylserine in elderly patients: an open trial. Clin Trials J 24(1):99-103. Puca, F.M.; Savarese, M.A.; Minervini, M.G. 1987. Exploratory trial of phosphatidylserine efficacy in mildly demented patients. Clin Trials J 24(1):94-98. Schreiber, S.; Kampf-Sherf, O.; Gorfine, M.; Kelly, D.; Oppenheim, Y.; Lerner, B. 2000. An open trial of plant-source derived phosphatidylserine for treatment of age-related cogntive decline. Isr J Psychiatry Relat Sci 37(4):302-307. Sinforiani, E.; Agostinis, C.; Merlo, P.; Gualteri, S.; Mauri, M.; Mancuso, A. 1987. Cognitive decline in ageing brain: Therapeutic approach with phosphatidylserine. Clin Trials J 24(1):115-124. 31 January 2008 Page 1,520 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Preclinical Studies: Animal studies providing evidence for the biological mode of action (supporting data, as cited in Independent Critical Scientific Review) References Claim ID Ammassari-Teule, M.; Fagioli, S.; Maritati, M.; Populin, R.; Pavone, F. 1990. Chronic administration of phosphatidylserine during ontogeny enhances subject-environment interactions and radial maze performance in C57BL/6 mice. Physiol Behav 47(4):755-760. Fagioli, S.; Castellano, C.; Oliverio, A.; Pavone, F.; Populin, R.; Toffano, G. 1989. Phosphatidylserine administration during postnatal development improves memory in adult mice. Neurosci Lett 101(2):229-233. Furushiro, M.; Suzuki, S.; Shishido, Y.; Sakai, M.; Yamatoya, H.; Kudo, S.; Hashimoto, S.; Yokokura, T. 1997. Effects of oral administration of soybean lecithin transphosphatidylated phosphatidylserine on impaired learning of passive avoidance in mice. Jpn J Pharmacol 75(4):447-450. Nunzi, M.G.; Guidolin, D.; Petrelli, L.; Potato, P.; Zanotti, A. 1992. Behavioral and morpho-functional correlates of brain aging: a preclinical study with phosphatidylserine. In: Bazan, N.G.; Murphy, M.G.; Toffano, G. (Eds.). Neurobiology of Essential Fatty Acids: Proceedings of a Symposium on the Essential Fatty Acids, July 10-12, 1981, Palm Cove, Far North Queensland, Australia. Plenum Press; New York, Advances in Experimental Medicine and Biology, Vol. 318, pp. 393-398. Suzuki, S.; Yamatoya, H.; Sakai, M.; Kataoka, A.; Furushiro, M.; Kudo, S. 2001. Oral administration of soybean lecithin transphosphatidylated phosphatidylserine improves memory impairment in aged rats. J Nutr 131(11):2951-2956. 31 January 2008 Page 1,521 of 3,931 Category Food Component Health Relationship Cognitive function (Memory) Suggested Conditions of Use 200 mg/day Nature of Evidence Authoritative Body Human Studies Animal Studies References Authoritative Body FDA. 2003. Phosphatidylserine and Cognitive Dysfunction and Dementia (Qualified Health Claim: Final Decision Letter). U.S. Food and Drug Administration (FDA), CFSAN/Office of Nutritional Products, Labeling, and Dietary Supplements; Bethesda, Maryland, May 13, 2003. Available from http://vm.cfsan.fda.gov/~dms/ds-ltr36.html. Claim ID 685 Human Studies (pivotal – cited in Critical Review) Amaducci, L.; SMID Group. 1988. Phosphatidylserine in the treatment of alzheimer's disease: results of a multicenter study. Psychopharmacol Bull 24(1):130-134. Cenacchi, T.; Bertoldin, T.; Farina, C.; Fiori, M.G.; Crepaldi, G. 1993. Cognitive decline in the elderly: a double-blind, placebo-controlled multicenter study on efficacy of phosphatidylserine administration. Aging (Milano) 5(2):123-133. Crook, T.H.; Tinklenberg, J.; Yesavage, J.; Petrie, W.; Nunzi, M.G.; Massari, D.C. 1991. Effects of phosphatidylserine in age-associated memory impairment. Neurology 41(5):644-649. Crook, T.; Petrie, W.; Wells, C.; Massari, D.C. 1992. Effects of phosphatidylserine in Alzheimer's disease. Psychopharmacol Bull 28(1):61-66. . Heiss, W.D.; Kessler, J.; Mielke, R.; Szelies, B.; Herholz, K. 1994. Long-term effects of phosphatidylserine, pyritinol, and cognitive training in Alzheimer's disease. a neuropsychological, EEG, and PET 31 January 2008 Page 1,522 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID investigation. Dementia 5(2):88-98. Villardita, C.; Grioli, S.; Salmeri, G.; Nicoletti, F.; Pennisi, G. 1987. Multicentre clinical trial of brain PS in elderly patients with intellectual deterioration. Clin Trials J 24(1):84-93. Animal Studies (supporting data – cited in Critical Review) Aporti, F.; Rubini, R.; Zanotti, S.; Toffano, G. 1985. EEG and behavioural patterns in aging rats: effect of brain phosphatidylserine. Electroencephalogr Clin Neurophysiol 61(3):156. Cited In: Caffara and Santamaria, 1987. Drago, F.; Toffano, G.; Catalano Rossi Danielli, L.; et al. 1983. Phosphatidylserine facilitates learning and memory processes in aged rats. . Cited In: Caffara and Santamaria, 1987. Nunzi, M.G.; Milan, F.; Guidolin, D.; Toffano, G. 1987. Dendritic spine loss in hippocampus of aged rats. effect of brain phosphatidylserine administration. Neurobiol Aging 8(6):501-510. Vannucchi, M.G.; Pepeu, G. 1987. Effect of phosphatidylserine on acetylcholine release and content in cortical slices from aging rats. Neurobiol Aging 8(5):403-407. Cited In: Cenacchi et al., 1993. 31 January 2008 Page 1,523 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Phospholipids (Phosphatidyl choline, Phosphatidyl ethanolamine, Phosphatidyl inositol, Lysophosphatidyl cholin) Liver health 31 January 2008 Min 1 g per day 430 Page 1,524 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence human study, review, animal study References Claim ID Review Ilic V, Kordac V, Alvarez SZ. Clinical experience with long-term administration of "essential" phospholipids in chronic active hepatitis. Review of 3 double-blind studies. Cas Lek Cesk. 1992 Dec 17;131(26):801-4. Canty DJ, Zeisel SH. Lecithin and choline in human health and disease. Nutr Rev. 1994 Oct;52(10):327-39. Human studies Jenkins PJ, Portmann BP, Eddleston AL, Williams R. Use of polyunsaturated phosphatidyl choline in HBsAg negative chronic active hepatitis: results of prospective double-blind controlled trial. Liver. 1982 Jun;2(2):77-81. Niederau C, Strohmeyer G, Heintges T, Peter K, Gopfert E. Polyunsaturated phosphatidyl¬choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double-blind, placebo-controlled trial. Leich Study Group. Hepatogastroenterology. 1998 May-Jun;45(21):797-804. Atoba MA, Olubuyide IO. The effects of essential phospholipid choline in HBs-Ag negative acute hepatitis. West Afr J Med. 1989 Oct-Dec;8(4):284-7. Singh NK, Prasad RC. A pilot study of polyunsaturated phosphatidyl choline in fulminant and subacute hepatic failure. J Assoc Physicians India. 1998 Jun;46(6):530-2. Animal studies Li Z, Agellon LB, Allen TM, Umeda M, Jewell L, Mason A, Vance DE. The ratio of phosphatidylcholine to phosphatidylethanolamine influences membrane integrity and steatohepatitis. Cell 31 January 2008 Page 1,525 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Metab. 2006 May;3(5):321-31. Phytostanols / sterols Heart health At least 800mg stanols/sterols per daily dose Individual studies and review 1) Hendriks HF, Weststrate JA, van Vliet T, Meijer GW. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. Eur J Clin Nutr. 1999;53: 319-327. 591 2) Vanhanen HT, Kajander J, Lehtovirta H, Miettinen TA. Serum levels, absorption efficiency, faecal elimination and synthesis of cholesterol during increasing doses of dietary sitostanol esters in hypercholesterolaemic subjects. Clin Sci (Lond). 1994;87:61-67 3) Hallikainen MA, Sarkkinen ES, Uusitupa MI. Plant stanol estersaffect serum cholesterol concentrations of hypercholesterolemic men and women in a dose-dependent manner. J Nutr. 2000;130:767-776. 4) Katan, M.B.; Grundy, S.M.; Jones, P.; Law, M.; Miettinen, T. and Paoletti, R. Efficacy and Safety of Plant Stanols and Sterols in the Management of Blood Cholesterol Levels Mayo Clin Proc. 2003;78:965-978 31 January 2008 Page 1,526 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Phytosterols Phytosterols to help maintain normal cholesterol levels. 31 January 2008 No RDA / RNI 2,407 Page 1,527 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID "Acuff RV, Cai DJ, Dong ZP, Bell D. The lipid lowering effect of plant sterol ester capsules in hypercholesterolemic subjects. Lipids Health Dis. 2007 Apr 9;6:11. Colgan HA, Floyd S, Noone EJ, Gibney MJ, Roche HM. Increased intake of fruit and vegetables and a low-fat diet, with and without low-fat plant sterol-enriched spread consumption: effects on plasma lipoprotein and carotenoid metabolism. J Hum Nutr Diet. 2004 Dec;17(6):561-9. Earnest CP, Mikus CR, Lemieux I, Arsenault BJ, Church TS. Examination of encapsulated phytosterol ester supplementation on lipid indices associated with cardiovascular disease. Nutrition. 2007 Sep;23(9):625-33. Polagruto JA, Wang-Polagruto JF, Braun MM, Lee L, Kwik-Uribe C, Keen CL. Cocoa flavanol-enriched snack bars containing phytosterols effectively lower total and low-density lipoprotein cholesterol levels. J Am Diet Assoc. 2006 Nov;106(11):1804-13. Seppo L, Jauhiainen T, Nevala R, Poussa T, Korpela R. Plant stanol esters in low-fat milk products lower serum total and LDL cholesterol. Eur J Nutr. 2007 Mar;46(2):111-7. Takeshita M, Katsuragi Y, Kusuhara M, Higashi K, Miyajima E, Mizuno K, Mori K, Obata T, Ohmori R, Ohsuzu F, Onodera Y, Sano J, Sawada S, Tabata S, Tokimitsu I, Tomonobu K, Yamashita T, Yasukawa T, Yonemura A, Nakamura H. Phytosterols dissolved in diacylglycerol oil reinforce the cholesterol-lowering effect of low-dose pravastatin treatment. Nutr Metab Cardiovasc 31 January 2008 Page 1,528 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Dis. 2007 Oct 25; [Epub ahead of print]." 1. Natural Medicines Comprehensive Database 2000 2. The Complete German Commission E Monographs Therapeutic Guide to Herbal Medicines 1998 American Botanical Council 3. PDR for Herbal Medicines 2nd Edition 2000 Medical Economics Co. Inc. 4. The Review of Natural Products Facts and Comparisons Wolters Kluwer Health Inc. 2003 5. A Dictionary of Natural Products George MacDonald Hawking, 1997 Plexus Publishing 6. The Natural Pharmacy 2nd Edition Prima Health 1999 Healthnotes Inc. 7. Pharmacognosy and Pharmacobiotechnology Robbers, Speedie and Tyler. 1996 Williams and Wilkins 8. Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetics 2nd Ed. Albert Leung and Steven Foster 1996 John Wiley & Sons, Inc. 10. 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Biochem J. 25 (5): 1687–1705. 31 January 2008 Page 1,530 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Phytosterols (mixture of Beta-sitosterol, Campesterol, Stigmasterol, Brassicasterol, Stigmastanol, Ergostanol, Campestanol) Cholesterol metabolism 31 January 2008 Min. 1 g per day 431 Page 1,531 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence human study, review References Claim ID Review Moghadasian MH, Frohlich JJ. Effects of dietary phytosterols on cholesterol metabolism and atherosclerosis: clinical and experimental evidence. Am J Med. 1999 Dec;107(6):588-94. Jones PJ, MacDougall DE, Ntanios F, Vanstone CA. Dietary phytosterols as cholesterol-lowering agents in humans. Can J Physiol Pharmacol. 1997 Mar;75(3):217-27. Ling WH, Jones PJ. Dietary phytosterols: a review of metabolism, benefits and side effects. Life Sci. 1995;57(3):195-206. de Jong A, Plat J, Mensink RP. Metabolic effects of plant sterols and stanols (Review). J Nutr Biochem. 2003 Jul;14(7):362-9. Ostlund RE Jr. Phytosterols, cholesterol absorption and healthy diets. Lipids. 2007 Feb;42(1):41-5. Epub 2007 Jan 9. Patch CS, Tapsell LC, Williams PG, Gordon M. Plant sterols as dietary adjuvants in the reduction of cardiovascular risk: theory and evidence. Vasc Health Risk Manag. 2006;2(2):157-62. Ellegard LH, Andersson SW, Normen AL, Andersson HA. Dietary plant sterols and cholesterol metabolism. Nutr Rev. 2007 Jan;65(1):39-45. Devaraj S, Jialal I. The role of dietary supplementation with plant sterols and stanols in the prevention of cardiovascular disease. Nutr Rev. 2006 Jul;64(7 Pt 1):348-54. John S, Sorokin AV, Thompson PD. Phytosterols and vascular disease. Curr Opin Lipidol. 2007 Feb;18(1):35-40. Fernandes P, Cabral JM. Phytosterols: Applications and recovery methods. Bioresour Technol. 2007 Sep;98(12):2335-2350. Epub 2006 Nov 22. 31 January 2008 Page 1,532 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Human studies Varady KA, Houweling AH, Jones PJ. Effect of plant sterols and exercise training on cholesterol absorption and synthesis in previously sedentary hypercholesterolemic subjects. Transl Res. 2007 Jan;149(1):22-30. Jones PJ, Howell T, MacDougall DE, Feng JY, Parsons W. Short-term administration of tall oil phytosterols improves plasma lipid profiles in subjects with different cholesterol levels. Metabolism. 1998 Jun;47(6):751-6. Acuff RV, Cai DJ, Dong ZP, Bell D. The lipid lowering effect of plant sterol ester capsules in hypercholesterolemic subjects. Lipids Health Dis. 2007 Apr 9;6:11. Prostate health 31 January 2008 280 mg/day 432 Page 1,533 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence review, animal study, in vitro study 31 January 2008 References Claim ID Coleman et al.(2002): The effect of phytosterols on quality of life in the treatment of benign prostatic hyperplasia. Pharmacotherapy 22(11): 1426-1432 Bradford PG, Awad AB. Phytosterols as anticancer compounds. Mol Nutr Food Res. 2007 Feb;51(2):161-70. Awad AB, Fink CS. Phytosterols as anticancer dietary components: evidence and mechanism of action. J Nutr. 2000 Sep;130(9):2127-30. Thomas JA. Diet, micronutrients, and the prostate gland. Nutr Rev. 1999 Apr;57(4):95103. Strom SS, Yamamura Y, Duphorne CM, Spitz MR, Babaian RJ, Pillow PC, Hursting SD. Phytoestrogen intake and prostate cancer: a case-control study using a new database. Nutr Cancer. 1999;33(1):20-5. McCann SE, Ambrosone CB, Moysich KB, Brasure J, Marshall JR, Freudenheim JL, Wilkinson GS, Graham S. Intakes of selected nutrients, foods, and phytochemicals and prostate cancer risk in western New York. Nutr Cancer. 2005;53(1):33-41. Animal study, in vitro study Awad AB, Fink CS, Williams H, Kim U. In vitro and in vivo (SCID mice) effects of phytosterols on the growth and dissemination of human prostate cancer PC-3 cells. Eur J Cancer Prev. 2001 Dec;10(6):507-13. Page 1,534 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Pine nut oil Satiety 3 g per occasion human studies Scott, C. et al., W. Pasman, J. Heimerikx, C. Rubingh, R. van den Berg, M. O’Shea, L. Gambelli, H. Hendriks, L. Mennen and A. Einerhand. 2007. Pinnothin suppresses appetite in overweight women. Appetite 49: in press. Appetite, Volume 49, Issue 1, July 2007, Page 330. 1,595 Pasman, W, J. Heimerikx, C. Rubingh, R. van den Berg, M. Einerhand, Alexandra Wilhelmina, Wilrike Pasman, Carina Rubingh, Rene van den Berg, Marianne O’Shea, Luisa Gambelli, and Henk Hendriks. Korean pine nut fatty acids affect appetite sensations, plasma CCK and GLP1 in overweight subjects. The FASEB Journal. 2006;20:A829. http://www.fasebj.org/cgi/content/meeting_abstr act/20/5/A829c?maxtoshow=&HITS=10&hits=10&RESULTF ORMAT=&author1=Einerhand&andore xacttitle=and&andorexacttitleabs=and&andorex actfulltext=and&searchid=1&FIRSTI NDEX=0&sortspec=relevance&resourcetype=H WCIT 31 January 2008 Page 1,535 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Plant stanol ester Lowers blood cholesterol levels Consume 2g of plant stanol, provided as plant stanol ester, per day preferably with a meal. 1,682 Consumption at the recommended intake. Mandatory labelling statements required as per Commission Regulation EC No 608/2004: Intended exclusively for people who want to lower their cholesterol level; patients on cholesterol lowering medication should only consume the product under medical supervision; products may not be nutritionally appropriate for pregnant and breast feeding women and children under the age of 5 years; the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels; consumption of more than 3g/d should be avoided). 31 January 2008 Page 1,536 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT Meta-analysis Review Observational Authorative Statements/ Health Claims Recommendation/repor t References Claim ID Alhassan S, Reese KA, Mahurin J, Plaisance EP, Hilson BD, Garner JC, Wee SO, Grandjean PW. Blood lipid responses to plant stanol ester supplementation and aerobic exercise training. Metabolism: Clinical and Experimental. 2006;55:No 4 p541-9 http://www.mrw.interscience.wiley.com/cochran e/clcentral/articles/785/CN-00555785/frame.ht ml Yae JH, Oh YK, Joo BK, Lee JH, Jang Y, Liponkoski L, Salo P. Plant stanol esters in low-fat yogurt reduces total and low-density lipoprotein cholesterol and low-density lipoprotein oxidation in normocholesterolemic and mildly hypercholesterolemic subjects. Nutrition Research. 2005;25: No8 p743-753 http://www.mrw.interscience.wiley.com/cochran e/clcentral/articles/859/CN-00569859/frame.ht ml Noakes M, Clifton PM, Doornbos AM, Trautwein EA. Plant sterol ester-enriched milk and yoghurt effectively reduce serum cholesterol in modestly hypercholesterolaemic subjects. 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Dietary sitostanol related to absorption, synthesis and serum level of cholesterol in different apolipoprotein E phenotypes. Atherosclerosis. 1994;105:No 2 p217-26. http://www.mrw.interscience.wiley.com/cochran e/clcentral/articles/119/CN-00102119/frame.ht ml Vanhanen HT, Kajander J, Lehtovirta H, Miettinen TA. Serum levels, absorption efficiency, faecal elimination and synthesis of cholesterol during increasing doses of dietary sitostanol esters in hypercholesterolaemic subjects. Clinical Science. 1994;87:No 1. p61-7. http://www.mrw.interscience.wiley.com/cochran e/clcentral/articles/718/CN-00103718/frame.ht ml Vanhanen HT, Blomqvist S, Ehnholm C, Hyvönen M, Jauhiainen M, Torstila I, Miettinen TA. Serum cholesterol, cholesterol precursors, and plant sterols in hypercholesterolemic subjects with different apoE phenotypes during dietary sitostanol ester treatment. Journal of Lipid Research. 1993;34:9. p1535-44. http://www.mrw.interscience.wiley.com/cochran e/clcentral/articles/945/CN-00096945/frame.ht ml Theuwissen E, Mensink R. Simultaneous intake of beta-glucan and plant stanol esters affects lipid metabolism in slightly hypercholesterolemic subjects. The Journal of Nutrition. 2007;137:583-8. 31 January 2008 Page 1,541 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Jauhiainen T, Salo P, Niittynen L, Poussa T, Korpela R. Effects of low-fat hard cheese enriched with plant stanol esters on serum lipids and apolipoprotein B in mildly hypercholesterolaemic subjects. European Journal of Clinical Nutrition. 2006;60:1253-7. Salo P, Wester I. Low-fat formulations of plant stanols and sterols. American Journal of Cardiology. 2005;96:No.1A, p51D-54D. Cater NB, Garcia-Garcia AB, Vega GL, Grundy S. Responsiveness of plasma lipids and lipoproteins to plant stanol esters. The American Journal of Cardiology. 2005;96:1A. p 23D-28D. Seppo L, Jauhiainen T, Nevala R, Poussa T, Korpela R. Plant stanol esters in low-fat milk products lower serum total and LDL cholesterol. European Journal of Nutrition 2007;46:/2 p111-117. Lagstroem H, Helenius H, Salo P. Serum cholesterol-lowering efficacy of stanol ester incorporated in gelatin capsules. Scandinavian Journal of Food and Nutrition 2006;50:p124-130. Woodgate D, Chan CHM, Conquer JA. Cholesterol-lowering ability of a phytostanol softgel supplement in adults with mild to moderate hypercholesterolemia. Lipids. 2006;41:2 p127-132. Law MR. Plant sterol and stanol margarines and health. British Medical Journal 2000;320, 31 January 2008 Page 1,542 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 861-864. Katan, M Grundy, S, Jones P, Law M, Miettinen T Paoletti R, For the Stressa Workshop participants. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clinic Proceedings 2003: 78, 965-978. Cater N. Plant stanol ester: review of cholesterol lowering efficacy and implications for coronary heart disease risk reduction. Preventive Cardiology 2000; Summer 3(3), 121-130 Wolfs M, de Jong N, Ocke MC, Verhagen H, Monique Verschuren WM. Effectiveness of customary use of phytosterol/-stanol enriched margarines on blood cholesterol lowering. Food Chemistry and Toxicology 2006;44:1682-8. US FDA Code of Federal Regulations, 21, Vol 2 Revised April 2006 [65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. 24, 2000, as amended at 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958, July 21, 2005] http://www.accessdata.fda.gov/scripts/cdrh/cfd ocs/cfcfr/CFRSearch.cfm?fr=101.83 31 January 2008 Page 1,543 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Joint Health Claims Initiative. UK. Consuming 1.6g of plant sterols per day, as part of a healthy diet and lifestyle, is proven to help lower blood cholesterol Approved April 2005. (Dossier archived FSA) Joint Health Claims Initiative. UK. Lowering blood cholesterol can help maintain a healthy heart. Approved September 2005. (Dossier archived FSA) Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final report. Circulation 2002; 106: 3143-3421. International Atherosclerosis Society Executive Board. International Atherosclerosis Society Harmonised Clinical Guidelines on Prevention of Atherosclerotic Vascular Disease. March 2003 Helps maintain arterial health by lowering cholesterol Consume 2g of plant stanol, provided as plant stanol ester, per day preferably with a meal. 1,681 Consumption at the recommended intake. Mandatory labelling statements required as per Commission Regulation EC No 608/2004: Intended exclusively for people who want to 31 January 2008 Page 1,544 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use lower their cholesterol level; patients on cholesterol lowering medication should only consume the product under medical supervision; products may not be nutritionally appropriate for pregnant and breast feeding women and children under the age of 5 years; the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels; consumption of more than 3g/d should be avoided). 31 January 2008 Nature of Evidence Guidelines Papers outlining theoretical basis for the claim References Claim ID Grundy SM, Cleeman JI, Merz CN et al. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Arteriosclerosis Thrombosis Vascular Biology 2004;24:e149-e161. RCT Long term RCT Case control study Oka K, Chan L. Inhibition and regression of atherosclerotic lesions. Acta Biochimica Polonica 2005;52:311-9. von BC, Hartmann M, Mintz GS, Baumgart D, Schmermund A, Erbel R. Relation between progression and regression of atherosclerotic left main coronary artery disease and serum cholesterol levels as assessed with serial long-term (> or =12 months) follow-up intravascular ultrasound. Circulation 2003;108:2757-62. Al-Benna S, Hamilton CA, McClure JD et al. Low-density lipoprotein cholesterol determines oxidative stress and endothelial dysfunction in saphenous veins from patients with coronary artery disease. Arteriosclerosis Thrombosis Vascular Biology 2006;26:218-23. Anderson TJ, Meredith IT, Yeung AC, Frei B, Selwyn AP, Ganz P. The effect of cholesterol-lowering and antioxidant therapy on endothelium-dependent coronary vasomotion. New England Journal of Medicine 1995;332:488-93. Galle J, Hansen-Hagge T, Wanner C, Seibold S. Impact of oxidized low density lipoprotein on vascular cells. Atherosclerosis 2006;185:219-26. Raitakari O, Gylling H., Salo P,Miettinen T. Impaired arterial elasticity and endothelial function are improved with consumption of plant stanol esters. P020-615, Atherosclerosis 2007 8(1),167. Page 1,545 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Raitakari O, Salo P, Ahotupa M. Carotid Artery compliance in users of plant stanol ester margarine. European Journal of Clinical Nutrition. 2007 March, 1-7 Hallikainen M, Lyyra-Laitinen T, Laitinen T, Agren J, Pihlajamaka J, Rauramaa R, Miettinen T, Gylling H. Endothelial function in hypercholesterolemic subjects: effects of plant stanol and sterol esters. Atherosclerosis 2006. 188, 425-432. Helps maintain a healthy heart due to LDL cholesterol lowering effect Consume 2g of plant stanol, provided as plant stanol ester, per day preferably with a meal. 1,680 Consumption at the recommended intake. Mandatory labelling statements required as per Commission Regulation EC No 608/2004: Intended exclusively for people who want to lower their cholesterol level; patients on cholesterol lowering medication should only consume the product under medical supervision; products may not be nutritionally appropriate for pregnant and breast feeding women and children 31 January 2008 Page 1,546 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use under the age of 5 years; the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels; consumption of more than 3g/d should be avoided). Nature of Evidence Authorative Statement Recommendation Review Report Guideline Authorative statements/ Health claims References Claim ID Lichenstein AH, Deckelbaum RJ. AHA Science Advisory. Stanol/sterol ester-containing foods and blood cholesterol levels. A statement for healthcare professionals from the Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association. Circulation 2001;103:1177-1179. Lichtenstein AH, Appel LJ, Brands M, Carnethon M, Daniels S, Franch HA, Franklin B, Kris-Etherton P, Harris WS, Howard B, Karanja N, Lefevre M, Rudel L, Sacks F, Van Horn L, Winston M, Wylie-Rosett J. Diet and lifestyle recommendations revision 2006. A scientific statement from the American Heart Association Nutrition Committee. Circulation 2006; 114: 82-96. Schneeman B. FDA’s review of scientific evidence from health claims. Journal of Nutrition 2007; 137: 493-4. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final report. Circulation 2002; 106: 3143-3421. Grundy SM, Cleeman JI, Merz CNB, Brewer HB, Clark LT, Hunninghake DB, Pasternak RC, Smith SC, Stone NJ for the Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation 2004; 110: 227-39. De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim 31 January 2008 Page 1,547 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID S, Faergeman O, Graham I, Mancia G, Cats VM, Orth-Gomer K, Perk J, Pyorala K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D. European guidelines on cardiovascular disease prevention in clinical practice. European Journal of Cardiovascular Preventionand Rehabilitation 2003; 10 (Suppl 1): S1-S78. JBS 2: Joint British Societies’ guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005; 91: 1-52 Smith S, Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC, Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pasternak RC, Pearson T, Pfeffer MA, Taubert KA. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. Circulation 2006; 113: 2363-72. Joint WHO/FAO Expert Consultation on Diet, Nutrition and the Prevention of Chronic Diseases 2002: Geneva, Switzerland. http://whqlibdoc.who.int/trs/WHO TRS 916.pdf). Joint Health Claims Initiative. UK. Consuming 1.6g of plant sterols per day, as part of a healthy diet and lifestyle, is proven to help lower blood cholesterol Approved April 2005. (Archived FSA, UK) Joint Health Claims Initiative. UK. Lowering blood cholesterol can help maintain a healthy heart. Approved September 2005. (Archived FSA, UK) FDA authorizes new coronary heart disease 31 January 2008 Page 1,548 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID health claim for plant sterol and stanol esters. Sept 5th, 2000. http://www.cfsan.fda.gov/~lrd/tpsterol.html Grundy SM. Stanol esters as a component of maximal dietary therapy in the National Cholesterol Education Program Adult Treatment Panel III report. American Journal of Cardiology 2005; 96(suppl): 47D-50D. Katan MB, Grundy SM, Jones P et al, for the Stresa Workshop Participants. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clinic Proceedings 2003; 78: 965-978. Inhibits the absorption of cholesterol Consume 2g of plant stanol, provided as plant stanol ester, per day preferably with a meal. 1,679 Consumption at the recommended intake. Mandatory labelling statements required as per Commission Regulation EC No 608/2004: Intended exclusively for people who want to lower their cholesterol level; patients on cholesterol lowering medication should only consume the product under medical supervision; products may not be nutritionally appropriate for pregnant 31 January 2008 Page 1,549 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use and breast feeding women and children under the age of 5 years; the product is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels; consumption of more than 3g/d should be avoided). Nature of Evidence Comparative study Infusion study Dose study Absorption study RCT Experimental trial Review Thesis References Claim ID Sudhop T, Lutjohann D, Agna M, von Ameln C Prange W, von Bergmann K. Comparison of the effects of sitostanol, sitostanol acetate and sitostanol oleate on the inhibition of cholesterol absorption in normolipemic healthy male volunteers. Arzneimittel-Forschung 2003; 53: 10:708-713. Normen L, Dutta P, lia A, Andersson H. Soy sterol esters and beta-sitostanol ester as inhibitors of cholesterol absorption in human small bowel. American Journal of Clinical Nutrition 2000; 71 4: 908-913 Nissinen M, Gylling H, Vuoristo M, Miettinen TA. Micellar distribution of cholesterol and phytosterols after duodenal plant stanol ester infusion. American Journal of PhysiologyGastrointestinal and Liver Physiology 2002;282:G1009-G1015. Vanhanen HT, Kajander J, Lehtovirta H, Miettinen TA. Serum levels, absorption efficiency, faecal elimination and synthesis of cholesterol during increasing doses of dietary sitostanol esters in hypercholesterolaemic subjects. Clinical Science (Lond) 1994;87:61-7. Gylling H, Miettinen TA. Effects of inhibiting cholesterol absorption and synthesis on cholesterol and lipoprotein metabolism in hypercholesterolaemic non-insulin-dependent diabetic men. Journal of Lipid Research 1996;37:1776-85. Gylling H, Radhakrishnan R, Miettinen TA. Reduction of serum cholesterol in postmenopausal women with previous 31 January 2008 Page 1,550 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID myocardial infarction and cholesterol malabsorption induced by dietary sitostanol ester margarine. Circulation 1977, 96; 42264231. http://circ.ahajournals.org/cgi/content/abstract/9 6/12/4226 Miettinen TA, Vuoristo M, Nissinen M, Jarvinen HJ, Gylling H. Serum, biliary, and faecal cholesterol and plant sterols in colonectomised patients before and during consumption of plant stanol ester margarine. American Journal of Clinical Nutrition 2000; 71, 1095-1102. Miettinen TA, Gylling H. Regulation of cholesterol metabolism by dietary plant sterols. Current Opinion in Lipidology 1999;10:9-14. Plat J, Mensink RP. Plant stanol and sterol esters in the control of blood cholesterol levels: mechanism and safety aspects. American Journal of Cardiology 2005;96:15D-22D. 31 January 2008 Page 1,551 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Plant sterols Cholesterol levels 200-300mg is the daily minimum dose recommended from dietary sources for optimum health. The most recent study used 1.3g. A meta-analysis of 41 trails Should be used with caution with patients on immuno-suppressant medication Meta-analysis Double-blind, placebo-controlled, sequential trial Randomised, placebo-controlled trial Katan MB, Grundy SM, Jones P, Law M, et al. Efficacy and safety of plant sterols and sterols in the management of blood cholesterol levels. Mayo Clin Proc. 2003 Aug;78(8):965-78. 1,078 Acuff RV, Cai DJ, Dong ZP, Bell D. The lipid lowering effect of plant sterol ester capsules in hypercholesterolemic subjects. Lipids Health Dis. 2007 Apr 9;6:11. Lau VW, Journoud M, Jones PJ. Plant sterols are efficacious in lowering plasma LDL and non-LDL cholesterol in hypercholesterolemic type 2 diabetic and non-diabetic persons. Am J Clinical Nutri. 2005 Jun; 81 (6):1351-8. De Jongh S, Vissers MN, Rol P, Bakker HD et al. Plant sterols lower LDL cholesterol without improving endothelial function in prepubertal children with familial hypercholesterolaemia. J Inherit Metab Dis. 2003;26(4):343-51. Homma Y, Ikeda I, Ishikawa T, Tateno M et al. Decrease in plasma low-density lipoprotein cholesterol, apolipoprotein B, cholesteryl ester transfer protein, and oxidised low-density lipoprotein by plant sterol ester-containing spread: a randomised, placebo-controlled trial. Nutrition.2003 Apr; 19(4):369-74 31 January 2008 Page 1,552 of 3,931 Category Food Component Health Relationship (1) Lowers blood cholesterol, which (2) helps to maintain a healthy heart Suggested Conditions of Use 1.6g per day Nature of Evidence Part 1 of health relationship: Systematic reviews and meta-analyses; Reviews; Human intervention studies; Observational study. References Systematic Reviews/Meta-analyses Katan, M., Grundy, SM, Jones, P, Law, M, Miettinen, T, Paoletti, R. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clin Proc 2003, 78(8): 965-78. Claim ID 2,395 Law, M. Plant sterol and stanol margarines and health. British Med Journal 2000, 320: 861-864. Reviews Lichtenstein AH. Plant sterols and blood lipid levels. Curr Opin Clin Nutr Metab Care 2002, 5(2): 147-52. Human Intervention Trials (included in meta-analysis in Danone Dossier, October 2004) Ayesh R et al. Safety evaluation of phytosterol esters. Part 5. Faecal short chain fatty acid and microflora content, faecal bacterial enzyme activity and serum female sex hormones in healthy normolipidaemic volunteers consuming a controlled diet either with or without a phytosterol ester enriched margarine. Food Chem Toxicol 1999, 37(12): 1127 Christiansen LI et al. Cholesterol-lowering effect of spreads enriched with microcrystalline plant sterols in hypercholesterolaemic subjects. Eur J Nutr 2001, 40: 66-73. Cleghorn CL et al. Plant sterol enriched spread enhances the cholesterol lowering potential of a fat. Eur J Clin Nutr 2003, 57: 170-6. Davidson MH et al. Safety and tolerability of esterified phytosterols administered in reduced fat spread and salad dressing to healthy adult 31 January 2008 Page 1,553 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID men and women. J Am Coll Nutr 2001, 20(4): 307-19. Devaraj SI et al. Plant sterol fortified orange juice effectively lowers cholesterol levels in mildly hypercholesterolaemic healthy individuals. Arterioscler Thromb Vasc Biol 2004, 24(3): e25. Geelen A et al. Apolipoprotein E polymorphism and serum lipid response to plant sterols in humans. European Journal of Clinical Investigation 2002, 32: 738-42. Hendriks HF et al. Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normocholesterolaemic and mildly hypercholesterolaemic subjects. Eur J Clin Nutr 1999, 53(4): 319-27. Hendriks HF et al. Safety of long term consumption of plant sterol esters enriched spread. Eur J Clin Nutr 2003, 57: 681. Jones PJ et al. Modulation of plasma lipid levels and cholesterol kinetics by phytosterol versus phytostanol esters. J Lipid Res 2000, 41(5): 697-705. Jones PJ et al. Phytosterols in low and nonfat beverages as part of a controlled diet fail to lower plasma lipid levels. J Lipid Res 2003, 44(9): 1713-9. Judd JT et al. Plant sterol esters lower plasma lipids and most carotenoids in mildly hypercholesterolaemic adults. Lipids 2002, 37: 33-42. Lottenberg AM et al. The human cholesteryl 31 January 2008 Page 1,554 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID ester transfer protein I405V polymorphism is associated with plasma cholesterol concentration and its reduction by dietary phytosterol esters. J Nutr 2003, 133: 1800-5. Maki KC et al. Lipid responses to plant sterol enriched reduced-fat spreads incorporated into a National Cholesterol Education Program Step I diet. Am J Clin Nutr 2001, 74: 33-43. Matvienko OA et al. A single daily dose of soybean phytosterols in ground beef decreases serum total cholesterol and LDL cholesterol in young, mildly hypercholesterolaemic men. Am J Clin Nutr 2002, 76(1): 57-64. Mussner MJ et al. Effects of phytosterol ester enriched margarine on plasma lipoproteins in mild to moderate hypercholesterolemia are related to basal cholesterol and fat intake. Metabolism 2002, 51(2): 189-94. Noakes M et al. An increase in dietary carotenoids when consuming plant sterols or stanols is effective in maintaining plasma carotenoid concentrations. Am J Clin Nutr 2002, 75(1): 79-86. Noakes M et al. Plant sterol ester enriched milk and yoghurt effectively reduce serum cholesterol in modestly hypercholesterolaemic subjects. Eur J Nutr 2005, 44: 214-222. Ntanios FY et al. A spread enriched with plant sterol-esters lowers blood cholesterol and lipoproteins without affecting vitamins A and E in normal and hypercholesterolaemic Japanese men and women. Journal of Nutrition 2002, 132: 3650-5. 31 January 2008 Page 1,555 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Pelletier X et al. A diet moderately enriched in phytosterols lowers plasma cholesterol concentrations in normocholesterolaemic humans. Ann Nutr Metab 1995, 39(5): 291-5. Quilez J et al. Bakery products enriched with phytosterol esters, alphaocopherol and beta-carotene decrease plasma LDL-cholesterol and maintain plasma beta-carotene concentrations in normocholesterolaemic men and women. J Nutr 2003, 133: 3103-9. Seki S et al. Effects of phytosterol ester enriched vegetable oil on plasma lipoproteins in healthy men. Asia Pac J Clin Nutr 2003, 12(3): 282-91. Sierksma A et al. Spreads enriched with plant sterols, either esterified 4,4dimethylsterols or free 4-desmethylsterols, and plasma totaland LDL-cholesterol concentrations Br J Nutr 1999, 82: 273-82. Temme EH et al. Effects of a plant sterol enriched spread on serum lipids and lipoproteins in mildly hypercholesterolaemic subjects. Acta Cardiologica 2002, 57: 111-5. Thomsen AB et al. Effect of free plant sterols in low fat milk on serum lipid profile in hypercholesterolaemic subjects. Eur J Clin Nutr 2004, 58(6): 860-70. Tikkanen MJ et al. Effect of a diet based on low-fat foods enriched with nonesterified plant sterols and mineral nutrients on serum cholesterol. Am J Cardiol 2001, 88: 1157-62. Vanstone CA et al. Unesterified plant sterols 31 January 2008 Page 1,556 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID and stanols lower LDL cholesterol concentrations equivalently in hypercholesterolaemic persons. Am J Clin Nutr 2002, 76(6): 1272-8. Vissers MN et al. Effect of plant sterols from rice bran oil and triterpene alcohols from sheanut oil on serum lipoprotein concentrations in humans. Am J Clin Nutr 2000, 72(6): 1510-5. Volpe, R, et al. Effects of yoghurt enriched with plant sterols on serum lipids in patients with moderate hypercholesterolaemia. Br J Nutr 2001, 86(2): 2339. Weststrate, J.A. &. Meijer, G.W. Plant sterol enriched margarines and reduction of plasma total and LDL cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects. Eur J Clin Nutr 1998, 52: 334-43. Single blind study (not included in meta-analysis in Danone Dossier, October 2004) Clifton PM, Noakes M, Sullivan D, Erichsen N, Ross D, Annison G, Fassoulakis A, Cehun M and Nestel P (2004). "Cholesterol-lowering effects of plant sterol esters differ in milk, yoghurt, bread and cereal." Eur J Clin Nutr 58(3): 503-9. Observational Study Andersson, S., Skinner, J, Ellegrd, L, Welch, A A, Bingham, S, Mulligan, A, Andersson, H, Khaw, K-T. Intake of dietary plant sterols is inversely related to serum cholesterol concentration in men and women in the EPIC Norfolk population: a cross-sectional study. Eur J Clin Nutr 2004, 58:1378-1385. 31 January 2008 Page 1,557 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID RECENT REFERENCES (SINCE OCTOBER 2004) Systematic Reviews/Meta-analyses Chen, J. T., R. Wesley, et al. Meta-analysis of natural therapies for hyperlipidemia: plant sterols and stanols versus policosanol. Pharmacotherapy 2005, 25(2): 171-83. Moruisi, K. G., W. Oosthuizen, et al. Phytosterols/stanols lower cholesterol concentrations in familial hypercholesterolemic subjects: a systematic review with meta-analysis. J Am Coll Nutr 2006, 25(1): 41-8. Reviews Miettinen TA, Gylling H. Plant stanol and sterol esters in prevention of cardiovascular diseases: a review. Int J Clin Pharmacol Ther 2006; 44(6): 247-50. Plat J, Mensink R. P. Plant stanol and sterol esters in the control of blood cholesterol levels: mechanism and safety aspects. Am J Cardiol 2005, 96(1A): 15D-22D. Human Intervention Trials Devaraj, S., B. C. Autret, et al. Reduced-calorie orange juice beverage with plant sterols lowers C-reactive protein concentrations and improves the lipid profile in human volunteers. Am J Clin Nutr 2006, 84(4): 756-61. Doornbos, A. M., E. M. Meynen, et al. Intake occasion affects the serum cholesterol lowering of a plant sterol-enriched single-dose yoghurt drink in mildly hypercholesterolaemic subjects. Eur J Clin Nutr 2006, 60(3): 325-33. 31 January 2008 Page 1,558 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Korpela R, Tuomilehto J, et al. Safety aspects and cholesterol-lowering efficacy of low fat dairy products containing plant sterols. Eur J Clin Nutr 2006, 60(5): 633-42. Lau VW, Journoud M, et al. Plant sterols are efficacious in lowering plasma LDL and non-HDL cholesterol in hypercholesterolemic type 2 diabetic and nondiabetic persons. Am J Clin Nutr 2005, 81(6): 1351-8. Trials with Danacol Hansel B, Nicolle C, Lalanne F, Tondu F, Lassel T, Donazzolo Y, Ferrieres J, Krempf M, Schlienger L, Verges B, Chapman MJ, Bruckert E. Effect of a low fat fermented milk enriched with plant sterols on serum lipid profile and oxidative stress in moderate hypercholesterolemia Am J Clin Nutr, 2007, 86:790-96 31 January 2008 Page 1,559 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Part 2 of health relationship: Textbooks; Authoritative reports; Systematic reviews and meta-analyses; Human intervention trials. References Claim ID Text Books Berdanier CD (Ed). CRC Handbook of Nutrition and Food; CRC Press, 2002. Gibney MJ et al (Eds). Introduction to Human Nutrition; Oxford: Blackwell Science, 2002. Law M. Lipids and Cardiovascular Disease, in Evidence Based Cardiology, 2nd Ed, BMJ Books: 2003, 121-129. Sadler MJ et al (Eds). Encyclopedia of Human Nutrition; London: Academic Press, 1999. Authoritative Reports Department of Health. Nutritional Aspects of Cardiovascular Disease; COMA report 46. London: HMSO, 1994. FDA. Food Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease. FDA Federal Register interim final rule - 2000, 65: 54685-54739. Hornstra G et al. Functional Food Science and the Cardiovascular System. Brit J Nutr 1998, 80 (S1): S113-S146. Mensink RP et al. PASSCLAIM – Diet-related cardiovascular disease. European Journal of Nutrition 2003, 42, Suppl 1: 6-27. Stanner S (Ed). Cardiovascular Disease – Diet, nutrition and emerging risk factors; Report of the BNF Task Force; Oxford: Blackwell Publishing, 2005. WHO. Diet Nutrition and Chronic diseases; WHO Technical Report Series 916, 2003. Systematic reviews and meta-analyses: Diet 31 January 2008 Page 1,560 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hooper L et al. Dietary fat intake and prevention of cardiovascular disease: systematic review. BMJ 2001, 322: 757-763. Katerndahl DA and Lawler WR. Variability in meta-analytic results concerning the value of cholesterol reduction in coronary heart disease: A meta-meta-analysis. Am J Epidemiol 1999,149: 429-41. Law et al. By how much and how quickly does reduction in serum cholesterol concentration lower risk of ischaemic heart disease. BMJ 1994, 308: 367-372. Systematic reviews and meta-analyses: Statin trials LaRosa JC et al. Effects of statins on risk of coronary disease - A meta-analysis of randomized controlled trials. JAMA 1999, 282: 2340-6. Pignone M et al. Use of lipid lowering drugs for primary prevention of coronary heart disease: meta-analysis of randomized trials. BMJ 2000, 321: 1-5. FURTHER SUPPORTING EVIDENCE (TO THAT CITED IN DANONE DOSSIER, 2005) Meta-analyses Baigent C.A, Keech, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005, 366 (9493): 1267-78. Human Intervention Trials Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering 31 January 2008 Page 1,561 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994, 344(8934): 1383-9. Shepherd J, Cobbe SM et al. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995, 333(20): 1301-7. Heart Health 1300mg/day Human Intervention Study Hansell B, Effect of low fat fermented milk enrisched with plant sterols on serum lipid profile and oxidative stress in moderate hypercholesterolemia. Am J Clin Nutr, 86 (3), 790-796 (2007) 956 Acuff RV, The lipid lowering effect of plant sterol ester capsules in hypercholesterolemic subjects. Lipids Health Dis, 9, 6:11 (2007) Patch CS et al,Vasc, Plant Sterols as dietary adjuvants in the reduction of cardiovascular risk: theory and evidence. Health Risk Manag. 2 (2), 157-62 (2006) 31 January 2008 Page 1,562 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Saturated fats/fatty acids (decrease) Blood cholesterol and artery/heart health 31 January 2008 . Authoritative Body JHCI - Joint Health Claims Initiative - Final Technical Report - A List of Well Established Nutrient Function Statements http://www.food.gov.uk/multimedia/pdfs/jhci_he althreport.pdf Authoritative Body SNF - Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm Authoritative Body NFA - Terveysvaitteiden valvontaopas, Finnish Food Authority Control guides number 2/2002 http://www.palvelu.fi/evi/evi_material.php Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Scientific Body WHO 2003. Diet, nutrition and the prevention of chronic diseases. Report of a Joint WHO/FAO expert consultation Geneva, World Health Organization, 28 January - 1 February 2002 [Public Health Nutrition, Volume 7(1A), February 2004. Special issue - Diet, nutrition and the prevention of chronic diseases: scientific background papers of the joint WHO/FAO expert consultation ] 153 Page 1,563 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Stearic acid Lipid metabolism 31 January 2008 Up to 5% daily energy intake as stearic acid 449 Page 1,564 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence monographs, peer-reviewed publications, WHO technical report References Claim ID Monographs: Joint WHO/FAO Expert Consultation (2003). Diet, Nutrition and the Prevention of Chronic Diseases, World Health Organization, Geneva. WHO Technical Report Series 916, pp. 147-148 (2003). Total and LDL cholesterol levels. Institute of Medicine (2002). Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) , Chapter 8, National Academy Press, Washington, D.C. , p. 483 Critical Reviews Kris-Etherton PM, Mustad VA (1994). Chocolate feeding studies: a novel approach for evaluating the plasma lipid effects of stearic acid. Am. J. Clin. Nutr. 60(Suppl.): 1029S – 36S. Kris-Etherton PM, Yu S. Am J Clin Nutr. 1997 Individual fatty acid effects on plasma lipids and lipoproteins: human studies. May;65(5 Suppl):1628S-1644S Kris-Etherton PM, Griel AE, Psota TL, Gebauer SK, Zhang J, Etherton TD (2005) Dietary stearic acid and risk of cardiovascular disease: intake, sources, digestion, and absorption. Lipids.;40:1193-2000.. Mensink RP , Effects of stearic acid on plasma lipid and lipoproteins in humans. Lipids. 2005 40(12):1201-5. Peer-reviewed publications: Yu S., et al. (1995) Plasma cholesterol-predictive equations demonstrate that stearic acid is neutral and monounsaturated fatty acids are hypocholesterolemic. Am. J. Clin. Nutr., 61 : 1129 1139. Tholstrup T et al. (1994) Fat High in Stearic 31 January 2008 Page 1,565 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Acid Favorably Affects Blood Lipids and Factor Thijssen M.A., Mensink R.P. (2005). Small differences in the effects of stearic acid, oleic acid, and linoleic acid on the serum lipoprotein profile of humans. Am. J. Clin. Nutr., 82(3): 510 -516. Bonanome A & Grundy SM (1988). Effect of dietary stearic acid on plasma cholesterol and lipoprotein levels. New Eng. J. Med. 318: 1244-1248. Grande, F, Anderson, JT, Keys A. (1970). Comparison of Effects of Palmitic and Stearic Acids in the Diet on Serum Cholesterol in Man. Am J. Clin. Nutr. 23 1184-1193 Denke, MA and Grundy SM (1991). Effects of fats high in stearic acid on lipid and lipoprotein concentrations in men Am. J. Clin. Nutr. 54 1036-1040. 31 January 2008 Page 1,566 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Sterols/ stanols and their esters Heart health and artery health because of LDL cholesterol lowering 31 January 2008 See reference section 450 Page 1,567 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence authoritative body, scientific body, expert panel, meta-analysis References Claim ID Note: where conditions of use are recommended these are given after the reference Authoritative/Scientific Bodies AHA. Diet and lifestyle recommendations revision 2006: a scientific statement from the American Heart Association Nutrition Committee.. Lichtenstein AH et al. Circulation 2006; 114: 82-96 [Recommend 2g Sterols/Stanols per day] Australia – New Zealand. National Heart Foundation of Australia, Cardiac Society of Australia and New Zealand, Australian Atherosclerosis Society, National Stroke Foundation, Internal Medicine Society of Australia and New Zealand, The Royal Australian College of General Practitioners. The Medical Journal of Australia 2001, volume 175, supplement http://www.heartfoundation.com.au/downloads/ Guideline_Lipid_Mgt_2001.pdf [Recommend 23g Sterols per day] EU Regulation 608/2004 concerning the labelling of foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters. [For food labelling purposes up to 3 g Sterols/Stanols may be provided per portion or per 3 portions. NOTE This is a regulatory requirement and not a recommended level of intake] FDA (2000). 21 CFR Part 101. Food labelling: health claims; plant sterol/stanol esters and coronary heart diseases. Federal Register: September 8, 2000 (Volume 65, Number 175); also FDA Letter of Discretion http://www.cfsan.fda.gov/~dms/ds-ltr30.html [Approved 800mg free phytosterols per day] Flemish Dietetic Association. Intervention 31 January 2008 Page 1,568 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID protocol for dyslipidemia published by the VVVD (Flemish Dietetic Association), 2002 [Recommend 2-3g Sterols/Stanols per day] International Atherosclerosis Society Executive Board (IAS). International Atherosclerosis Society Harmonised Clinical Guidelines on Prevention of Atherosclerotic Vascular Disease. March 2003. [Recommend 2g Sterols/Stanols per day] JHCI 2005 Approval of product specific claim in relation to plant sterols and blood cholesterol “Consuming 1.6g of plant sterols per day, as part of a healthy diet and lifestyle, is proven to help lower blood cholesterol” [Approved 1.6g sterols/stanols per day] NCEP. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) JAMA, May 2001; 285: 2486 - 2497. [Recommend 2g Sterols/Stanols per day ] SCF (Scientific Committee on Food) (2002). General view on the long-term effects of the intake of elevated levels of phytosterols from multiple dietary sources, with particular attention to the effects on R-carotene. Opinion adopted by the SCF on 26 September 2002. [opinion that 1-3g Sterols/Stanols per day was effective] Swedish Nutrition Foundation. Product specific claims. Voedingscentrum. Product specific claims. Meta-Analysis Martijn B. Katan, Scott M. Grundy, Peter Jones, Malcolm Law, Tatu Miettinen and Rodolfo Paoletti, for the Stresa Workshop Participants. Efficacy and Safety of Plant Stanols and Sterols in the Management of 31 January 2008 Page 1,569 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Blood Cholesterol Levels Mayo Clin Proc. 2003;78:965-978. [Meta-analysis suggests 2g per day for 10% lowering of LDL cholesterol] 31 January 2008 Page 1,570 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Unsaturated fats/ fatty acids (poly and/or monounsaturates) Blood cholesterol and artery/heart health 31 January 2008 Authoritative/Scientific Bodies Institute of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty acids, Cholesterol, Protein, and Amino Acids. 2002. National Academy of Sciences, Washington, DC. Authoritative/Scientific Bodies EFSA 2005. Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to nutrition claims concerning omega-3 fatty acids, monounsaturated fat, polyunsaturated fat and unsaturated fat Request N° EFSA-Q-2004-107)(adopted on 6 July 2005) Authoritative/Scientific Bodies FDA. FDA USA Authoritative Statement on MUFA from olive oil and CHD. Authoritative/Scientific Bodies WHO 2003 Diet, Nutrition and the Prevention of Chronic Diseases. WHO Technical Report Series, no. 916 (TRS 916). Meta-Analysis Mensink RP et al., Effects of dietary fatty acids and carbohydrates on the ratio of serum total to HDL cholesterol and on serum lipids and apolipoproteins: a meta-analysis of 60 controlled trials. Am J Clin Nutr. 2003;77:1146-55. Meta-Analysis Brouwer IA, Katan MB, Zock PL. Dietary alpha-linolenic acid is associated with reduced risk of fatal coronary heart disease, but increased prostate cancer risk: a meta-analysis. J Nutr. 2004;134:919-22. Reviews De Lorgeril M, Salen P. Dietary prevention of coronary heart disease: the Lyon diet heart study and after.World Rev Nutr Diet. 2005;95:103-14. Review. 154 Page 1,571 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews British Nutrition Foundation 2005. Stanner S (ed) Cardiovascular Diease: Diet, Nutrition and Emerging Risk Factors Individual Studies Finnegan YE, Minihane AM, Leigh-Firbank EC et al. Plant- and marine-derived polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid concentrations and on the susceptibility of LDL to oxidative modification in moderately hyperlipidemic subjects. Am J Clin Nutr 2003;77:783-95. Individual Studies Petra L. L. Goyens and Ronald P. MensinkThe Dietary alpha-Linolenic Acid to Linoleic Acid Ratio Does Not Affect the Serum Lipoprotein Profile in Humans.J. Nutr. 135: 2799–2804, 2005 Scientific Body Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbook Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Textbook Gibney MJ, Voster, HH, Kok FJ (eds) Introduction to human nutrition. Blackwell Publishing, Oxford, 2002. Textbook Mann J, Truswell AS. Essentials of Human Nutrition, 2nd ed. Oxford University Press, 2001. Claim ID Unsaturated fats/fatty acids Function of the cell membrane 31 January 2008 155 Page 1,572 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID FIBRE 31 January 2008 Page 1,573 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Acacia gum (gum arabic) Improved intestinal conditions (pH, SCFA production) and intestinal functions 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 10g/day Authoritative/Scientific Body AFSSA Opinion 23 April 2001 http://www.afssa.fr/ftp/afssa/basedoc/NUT2000 sa0138.pdf Individual Studies Bliss, D. Z., Jung, H. J., Savik, K., Lowry, A., LeMoine, M., Jensen, L., Werner, C., & Schaffer, K. 2001, "Supplementation with dietary fiber improves fecal incontinence", Nurs.Res., vol. 50, no. 4, pp. 203-213. Individual Studies Bliss, D. Z., Stein, T. P., Schleifer, C. R., & Settle, R. G. 1996, "Supplementation with gum arabic fiber increases fecal nitrogen excretion and lowers serum urea nitrogen concentration in chronic renal failure patients consuming a low-protein diet", Am.J.Clin.Nutr., vol. 63, no. 3, pp. 392-398. Individual Studies Campbell, J. M., Fahey, G. C., Jr., Demichele, S. J., & Garleb, K. A. 1997a, "Metabolic characteristics of healthy adult males as affected by ingestion of a liquid nutritional formula containing fish oil, oligosaccharides, gum arabic and antioxidant vitamins", Food Chem.Toxicol., vol. 35, no. 12, pp. 1165-1176. Individual Studies Cherbut, C., Michel, C., Raison, V., Kravtchenko, T. P., & Meance, S. 2003, "Acacia gum is a bifidogenic dietary fiber with high digestive tolerance in healthy humans", Microbial Ecol Health Dis, vol. 15, pp. 43-50. Individual Studies Codipilly, C. N., Teichberg, S., & Wapnir, R. A. 2006, "Enhancement of absorption by gum arabic in a model of gastrointestinal dysfunction", J.Am.Coll.Nutr., vol. 25, no. 4, pp. 307-312. 180 Page 1,574 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Codipilly, C. N. & Wapnir, R. A. 2004, "Proabsorptive action of gum arabic in isotonic solutions orally administered to rats. II. Effects on solutes under normal and secretory conditions", Dig.Dis.Sci., vol. 49, no. 9, pp. 1473-1478. Individual Studies McLean Ross, A. H., Eastwood, M. A., Brydon, W. G., Anderson, J. R., & Anderson, D. M. 1983, "A study of the effects of dietary gum arabic in humans", Am.J.Clin.Nutr., vol. 37, no. 3, pp. 368-375. Individual Studies Rehman, K. U., Codipilly, C. N., & Wapnir, R. A. 2004, "Modulation of small intestinal nitric oxide synthase by gum arabic", Exp.Biol.Med. (Maywood.), vol. 229, no. 9, pp. 895-901. Individual Studies Rehman, K. U., Wingertzahn, M. A., Harper, R. G., & Wapnir, R. A. 2001, "Proabsorptive action of gum arabic: regulation of nitric oxide metabolism in the basolateral potassium channel of the small intestine", J.Pediatr.Gastroenterol.Nutr., vol. 32, no. 5, pp. 529-533. Individual Studies Rehman, K. U., Wingertzahn, M. A., Teichberg, S., Harper, R. G., & Wapnir, R. A. 2003, "Gum arabic (GA) modifies paracellular water and electrolyte transport in the small intestine", Dig.Dis.Sci., vol. 48, no. 4, pp. 755-760. Individual Studies Teichberg, S., Wingertzahn, M. A., Moyse, J., & Wapnir, R. A. 1999, "Effect of gum arabic in an oral rehydration solution on recovery from diarrhea in rats", J.Pediatr.Gastroenterol.Nutr., vol. 29, no. 4, pp. 411-417. Individual Studies Tulung, B., Remesy, C., & Demigne, C. 1987, "Specific effect of guar gum or gum arabic on adaptation of cecal digestion to high fiber diets in the rat", J.Nutr., vol. 117, no. 9, pp. 1556-1561. Claim ID Page 1,575 of 3,931 Category Food Component Health Relationship Prebiotic action: increase in beneficial bacteria in the colon 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 6g/day Nature of Evidence References Individual Studies Turvill, J. L., Wapnir, R. A., Wingertzahn, M. A., Teichberg, S., & Farthing, M. J. 2000, "Cholera toxin-induced secretion in rats is reduced by a soluble fiber, gum arabic", Dig.Dis.Sci., vol. 45, no. 5, pp. 946-951. Individual Studies Wapnir, R. A., Teichberg, S., Go, J. T., Wingertzahn, M. A., & Harper, R. G. 1996, "Oral rehydration solutions: enhanced sodium absorption with gum arabic", J.Am.Coll.Nutr., vol. 15, no. 4, pp. 377-382. Individual Studies Wapnir, R. A., Wingertzahn, M. A., Moyse, J., & Teichberg, S. 1997, "Gum arabic promotes rat jejunal sodium and water absorption from oral rehydration solutions in two models of diarrhea", Gastroenterology, vol. 112, no. 6, pp. 1979-1985. Individual Studies Wingertzahn, M. A., Teichberg, S., & Wapnir, R. A. Jejunal nitric oxide (NO) levels are reduced by gum arabic (GA). J.Am.Coll.Nutr. Abstract 52, 509. 1998. Individual Studies Wingertzahn, M. A., Teichberg, S., & Wapnir, R. A. 2001, "Stimulation of non-sodium-dependent water, electrolyte, and glucose transport in rat small intestine by gum arabic", Dig.Dis.Sci., vol. 46, no. 5, pp. 1105-1112. Individual Studies Wyatt, G. M., Bayliss, C. E., & Holcroft, J. D. 1986, "A change in human faecal flora in response to inclusion of gum arabic in the diet", Br.J.Nutr., vol. 55, no. 2, pp. 261-266. Authoritative/Scientific Body AFSSA opinion 2005-SA-0008 AFSSA opinion 23 April 2001 http://www.afssa.fr/ftp/afssa/basedoc/NUT2000 sa0138.pdf http://www.afssa.fr/Ftp/Afssa/31119-31120.pdf) Claim ID 179 Page 1,576 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Adiotomre J, Eastwood MA, Edwards CA, Brydon WG. Dietary fiber: in vitro methods that anticipate nutrition and metabolic activity in humans. Am.J.Clin.Nutr. 1990;52:128-34. Individual Studies Annison G, Trimble RP, Topping DL. Feeding Australian Acacia gums and gum arabic leads to non-starch polysaccharide accumulation in the cecum of rats. J.Nutr. 1995;125:283-92. Individual Studies Bliss DZ, Stein TP, Schleifer CR, Settle RG. Supplementation with gum arabic fiber increases fecal nitrogen excretion and lowers serum urea nitrogen concentration in chronic renal failure patients consuming a low-protein diet. Am.J.Clin.Nutr. 1996;63:392-8. Individual Studies Bourquin LD, Titgemeyer EC, Fahey GC, Jr., Garleb KA. Fermentation of dietary fibre by human colonic bacteria: disappearance of, short-chain fatty acid production from, and potential water-holding capacity of, various substrates. Scand.J.Gastroenterol. 1993;28:249-55. Individual Studies Cherbut C, Michel C, Raison V, Kravtchenko T, Meance S. Acacia gum is a bifidogenic dietary fiber with high digestive tolerance in healthy humans. Microbial Ecology in Health and Disease 2003;15:43-50. Individual Studies Crociani F, Alessandrini A, Mucci MM, Biavati B. Degradation of complex carbohydrates by Bifidobacterium spp. Int.J.Food Microbiol. 1994;24:199-210. Individual Studies May T, Mackie RI, Fahey GC, Jr., Cremin JC, Garleb KA. Effect of fiber source on short-chain fatty acid production and on the growth and toxin production by Clostridium difficile. Scand.J.Gastroenterol. 1994;29:916-22. Claim ID Page 1,577 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies McLean Ross AH, Eastwood MA, Brydon WG, Anderson JR, Anderson DM. A study of the effects of dietary gum arabic in humans. Am.J.Clin.Nutr. 1983;37:368-75. Individual Studies McLean Ross AH, Eastwood MA, Brydon WG, Busuttil A, McKay LF. A study of the effects of dietary gum arabic in the rat. Br.J.Nutr. 1984;51:47-56. Individual Studies Meance S. Acacia gum (FIBREGUM), a very well tolerated specific natural prebiotic having a wide range of food applications - Part 1. AgroFood Industry Hi-tech:24-28, 2004. Individual Studies Michel C, Kravtchenko T, David A, Gueneau S, Kozlowski F, Cherbut C. In vitro prebiotic effects of Acacia gums onto the human intestinal microbiota depends on both botanical origin and environmental pH. Anaerobe 1998;4:257-66. Individual Studies Mortensen PB, Hove H, Clausen MR, Holtug K. Fermentation to short-chain fatty acids and lactate in human faecal batch cultures. Intraand inter-individual variations versus variations caused by changes in fermented saccharides. Scand.J.Gastroenterol. 1991;26:1285-94. Individual Studies Rochat, F., Ballevre, O, and Jann, A. Nutritional Composition. NESTLE, S. A. 00115850.0(EP 1 175 905 A1), 1-12. 30-1-2002. Suisse (CH). 24-7-2000. Individual Studies Salyers AA, Palmer JK, Wilkins TD. Degradation of polysaccharides by intestinal bacterial enzymes. Am.J.Clin.Nutr. 1978;31:S128-S130. Claim ID Page 1,578 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Storer GB, Illman RJ, Trimble RP, Snoswell AM, Topping DL. Plasma and caecal volatile fatty acids in male and female rats : effects of dietary gum arabic and cellulose. Nutrition Research 1984;4:701-7. Individual Studies Titgemeyer EC, Bourquin LD, Fahey GC, Jr., Garleb KA. Fermentability of various fiber sources by human fecal bacteria in vitro. Am.J.Clin.Nutr. 1991;53:1418-24. Individual Studies Tomlin J. Which fibre is best for the colon? Scand.J.Gastroenterol.Suppl 1987;129:100-4. Individual Studies Topping DL, Mock S, Trimble RP, Storer GB, Illman RJ. Effects of varying the content and proportions of gum arabic and cellulose on caecal volatile fatty acid concentrations in the rat. Nutrition Research 1988;8:1013-20. Individual Studies Tulung B, Remesy C, Demigne C. Specific effect of guar gum or gum arabic on adaptation of cecal digestion to high fiber diets in the rat. J.Nutr. 1987;117:1556-61. Individual Studies Walter DJ, Eastwood MA, Brydon WG, Elton RA. Fermentation of wheat bran and gum arabic in rats fed on an elemental diet. Br.J.Nutr. 1988;60:225-32. Individual Studies Wyatt GM, Bayliss CE, Holcroft JD. A change in human faecal flora in response to inclusion of gum arabic in the diet. Br.J.Nutr. 1986;55:261-6. Claim ID Page 1,579 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Barley/ barley beta-glucan Blood cholesterol levels 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 3g/day Authoritative/Scientific Bodies FDA - Interim final rule: Federal Register: December 23, 2005 (Volume 70, Number 246, Page 76150-76162) http://www.access.gpo.gov/su_docs/fedreg/a05 1223c.htmlhttp://a257.g.akamaitech.net/7/257/ 2422/01jan20051800/edocket.access.gpo.gov/ 2005/pdf/05-24387.pdf Authoritative/Scientific Bodies FDA - Final rule Federal Register: May 22, 2006 (Volume 71, Number 98, Page 29248-29250] http://www.fda.gov/OHRMS/DOCKETS/98fr/064703.h Individual Studies Behall, K. M., Scholfield, D. & Hallfrisch, J. (2003). Barley consumption lowers cholesterol in men and overweight women. FASEB Journal, 17, A1.1, Individual Studies Behall, K. M., Scholfield, D. J. & Hallfrisch, J. G. (2004a). Lipids significantly reduced by diets containing barley in moderately hypercholesterolemic men. J Am Coll Nutr, 23, 55-62. , Individual Studies Behall, K. M., Scholfield, D. & Hallfrisch, J. (2004b). Diets containing barley reduce lipids significantly in mildly hypercholesterolemic men and women. Am J Clin Nutr, 80(5):1185-93., Individual Studies Hallfrisch, J., Scholfield, D. J. & Behall, K. M. (2002). Increasing whole grain foods (barley or wheat and rice) in a Step 1 diet lowers blood pressure in moderately hypercholesterolemic men. The FASEB Journal, 16, A655.1, 178 Page 1,580 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Hallfrisch, J., Scholfield, D. J. & Behall, K. M. (2003). Blood pressure reduced by whole grain diet containing barley or whole wheat and brown rice) in moderately hypercholesterolemic men. Nutrition Research, 23, 1631-1642., Individual Studies Keenan JM, Goulson M, Shamliyan T, Knutson N, Kolberg L & Curry L (2007) The effects of concentrated barley R-glucan on blood lipids in a population of hypercholesterolaemic men and women. Br J Nutr, 97 (6), 1162-68 Individual Studies Keogh, G. F., Cooper, G. J. S., Mulvey, T. B., McArdle, B. H., Coles, G. D., Monro, J. A. & Poppitt, S. D. (2003). Randomized controlled crossover study of the effect of a highly R-glucan-enriched barley on cardiovascular disease risk factors in mildly hypercholesterolemic men. Am J Clin Nutr, 78, 711-718., Individual Studies Li, J., Kaneko, T., Qin, L., Wang, J. & Wang, Y. (2003). Effects of barley intake on glucose tolerance, lipid metabolism, and bowel function in women. Nutrition, 19, 926-929., Individual Studies McIntosh, G. H., Whyte, J., McArthur, R. & Nestel, P. J. (1991). Barley and wheat foods: influence on plasma cholesterol concentrations in hypercholesterolemic men. Am J Clin Nutr, 53, 1205-1209.1, Individual Studies Newman, R. K., Newman, C. W. & Graham, H. (1989). The hypocholesterolemic function of barley beta-glucans. Cereal Foods World, 34, 883-886.1, Individual Studies Yang, J. L. & Moon, Y. K. (2002). Effects of waxy barley and barley 13-glucan on serum and liver cholesterol concentrations in rats fed a high cholesterol diet. The FASEB Journal, 16, A655.1, Claim ID Page 1,581 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Individual Studies 31 January 2008 References Claim ID Yang, J.-L., Kim, Y.-H., Lee, H.-S., Lee, M.-S. & Moon, Y.-K. (2003). Barley R-glucan lowers serum cholesterol based on the up-regulation of cholesterol 7a-hydroxylase activity and mRNA abundance in cholesterol-fed rats. J Nutr Sci Vitaminol, 49, 381-387. Page 1,582 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID BarleyTrim™ Barley Bran Contribution to the maintenance of healthy blood cholesterol levels 1,904 5 grams of BarleyTrim® Barley Bran per serving provides 0.75 grams of beta-glucan barley soluble fiber 20 grams of BarleyTrim ™ Barley Bran per day provides 3 grams beta-glucan barly soluble fiber Barley Soluble Fiber = 15% Insoluble Dietary Fiber = 5% Total Dietary Fiber = 20% 31 January 2008 Page 1,583 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Federal Register U.S. Department of Health and Human Services Food and Drug Administration References U.S. Patent #6,060,519 http://www.uspto.gov/ Claim ID “Food Labeling: Health Claims; Soluble Dietary Fiber from Certain Foods and Coronary Heart Disease, Final Rule.” United States Federal Register 70:246 (23 December 2005) p. 76150 Scientific Journal Behall KM, Scholfield DJ & Hallfrisch J (2004) Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr 80, 1185-1193. Behall KM, Scholfield DJ & Hallfrisch J (1997) Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J Am Coll Nutr 16, 46-51. Kays SE & Barton FE (2002) Near-infrared analysis of soluble and insoluble dietary fiber fractions of cereal food products. J Agric Food Chem 50, 3024-3029. McCarty MF (2005) Nutraceutical resources for diabetes prevention--an update. Med Hypotheses 64, 151-158. Queenan KM, Stewart ML, Smith KN, Thomas W, Fulcher RG & Slavin JL (2007) Concentrated oat beta-glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized controlled trial. Nutr J 6, 6. Reyna-Villasmil N, Bermudez-Pirela V, Mengual-Moreno E, et al. (2007) Oat-derived beta-glucan significantly improves HDLC and 31 January 2008 Page 1,584 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID diminishes LDLC and non-HDL cholesterol in overweight individuals with mild hypercholesterolemia. Am J Ther 14, 203-212. Contribution to the maintenance of healthy blood glucose levels 5 grams of BarleyTrim® Barley Bran per serving provides 0.75 grams of beta-glucan barley soluble fiber 1,893 20 grams of BarleyTrim ™ Barley Bran per day provides 3 grams beta-glucan barly soluble fiber Barley Soluble Fiber = 15% Insoluble Dietary Fiber = 5% Total Dietary Fiber = 20% 31 January 2008 Page 1,585 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Federal Register U.S. Department of Health and Human Services Food and Drug Administration References Claim ID “Food Labeling: Health Claims; Oats and Coronary Heart Disease, Final Rule.” United States Federal Register 62:15 (23 January 1997) p. 15343 http://www.uspto.gov/ U.S. Patent #6,060,519 Scientific Journal Behall KM, Scholfield DJ & Hallfrisch J (2004) Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr 80, 1185-1193. Bjorck I & Elmstahl HL (2003) The glycaemic index: importance of dietary fibre and other food properties. Proc Nutr Soc 62, 201-206. Bourdon I, Yokoyama W, Davis P, Hudson C, Backus R, Richter D, Knuckles B & Schneeman BO (1999) Postprandial lipid, glucose, insulin, and cholecystokinin responses in men fed barley pasta enriched with beta-glucan. Am J Clin Nutr 69, 55-63. Fluckiger-Isler R, Morikofer-Zwez S, Kahn JM & Walter P (1994) Dietary components of malt extract such as maltodextrins, proteins and inorganic salts have distinct effects on glucose uptake and glycogen concentrations in rats. J Nutr 124, 1647-1653. Granfeldt Y, Liljeberg H, Drews A, Newman R & Bjorck I (1994) Glucose and insulin responses to barley products: influence of food structure and amylose-amylopectin ratio. Am J Clin Nutr 59, 1075-1082. Hong H & Jai MW (2004) Effects of malted barley extract and banaba extract on blood glucose levels in genetically diabetic mice. J Med Food 7, 487-490. 31 January 2008 Page 1,586 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Kay M.Behall, Daniel J.Scholfield & Judith G.Hallfrisch (2006) Barley ß-glucan reduces plasma glucose and insulin responses compared with resistant starch in men. Nutrition Research 26, 644-650. Li J, Kaneko T, Qin LQ, Wang J & Wang Y (2003) Effects of barley intake on glucose tolerance, lipid metabolism, and bowel function in women. Nutrition 19, 926-929. Li J, Kaneko T, Qin LQ, Wang J, Wang Y & Sato A (2003) Long-term effects of high dietary fiber intake on glucose tolerance and lipid metabolism in GK rats: comparison among barley, rice, and cornstarch. Metabolism 52, 1206-1210. Liljeberg HGM, Granfeldt YE & Bjorck IME (1996) Products Based on a High Fiber Barley Genotype, but Not on Common Barley or Oats, Lower Postprandial Glucose and Insulin Responses in Healthy Humans. J Nutr 126, 458-466. McCarty MF (2005) Nutraceutical resources for diabetes prevention--an update. Med Hypotheses 64, 151-158. Naismith DJ, Mahdi GS & Shakir NN (1991) Therapeutic value of barley in the management of diabetes. Ann Nutr Metab 35, 61-64. Ostman EM, Liljeberg Elmstahl HG & Bjorck IM (2002) Barley bread containing lactic acid improves glucose tolerance at a subsequent meal in healthy men and women. J Nutr 132, 1173-1175. 31 January 2008 Page 1,587 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Shukla K, Narain JP, Puri P, Gupta A, Bijlani RL, Mahapatra SC & Karmarkar MG (1991) Glycaemic response to maize, bajra and barley. Indian J Physiol Pharmacol 35, 249-254. 31 January 2008 Page 1,588 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID CalorieControl Trim® Oat Bran 20% Contribution to the maintenance of healthy blood cholesterol levels 3.25 grams of Calorie ControlTrim® Oat Bran per serving provides 0.75 grams of beta-glucan oat soluble fiber. 2,519 15 grams of Calorie ControlTrim® per day provides 3 grams beta-glucan oat soluble fiber Oat Beta Glucan Soluble Fiber = 20% Insoluble Fiber = 6% Total Dietary Fiber = 26% 31 January 2008 Page 1,589 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Federal Register U.S. Department of Health and Human Services Food and Drug Administration “Food Labeling: Health Claims; Oats and Coronary Heart Disease, Final Rule.” United States Federal Register 62:15 (23 January 1997) p. 15343 Scientific Dossier submitted to JCHI “The inclusion of at least 3 grams of oat beta glucan per day as part of a diet low in saturated fat and a health lifestyle can help reduce blood cholesterol.” Scientific Dossier Submitted to the UK Joint Health Claims Initiative. (29 January 2004). Claim ID http://www.uspto.gov/ U.S. Patent #6,060,519 Scientific Journal Behall KM, Scholfield DJ & Hallfrisch J (2004) Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr 80, 1185-1193. Behall KM, Scholfield DJ & Hallfrisch J (1997) Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J Am Coll Nutr 16, 46-51. Kays SE & Barton FE (2002) Near-infrared analysis of soluble and insoluble dietary fiber fractions of cereal food products. J Agric Food Chem 50, 3024-3029. McCarty MF (2005) Nutraceutical resources for diabetes prevention--an update. Med Hypotheses 64, 151-158. Queenan KM, Stewart ML, Smith KN, Thomas W, Fulcher RG & Slavin JL (2007) Concentrated oat beta-glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized 31 January 2008 Page 1,590 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID controlled trial. Nutr J 6, 6. Reyna-Villasmil N, Bermudez-Pirela V, Mengual-Moreno E, et al. (2007) Oat-derived beta-glucan significantly improves HDLC and diminishes LDLC and non-HDL cholesterol in overweight individuals with mild hypercholesterolemia. Am J Ther 14, 203-212 Contribution to the maintenance of healthy blood cholesterol levels 3.25 grams of Calorie ControlTrim® Oat Bran per serving provides 0.75 grams of beta-glucan oat soluble fiber. 1,892 15 grams of Calorie ControlTrim® per day provides 3 grams beta-glucan oat soluble fiber Oat Beta Glucan Soluble Fiber = 20% Insoluble Fiber = 6% Total Dietary Fiber = 26% 31 January 2008 Page 1,591 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Federal Register U.S. Department of Health and Human Services Food and Drug Administration Scientific Dossier submitted to JCHI References Claim ID CalorieControl Trim® Oat Bran 20% Contribution to the maintenance of healthy blood cholesterol levels 3.25 grams of Calorie ControlTrim® Oat Bran per serving provides 0.75 grams of beta-glucan oat soluble fiber. 15 grams of Calorie ControlTrim® per day provides 3 grams beta-glucan oat soluble fiber U.S. Patent #6,060,519 Oat Beta Glucan Soluble Fiber = 20% Insoluble Fiber = 6% Total Dietary Fiber = 26% Federal Register U.S. Department of Health and Human Services Food and Drug Administration Scientific Journal Scientific Dossier submitted to JCHI U.S. Patent #6,060,519 Scientific Journal “Food Labeling: Health Claims; Oats and Coronary Heart Disease, Final Rule.” United States Federal Register 62:15 (23 January 1997) p. 15343 “The inclusion of at least 3 grams of oat beta glucan per day as part of a diet low in saturated fat and a health lifestyle can help reduce blood cholesterol.” Scientific Dossier Submitted to the 31 January 2008 Page 1,592 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID UK Joint Health Claims Initiative. (29 January 2004). http://www.uspto.gov/ Behall KM, Scholfield DJ & Hallfrisch J (2004) Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr 80, 1185-1193. Behall KM, Scholfield DJ & Hallfrisch J (1997) Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J Am Coll Nutr 16, 46-51. Kays SE & Barton FE (2002) Near-infrared analysis of soluble and insoluble dietary fiber fractions of cereal food products. J Agric Food Chem 50, 3024-3029. McCarty MF (2005) Nutraceutical resources for diabetes prevention--an update. Med Hypotheses 64, 151-158. Queenan KM, Stewart ML, Smith KN, Thomas W, Fulcher RG & Slavin JL (2007) Concentrated oat beta-glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized controlled trial. Nutr J 6, 6. Reyna-Villasmil N, Bermudez-Pirela V, Mengual-Moreno E, et al. (2007) Oat-derived beta-glucan significantly improves HDLC and diminishes LDLC and non-HDL cholesterol in overweight individuals with mild hypercholesterolemia. Am J Ther 14, 203-212. The inclusion of 3 grams oat beta glucan 31 January 2008 Page 1,593 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID soluble fiber per day from Calorie ControlTrim® Oat Bran, as part of a diet low in saturated fat and a healthy lifestyle, can help maintain healthy blood cholesterol levels. Oat beta glucan soluble fiber from Calorie ControlTrim® Oat Bran, as part of a diet low in saturated fat and a healthy lifestyle, can help maintain healthy blood cholesterol levels. Calorie ControlTrim® Oat Bran helps maintain healthy blood cholesterol levels. 31 January 2008 Page 1,594 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Chicory inulin/oligofructose Blood glucose/insulin levels Alles, M.S., de Roos, N.M., Baks, J.C., van de Lisdonk, E., Zock, P.L., Hautvast, J.G. 1999. Consumption of fructooligosaccharides does not favorably affect blood glucose and serum lipid concentrations in patients with type 2 diabetes. Am. J. Clin. Nutr. 69, 64-69. 453 Brighenti, F., Casiraghi, M.C., Canzi, E. and Ferrari, A. 1999. Effect of consumption of a ready-to-eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy male volunteers. Eur. J. Clin. Nutr. 53, 726-733. Jackson, K.G., Taylor, G.R.J., Clohessy, A.M., Williams, C.M. 1999. The effect of daily intake of inulin on fasting lipid, insulin and glucose concentrations in middle-aged men and women. Br. J. Nutr. 82, 23-30. Van Dokkum, W., Wezendonk, B., Srikumar, T.S., van den Heuvel, E.G. 1999. Effect of nondigestible oligosaccharides on large-bowel functions, blood lipid concentrations and glucose absorption in young healthy male subjects. Eur. J. Clin. Nutr. 53, 1-7 31 January 2008 Page 1,595 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Chicory oligofructose Increased inner protection/ resistance 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 12g/day DIETARY FIBRE Inulin from Chicory 8 Oligofructose: Increased inner protection/resistance Clinical Studies -Bunout D., Barrera G., Hirsch S.; Gattas V.; de la Maza M.; Haschke F.; Steenhout P.; Klassen P.; Hager C.; Avendano M.; Petermann M.; Munoz C.; 2004; "Effects of a Nutritional Supplement on the Immune Response and Cytokine Production in Free-Living Chilean Elderly"; J. Parenteral & Enteral Nut.; 28; 5; 348-354. Clinical Studies -Cummings J., Christie S., 2001; "A study of fructo oligosaccharides in the prevention of travellers’ diarrhoea"; aliment Pharmacol Ther, 15, pp. 1139-1145. Clinical Studies -Jain P.; McNaught C.; Anderson A.; MacFie J.; Mitchell C.; 2004; "Influence of Synbiotic containing Lactobacillus acidophilus La5, Bifidobacterium Bb12, Streptococcus thermidophilus, Lactobacillus bulharicus and oligofructose on gut barrier function and sepsis in critically ill patients: a randomised controlled trial"; Clin. Nut.; 23; 467-475. Clinical Studies -Lewis S.; Burmeister S.; Brazier J.; 2005; "Effect of the Prebiotic Oligofructose on Relapse of Clostridium difficile-Associated diarrhoea: A Randomised, Controlled Study"; Clin. Gastroent. And Hepat.; 3; 442-448. Clinical Studies -Lindsay J.; Whelan K.; Stagg A.; Gobin P.; Al-Hassi H.; Rayment N.; Kamm M.; Knight S.; Forbes A.; 2006; "Clinical, microbiological, and immunological effects of fructo-oligosaccharides in patients with Crohn’s disease"; Gut; 55; 348-355. 189 Page 1,596 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Orrhage K.. Sjostedt S.; Nord C.; 2000; "Effect of supplements with lactic acid bacteria and oligofructose on the intestinal microflora during administration of cefpodoxime proxetil"; J. Antimicrobial Chemotherapy; 46; 603-611. Clinical Studies -Saavedra J. M.; Tschernia A..; 2002; "Human studies with probiotics and prebiotics: clinical implications"; BJN; 87; Suppl. 2; S241-S246. Clinical Studies -Waligora-Dupriet A.; Campeotto F.; Nicolis I.; Bonet A.; Soulaines P.; Dupont C.; Butel M.; 2006; "Effects of oligofructose supplementation on gut microflora and well-being in young children attending a day care centre"; Int J of Food Microbiology; doi:10.1016/ijffoodmicro.2006.07.009. Animal Studies -Bomba A.; Nemcova R.; Gancarcikova S.; Herich R.; Guba P.. Mudronova D.; 2002; "Impovement of the probiotic effect of micro-organisms by their combination with maltodextrins, fructo¬oligosaccharides and polyunsaturated fatty acids"; BJN; 88; S1; S95-S99. Animal Studies -Buddington K.; DonahooJ.; Buddington, R.; 2002, "Dietary oligofructose and inulin protect mice from enteric and systemic pathogens and tumor inducers", J Nutr, vol. 132; pp. 472-477. Animal Studies -Butel M.; Catala I.; Waligora-Dupriet A.; Taper H.; Tessedre A.; Durao J.; Szylit O.; 2001; "Protective effect of dietary oligofructose against cecitis by Clostridia in gnotobiotic quails"; Microbial Ecology in Health & Disease; 13; 166-172. Claim ID Page 1,597 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal Studies -Catala I., Butel M.-J., Bensaada M., Popot F., Tessedre A.C., Rimbault A., Szylit 0.; 1999; "Oligofructose contributes to the protective role of bifidobacteria on experimental necrotising colitis in gnotoxenic quails.", J. Med. Microbiology, 48, 89-94. Animal Studies -Kelly-Quagliana K.; Nelson P.; Buddington R.; 2003; "Dietary oligofructose and inulin modulate immune functions in mice"; Nut. Research; 23; 257-267. Animal Studies -Manhart N.; Spittler A.; Bergmeister H.; Mittlbock M.; Roth E.; 2003; "Influence of fructooligosaccharides on Peyer’s patch lymphocyte numbers in healthy and endotoxemic mice"; Nutrition; 19; 657-660; Elsevier. Animal Studies -Oli M.; Petschow B.; Buddington R.; 1998; "Evaluation of fructooligosaccharide supplementation of oral electrolytre solutions for treatment of diarrhoea"; Digestive Disease & Science; 43, 1, 138-147. Claim ID Page 1,598 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Dietary fibre Bowel function/Normal gastrointestinal function/colonic function 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated Conditions of "source of" from HC regulation 1924/2006, specific condtions of use are listed in the list of references Authoritative Body SNF - Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm Authoritative Body NHPD - Health Canada Permitted Health Claims http://laws.justice.gc.ca/en/F-27/C.R.C. -c.870/236932.html#Section-B.01.603 Authoritative Body JHCI - Joint Health Claims Initiative - Final Technical Report - A List of Well Established Nutrient Function Statements http://www.food.gov.uk/multimedia/pdfs/jhci_he althreport.pdf Authoritative Body NFA - Terveysvaitteiden valvontaopas, Finnish Food Authority Control guides number 2/2002 http://www.palvelu.fi/evi/evi_material.php Authoritative/Scientific Bodies (INULIN OLIGOFRUCTOSE and Bowel Function) AFSSA. 2005. Effects of probiotics and prebiotics on flora and immunity in adults Books (INULIN OLIGOFRUCTOSE and Bowel Function) Roberfroid, M. B. 2005. Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL. Reviews (INULIN OLIGOFRUCTOSE and Bowel Function) Flamm G, Glinsmann W, Kritchevsky D, Prosky L, Roberfroid M. Inulin and oligofructose as dietary fiber: a review of the evidence. Crit Rev Food Sci Nutr. 2001 Jul;41(5):353-62. Reviews (INULIN OLIGOFRUCTOSE and Bowel Function) Gibson, G., and M. Roberfroid. 1995. Dietary modulation of the human colonic microbiota: Introducing the concept of prebiotics. J. Nutr. 125:(6) 1401-1412. 174 Page 1,599 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews (INULIN OLIGOFRUCTOSE and Bowel Function) Gibson, G. R., H. Probert, J. van Loo, R. A. Rastall, and M. B. Roberfroid. 2004. Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. Clinical Studies (INULIN OLIGOFRUCTOSE and Bowel Function) Den Hond E., Geypens B., Ghoos Y., 2000; “Effect on high performance chicory inulin on constipation”; Nut. Res. 20,5, pp. 731-736. Clinical Studies (INULIN OLIGOFRUCTOSE and Bowel Function) Gibson, G.R., Beatty, E.R., Wang, X. and Cummings, J.H. 1995. Selective stimulation of bifidobacteria in the human colon by oligofructose and inulin. Gastroenterolgy 108, 975-982. Clinical Studies (INULIN OLIGOFRUCTOSE and Bowel Function) Kleessen B., Sykura B., Zunft H., Blaut M., 1997; “Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons”; Am. J; Clin. Nutr., 65, 1397-1402. Clinical Studies (INULIN OLIGOFRUCTOSE and Bowel Function) Menne, E., Guggenbuhl, N. and Roberfroid, M. 2000. Chicory inulin hydrolysate has a prebiotic effect in humans. J. Nutrition 130, 1197-1199. Authoritative/Scientific Bodies (FRUCTO-OLIGOSAC CHARIDES FROM SUCROSE and Bowel Function (transit)) AFSSA. February 2005. Effects of probiotics and prebiotics on flora and immunity in adults. p 98. http://www.afssa.fr/Object.asp?IdObj=28184&P ge=0&CCH=060314094213:26:4&cwSID=E881 3D 883E014BF1A75E3341A1807E1D&AID=0 Individual Studies (FRUCTO-OLIGOSAC CHARIDES FROM SUCROSE and Bowel Function (transit)) Hidaka, H., T. Eida, T. Takizawa, T. Tokunaga, and Y. Tashiro. 1986. Effects of fructo¬oligosaccharides on intestinal flora and human health. Bifidobacteria Microflora 5:37-50. Claim ID Page 1,600 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References ndividual Studies (FRUCTO-OLIGOSAC CHARIDES FROM SUCROSE and Bowel Function (transit)) Tahiri, M., Tressol, J.C., Arnaud, J., Bornet, F., Bouteloup-Demange, C., Feillet-Coudray, C., Ducros, V., Pepin, D., Brouns, F., Rayssiguier, A.M. and Coudray, C. 2001. Five-week intake of short-chain fructo-oligosaccharides increases intestinal absorption and status of magnesium in postmenopausal women. Journal of Bone Mineral Research. 11, 2152-2160. Clinical Trial (RESISTANT STARCH and Bowel Function) Grubben MJ, van den Braak CC, Essenberg M et al. Effect of resistant starch on potential biomarkers for colonic cancer risk in patients with colonic adenomas: a controlled trial. Dig Dis Sci 2001;46:750-6. Individual Studies (RESISTANT STARCH and Bowel Function) Cummings JH, Beatty ER, Kingman SM, Bingham SA, Englyst HN. Digestion and physiological properties of resistant starch in the human large bowel. Br J Nutr 1996;75:733-47. Individual Studies (RESISTANT STARCH and Bowel Function) Heijnen ML, van Amelsvoort JM, Deurenberg P, Beynen AC. Limited effect of consumption of uncooked (RS2) or retrograded (RS3) resistant starch on putative risk factors for colon cancer in healthy men. Am J Clin Nutr 1998;67:322-31. Individual Studies (RESISTANT STARCH and Bowel Function) Jenkins DJ, Vuksan V, Kendall CW et al. Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index. J Am Coll Nutr 1998;17:609-16. Individual Studies (RESISTANT STARCH and Bowel Function) Muir JG, Yeow EG, Keogh J et al. Combining wheat bran with resistant starch has more beneficial effects on fecal indexes than does wheat bran alone. Am J Clin Nutr 2004;79:1020-8. Claim ID Page 1,601 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (RESISTANT STARCH and Bowel Function) Phillips J, Muir JG, Birkett A et al. Effect of resistant starch on fecal bulk and fermentation-dependent events in humans. Am J Clin Nutr 1995;62:121-30. Individual Studies (RESISTANT STARCH and Bowel Function) Raghupathy P, Ramakrishna BS, Oommen SP et al. Amylase-resistant starch as adjunct to oral rehydration therapy in children with diarrhea. J Pediatr Gastroenterol Nutr 2006;42:362-8. Individual Studies (RESISTANT STARCH and Bowel Function) Van M, I, Tangerman A, Nagengast FM. Effect of resistant starch on colonic fermentation, bile acid metabolism, and mucosal proliferation. Dig Dis Sci 1994;39:834-42. Individual Studies (RESISTANT STARCH and Bowel Function) Van M, I, Nagengast FM. The role of carbohydrate fermentation in colon cancer prevention. Scand J Gastroenterol Suppl 1993;200:80-6.:80-6. Human Studies (SUGAR BEET FIBRE and Bowel Function) Hamberg, O; Rumessen, J; Gudmand-Hoyer, E (1989): Inhibition of starch absorption by dietary fibre. A comparative study of wheat bran, sugar-beet fibre and pea fibre. Scandinavian Journal of Gastroenterology, 24, 103-109. Animal Studies (SUGAR BEET FIBRE and Bowel Function) Nyman, M; Asp, N G (1982): Fermentation of dietary fibre components in the rat intestinal tract. British Journal of Nutrition, 47, 357-366. Authoritative/Scientific Body (DIETARY FIBRE (SOLUBLE) and Colonic Function) ILSI (2006) - Dietary Fibre, Definition, Analysis & Health. ILSI Europe Concise Monongraph Series, 35 pages Review (DIETARY FIBRE (SOLUBLE) and Colonic Function) Topping D. L., Clifton P. M. Short-Chain Fatty Acids and Human Colonic Function: Roles of Resistant Starch and Non starch Polysaccharides Physiological Review, 2001, 81, 1031-1064. Claim ID Page 1,602 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Brown I.L. Applications and uses of resistant starch Journal of AOAC International, 2004, 87, 3, 727-732; Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Brown I.L., Wang X., Topping D.L., Playne M.J., Conway .L. High amylose maize starch as a versatile prebiotic for use with probiotic bacteria. Food Australia, 1998, 50, 12, 603-610; Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Conway P.L. (2001) Prebiotics and human health: the state-of-the-art and future perspectives. Scandinavian Journal of Nutrition 45: 13-21. Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Gibson G.R., Roberfroid M. B. (1995) Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. Journal of Nutrition 125: 1401-12. Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Lim C.C., Ferguson L.R., Tannock G.W. Dietary fibres as “prebiotics”: Implications for colorectal cancer Molecular Nutrition Food Research, 2005, 49, 609-619; Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Nugent A. P. Health properties of resistant starch. Nutrition Bulletin, British Nutrition Foundation, 2005, 30, 27-54 Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Queiroz-Monici K., Costa G.E.A., Silva N., Reis S.M., Oliveira A.C. Bifidogenic effect of dietary fiber and resistant starch from leguminous on the intestinal microbiota of rats Nutrition, 2005, 21, 602-605 Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Roberfroid M., Slavin J.L. Resistant oligosaccharides Handbook of dietary fiber, 2001, chap. 8, 125-145 Claim ID Page 1,603 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Satouchi M., Wakabayashi S., Ohkuma K., Tsuji K. Effect of depolymerized pyrodextrin on human intestinal flora Biosci Microflora, 1996, 15, 2, 93-101 Individual Studies (DIETARY FIBRE (SOLUBLE) and Colonic Function) Wang X., Brown I.L., Evans A.J., Conway P.L. The protective effects of high amylose maize (amylomaize) starch granules on the survival of Bifidobacterium spp. in the mouse intestinal tract Journal of Applied Microbiology, 1999, 87, 631-639 Individual Studies (PECTINS) Cummings JH, Southgate DA, Branch WJ, Wiggins HS, Houston H, Jenkins DJ, Jivraj T, Hill MJ, The digestion of pectin in the human gut and its effect on calcium absorption and large bowel function, Br. J. Nutr. 1979 May, 41(3): 477-85 Claim ID Page 1,604 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review Published Research Study References Claim ID Escudero E, Gonzalez P (2006) Dietary fibre. Nutr Hosp; 21(2): 61-72. Trepel F (2004) Dietary fibre: more than a matter of dietetics. Compounds, properties, physiological effects. Wien Klin Wochenschr; 116(14): 465-476. Edwards CA, Parrett AM (2003) Dietary fibre in infancy and childhood. Proc Nutr Soc; 62(1): 17-23. James SL, Muir JG, Curtis SL et al (2003) Dietary fibre: a roughage guide. Intern Med J; 33(7): 291-296. Gomez C, de Cos Blanco AI, Iglesias C (2002) Fibre and enteral nutrition. Nutr Hosp; 17(2): 30-40. Bianchi M, Capurso L (2002) Effects of guar gum, ispaghula and microcrystalline cellulose on abdominal symptoms, gastric emptying, abdominal symptoms, gastric emptying, orocaecal transit time and gas production in healthy volunteers. Dig Liver Dis; 34(2): 129-133. Scheppach W, Luehrs H, Menzel T (2001) Beneficial health effects of low digestible carbohydrate consumption. Br J Nutr; 85(1): 23-30. Chen HL, Haack VS, Janecky CW et al (1998) Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr; 68(3): 711-719. Williams CL (1995) Importance of dietary fibre 31 January 2008 Page 1,605 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID in childhood. J Am Diet Assoc; 95(10): 1140-1146. Vincent R, Roberts A, Frier M et al (1995) Effect of bran particle size on gastric emptying and small bowel transit in humans. Gut; 37(2): 216-219. Roberfroid M (1993) Dietary fibre, inulin and oligofrucyose: a review comparing their physiological effects. Crit Rev Food Sci; 33(2): 103-148. Reports, Scientific Reviews and Dietary Reference Values from Authoritative and other Scientific Bodies Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Textbooks Encyclopedia of Human Nutrition 2nd Edition. Editor-in-chief, Michele J. Sadler, editors, J.J. Strain, Benjamin Caballero. San Diego : Academic Press, 1999. Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Shils M.E.; Olson, J.A.; Shike, M. and Ross, A.C. (eds): Modern Nutrition in Health and Disease, 9th edition. Williams & Wilkins, Baltimore, 1999. Satiety 31 January 2008 Condition of use to meet the defintion of "high Books Britt Burton-Freeman "Dietary Fiber and Energy Regulation" Journal of Nutrition. 2000 175 Page 1,606 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use fibre" (6g/100g) and provide at least 5g of total dietary fibre per serving of food which can reasonably be consumed in one day 31 January 2008 Nature of Evidence References Book Diet & Health, Implications for Reducing Chronic Disease. National Research Council. National Academy Press. 1989, page 292. Books Health Council for the Netherlands : Guideline for dietary fiber intake A high-fibre diet is important for preventing overweight. Books Human Nutrition & Dietetics 9E, Edited by J.S.Garrow. W.P.T.James. Churchill Livingstone.1996. Page 53. Books Introduction to Human Nutrition. Edited on behalf of The Nutrition Society by Michael J. Gibney, Hester H. Vorster and Frans J. Kok. Blackwell Science, September 2002. page 77. Books Manual of dietetic practice 3E. Edited by Briony Thomas in conjunction with the British Dietetic association. Blackwell Science 2001. page 3, 14. Clinical Trial Rigaud D, Ryttig KR, Leeds AR, Bard D, Apfelbaum M (1987), Effects of a moderate dietary fibre supplement on hunger rating, energy input and faecal energy output in young, healthy volunteers. A randomized, double-blind, cross-over trial, Int.J Obes. 11 Suppl 1: 73-78 Individual Studies Astrup A, Vrist E, Quaade F (1990), Dietary fibre added to very low calorie diet reduces hunger and alleviates constipation, Int.J Obes. 14: 105-112 Individual Studies Blundell JE, Burley VJ (1987), Satiation, satiety and the action of fibre on food intake, Int.J Obes. 11 Suppl 1: 9-25 Individual Studies Bolton RP, Heaton KW, Burroughs LF (1981), The role of dietary fiber in satiety, glucose, and insulin: studies with fruit and fruit juice, Am J Clin Nutr; 34; 211-17. Claim ID Page 1,607 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies Burley VJ, Blundell JE (1990). The action of dietary fibre on the satiety cascade. In: Dietary fibre. Chemistry, physiology and health effects, eds D Kritchevsky, C Bonfield & J Anderson, pp. 227-246. New Your: Plenum Publishing. Individual Studies Burley VJ, Leeds AR, Blundell JE (1987), The effect of high and low-fibre breakfasts on hunger, satiety and food intake in a subsequent meal. Int. J. Obes, 11, Suppl 1:87-93. Individual Studies Burley VJ, Paul AW, Blundell JE (1992). An investigation of the effects of a sugar beet fibre-supplemented breakfast on energy intake in young non-obese subjects. Int J Obes 16 (Suppl. 1), 53 Individual Studies Delargy HJ, O'Sullivan KR, Fletcher RJ, Blundell JE (1997), Effects of amount and type of dietary fibre (soluble and insoluble) on short-term control of appetite, Int.J Food Sci.Nutr 48: 67-77 Individual Studies Ellis PR, Apling EC, Leeds AR et al (1985). Guar bread and satiety: effects of an acceptable new product in overweight diabetic patients and normal subjects. J Plant Foods; 6: 253-62. Individual Studies Gustafsson K, Asp NG, Hagander B, Nyman M (1995), Satiety effects of spinach in mixed meals: comparison with other vegetables, Int.J Food Sci.Nutr 46: 327-334 Individual Studies Hulshof T, De Graaf C, Weststrate JA (1993), The effects of preloads varying in physical state and fat content on satiety and energy intake, Appetite; 21; 273-286. Individual Studies Hylander B, Rossner S (1983), Effects of dietary fiber intake before meals on weight loss and hunger in a weight-reducing club, Acta Med.Scand. 213: 217-220 Claim ID Page 1,608 of 3,931 Category Food Component Health Relationship Reduction of glycemic response 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated Conditions of "source of" from HC regulation Nature of Evidence References Individual Studies Pasman WJ, Saris WH, Wauters MA, Westerterp-Plantenga MS (1997), Effect of one week of fibre supplementation on hunger and satiety ratings and energy intake, Appetite 29: 77-87 Individual Studies Raben A, Christensen NJ, Madsen J, Holst JJ, Astrup A (1994), Decreased postprandial thermogenesis and fat oxidation but increased fullness after a high-fiber meal compared with a low-fiber meal, Am.J Clin.Nutr 59: 1386-1394 Individual Studies Ryttig KR, Larsen S, Haegh L (1985). Treatment of slightly to moderately overweight persons. A double blind placebo-controlled investigation with diet and fiber tablets (DumoVital). In : Bjoerntorp P, Kritchevsky GV, eds. Dietary fiber and obesity. New York, Individual Studies Tiwary CM, Ward JA, Jackson BA (1997), Effect of pectin on satiety in healthy US Army adults, J Am.Coll.Nutr 16: 423-428. Individual Studies Turnbull WH, Walton J, Leeds AR (1993), Acute effects of mycoprotein on subsequent energy intake and appetite variables, Am J Clin Nutr; 58; 507-12. Individual Studies Van Itallie T. B. Dietary fiber and obesity. Am. J. Clin. Nutr. 1978;31(suppl.):S43-S52 Individual Studies Wilmshurst P, Crawley JC (1980), The measurement of gastric transit time in obese subjects using 24Na and the effects of energy content and guar gum on gastric emptying and satiety, Br.J Nutr 44: 1-6 Authoritative/Scientific Bodies (FRUCTOLIGOSACCH ARIDES FROM SUCROSE) DGCCRF, 1992: 92: 5673/1 Ref: CS/SE//BEGH-FOS Claim ID 176 Page 1,609 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use 1924/2006, specific condtions of use are listed in the list of references 31 January 2008 Nature of Evidence References Individual Studies (FRUCTOLIGOSACCH ARIDES FROM SUCROSE) Yamashita, N., K. Kawai, and M. Itakura. 1984. Effects of fructooligosaccharides on blood glucose and serum lipids in diabetic subjects. Nutr. Res. 4:961-966. Individual Studies (FRUCTOLIGOSACCH ARIDES FROM SUCROSE) Bornet, F. 1994. Undigestible sugars in food products. Am. J. Clin. Nutr. 59:S763-S769. Individual Studies (ACACIA GUM) Castellani F. Fibregum (acacia gum) helps reduce the glycemic index of food products. AgroFood Industry Hi-tech 2006;16:24-6. Individual Studies (ACACIA GUM) Gee JM, Lee-Finglas WE, Wortley GM, Pell JD, Johnson IT. Influence of non-starch polysaccharides on gastrointestinal endocrine mechanisms. Eur.J.Clin.Nutr. 1995;49 Suppl 3:S170-S172. Individual Studies (ACACIA GUM) Sharma RD. Hypoglycemic effect of gum acaccia in healthy human subjects. Nutrition Research 1985;5:1437-41. Individual Studies (INULIN-OLIGOFRUCT OSE) Alles, M.S., de Roos, N.M., Baks, J.C., van de Lisdonk, E., Zock, P.L., Hautvast, J.G. 1999. Consumption of fructooligosaccharides does not favorably affect blood glucose and serum lipid concentrations in patients with type 2 diabetes. Am. J. Clin. Nutr. 69, 64-69. Individual Studies (INULIN-OLIGOFRUCT OSE) Bornet, F. 1994. Undigestible sugars in food products. Am. J. Clin. Nutr. 59:S763-S769. Individual Studies (INULIN-OLIGOFRUCT OSE) Brighenti, F., Casiraghi, M.C., Canzi, E. and Ferrari, A. 1999. Effect of consumption of a ready-to¬eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy male volunteers. Eur. J. Clin. Nutr. 53, 726-733. Claim ID Page 1,610 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (INULIN-OLIGOFRUCT OSE) Van Dokkum, W., Wezendonk, B., Srikumar, T.S., van den Heuvel, E.G. 1999. Effect of nondigestible oligosaccharides on large-bowel functions, blood lipid concentrations and glucose absorption in young healthy male subjects. Eur. J. Clin. Nutr. 53, 1-7. Individual Studies (INULIN-OLIGOFRUCT OSE) Yamashita, N., K. Kawai, and M. Itakura. 1984. Effects of fructooligosaccharides on blood glucose and serum lipids in diabetic subjects. Nutr. Res. 4:961-966. Authoritative/Scientific Body (OAT BETA-GLUCAN) Primaliv/OatWell D oat bran Muesli with 4 g oat beta-glucans lowers glucose and insulin responses after a bread meal http://www.hp-info.nu/prodsp/Finalreport_Prima liv.pdf Human Intervention Study (OAT BETA-GLUCAN) Granfeldt Y, Nyberg L, and Bjorck I, 2007. Muesli with 4 g oat beta-glucans lowers glucose and insulin responses after a bread meal in healthy subjects. Eur J Clin Nutr. 4 April, 1-8, online publication doi:10.1038/sj.ejcn.1602747 Review (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Wursch P; Pi-Sunyer FX. 1997. The role of viscous soluble fiber in the metabolic control of diabetes. A review with special emphasis on cereals rich in beta-glucan. Diabetes care, Vol. 20 (11), p: 1774-80 Clinical Trial (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Biorklund M; van Rees A; Mensink RP; Onning G. 2005. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with beta-glucans from oats or barley: a randomised dose-controlled trial. European journal of clinical nutrition, Vol. 59 (11), p: 1272-81 Claim ID Page 1,611 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Battilana, P., Ornstein, K., Minehira, K., Schwarz, J.M., Acheson, K., Burri, J., Jeequier, E. and Tappy, L. 2001. Mechanisms of action of R-glucan in postprandial glucose metabolism in healthy men. European Journal of Clinical Nutrition 55(5):327-333. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Behall KM; Scholfield DJ; Hallfrisch J. 2005. Comparison of hormone and glucose responses of overweight women to barley and oats. Journal of the American College of Nutrition, Vol. 24 (3), p: 182-8. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Behall KM; Scholfield DJ; Hallfrisch JG; Liljeberg-Elmst6hl HG. 2006. Consumption of both resistant starch and beta-glucan improves postprandial plasma glucose and insulin in women. Diabetes care, Vol. 29 (5), p: 976-81. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Braaten, J. T., Scott, F. W., Wood, P. J., Riedel, K. D., Wolynetz, M. S., Brule, D. and Collins, M. W. 1994. High R-glucan oat bran and oat gum reduce postprandial blood glucose and insulin in subjects with and without type 2 diabetes. Diabetic Medicine 11: 312-318. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Braaten, J. T., Wood, P. J., Scott, F. W., Riedel, K. D, Poste, L. M. and Collins, M. W. 1991. Oat gum glucose and insulin after an oral glucose load. American Journal of Clinical Nutrition 53:1425-1430. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Ellis PR; Roberts FG; Blake DE.1992. Effect of oat gum on postprandial hyperglycemia. The American journal of clinical nutrition, Vol. 55 (1): 142-4. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Granfeldt, Y., Eliasson, A.-C., Bjorck, I. 2000. An examination of the possibility of lowering the glycemic index of oat and barley flakes by minimal processing. Journal of Nutrition 130(9):2207-2214. Claim ID Page 1,612 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Hallfrisch, J., Schofield, D. J. and Behall, K. M. 2003. Physiological responses of men and women to barley and oat extracts (Nu-trimX). II. Comparison of glucose and insulin responses. Cereal Chemistry 80:80-83. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Hallfrisch, J., Scholfield, D.J., Behall, K.M. 1995. Diets containing soluble oat extracts improve glucose and insulin responses of moderately hypercholesterolemic men and women. American Journal of Clinical Nutrition 61(2):379-384. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Jenkins, A.L., Jenkins, D.J.A., Zdravkovic, U., Wursch, P. and Vuksan, V. 2002. Depression of the glycemic index by high levels of R-glucan fiber in two functional foods tested in type 2 diabetes. European Journal of Clinical Nutrition 56(7):622-628. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Kabir, M., Oppert, J.-M., Vidal, H., Bruzzo, F., Fiquet, C., Wursch, P., Slama, G. and Rizkalla, S.W. 2002 Four-week low-glycemic index breakfast with a modest amount of soluble fibers in type 2 diabetic men. Metabolism: Clinical and Experimental 51(7):819-826. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Kim SY; Song HJ; Lee YY; Cho KH; Roh YK. 2006. Biomedical issues of dietary fiber beta-glucan. Journal of Korean medical science. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Maki KC, Galant R, Samuel P, Tesser J, Witchger MS, Ribaya-Mercado JD, Blumberg; JB, Geohas J. 2006. Effects of consuming foods containing oat beta-glucan on blood pressure, carbohydrate metabolism and biomarkers of oxidative stress in men and women with elevated blood pressure. Eur J Clin Nutr. 2006 Dec 6; (Epub ahead of print). Claim ID Page 1,613 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Pick, M.E., Hawrysh, Z.J., Gee, M.I., Toth, E., Garg, M.L., Hardin, R.T. 1996. Oat bran concentrate bread products improve long-term control of diabetes: A pilot study. Journal of the American Dietetic Association 96(12):1254-1261. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Tapola, N., Karvonen, H., Niskanen, L., Mikola, M. and Sarkkinen, E. 2005. Glycemic responses of oat bran products in type 2 diabetes patients. Nutrition, Metabolism and Cardiovascular diseases 15:255-261. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Tappy, L., Gugolz, E. and Wursch, P. 1996. Effects of breakfast cereals containing various amounts of beta-glucan fibers on plasma glucose and insulin responses in NIDDM subjects. Diabetes Care 19:831-834. Individual Studies (OAT AND BARLEY BETA-GLUCAN and Blood Glucose Lowering) Wood, P. J., Braaten, J. T., Scott, F. W., Riedel, K. D., Wolynetz, M. S. and Collins M. W. 1994. Effect of dose and modification of viscous properties of oat gum on plasma glucose and insulin following an oral glucose load. British Journal of Nutrition 72:731-743. Reports, Scientific Reviews and Dietary Reference Values from Authoritative and other Scientific Bodies Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 Claim ID Page 1,614 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Textbooks References Claim ID Encyclopedia of Human Nutrition 2nd Edition. Editor-in-chief, Michele J. Sadler, editors, J.J. Strain, Benjamin Caballero. San Diego : Academic Press, 1999. Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Shils M.E.; Olson, J.A.; Shike, M. and Ross, A.C. (eds): Modern Nutrition in Health and Disease, 9th edition. Williams & Wilkins, Baltimore, 1999. Cholesterol level 31 January 2008 Must meet minimum requirements for use of the claim "source of fibre" as per Annex to Regulation 1924/2006. Reports, Scientific Reviews and Dietary Reference Values from Authoritative and other Scientific Bodies Institute of Medicine Dietary Reference Intakes Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) Washington D.C. National Academy 2005. http://books.nap.edu/openbook.php?isbn=0309 085373 676 Page 1,615 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Textbooks References Claim ID Encyclopedia of Human Nutrition 2nd Edition. Editor-in-chief, Michele J. Sadler, editors, J.J. Strain, Benjamin Caballero. San Diego : Academic Press, 1999. Garrow JS, James WPT, Ralph A. Human Nutrition and Dietetics. Tenth Edition, Churchill Livingstone (Harcourt Publishers) London, 2000. Shils M.E.; Olson, J.A.; Shike, M. and Ross, A.C. (eds): Modern Nutrition in Health and Disease, 9th edition. Williams & Wilkins, Baltimore, 1999. Normal cardiovascular function 31 January 2008 Must meet minimum requirements for use of the claim "source of fibre" as per Annex to Regulation 1924/2006 527 Page 1,616 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Published Review Published Research Study Meta-analysis References Claim ID Wong JM, de Souza R, Kendall CW et al (2006) Colonic health: fermentation and short chain fatty acids. J Clin Gastroenterol; 40(3): 235-243. Bertsias G, Linardakis M, Mammas I et al (2005) Fruit and vegetable consumption in relation to health and diet of medical students in Greece. Int J Vitam Nutr Res; 75(2): 107-117. Streppel MT, Arends LR, Veer P et al (2005) Dietary fibre and blood pressure: a meta-analysis of randomized placebo controlled trials. Arch Intern Med; 165(2): 150-156. Williams CM, Jackson KG (2002) Inulin and oligofructose: effects on lipid metabolism from human studies. Br J Nutr; 87(2): 261-264. Jenkins DJ, Kendall CW, Popovich DG et al (2001) Effect of a very high fibre vegetable, fruit and nut diet on serum lipids and colonic function. Metabolism; 50(4): 494-503. Scheppach W, Luehrs H, Menzel T (2001) Beneficial health effects of low digestible carbohydrate consumption. Br J Nutr; 85(1): 23-30. Kritchevsky D, Tepper SA, Cassidy MM et al (1988) Dietary fibre supplements: effects on serum and liver lipids and on liver phospholipids composition in rats. Lipids; 23(4): 318-321. Jenkins DJ, Popovich DG, Kendall CW et al 31 January 2008 Page 1,617 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID (1997) Effect of a diet high in vegetables, fruit and nuts on serum lipids. Metabolism; 46(5): 530-537. Story JA (1985) Dietary fibre and lipid metabolism. Proc Soc Exp Biol Med; 180(3): 447-452. Mueller MA, Cleary MP, Kritchevsky D (1983) Influence of dietary fibre on lipid metabolism in meal fed rats. J Nutr; 113(11): 2229-2238. Normal immune function Must meet minimum requirements for use of the claim "source of fibre" as per Annex to Regulation 1924/2006 Published Review Gibson GR, McCartney AL, Rastall RA (2005) Prebiotics and resistance to gastrointestinal infection. Br J Nutr; 93(1): 31-34. 529 Ried K (2004) Gastrointestinal health. The role of pro and pre biotics. Aust Fam Physician; 33(4): 253-255. Cummings JH, MacFarlane GT (2002) Gastrointestinal effects of prebiotics. Br J Nutr; 87(2): 145-151. Schley PD, Field CJ (2002) The immune enhancing effects of dietary fibres and prebiotics. Br J Nutr; 87(2): 221-230. Saavedra JM, Tschernia A (2002) Human studies with probiotics and prebiotics: clinical implications. Br J Nutr; 87(2): 241-246. Scheppach W, Luehrs H, Menzel T (2001) Beneficial health effects of low digestible carbohydrate consumption. Br J Nutr; 85(1): 23-30. Normal glucose homeostasis 31 January 2008 Must meet minimum requirements for use of the claim "source of 528 Page 1,618 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use fibre" as per Annex to Regulation 1924/2006 Nature of Evidence Published Review Published Research Study References Claim ID Suter PM (2005) Carbohydrates and dietary fibre. Handb Exp Pharmacol; 170: 231-261. Scheppach W, Luehrs H, Menzel T (2001) Beneficial health effects of low digestible carbohydrate consumption. Br J Nutr; 85(1): 23-30. Anderson JW (2000) Dietary fibre prevents carbohydrate induced hypertriglyceridemia. Curr Atherscl Rep; 2(6): 536-541. Jenkins DJ, Jenkins AL (1985) Dietary fibre and the glycaemic response. Proc Soc Exp Biol Med; 180(3): 422-431. Smith U, Holm G (1982) Effect of a modified guar gum preparation on glucose and lipid levels in diabetics and healthy volunteers. Atherosclerosis; 45(1): 1-10. Anderson JW, Chen WJ (1979) Plant fibre. Carbohydrate and lipid metabolism. Am J Clin Nutr; 32(2): 346-363. 31 January 2008 Page 1,619 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fibersol-2™ Brand name Pinefiber® in Japan (Chemical name in Japan: Indigestible dextrin. Also called resistant dextrin within the European Union) Bowel Function 31 January 2008 For addition to food and beverages with daily intake in the range 4g to 30g. Intake per consumption occasion up to 10g. 718 Page 1,620 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human intervention studies 31 January 2008 References Claim ID 1. Furukawa, T., Yonekawa, S., Kurosawa, M. Effects of prepared cocoa powder containing indigestible dextrin on human defecation. J Jpn Council for Advanced Food Ingredients, 2004, 7, 55-62. 2. Inaki, M., Fujii, S., Lino, H. Effects of the administration of soft drink containing indigestible dextrin on defecation frequency and faecal characteristics of Japanese healthy female volunteers. J Nutr Food, 1999, 2, 44-51. 3. Sato, M., Oishi, Y., Ohmori, T., et al. Effect of sausage containing indigestible dextrin on faecal amount and defecation frequency. J Nutr Food, 2000, 3(4), 55-62 4. Sato, M., Oishi, Y., Ohmori, T., et al., Effect of cooked and cured loin-roll ham containing indigestible dextrin on faecal amount and defecation frequency. J Nutr Food, 2000, 3(4), 4754. 5. Shi, S., Kato, K., Kusuhara, S. The effects of rice crackers containing indigestible dextrin on female defecation. J Nutr Food, 2000, 3(2), 37-44. 6. Takagaki, K., Ikeguchi, M., Ariura, Y., Fujinaga,N., Ishibashi, Y., Sugawa-Katayama, Y. The effect of AOJIRU drink powder containing indigestible dextrin on defecation frequency and faecal characteristics. J Nutr Food, 2001, 4(4), 2935. 7. Tanaka, Y., Mizutani, H., Yamada, S., Iwata, Y., Page 1,621 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Katada, T., Nakata, S. Beneficial effect of a vegetable drink containing indigestible dextrin on defecation in women with constipation. J Nutr Food, 2000, 3(4), 39-45. 8. Umekawa, T., Fujii, K., Matuoka, T. Effect of drinks supplemented with indigestible dextrin on faecal amount. J Nutr Food, 1999, 2(2), 52-57. 9. Unno, T., Nagata, K., Yayabe, F.,Horiguchi, T. Effect of drinks supplemented with indigestible dextrin on defecation in human. J Nutr Food, 2000, 3(4), 31-38. 10. Unno, T., Nagata, K., Suzuki, N., Yayabe, F., Horiguchi, T. Effect of a vegetable drink supplemented with indigestible dextrin on defecation in females. J Nutr Food, 4(4), 21-27. 11. Yamamoto, Y., Nishida, T., Sone, Y. The effect of indigestible dextrin on human defecation. J Nutr Food, 3(2), 29-36. 12. Satouchi, M., Wakabayashe, S., Ohkuma, K., Fujiwara, K., Matsuoka, A., Effects of indigestible dextrin on bowel movements. Jpn J Nutr., 1993, 51,31-37. 13. Kimura, K., Ida, M., Matoba, T. Effect of jelly drink containing dietary fibre on human defecation. J Nutr Food, 1998, 1, 12-19. 14. Ogiso, H., Ito, Y., Hayashi, K. Effects of cookies containing indigestible dextrin on defecation and faecal condition in human subjects. J Jpn Assoc Dietary Fibre Res, 1999, 3, 79-83. 31 January 2008 Page 1,622 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fibersol-2™ Brand name Pinefiber® in Japan (Chemical name in Japan: Indigestible . dextrin. Also called resistant dextrin within the European Union) Postprandial blood glucose 31 January 2008 For addition to food and beverages with daily intake in the range 4g to 30g' Intake per consumption occasion up to 10g. 717 Page 1,623 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human intervention studies 31 January 2008 References Claim ID 1. Fuse, T., Takano, K., Kumagai, T., Watanabe, T. Effect of cooked rice containing indigestible dextrin on postprandial blood glucose level in healthy human subjects. J Nutr Food, 2002, 5(1 ), 69-74. 2. Inoue, T., Teramoto, N., Watanabe, K., Yamada, M., Sano, M. Attenuation effect of bread containing indigestible dextrin on elevation of postprandial blood glucose level and its safety in long-term ingestion. J Jpn Clin Nutr, 2005, 26(4), 281-286' Mizushima, N., Chiba, Y., Katsuyama, S., Daigo, Y., Kobayashi, C. Effect of indigestible dextrin-containing soft drinks on blood glucose level in healthy human subjects. J Nutr Food, 1999, 2(4), 17-23. 4. Uno, K., Takagi, K., Akaza, M., Takagi, N., yoshio, N., Maeda, I. Effect of indigestible dextrin containing tofu on blood glucose level in healthy human subjects. J Nutr Food, 1999, 2(4), 25-31. 5. Ito, S, Kusaba, N., Kawamura, K., et al., Effects of powdered drink containing indigestible dextrin and young barley leaf powder on postprandial blood glucose level. Jpn Pharmacol Ther, 2006, 34(8), 945-952. 6. Kaneda, R., Ysutsui, Y., Shionoya, K. Effect of intake of powdered green tea containing indigestible dextrin on postprandial blood glucose Page 1,624 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID levels and safety of its over ingestion and long term ingestion. Jpn Innovative Food Ingr Res, 2005, 8(2), 119-124. 7. Kawai, H., Sasaki, R., Ohbayashi, K. The effect of the intake of freeze-dried rice gruel (egg) containing indigestible dextrin on postprandial hyperglycemia, and the safety of its long-term intake. Health Sci, 2005, 21(1), 61-68. 8. Kawai, H., Kubo, M., Sasaki, R., Ohbayashi, K. Effect of intake of freeze-dried tomato soup and Harusame soup containing indigestible dextrin on postprandial hyperglycemia and safety of their long-term intake. J Jpn Council Adv Food Ingr Res, 2005, 8(2), 81-91. 9. Suzuki, I., Gu, H-Y., Hasegawa, T. et al., Postprandial hyperglycemia inhibitory effect of single intake of avellanedae tea containing indigestible dextrin and the safety of its long-term intake. J Nutr Food, 2001, 4(4), 71-78. 10. Kawai, H., Yamada Y., Sasaki, T., Ohbayashi, K. The effect of the intake of green tea beverage and freeze-dried miso-soup (awase-miso) containing indigestible dextrin on inhibition of postprandial hyperglycemia and the safety of single and long-term intake. J Nutr Food, 2002, 5(4), 33-45. 11. Takeyasu, H., Suzuki, T., Sakamoto, H., Muraoka, T., Imamura, Y., Shionoya, K-I. Effect of cooked rice containing indigestible dextrin on postprandial blood glucose level and safety of its long-term ingestion. Jpn Innov Food Ingr Res, 31 January 2008 Page 1,625 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 2006, 9(1), 37-45. 12. Fukuda, S., Sumi, S., Ima, K., et al., Effect of green tea beverage containing indigestible dextrin on the suppression postprandial blood glucose elevation and the safety of its long-term use. J Nutr Food, 2002, 5(2), 21-29. 13. Ikeguchi, M., Ito, S., Kamiya, T., et al., Effects of soup powder containing indigestible dextrin on postprandial blood glucose level and safety of long-term intake. J Jpn Council Adv Food Ingr Res, 2006, 9(1), 57-64. 14. Sekizaki, K., Yonezawa, H. Efficacy of packed boiled rice containing indigestible dextrin on moderating the rise of postprandial blood glucose levels and safety of long-term administration. J Nutr Food, 2001, 4(3), 81-88. 15. Unno, T., Nagata, K., Horiguchi, T. Effects of green tea supplemented with indigestible dextrin on postprandial levels of blood glucose and insulin in human subjects. J Nutr Food, 2002, 5(2), 3139. 16. Ueda, Y., Wakabayashi, S., Matsuoka, A. Effects of indigestible dextrin on blood glucose and urine C-peptide levels following sucrose loading. J Jpn Diabetic Soc, 1993, 36, 715-723. 17. Tamura, H., Kusano, S., Okada, A., Aki, O., Kubo, A. A green tea powder containing indigestible dextrin: its intake effect on postprandial blood glucose level and safety of long-term intake. J Nutr Food, 2003, 6(3), 55-63. 31 January 2008 Page 1,626 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 18. Shoya, H., Masuo, K., Tanaka, S., Shimada, Y., Shioya, K. The inhibitory effect on the postprandial increase in blood glucose exerted by a powdered beverage containing indigestible dextrin and its safety in over-ingestion and long term ingestion. J Nutr Food, 2004, 7(4), 31-41. 19. Yuasa, M., Yasue, M., Ikeda, M., Shinoda,.Y., Sato, K., Kondo, A. The effects of tea beverages containing indigestible dextrin on postprandial blood glucose level after single intake and safety in continuous intake. Jpn Innov Food Ingr Res, 2004, 7(1), 83-93. 20. Morita, H., Fang, H., Kubota, et al., Effect of yoghurt containing indigestible dextrin on blood glucose and other blood components. Jpn Innov Food Ingr Res, 2004, 8(1), 33-42. 21. Fukushima,Y., Jun, C.J., Kegai, K., Takahashi, Y., Effects of blend tea containing indigestible dextrin on postprandial blood glucose level and safety of long-term administration. J Nutr Food, 2002, 5(3), 109-116. 22. Nakagawa, M., Ohkawara, M., Kitagawa, Y., Matsumoto, T. The effect of the intake of green tea beverage containing indigestible dextrin on postprandial blood glucose level and the investigation of the safety of its long-term intake. J Nutr Food, 2003, 6(1), 81-88. 23. Kawai, H., Takayama, K., Sasaki, T., Ohbayashi, K. The effect of the intake of freezed 31 January 2008 Page 1,627 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID dried miso-soup (white miso) and Japanese clear soup both containing indigestible dextrin on inhibition of postprandial hyperglycemia and the safety of their long-term intake. J Nutr Food, 2003, 6(3), 129-139. 24. Sumi, R., Ima, K., Mabuchi, S., Hasegawa, K. The suppressive effect of the intake of soft drink containing indigestible dextrin on the elevation of postprandial blood glucose level and the safety of its long-term intake. J Nutr Food, 2003, 6(1), 8998. 25. Fuse, T., Kumagai, T., Watanabe, T. Effect of cooked rice containing indigestible dextrin on postprandial blood glucose level and the safety of eating it in long term. J Nutr Food. 2002, 5(4), 4753. 26. Shinohara, H., Tsuji, H., Seto, A. Effects of indigestible dextrin-containing green tea on blood glucose level in healthy human subjects. J Nutr Food, 1999, 2(1), 52-56. 27. Wolf, B.W., Wolever, T.M.S., Bolognesi, C., Zinker, B.A., Barleb, K.A. Glycemic response to a rapidly digested starch is not affected by the addition of an indigestible dextrin in humans. Nutr Res, 2001, 21, 1099-1106. 28. Wakabayashi, S. The effects of indigestible dextrin on sugar tolerance: 1. Studies on digestion-absorption and sugar tolerance. Folia 31 January 2008 Page 1,628 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Endocrinol, 1992, 68, 623-635. 29. Fujiwara, K, Matsuoka, A. Improvement of glucose tolerance by low-viscosity water-soluble dietary fibre: indigestible dextrin. Jpn J Nutr, 1995, 53(6), 361-368. 30. Kawasaki, F., Matsuda, M., Hiramatsu, T., et al., Efficacy of tea drink containing indigestible dextrin. J Nutr Food, 2000, 3(1), 65-72. 31. Kishimoto, Y., Oga, H., Tagami, H., Okuma, K., Gordon, D.T. Suppressive effect of resistant maltodextrin on postprandial blood triglycerol elevation. Eur J Nutr, 2007, 46(3), 133-138. 32. Takeuchi, H., Sano, J., Nakamura, F., et al., Effect of a tea beverage containing indigestible dextrin on the blood glucose level after ingestion of starchy food. J Nutr Food, 2001, 4(4), 61-69. 33. Kishimoto, Y, Wakabayashi, S., Yuba, K. Effects of instant miso-soup containing indigestible dextrin on moderating the rise of postprandial blood glucose levels and safety of long-term administration. J Nutr Food, 2000, 3(2), 19-27. 34. Moriguchi, S., Kusumoto, A., Shibata, H., et al., The suppressive effect of the intake of beverage containing indigestible dextrin on the rise in postprandial blood glucose level. Jpn Innov Food Ingr Res, 2004, 7(1), 63-67. 35. In, R., Kawamori, R., Fukuwatari, Y. Inhibiting effect of RY tea containing indigestible dextrin on the increase in blood glucose levels after 31 January 2008 Page 1,629 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID meals. Eastern Medicine, 1999, 15(2), 19-25. 36. Hori, T., Hori. T., Komroi, Y., Shioya, N., Tho, Y. Effect of black tea containing indigestible dextrin on postprandial blood glucose level and safety of long-term administration. J Nutr Food, 2005, 8(2), 27-35. 37. Tokunaga, K., Matsuoka, A. Effect of FOSHU (Food for Specified Health Use) containing indigestible dextrin as a functional component on glucose and fat metabolisms. J Jpn Diabetic Soc, 1999, 42(1), 61-65. 38. Wakabayashi, Kishimoto, Y., Nanbu, S., Matsuoka, A. Effects of indigestible dextrin on postprandial rise in blood glucose levels in man. J Jpn Assoc Dietary Fiber Res, 1999, 3, 13-19. 39. Maeda, H., Yasuda, K., Ohara, I. Effects of indigestible dextrin containing soft drinks on postprandial blood glucose levels in healthy human subjects. J Nutr Food, 2001, 4(3), 73-79. 40. Shioda, N., Shimizu, M., Shimizu, Y., et al. Effects of yoghurt drink containing indigestible dextrin on postprandial blood glucose levels in Japanese healthy volunteers. J Nutr Food, 2001, 4(2), 7-18. 31 January 2008 Page 1,630 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fibre Faecal bulking effect, fermentation substrate 31 January 2008 Tablets 2-3 g per day equal to 10% of recommended intake (NNR) Must meet minimum requirements for use of the claim "source of fibre" as per Annex to Regulation 1924/2006. Expert Textbook Review Clinical trial Nordic Nutrition Recommendations (NNR) -Integrating nutrition and physical activity. Nordic Council of Ministers, Norden, 2004. Shils ME, Olson JA, Shike M, Ross AC. Modern Nutrition in Health and Disease. Lippincott Williams & Wilkins, 1999. James SL, Muir JG, Curtis SL, Gibson PR. Dietary fibre: a roughage guide. Intern Med J 2003;33:291-6. Cummings JH, Branch W, Jenkins DJ, Southgate DA, Houston H, James WP. Colonic response to dietary fibre from carrot, cabbage, apple, bran. Lancet 1978;1:5-9. 1,780 Page 1,631 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fructoligosaccharides from sucrose Improved intestinal conditions (pH, SCFA production) and intestinal functions 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 5g/day DIETARY FIBRE Fructoligosaccharides from Sucrose 2 Authoritative/Scientific Bodies -AFSSA Report. 2005. Effects of probiotics and prebiotics on flora and immunity in adults. AFSSA, 17 February 2005. http://www.afssa.fr/Object.asp?IdObj=28184&P ge=0&CCH=060314094213:26:4&cwSID=E881 3D 883E014BF1A75E3341A1807E1D&AID=0 Reviews -Bornet, F., and F. Brouns. 2002. Immune-stimulating and gut health-promoting properties of short-chain fructo-oligosaccharides. Nutr. Rev. 60:326-334. Reviews -Bornet, F., K. Meflah, and J. Menanteau. 2002. Enhancement of gut immune functions by short-chain fructo-oligosaccharides and reduction of colon cancer risk. Bioscience Microflora 21:(1) 55-62. Reviews -Gibson, G. R., H. Probert, et al. (2004). "Dietary modulation of the human colonic microbiota: updating the concept of prebiotics." Nutrition Research Reviews 17(2): 259-275. Reviews -Macfarlane, S., G. T. Macfarlane, et al. (2006). "Prebiotics in the gastrointestinal tract." Aliment. Pharmacol. Ther. 24(5): 701-714. Reviews -Roberfroid, M. 2002. Functional foods: Concepts and application to inulin and oligofructose. B. J. Nutr. 87:(suppl.2) S139-S143. Individual Studies -Bouhnik, Y. et al. 1996. Effects of fructo-oligosaccharides ingestion on fecal bifidobacteria and selected metabolic indexes of colon carcinogenesis in healthy humans. Nutr. Cancer 26:(1) 21-29. 191 Page 1,632 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Boutron-Ruault, M. C. et al. 2005. Effects of a 3-mo consumption of short-chain fructo¬oligosaccharides on parameters of colorectal carcinogenesis in patients with or without small large colorectal adenomas. Nutr. Canc. 53:(2) 160-168. Individual Studies -Bornet, F., and F. Brouns. 2002. Immune-stimulating and gut health-promoting properties of short-chain fructo-oligosaccharides. Nutr. Rev. 60:326-334. Individual Studies -Bornet, F., K. Meflah, and J. Menanteau. 2002. Enhancement of gut immune functions by short-chain fructo-oligosaccharides and reduction of colon cancer risk. Bioscience Microflora 21:(1) 55-62. Individual Studies -Roberfroid, M. 2002. Functional foods: Concepts and application to inulin and oligofructose. B. J. Nutr. 87:(suppl.2) S139-S143. Human Studies -Bouhnik, Y. et al. 1996. Effects of fructo-oligosaccharides ingestion on fecal bifidobacteria and selected metabolic indexes of colon carcinogenesis in healthy humans. Nutr. Cancer 26:(1) 21-29. Human Studies -Boutron-Ruault, M. C. et al. 2005. Effects of a 3-mo consumption of short-chain fructo¬oligosaccharides on parameters of colorectal carcinogenesis in patients with or without small large colorectal adenomas. Nutr. Canc. 53:(2) 160-168. Human Studies -Colecchia, A., A. Vestito, et al. (2006). "Effect of a symbiotic preparation on the clinical manifestations of irritable bowel syndrome, constipation-variant." Minerva Gastroenterol Dietol 52: 349-358. Claim ID Page 1,633 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Studies -Hidaka, H., Y. Tashiro, et al. (1991). "Proliferation of bifidobacteria by oligosaccharides and their useful effects on human health." Bifidobacteria Microflora 10(1): 65-79. Human Studies -Tahiri, M., J. C. Tressol, et al. (2001). "Five-week intake of short-chain fructo-oligosaccharides increases intestinal absorption and status of magnesium in postmenopausal women." Journal of Bone Mineral Research 11(16): 2152-60. Human Studies -Tokunaga, T., Y. Nakada, et al. (1993). "Effects of fructo-oligosaccharides (FOS) intake on the intestinal microflora and defecation in healthy volunteers." Bifidus(6): 143-150. Animal / In-vitro Studies -Hashizume, K., T. Tsukahara, et al. (2003). "Megasphera elsdenii JCM 1772 normalizes hyperlactate production in the large intestine of fructooligosaccharide-fed rats by stimulating butyrate production." Journal of Nutrition 133: 3187-3190. Animal / In-vitro Studies -Le Blay, G., C. Michel, et al. (1999). "Prolonged intake of fructo-oligosaccharides induces a short-term elevation of lactic acid-producing bacteria and a persistent increase in caecal butyrate in rats." Journal of Nutrition 129: 2231-2235. Animal / In-vitro Studies -Luo, J., S. W. Rizkalla, et al. (1996). "Chronic consumption of short-chain fructooligosaccharides by healthy subjects decreased basal hepatic glucose production but had no effect on insulin-stimulated glucose metabolism." American Journal of Clinical Nutrition 63(6): 939-945. Claim ID Page 1,634 of 3,931 Category Food Component Health Relationship Reduction in blood plasma lipids 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per Nature of Evidence References Animal / In-vitro Studies -Perrin, P., F. Pierre, et al. (2001). "Only fibers promoting a stable butyrate producing colonic ecosystem decrease the rate of aberrrant crypt foci in rats." Gut 48: 53-61. Animal / In-vitro Studies -Perrin, S., M. Warchol, et al. (2001). "Fermentations of fructo-oligosaccharides and their components by Bififdobacterium infantis ATCC on batch culture in semi-synthetic medium." Journal of Applied Microbiology 90: 859-865. Animal / In-vitro Studies -Pierre, F., P. Perrin, et al. (1997). "Short-chain fructoligosaccharides reduce the occurence of colon tumors and develop gut-associated lymphoid tissue in min mice." Cancer Research 57: 225-228. Animal / In-vitro Studies -Sunvold, G., G. Fahey, et al. (1995). "Dietary fiber for dogs: IV In vitro fermentation of selected fiber sources by dog fecal inoculum and in vivo digestion and metabolism of fiber-supplemented diets." Journal of Animal Science 73: 1099-1109. Animal / In-vitro Studies -Swanson, K., C. Grieshop, et al. (2002). "Fructooligosaccharides and Lactobacillus acidophilus modify gut microbial populations, total tract digestibilities and fecal protein catabolite in healthy adult dogs." Journal of Nutrition 132(suppl): 3721S-3731S. Animal / In-vitro Studies -Tsukahara, T., Y. Iwasaki, et al. (2003). "Stimulation of butyrate production in the large intestine of weaning piglets by dietary fructooligosaccharides and its influence on the histological variables of the large intestinal mucosa." Journal of Nutritional Science and Vitaminology 49: 414-421. Claim ID 193 Page 1,635 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use serving is typicaly 25% unless otherwise stated 8g/day 31 January 2008 Nature of Evidence References Review -Delzenne, N. M. and N. Kok (2001). "Effects of fructans-type prebiotics on lipid metabolism." American Journal of Clinical Nutrition 73(2): 456S-458. Individual Studies -Giacco, R., G. Clemente, et al. (2004). "Effects of short-chain fructo-oligosaccharides on glucose and lipid metabolism in mild hypercholsterolaemic individuals." Clinical Nutrition 23: 331-340. Individual Studies -Hidaka, H., Y. Tashiro, and T. Eida. 1991. Proliferation of bifidobacteria by oligosaccharides and their useful effects on human health. Bifidobacteria Microflora 10: 65-79. Individual Studies -Luo, J., M. Van Yperselle, et al. (2000). "Chronic Consumption of Short-Chain Fructooligosaccharides Does Not affect Basal Hepatic Glucose Production or Insulin Resistance in Type 2 Diabetics1." Journal of Nutrition 130: 1572-1577. Individual Studies -Luo, J., S. W. Rizkalla, et al. (1996). "Chronic consumption of short-chain fructooligosaccharides by healthy subjects decreased basal hepatic glucose production but had no effect on insulin-stimulated glucose metabolism." American Journal of Clinical Nutrition 63(6): 939-945. Individual Studies -Yamashita, N., K. Kawai, and M. Itakura. 1984. Effects of fructo-oligosaccharides on blood glucose and serum lipids in diabetic subjects. Nutrition Research 4: 961-966. Animal Studies -Agheli, N. et al. 1998. Plasma lipids and fatty acid synthase activity are regulated by short-chain fructo-oligosaccharides in sucrose-fed insulin-resistant rats. Journal of Nutrition 128: 1283-1288. Claim ID Page 1,636 of 3,931 Category Food Component Health Relationship Increase mineral (Ca/ Mg) absorption 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 10g/day Nature of Evidence References Animal Studies -Jeusette, I. (2004). PhD thesis: Contribution to the study of obesity and lipid metabolism in the dog: relations between nutritional treatments, body weight loss and blood parameters. Faculty of Veterinary Medicine. Liege, University of Liege: 297p. Animal Studies -Jeusette, I. et al. 2004. Hypercholesterolaemia in a family of rough collie dogs. Journal of Small Animal Practices 45: 319-324 Animal Studies -Zdunczyk, Z., B. krol, et al. (2005). "Biological properties of fructooligosaccharides with different contents of kestose and nystose in rats." Archives of Animal Nutrition 59(4): 247-256. DIETARY FIBREFructoligosaccharides from Sucrose 3 Reviews -Coxam, V. 2005. Inulin-type fructans and bone health: State of the art and perspectives in the management of osteoporosis. British journal of Nutrition 93: S111-S123. Reviews -Scholz-Ahrens, K. E., G. Schaafsma, et al. (2001). "Effects of prebiotics on mineral metabolism." American Journal of Clinical Nutrition 73(suppl2): 459S-464S Individual Studies -Ducros, V., J. Arnaud, et al. (2005). "Influence of schort-chain fructo-oligosaccharides on absorption of Cu, Zn and Se in healthy postmenopausal women." Journal of the American College of Nutrition 24(1): 30-37. Individual Studies -Tahiri, M. et al. 2003. Effect of short-chain fructooligosaccharides on intestinal calcium absorption and calcium status in postmenopausal women: A stable-isotope study. American Journal of Clinical Nutrition 77: 449-457. Claim ID 192 Page 1,637 of 3,931 Category Food Component Health Relationship Prebiotic / Bifidogenic 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 2.5g/day Nature of Evidence References Individual Studies -Tahiri, M. et al. 2001. Five-week intake of short-chain fructo-oligosaccharides increases intestinal absorption and status of magnesium in postmenopausal women. Journal of Bone Mineral Research 11: 2152-2160. Supporting Data -Mathey, J. et al. 2004. Fructooligosaccharides maximize bone-sparing effects of soy isoflavone¬enriched diet in the ovariectomized rat. Calcified Tissue International 75: 169-179. Supporting Data -Mathey, J. et al., 2007. Modulation of soy isoflafones bioavailability and subsequent effects on bone health in ovariectomized rats: the case for equol. Osteoporos Int. 2007. Feb 28 Supporting Data -Ohta, A., M. Ohtsuki, M. Baba, M. Hirayama, and A. Adachi. 1998. Comparison of the nutritionnal effects of fructooligosaccharides of different sugar chain length in rats. Nutrition Research 18: 109-120. Supporting Data -Ohta, A. et al. 1998. Dietary fructo-oligosaccharides increase calcium absorption and levels of mucosal calbindin-d9k in the large intestine of gastrectomized rats. Scandinavian Journal of Gastroenterology 33: 1062-1068. Supporting Data -Ohta, A. et al. 1995. Calcium and magnesium absorption from the colon and rectum are increased in rats fed fructo-oligosaccharides. Journal of Nutrition 125: 2417-2424. Claim ID 190 Page 1,638 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References DIETARY FIBRE -Fructoligosaccharides from Sucrose 1 Authoritative/Scientific Bodies -AFSSA Report. 2005. Effects of probiotics and prebiotics on flora and immunity in adults. AFSSA, 17 February 2005. http://www.afssa.fr/Object.asp?IdObj=28184&P ge=0&CCH=060314094213:26:4&cwSID=E881 3D 883E014BF1A75E3341A1807E1D&AID=0 Authoritative/Scientific Bodies -CSHPF (Conseil superieur d’hygiene publique de France), 2 octobre 1997, Avis relatif aux effets des fructo-oligosaccharides sur le developpement des bifidobacteries Reviews -Gibson, G. R., H. Probert, J. van Loo, R. A. Rastall, and M. B. Roberfroid. 2004. Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. Reviews -Gibson, G., and M. Roberfroid. 1995. Dietary modulation of the human colonic microbiota: Introducing the concept of prebiotics. J. Nutr. 125:(6) 1401-1412. Reviews -Roberfroid, M. B. 2005. Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL. Individual Studies -Bouhnik, Y. et al. 1996. Effects of fructo-oligosaccharides ingestion on fecal bifidobacteria and selected metabolic indexes of colon carcinogenesis in healthy humans. Nutr. Cancer 26:(1) 21-29. Individual Studies -Bouhnik, Y. et al. 1999. Short-chain fructo-oligosaccharides administration dose-dependently increases faecal bifidobacteria in healthy humans. J. Nutr. 129: (1) 113-116. Claim ID Page 1,639 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Bouhnik, Y., L. Raskine, G. Simoneau, D. Paineau, and F. Bornet. 2006. The capacity of short-chain fructo-oligosaccharides to stimulate fecal bifidobacteria: A dose-response relationship study in healthy humans. Nutrition Journal. 5:(8). Individual Studies -Bouhnik, Y. et al. 2004. The capacity of nondigestible carbohydrates to stimulate fecal bifidobacteria in healthy humans: A double-blind, randomized, placebo-controlled, parallel-group, dose-response relation study. Am. J. Clin. Nutr. 80:1658-1664. Individual Studies -Buddington, R. K., C. H. Williams, S. C. Chen, and S. A. Witherly. 1996. Dietary supplement of neosugar alters the fecal flora and decreases activities of some reductive enzymes in human subjects. Am. J. Clin. Nutr. 63:(5) 709-716. Individual Studies -Clavel, T. et al. 2005. Isoflavones and functional foods alter the dominant intestinal microbiota in postmenopausal women. J. Nutr. 135:(12) 2786-2792. Individual Studies -Gibson, G. R., H. Probert, J. van Loo, R. A. Rastall, and M. B. Roberfroid. 2004. Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. Individual Studies -Gibson, G., and M. Roberfroid. 1995. Dietary modulation of the human colonic microbiota: Introducing the concept of prebiotics. J. Nutr. 125:(6) 1401-1412. Individual Studies -Mitsuoka, T., H. Hidaka, and T. Eida. 1987. Effect of fructo-oligosaccharides on intestinal microflora. Nahrung 31:(5-6) 427-436. Individual Studies -Roberfroid, M. B. 2005. Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL. Claim ID Page 1,640 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Tokunaga, T., Y. Nakada, Y. Tashiro, M. Hirayama, and H. Hidaka. 1993. Effects of fructooligosaccharides (fos) intake on the intestinal microflora and defecation in healthy volunteers. Bifidus(6) 143-150. Animal / In-vitro Studies -Bunce, T. J., M. D. Howard, et al. (1995). "Protective effect of fructooligosaccharide (FOS) in prevention of mortality and morbidity from infectious E coli K88 challenge." Journal of Animal Science 73(suppl 1): 69 (Abstract). Animal / In-vitro Studies -Cherbut, C., C. Michel, et al. (2003). "The Prebiotic Characteristics of Fructooligosaccharides Are Necessary for Reduction of TNBS-Induced Colitis in Rats." Journal of Nutrition 133(1): 21-27. Animal / In-vitro Studies -Howard, M. D., D. T. Gordon, et al. (1995). "Dietary fructooligosaccharides, xylooligosaccharides and gum arabic have variable effects on cecal and colonic microbiota and epithelial cell proliferation in mice and rats." Journal of Nutrition 125: 2604-2609. Animal / In-vitro Studies -Hsu, C.-K., J.-W. Liao, et al. (2004). "Xylooligosaccharides and Fructooligosaccharides Affect the Intestinal Microbiota and Precancerous Colonic Lesion Development in Rats." Journal of Nutrition 134(6): 1523-1528. Animal / In-vitro Studies -Le Blay, G., C. Michel, et al. (1999). "Prolonged intake of fructo-oligosaccharides induces a short-term elevation of lactic acid-producing bacteria and a persistent increase in caecal butyrate in rats." Journal of Nutrition 129: 2231-2235. Claim ID Page 1,641 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal / In-vitro Studies -Perrin, S., M. Warchol, et al. (2001). "Fermentations of fructo-oligosaccharides and their components by Bififdobacterium infantis ATCC on batch culture in semi-synthetic medium." Journal of Applied Microbiology 90: 859-865. Animal / In-vitro Studies -Respondek, F., A. G. Goachet, et al. (2007). "Effects of short-chain fructo-oligosaccharides on the microbial and biochemical profiles of different segments of the gastrointestinal tract of horses." Pferdeheilkunde 22(2/2007): 146-150. Animal / In-vitro Studies -Rycroft, C. E., M. R. Jones, et al. (2001). "A comparative in vitro evaluation of the fermentation properties of prebiotic oligosacharides." Journal of Applied Microbiology 91: 878-887. Animal / In-vitro Studies -Sparkes, A. H., K. Papasouliotis, et al. (1998). "Effect of dietary supplementation with fructooligosaccharides on fecal flora of healthy cats." American Journal of Veterinary Research 59(4): 436-440. Animal / In-vitro Studies -Swanson, K., C. Grieshop, et al. (2002). "Supplemental Fructooligosaccharides and Mannanoligosaccharides influence immune function, ileal and tract nutrient digestibilities, microbial populations and concentrations of protein catabolites in the large bowel of dogs." Journal of Nutrition 132(suppl): 980S-989S. Animal / In-vitro Studies -Swanson, K., C. Grieshop, et al. (2002). "Fructooligosaccharides and Lactobacillus acidophilus modify gut microbial populations, total tract digestibilities and fecal protein catabolite in healthy adult dogs." Journal of Nutrition 132(suppl): 3721S-3731S. Claim ID Page 1,642 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Animal / In-vitro Studies 31 January 2008 References Claim ID -Xu, Z. R., C. H. Hu, et al. (2003). "Effects of dietary fructooligosaccharides on digestive enzyme activities, intestinal microflora and morphology of male broilers." Poultry Science 82(6): 1030-1036. Page 1,643 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fructo-oligosaccharide Beneficial effect on intestinal microflora, gut integrity, digestion 31 January 2008 Daily Intake: 5g - 30g 714 Page 1,644 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Textbooks & peer reviewed journal articles References Claim ID Gibson, GR and Roberfroid, MB (eds). (1999). Colonic Microbiota, Nutrition and health. Kluwer Academic Publishers, Dordrecht. Rastall, RA. (2004). Bacteria in the gut: friends and foes and how to alter the balance. J Nutr. 2004 Aug;134(8 Suppl): 2022S-2026S Tuohy KM, Rouzaud GC, Bruck WM and Gibson GR. (2005). Modulation of the human gut microflora towards improved health using prebiotics--assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. Simmering R and Blaut M. (2001). Pro- and prebiotics--the tasty guardian angels? Appl Microbiol Biotechnol. 2001 Jan; 55(1):19-28. Trafalska E and Grzybowska K (2004). Probiotics--an alternative for antibiotics? Wiad Lek. 2004;57(9-10):491-8. Gibson, GR. (1998). Dietary modulation of the human gut microflora using prebiotics. Br J Nutr. 1998 Oct;80(4):S209-12 Cummings JH and Macfarlane GT. (2002). Gastrointestinal effects of prebiotics. 38: Br J Nutr. 2002 May;87 Suppl 2:S145-51 Mandalari G, Nueno Palop C, Tuohy K, Gibson GR, Bennett RN, Waldron KW, Bisignano G, Narbad A and Faulds CB. (2007) In vitro evaluation of the prebiotic activity of a pectic oligosaccharide-rich extract enzymatically derived from bergamot peel. Appl Microbiol Biotechnol. 2007 Jan;73(5):1173-9 31 January 2008 Page 1,645 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Tuohy KM, Kolida S, Lustenberger AM and Gibson GR. (2001). The prebiotic effects of biscuits containing partially hydrolysed guar gum and fructo-oligosaccharides – a human volunteer study. Br J Nutr. 2001 Sep;86(3):341-8 Chow, J (2002). Probiotics and prebiotics: A brief overview. J Ren Nutr. 2002 Apr;12(2):76-86 Gibson, GR. (1999). Dietary modulation of the human gut microflora using the prebiotics oligofructose and inulin. J Nutr. 1999 Jul;129(7 Suppl):1438S-41S. Int J Food Microbiol. 2006 Nov 28 Manning TS and Gibson GR. (2004). Microbial-gut interactions in health and disease. Prebiotics. Best Pract Res Clin Gastroenterol. 2004 Apr;18(2):287-98. Microbiological effects of consuming a synbiotic containing Bifidobacterium bifidum, Bifidobacterium lactis, and oligofructose in elderly persons, determined by real-time polymerase chain reaction and counting of viable bacteria. Clin Infect Dis. Jan 1;40(1):28-37. Epub 2004 Dec 6 Prebiotic Effect 31 January 2008 Daily Intake: 5g - 30g Textbooks, peer reviewed journal articles and scientific opinions by official scientific bodies. Gibson, GR and Roberfroid, MB. (1995). Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 125: 1401-12. 713 Page 1,646 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Scientific reviews References Claim ID Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. Review. Kolida S, Tuohy K, Gibson GR Prebiotic effects of inulin and oligofructose. Br J Nutr 2002 May;87 Suppl 2:S193-7. Review. 31 January 2008 Page 1,647 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Fructooligosaccharides from sucrose Intestinal Bifidobacteria Min. 2.5g per day FOSHU Japan FOSHU Japan Several approvals as of June 1992 onwards for Meioligo (commercial product name) Id 911107 Authoritative/ Scientific bodies Effects of probiotics and prebiotics on flora and immunity in adults (2005) (http://www.afssa.fr/ftp/afssa/28176-28177.pdf) 783 AFSSA 31 January 2008 Nordic Committee of Senior officials for Food Issues Safety evaluation of fructans. Nordic Council of Ministers, 2000, Copenhagen (DK) Textbook Roberfroid, M. B. (2005) Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL Reviews Gibson, G. R., Probert H., van Loo, J., Rastall, R. A., and Roberfroid, M. B. (2004) Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. Gibson, G., and Roberfroid M. (1995) Dietary modulation of the human colonic microbiota: Introducing the concept of prebiotics. J. Nutr. 125:(6) 1401-1412. Page 1,648 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human studies 7-day Human intervention study, randomised, double blind, placebo-controlled trial, 40 healthy volunteers Bouhnik, Y., Raskine, L., Simoneau, G., Paineau, D., and Bornet, F. (2006) The capacity of short-chain fructooligosaccharides to stimulate fecal bifidobacteria: A dose-response relationship study in healthy humans. (Gastroenterology, Hôpital Lariboisière, Paris, France) Nutrition Journal 5: (8) (http://www.nutritionj.com/content/5/1/8) Objective: Detailed analysis of the dose response relationship of FOS at doses ranging from 2.5 to 10 g/day 2-month Human intervention study, randomised, double blind, placebo-controlled, 39 postmenopausal women. Clavel, T., Fallani, M., Lepage, P., Levenez, F., Mathey, J., Rochet, V., Serezat, M., Sutren, M., Henderson, G., Benneteau-Pelissero, C., Tondu, F., Blaut, M., Dore, J. & Coxam, V. (2005) Isoflavones and functional foods alter the dominant intestinal microbiota in postmenopausal women (INRA Jouy en Josas, France). J. Nutr. 135:(12) 2786-2792. Objective: Evaluate the diversity and composition of the dominant microbiota as influenced by isoflavones alone or with FOS. 7-day Human intervention study, randomised on 40 healthy volunteers, double blind, placebo-controlled Bouhnik, Y., Vahedi, K., Achour, L., Attar, A., Salfati, J., Pochart, P., Marteau, P., Flourie, B., Bornet, F. & Rambaud, J. C. (1999) Short-chain fructooligosaccharides administration dose-dependently increases faecal bifidobacteria in healthy humans. (INSERM, Hôpital Saint-Lazare, Paris, France). J. Nutr. 129:(1) 113-116. Objective: Evaluate the tolerance and threshold dose of FOS (2.5 to 20 g) that significantly increases faecal Bifidobacteria counts. Claim ID Page 1,649 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References 42-day Human intervention study, 12 healthy volunteers sampled before, during and after FOS supplementation Buddington, R. K., C. H. Williams, S. C. Chen, and S. A. Witherly. (1996) Dietary supplement of neosugar alters the fecal flora and decreases activities of some reductive enzymes in human subjects. (Department of biological sciences, Mississippi State University, USA) Am. J. Clin. Nutr. 63:(5) 709-716. Objective: Evaluate the influence of 4 g of FOS on the faecal flora and on activities of reductive enzymes. 3x12-day (basal, ingestion & post-ingestion period) Human intervention study, randomised, double blind, placebo-controlled, 20 healthy volunteers Bouhnik, Y., Flourie, B., Riottot, M., Bisetti, N., Gailing, M. F., Guibert, A., Bornet, F. & Rambaud, J. C. (1996) (INSERM, Hôpital Saint-Lazare, Paris, France). Effects of fructooligosaccharides ingestion on fecal bifidobacteria and selected metabolic indexes of colon carcinogenesis in healthy humans. Nutr. Cancer 26:(1) 21-29. Objective: Evaluate the effects of 12.5 g/d of FOS on faecal Bifidobacteria and selected metabolic indexes involved in colonic carcinogenesis. 3 x 2-week (basal, FOS ingestion & post-ingestion periods) Human intervention study, randomised, double blind, 27 healthy volunteers Tokunaga, T., Nakada, Y., Tashiro, Y., Hirayama, M., and Hidaka, H. (1993) Effects of fructooligosaccharides (FOS) intake on the intestinal microflora and defecation in healthy volunteers. (Biosciences Laboratories, Meiji Seika Keisha, Japan) Bifidus (6) 143-150. Objective: Evaluate the effects of 1, 3, or 5 g/d of FOS on faecal microflora and pH. 2-week Human intervention study, randomised, 23 elderly people (73 ± 9 years old) Mitsuoka, T., Hidaka, H. and Eida, T.. (1987) Effect of fructo-oligosaccharides on intestinal microflora. (Tokyo University, Japan) Nahrung 31:(5-6) 427-436. Objective: Evaluate the effects of 8 g/d of FOS on faecal Bifidobacteria counts. Claim ID Page 1,650 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Animal studies In-vitro studies 31 January 2008 References Claim ID Hsu, C.-K., Liao, J.-W., et al. (2004) Xylooligosaccharides and Fructooligosaccharides Affect the Intestinal Microbiota and Precancerous Colonic Lesion Development in Rats. J. Nutr. 134(6): 1523-1528. Cherbut, C., Michel C., et al. (2003) The Prebiotic Characteristics of Fructooligosaccharides Are Necessary for Reduction of TNBS-Induced Colitis in Rats. J. Nutr. 133(1): 21-27. Xu, Z. R., Hu, C. H., et al. (2003) Effects of dietary fructooligosaccharides on digestive enzyme activities, intestinal microflora and morphology of male broilers. Poultry Science 82(6): 1030-1036. Swanson, K., Grieshop C., et al. (2002) Supplemental Fructooligosaccharides and Mannanoligosaccharides influence immune function, ileal and tract nutrient digestibilities, microbial populations and concentrations of protein catabolites in the large bowel of dogs. J. Nutr. 132(suppl): 980S-989S. Swanson, K., Grieshop, C. et al. (2002) Fructooligosaccharides and Lactobacillus acidophilus modify gut microbial populations, total tract digestibilities and fecal protein catabolite in healthy adult dogs. J. Nutr. 132(suppl): 3721S-3731S. Rycroft, C. E., Jones, M. R., et al. (2001) A comparative in vitro evaluation of the fermentation properties of prebiotic oligosacharides. J. Appl. Microbiol. 91: 878-887. Perrin, S., Warchol, M., et al. (2001) Fermentations of fructooligosaccharides and their components by Bififdobacterium infantis ATCC on batch culture in semi-synthetic medium. J. Appl. Microbiol 90: 859-865. Page 1,651 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Le Blay, G., Michel, C., et al. (1999) Prolonged intake of fructooligosaccharides induces a short-term elevation of lactic acid-producing bacteria and a persistent increase in caecal butyrate in rats. J. Nutr. 129: 2231-2235. Sparkes, A. H., Papasouliotis K., et al. (1998) Effect of dietary supplementation with fructooligosaccharides on fecal flora of healthy cats. Am. J. Vet. Res. 59(4): 436-440. Howard, M. D., Gordon, D. T., et al. (1995) Dietary fructooligosaccharides, xylooligosaccharides and gum arabic have variable effects on cecal and colonic microbiota and epithelial cell proliferation in mice and rats. J. Nutr. 125: 2604-2609. Bunce, T. J., M. D. Howard, et al. (1995) Protective effect of fructooligosaccharide (FOS) in prevention of mortality and morbidity from infectious E coli K88 challenge. J. Anim. Sci. 73(suppl 1): 69 (Abstract). Gastrointestinal conditions and functions 31 January 2008 Min. 5g per day FOSHU Japan FOSHU Japan Several approvals as of June 1992 onwards for Meioligo (commercial product name) Id 911107REASON: unsure if this is acceptable AFSSA Effects of probiotics and prebiotics on flora and immunity in adults (2005) (http://www.afssa.fr/ftp/afssa/28176-28177.pdf) Nordic Committee of Senior officials for Food Issues Safety evaluation of fructans. Nordic Council of Ministers, 2000, Copenhagen (DK) SCF Opinion on Actilight – a fructooligosaccharide (FOS). Annex IV to document III/5157/97 (21 March 1997) 782 Page 1,652 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews References Claim ID Louis, P., Scott, F., Duncan, S. H. & Flint, H. J. (2007) Understanding the effects of diet on bacterial metabolism in the large intestine. J. Appl. Microbiol. 102: 1197-1208. Macfarlane, S., Macfarlane G. T., et al. (2006) Prebiotics in the gastrointestinal tract. Aliment. Pharmacol. Ther. 24(5): 701-714. Gibson, G. R., Probert H., et al. (2004) Dietary modulation of the human colonic microbiota: updating the concept of prebiotics. Nutrition Research Reviews 17(2): 259-275. Roberfroid, M. (2002) Functional foods: Concepts and application to inulin and oligofructose. B. J. Nutr. 87:(suppl.2) S139-S143. Bornet, F., and Brouns, F. (2002) Immune-stimulating and gut health-promoting properties of short-chain fructooligosaccharides. Nutr. Rev. 60:326-334. Bornet, F., Meflah, K., and Menanteau J. (2002) Enhancement of gut immune functions by short-chain fructooligosaccharides and reduction of colon cancer risk. Bioscience Microflora 21:(1) 55-62. Gibson, G. R., Probert, H., van Loo, J., Rastall, R. A., and Roberfroid, M. B. (2004) Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. 31 January 2008 Page 1,653 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human studies 43-day Human intervention study, randomised, 105 healthy subjects suffering from minor digestive disorders, double blind, placebo-controlled Paineau, D., Payen, F., Panserieu, S., Coulombier, G., Sobaszek, A., Lartigau, I., Brabet, M., Galmiche, J. P., Tripodi, D., Sacher-Huvelin, S., Chapalain, V., Zourabichvili, O., Respondek, F., Wagner, A. & Bornet, F. R. (2007) Regular consumption of short-chain fructo-oligosaccharides improves digestive comfort with minor functional bowel disorders. (5 different hospitals under Nutri-Health, France coordination). Br. J. Nutr. Aug 13:1-8 [Epub ahead of print] Objective: Evaluate the effects of 5 g/d of FOS on digestive comfort and quality of life according to standardised criteria of ROME II. 36-day Human intervention study, 636 patients (250 men, 386 women) diagnosed with constipation-variant IBS Colecchia, A., Vestito, A., La Rocca, A., Pasqui, F., Nikiforaki, A. & Festi, D. (2006) Effect of a symbiotic preparation on the clinical manifestations of irritable bowel syndrome, constipation-variant (Department of Internal Medicine and Gastroenterology, University of Bologna, Italy). Minerva Gastroenterol. Dietol. 2006. 52: 349-358 http://www.minervamedica.it/index2.t?show=R0 8Y2006N04A0349 Objective: Evaluate the effect of 3 g/d of FOS and a probiotic on digestive comfort according to standardised criteria of ROME II. Claim ID Page 1,654 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References 3-month Human intervention study, adenoma and adenoma-free subjects, open pilot study Boutron-Ruault, M. C., Marteau, P., Lavergne-Slove, A., Myara, A., Gerhardt, M. F., Franchisseur, C. & Bornet, F. (2005) Effects of a 3-mo consumption of short-chain fructo-oligosaccharides on parameters of colorectal carcinogenesis in patients with or without small large colorectal adenomas (Nutrition, Hormones and Cancer Unit, Institut Gustave Roussy, Villejuif, France). Nutr. Cancer. 53:(2) 160-168 Objective: Evaluate the effect of 10 g/d of FOS on faecal concentrations of SCFA, particularly butyrate and of bile acids 35-day Human intervention study, randomised, 14 healthy postmenopausal women, double-blind, placebo controlled Tahiri, M., Tressol, J. C., Arnaud, J., Bornet, F., Bouteloup-Demange, C., Feillet-Coudray, C., Ducros, V., Pepin, D., Brouns, F., Rayssiguier, A. M. & Coudray, C. (2001) Five-week intake of short-chain fructo-oligosaccharides increases intestinal absorption and status of magnesium in postmenopausal women (Nutrition Humaine, INRA Clermont-Ferrand/Theix, St Gènes Champanelle, France). J. Bone Min. Res. 11(16): 2152-60. Objective: Evaluate the effect of 10 g / d of FOS on intestinal transit time and magnesium absorption. 3 x 12-day (basal period, ingestion period & post-ingestion period) Human intervention study, randomised on 20 healthy volunteers, double blind, placebo-controlled Bouhnik, Y., Flourie, B., Riottot, M., Bisetti, N., Gailing, M. F., Guibert, A., Bornet, F. & Rambaud, J. C. (1996) Effects of fructo-oligosaccharides ingestion on fecal bifidobacteria and selected metabolic indexes of colon carcinogenesis in healthy humans (INSERM, Hôpital Saint-Lazare, Paris, France). Nutr. Cancer 26:(1) 21-29 Objective: Evaluate the effects of 12.5 g / d of FOS on faecal Bifidobacteria and selected metabolic indexes involved in colonic carcinogenesis. Claim ID Page 1,655 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References 3 x 2-week (basal, FOS ingestion & post-ingestion periods) Human intervention study, randomised, 27 healthy volunteers, double blind. Tokunaga, T., Y. Nakada, Y. Tashiro, M. Hirayama, and H. Hidaka (1993) Effects of fructooligosaccharides (fos) intake on the intestinal microflora and defecation in healthy volunteers (Biosciences Laboratories, Meiji Seika Keisha, Japan). Bifidus. (6) 143-150. Objective: Evaluate the effects of 1, 3, or 5 g /d of FOS on faecal microflora and pH. 5-week Human intervention study, randomised, 46 hyperlipidemic patients (20 men, 26 women), double blind, placebo controlled Hidaka, H., Tashiro, Y. & Eida, T. (1991) Proliferation of bifidobacteria by oligosaccharides and their useful effects on human health. Bifidobacteria Microflora 10(1): 65-79. Objective: Evaluate the effect of 8 g / d of FOS on intestinal microflora, fermentative parameters and blood parameters Claim ID Page 1,656 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Animal studies In-vitro studies 31 January 2008 References Claim ID Tsukahara, T., Iwasaki Y., et al. (2003) Stimulation of butyrate production in the large intestine of weaning piglets by dietary fructooligosaccharides and its influence on the histological variables of the large intestinal mucosa. J. Nutr. Sci. Vitaminol. 49: 414-421. Hashizume, K., Tsukahara T., et al. (2003) Megasphera elsdenii JCM 1772 normalizes hyperlactate production in the large intestine of fructooligosaccharide-fed rats by stimulating butyrate production. J. Nutr. 133: 3187-3190. Swanson, K., Grieshop C., et al. (2002) Fructooligosaccharides and Lactobacillus acidophilus modify gut microbial populations, total tract digestibilities and fecal protein catabolite in healthy adult dogs. J. Nutr. 132(suppl): 3721S-3731S. Perrin, P., Pierre F., et al. (2001) Only fibers promoting a stable butyrate producing colonic ecosystem decrease the rate of aberrrant crypt foci in rats. Gut 48: 53-61. Perrin, S., Warchol M., et al. (2001) Fermentations of fructo-oligosaccharides and their components by Bififdobacterium infantis ATCC on batch culture in semi-synthetic medium. J. Appl. Microbiol. 90: 859-865. Le Blay, G., Michel C., et al. (1999). Prolonged intake of fructo-oligosaccharides induces a short-term elevation of lactic acid-producing bacteria and a persistent increase in caecal butyrate in rats. J. Nutr. 129: 2231-2235. Pierre, F., Perrin P., et al. (1997) Short-chain fructoligosaccharides reduce the occurence of colon tumors and develop gut-associated lymphoid tissue in min mice." Cancer Research 57: 225-228. Luo, J., S. Rizkalla W., et al. (1996) Chronic consumption of short-chain fructooligosaccharides by healthy subjects decreased basal hepatic glucose production Page 1,657 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID but had no effect on insulin-stimulated glucose metabolism. Am. J. Clin. Nutr. 63(6): 939-945. Sunvold, G., Fahey G., et al. (1995) Dietary fiber for dogs: IV In vitro fermentation of selected fiber sources by dog fecal inoculum and in vivo digestion and metabolism of fiber-supplemented diets. J. Anim. Sci. 73: 1099-1109. Blood lipids 31 January 2008 Min. 8g/day Authoritative/ Scientific bodies Nordic Committee of Senior officials for Food Issues. 2000. Safety evaluation of fructans. Nordic Council of Ministers, Copenhagen, DK Review Delzenne, N. M. and N. Kok (2001). "Effects of fructans-type prebiotics on lipid metabolism." American Journal of Clinical Nutrition 73(2): 456S-458. 2-month Human intervention study, randomised, double blind, 30 subjects with mild hypercholesterolaemia, placebo controlled, cross-over design Giacco, R., Clemente, G., Luongo, D., Lasorella, G., Fiume, I., Brouns, F., Bornet, F., Patti, L., Cipriano, P., Rivellese, A. A. & Riccardi, G. (2004) (Institute of Food Science and Technology of National Research Council, Avellino, Italy) "Effects of short-chain fructooligosaccharides on glucose and lipid metabolism in mild hypercholsterolaemic individuals." Clinical Nutrition 23: 331-340. Objective: Evaluate the effects of 10.6 g / d of FOS on glucose and lipid metabolism in individuals with mild hypercholesterolaemia 780 Page 1,658 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence 4-week Human intervention study, randomised, double blind, 12 healthy volunteers, placebo controlled, cross-over design References Claim ID Luo, J., Rizkalla, S. W., Alamowitch, C., Boussairi, A., Blayo, A., Barry, J. L., Laffitte, A., Guyon, F., Bornet, F. R. J. & Slama, G. (2000) (INSERM, Hôpital Hotel-Dieu, Paris, France) “Chronic Consumption of Short-Chain Fructooligosaccharides Does Not affect Basal Hepatic Glucose Production or Insulin Resistance in Type 2 Diabetics”. Journal of Nutrition 130: 1572-1577. Objective: Evaluate the effects of 20 g / d of FOS on plasma lipids and glucose concentrations in type 2 diabetic patients Luo, J., Rizkalla, S. W., Alamowitch, C., Boussairi, A., Blayo, A., Barry, J. L., Laffitte, A., Guyon, F., Bornet, F. R. J. & Slama, G. (1996) (INSERM, Hôpital Hotel-Dieu, Paris, France) “Chronic consumption of short-chain fructooligosaccharides by healthy subjects decreased basal hepatic glucose production but had no effect on insulin-stimulated glucose metabolism." American Journal of Clinical Nutrition 63(6): 939-945. Objective: Evaluate the effects of 20 g / d of FOS on plasma lipids and glucose concentrations in healthy people 5-week Human intervention study, randomised, double blind, 46 hyperlipidemic patients, placebo controlled, parallel study 31 January 2008 Hidaka, H., Tashiro Y. and Eida T. (1991) (Bioscience Laboratoires, Meiji Seika, Japan) Proliferation of bifidobacteria by oligosaccharides and their useful effects on human health. Bifidobacteria Microflora 10: 65-79. Objective: Evaluate the effect of 8 g / d of FOS on fasting serum total cholesterol, triglycerides, HDL-cholesterol, free fatty acids, blood glucose, blood pressure Page 1,659 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References 14-day Human intervention study, RCT, double blind, 28 non-insulin dependent diabetic subjects, parallel study Yamashita, N., Kawai K., and Itakura, M. (1984) (Bioscience Laboratoires, Meiji Seika, Japan) Effects of fructooligosaccharides on blood glucose and serum lipids in diabetic subjects. Nutr. Res. 4: 961-966. Objective: Evaluate the effect of 8 g / d of FOS on fasting serum total cholesterol, triglycerides, HDL-cholesterol, free fatty acids, blood glucose, blood pressure In-vitro studies Liong, M. T. & Shah, N. P. (2005) Production of organic acids from fermentation of mannitol, fructooligosaccharides and inulin by cholesterol removing Lactobacillus acidophilus strain. J. Appl. Microbiol. 99: 783-793. Claim ID Liong, M. T. & Shah, N. P. (2005) Optimization of cholesterol removal, growth and fermentation patterns of Lactobacillus acidophilus ATCC 4962 in the presence of mannitol, fructo-oligosaccharides and inulin: a response surface methodology approach. J. Appl. Microbiol. 98: 1115-1126. Animal studies Zdunczyk, Z., B. krol, et al. (2005). "Biological properties of fructooligosaccharides with different contents of kestose and nystose in rats." Arch. Anim. Nutr. 59(4): 247-256. Jeusette, I. et al. 2004. Hypercholesterolaemia in a family of rough collie dogs. J. Small Anim. Practic. 45: 319-324. Agheli, N. et al. 1998. Plasma lipids and fatty acid synthase activity are regulated by short-chain fructo-oligosaccharides in sucrose-fed insulin-resistant rats. J. Nutr. 128: 1283-1288. Mineral absorption 31 January 2008 Min. 10 g per day 781 Page 1,660 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Authoritative/ Scientific bodies Nordic Committee of Senior officials for Food Issues Safety evaluation of fructans. Nordic Council of Ministers, 2000, Copenhagen (DK) Reviews Coxam, V. 2005. Inulin-type fructans and bone health: State of the art and perspectives in the management of osteoporosis. British journal of Nutrition 93: S111-S123 Claim ID Scholz-Ahrens, K. E., G. Schaafsma, et al. (2001). "Effects of prebiotics on mineral metabolism." American Journal of Clinical Nutrition 73(suppl2): 459S-464S Human studies 2 x 5-week Human intervention study, randomised, 31 postmenopausal women, double blind, placebo controlled 31 January 2008 Ducros, V., Arnaud, J., Tahiri, M., Coudray, C., Bornet, F., Bouteloup-Demange, C., Brouns, F., Rayssiguier, Y. & Roussel, A. M. (2005) Influence of short-chain fructo-oligosaccharides on absorption of Cu, Zn and Se in healthy postmenopausal women (Université Joseph Fournier, Grenoble, France). J. Am. Col. Nutr. 2005. 24(1): 30-37. Objective: Evaluate the effect of 10 g/d of FOS on Cu, Zn and Se absorption Page 1,661 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References 5-week Human intervention study, randomised, 12 healthy postmenopausal women, double blind cross-over, placebo controlled. Tahiri, M., Tressol, J. C., Arnaud, J., Bornet, F. R., Bouteloup-Demange, C., Feillet-Coudray, C., Brandolini, M., Ducros, V., Pepin, D., Brouns, F., Roussel, A. M., Rayssiguier, Y. & Coudray, C. (2003) Effect of short-chain fructooligosaccharides on intestinal calcium absorption and calcium status in postmenopausal women: A stable-isotope study (Nutrition Humaine, INRA Clermont-Ferrand/Theix, St Gènes Champanelle, France) Am. J. Clin. Nutr. 2003. 77: 449-457 Objective: Evaluate the effect of 10 g/d of FOS on calcium absorption in postmenopausal women 35-day Human intervention study, randomised, 14 healthy postmenopausal women, double-blind, placebo controlled Tahiri, M., Tressol, J. C., Arnaud, J., Bornet, F., Bouteloup-Demange, C., Feillet-Coudray, C., Ducros, V., Pepin, D., Brouns, F., Rayssiguier, A. M. & Coudray, C. (2001) Five-week intake of short-chain fructo-oligosaccharides increases intestinal absorption and status of magnesium in postmenopausal women (Nutrition Humaine, INRA Clermont-Ferrand/Theix, St Gènes Champanelle, France) J. Bone Min. Res. 2001. 11(16): 2152-60. Objective: Evaluate the effect of 10 g / d of FOS on intestinal transit time and magnesium absorption. Human intervention study, randomised, blind, 10 healthy men, cross-over, placebo controlled Ohta, A., Sakai, K., Takasaki, M. & Tokunaga, T. (1999) The advantages of calcium supplement tablet containing fructooligosaccharides for the healthy human being (Biosciences Lab., Meiji Seika Kaisha). Health Nutr. Food Res. 1999. 2: 37-43. Objective: Evaluate the effects of 9 g of FOS given in a single dose on calcium absorption Claim ID Page 1,662 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human intervention study, blind, 5 healthy men, cross-over, placebo controlled Hosono, A., Ohtsuki, M., Ohta, A. & Adachi, A. (1999) The trial experiment of minerals absorption as assesed by urinary excretion of calcium and magnesium in healthy humans ingested calcium and magnesium with fructooligosaccharides (Biosciences Lab., Meiji Seika Kaisha). Jap. J. S. Mg. R. 1999. 16: 87-95. Objective: Evaluate the calcium and magnesium absorption following a single ingestion of 10 g of FOS Animal studies In-vitro studies 90-day study in rats, parallel study against isoflavones alone Mathey, J., Puel, C., Kati-Coulibalys, S., Benneteau-Pelissero, C., Davicco, M. J., Lebecque, P., Horcajada, M. N. & Coxam, V. (2004) Fructo-oligosaccharides maximize bone-sparing effects of soy isoflavone-enriched diet in the ovariectomized rat (Nutrition Humaine, INRA Clermont-Ferrand/Theix, St Gènes Champanelle, France). Calcified Tissue Internat. 75: 169-179 Objective: Evaluate the dose-dependent bone sparing effects of long term daily isoflavones consumption in ovariectomized rats and test if FOS (up to 7.5% in the diet) may improve the effect of isoflavones Ohta, A., Ohtsuki M., Baba M., Hirayama M., and Adachi A. (1998) Comparison of the nutritional effects of fructooligosaccharides of different sugar chain length in rats. Nutr. Res. 1998. 18: 109-120 Claim ID Page 1,663 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References 4-week study in gastrectomized rats, parallel study against control, 7 rats per group Ohta, A., Motohashi, K., Sakai, K., Hirayama, M., Adachi, A. & Sakuma, K. (1998) Dietary fructo-oligosaccharides increase calcium absorption and levels of mucosal calbindin-d9k in the large intestine of gastrectomized rats Scandinavian J. Gastroenterol. 33: 1062-1068 Objective: Evaluate the effect of 7.5% FOS in the diet of gastrectomized rats on calcium absorption and prevention of postgastrectomized osteopenia Study in healthy rats, parallel study against a control diet, 14 rats per group Ohta, A., Ohtsuki, M., Baba, S., Takizawa, T., Adachi, A. & Kimura, T. (1995) Calcium and magnesium absorption from the colon and rectum are increased in rats fed fructo-oligosaccharides. J. Nutr. 125: 2417-2424 Objective: Evaluate the effect of 5% of FOS in the diet of rats on calcium and magnesium absorption from the colon and the rectum Claim ID Page 1,664 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Galactoligo-saccharide (Arabino-galactans or Gum Acacia) 31 January 2008 Contains Prebiotic/ has prebiotic effect Daily Intake: 5g - 30g Beneficial effect on intestinal microflora, gut integrity, digestion Daily Intake: 5g - 30g Textbooks, peer reviewed journal articles and scientific opinions by official scientific bodies. Gibson, GR and Roberfroid, MB. (1995). Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 125: 1401-12. 715 716 Page 1,665 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Textbooks & peer reviewed journal articles References Claim ID Gibson, GR and Roberfroid, MB (eds). (1999). Colonic Microbiota, Nutrition and health. Kluwer Academic Publishers, Dordrecht. Rastall, RA. (2004). Bacteria in the gut: friends and foes and how to alter the balance. J Nutr. 2004 Aug;134(8 Suppl): 2022S-2026S Tuohy KM, Rouzaud GC, Bruck WM and Gibson GR. (2005). Modulation of the human gut microflora towards improved health using prebiotics--assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. Simmering R and Blaut M. (2001). Pro- and prebiotics--the tasty guardian angels? Appl Microbiol Biotechnol. 2001 Jan; 55(1):19-28. Trafalska E and Grzybowska K (2004). Probiotics--an alternative for antibiotics? Wiad Lek. 2004;57(9-10):491-8. Gibson, GR. (1998). Dietary modulation of the human gut microflora using prebiotics. Br J Nutr. 1998 Oct;80(4):S209-12 Cummings JH and Macfarlane GT. (2002). Gastrointestinal effects of prebiotics. 38: Br J Nutr. 2002 May;87 Suppl 2:S145-51 Macfarlane S, Macfarlane GT and Cummings JH. (2006). Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. Kolida S, Tuohy K and Gibson GR. (2002). Prebiotic effects of inulin and oligofructose. Br J Nutr. 2002 May;87 Suppl 2:S193-7. Wisker, E. (2003). The colonic flora is thought 31 January 2008 Page 1,666 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID to play a key role in human health. Gut bacteria produce desirable as well as undesirable Zentralbl Gynakol. 2003 Dec;125(12):475-9. Chow, J (2002). Probiotics and prebiotics: A brief overview. J Ren Nutr. 2002 Apr;12(2):76-86 Gibson, GR. (1999). Dietary modulation of the human gut microflora using the prebiotics oligofructose and inulin. J Nutr. 1999 Jul;129(7 Suppl):1438S-41S. Int J Food Microbiol. 2006 Nov 28 31 January 2008 Page 1,667 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Galacto-oligosaccahrides (Prebiotic) Improvement of calcium absorption 31 January 2008 2,512 Page 1,668 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Textbook Reviews Individual study in humans Individual study in animals References Claim ID Improvement of calcium absorption Schoterman HC (2001) Chapter 42 Galacto-oligosaccharides: Properties and health aspects. In: Advanced Dietary Fibre Technology. Eds: McCleary, B.V. & Prosky, L. Blackwell Science Ltd. 494-502. Bongers A & van den Heuvel EGHM (2003) Prebiotics and the bioavailability of minerals and trace elements. Food Reviews International 19(4);397-422. Sako T, Matsumoto K & Tanaka R (1999) Recent progress on research and applications of non-digestible galacto-oligosaccharides. International Dairy Journal. 9, 69-80. Heuvel van den EGHM, Schoterman MHC & Muijs T (2000) Transgalactooligosaccharides stimulate calcium absorption in postmenopausal women. J Nutr 130; 2938-2942. Chonan O & Watanuki M (1995) Effect of galactooligosaccharides on calcium absorption in rats. J Nutr Sci Vitaminol 41, 95-104. Chonan O & Watanuki M (1996) The effect of 6´-galactooligosaccharides on bone mineralization of rats adapted to different levels of dietary calcium. Int J Vit Nutr Res. 66; 244-249. Chonan O, Matsumoto K & Watanuki M (1995) Effects of galactooligosaccharides on calcium absorption and preventing bone loss in ovariectomized rats. Biosci Biotech Biochem 59; 236-239. 31 January 2008 Page 1,669 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Galacto-oligosaccharides Immune support and immune health Maintains a healthy normal digestive system 31 January 2008 The recommended dosage for Bimuno (Clasado Ltd Galacto-oligosaccharide product) is 5.5 g per day. This is equivalent to 3.6 g per day of galacto-oligosaccharides . No adverse effects reported. Consumers who are lactose intolerant should exercise caution when taking Bimuno. Women who are pregnant or planning a pregnancy should consult a healthcare professional before taking any food supplements. Depeint, F et al (under submission - 2007) Prebiotic evaluation of a novel galacto-oligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIM 41171, in healthy humans: a randomised, double-blind, placebo-controlled intervention study. Cummings, JH et al (2004) PASSCLAIM – Gut Health and Immunity. European Journal of Nutrition 43 Suppl 2 pp 118-173 Forchielli, ML; Walker, WA (2005) The role of gut-associated lymphoid tissues and mucosal defence. British Journal of Nutrition, Apr; 93 Suppl 1:S41-8. Review de Vrese et al (2005) Effect of Lactobacillus gasseri PA 16/8, Bifidobacterium longum SP 07/3, B. bifidum MF 20/5 on common cold episodes: a double blind, randomized, controlled trial. Clinical Nutrition Aug;24(4):481-91 de Vrese et al (2006) Probiotic bacteria reduced duration and severity but not the incidence of common cold episodes in a double blind, randomized, controlled trial. Vaccine Nov 10;24(44-46):6670-4. The recommended dosage for Bimuno (Clasado Ltd Galacto-oligosaccharide product) is 5.5 g per day. This is equivalent to 3.6 g per day of galacto-oligosaccharides . No adverse effects reported. Depeint, F et al (under submission - 2007) Prebiotic evaluation of a novel galacto-oligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIM 41171, in healthy humans: a randomised, double-blind, placebo-controlled intervention study. Quigley, EM; Flourie, B (2007) Probiotics and irritable bowel syndrome: a rationale for their use and an assessment of the evidence to date. Neurogastroenterology and Motility Mar;19(3):166-72. Review 790 789 Page 1,670 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Consumers who have are lactose intolerant should exercise caution when taking Bimuno. Women who are pregnant or planning a pregnancy should consult a healthcare professional before taking any food supplements. Helps maintain a healthy immune response in the elderly 31 January 2008 The recommended dosage for Bimuno (Clasado Ltd Galacto-oligosaccharide product) is 5.5 g per day. This is equivalent to 3.6 g per day of galacto-oligosaccharides . No adverse effects reported. Consumers who are lactose intolerant should exercise caution when taking Bimuno. Women who are pregnant or planning a pregnancy should consult a healthcare professional before any food supplements. Nature of Evidence References Guyonnet, D et al (2007) Effect of a fermented milk containing Bifidobacterium animalis DN-173 010 on the health-related quality of life and symptoms in irritable bowel syndrome in adults in primary care: a multicentre, randomized, double-blind, controlled trial. Alimentary Pharmacology and Therapeutics. Aug 1;26(3):475-86 O'Mahony, L et al (2005) Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. Mar; 128 (3): 541-51 Whorwell, PJ et al (2006) Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome American Journal of Gastroenterology. 101 (7):1581-90 Hamilton-Miller, JMT (2004) Probiotics and prebiotics in the elderly. Postgraduate Medical Journal 80 pp 447-451 Hebuterne, X (2003) Gut changes attributed to ageing: Effects on intestinal microflora. Current Opinion in Clinical Nutrition and Metabolic Care 6 (1) pp 49-54 Gill, HS et al (2001a) Enhancement of immunity in the elderly by dietary supplementation with the probiotic Bifidobacteria lactis HN019. American Journal of Clinical Nutrition 74 pp 833-839 Gill, HS et al (2001b) Dietary probiotic supplementation enhances natural killer cell activity in the elderly: an investigation of age-related immunological changes. Journal of Clinical Immunology 21 (4) pp 264-271 Arunachalam, K et al (2000) Enhancement of natural immune function by dietary composition of Bifidobacterium lactis (HN019). European Journal of Clinical Nutrition 54 (3) pp 263-267 Claim ID 788 Page 1,671 of 3,931 Category Food Component Health Relationship Prebiotic/ Bifidogenic Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 2.5g/day (0.625g per portion) The recommended dosage for Bimuno (Clasado Ltd Galacto-oligosaccharide product) is 5.5 g per day. This is equivalent to 3.6 g per day of galacto-oligosaccharides . Nature of Evidence Chiang, BL et al (2000) Enhancing immunity by dietary consumption of a probiotic lactic acid bacterium (Bifidobacterium lactis HN019): Optimisation and definition of cellular immune responses. European Journal of Clinical Nutrition 54 (11) pp 849-855 Depeint, F et al (under submission - 2007) Prebiotic evaluation of a novel galacto-oligosaccharide mixture produced by the enzymatic activity of Bifidobacterium bifidum NCIM 41171, in healthy humans: a randomised, double-blind, placebo-controlled intervention study. DIETARY FIBRE Galacto-Oligosaccharid es and Prebiotic Action Reviews -Boehm G et al. Oligosaccharides. In: Functional dairy products. Sandholm TM & Saarela M (eds) Woodhead Publishing Ltd. Cambridge England. 2003, 203-43. Reviews -Dombo M, Yamamoto H, Nakajima H. Production, health benefits and applications of galato¬oligosaccharides. In: New technologies for healthy foods & nutraceuticals. Yalpani M (ed.) ATL Press. 1997, 143-56 Reviews -Matsumoto K et al. Galactooligosaccharides. In: Nakakuki T, editor. Oligosacchairdes, productions, properties and applcliations. Japanese Technology Reviews. Geneva: Gordon & Breach Science. 1994 Reviews -Sako, T., et al. Recent progress on research and applications of non-digestible galacto¬oligosaccharides. International Dairy Journal.1999, 9: 69-80. Reviews -Schoterman, H.C. Chapter 42 Galacto-oligosaccharides: Properties and health aspects. In: Advanced Dietary Fibre Technology. Eds: McCleary, B.V. & Prosky, L. Blackwell Science Ltd. 2001, 494-502. No adverse effects reported. Consumers who are lactose intolerant should exercise caution when taking Bimuno. Women who are pregnant or planning a 31 January 2008 References Claim ID 194 Page 1,672 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use pregnancy should consult a healthcare professional before taking any food supplements. 31 January 2008 Nature of Evidence References Reviews -Tanaka R et al. Recent progress on prebiotics in Japan, including galactooligosacharides. Bull IDF, 1998, 336:21-27. Individual Human Studies -Ben XM, Zhou XY, Zhao WH, Yu WL, Pan W, Zhang WL, Wu SM, Van Beusekom CM, Schaafsma A. Supplementation of milk formula with galacto-oligosaccharides improves intestinal micro-flora and fermentation in term infants. Chin Med J (Engl). 2004 Jun;117(6):927-31. Individual Human Studies -Bouhnik Y, Raskine L, Simoneau G, Vicaut E, Neut C, Flourie B, Brouns F, Bornet FR. The capacity of nondigestible carbohydrates to stimulate fecal bifidobacteria in healthy humans: a double-blind, randomized, placebo-controlled, parallel-group, dose-response relation study. Am J Clin Nutr. 2004 Dec;80(6):1658-64. Individual Human Studies -Bouhnik Y, Flourie B, D'Agay-Abensour L, Pochart P, Gramet G, Durand M, Rambaud JC. Administration of transgalacto-oligosaccharides increases fecal bifidobacteria and modifies colonic fermentation metabolism in healthy humans. J Nutr. 1997 Mar;127(3):444-8. Individual Human Studies -Ito, M., et al. Effects of administration of galactooligosaccharides on the human faecal microflora, stool weight and abdominal sensation. Microb. Ecol. Health Dis. 19990, 3:285-292. Individual Human Studies -Ito M, Kimura M, Deguchi Y, Miyamori-Watabe A, Yajima T, Kan T. Effects of transgalactosylated disaccharides on the human intestinal microflora and their metabolism. J Nutr Sci Vitaminol (Tokyo). 1993 Jun;39(3):279-88. Claim ID Page 1,673 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Human Studies -Ito M, Deguchi Y, Matsumoto K, Kimura M, Onodera N, Yajima T. Influence of galactooligosaccharides on the human fecal microflora. J Nutr Sci Vitaminol (Tokyo). 1993 Dec;39(6):635-40. Individual Human Studies -Napoli JE, Brand-Miller JC, Conway P. Bifidogenic effects of feeding infant formula containing galacto-oligosaccharides in healthy formula-fed infants. Asia Pac J Clin Nutr. 2003 Nov;12(Suppl):S60. Individual Human Studies -Tanaka, R., et al. Effects of administration of TOS and bifidobacterium breve 4006 on the human fecal flora. Bifidobacteria Microflora. 1983, 2:17-24. Reviews Bongers A & van den Heuvel EGHM (2003) Prebiotics and the bioavailability of minerals and trace elements. Food Reviews International 19(4);397-422 Claim ID Page 1,674 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Individual Studies References Claim ID Heuvel van den EGHM, Schoterman MHC & Muijs T (2000) Transgalactooligosaccharides stimulate calcium absorption in postmenopausal women. J Nutr 130; 2938-2942. Chonan O, Matsumoto K & Watanuki M (1995) Effects of galactooligosaccharides on calcium absorption and preventing bone loss in ovariectomized rats. Biosci Biotech Biochem 59; 236-239. Chonan O & Watanuki M (1995) Effect of galactooligosaccharides on calcium absorption in rats. J Nutr Sci Vitaminol 41, 95-104. Chonan O & Watanuki M (1996) The effect of 6´ galactooligosaccharides on bone mineralization of rats adapted to different levels of dietary calcium. Int J Vit Nutr Res. 66; 244-249. Scientific reviews Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. Review. Kolida S, Tuohy K, Gibson GR Prebiotic effects of inulin and oligofructose. Br J Nutr 2002 May;87 Suppl 2:S193-7. Review. 31 January 2008 Page 1,675 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References van Loo, J et al (1999) Functional food properties of non-digestible oligosaccharides: a consensus report from the ENDO project (DGXII AIRII-CT94-1095) British Journal of Nutrition 81: pp 121-131 Tamai, S et al (1992) Effect of small amount of galacto-oligosaccharide on fecal bifidobacterium. Journal of the Japanese Society of Nutrition and Food Science 45 (5): pp 456-460 Tzortzis, G et al (2005) A novel galacto-oligosaccharide mixture increases the bifidobacterial population numbers in a continuous in vitro fermentation system and in the proximal colonic contents of pigs in vivo. Journal of Nutrition 135(7) pp 1726-1731 Claim ID Page 1,676 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Guar Gum Impact on blood glucose / Glycemic control / Glycemic response 31 January 2008 Single dose of 1.8 g/day 822 Page 1,677 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative bodies Human studies References Claim ID Authoritative bodies AFSSA Opinion, 23 September 2002. AVIS de l’Agence française de sécurité sanitaire des aliments relatif à l’évaluation sur l’emploi, dans des denrées destinées à une alimentation particulière, de la gomme de guar (actuellement considérée comme additif technologique conformément à l’arrêté du 2 octobre 1997), en tant qu’additif à but nutritionnel (23 septembre 2002, Saisine n° 2002-SA-0069). National Research Council (1989) Diet and Health: Implications for Reducing Chronic Disease Risk. Washington, DC, National Academy Press: Committee on Diet and Health, Food and Nutrition Board, Commission on Life Sciences, National Research Council. Human studies Alam N, Meier R, Rausch T, Meyer-Wyss B, Hildebrand P, Schneider H, Bachmann C, Minder E, Fowler B & Gyr K (1998) Effects of a partially hydrolyzed guar gum on intestinal absorption of carbohydrate, protein and fat: a double-blind controlled study in volunteers. Clin Nutr 17, 125-129. Aro A, Uusitupa M, Voutilainen E & Korhonen T (1984) Effects of guar gum in male subjects with hypercholesterolemia. Am J Clin Nutr 39, 911-916. Beattie VA, Edwards CA, Hosker JP, Cullen DR, Ward JD & Read NW (1988) Does adding fibre to a low energy, high carbohydrate, low fat diet confer any benefit to the management of newly diagnosed overweight type II diabetics ? BMJ 296, 1147-1149. 31 January 2008 Page 1,678 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Blackburn N, Holgate A & Read N (1984a) Does guar gum improve post-prandial hyperglycaemia in humans by reducing small intestinal contact area? Br J Nutr 52, 197-204. Blackburn N, Redfern J, Jarjis H, Holgate A, Hanning I, Scarpello J, Johnson I & Read N (1984b) The mechanism of action of guar gum in improving glucose tolerance in man. Clin Sci (Lond) 66, 329-336. Chuang L, Jou T, Yang W, Wu H, Huang S, Tai T & Lin B (1992) Therapeutic effect of guar gum in patients with non-insulin-dependent diabetes mellitus. J Formos Med Assoc 91, 15-19. Cohen M, Leong V, Salmon E & Martin F (1980) Role of guar and dietary fibre in the management of diabetes mellitus. Med J Aust 1, 59-61. Ebeling P, Yki-Jarvinen H, Aro A, Helve E, Sinisalo M & Koivisto V (1988) Glucose and lipid metabolism and insulin sensitivity in type 1 diabetes: the effect of guar gum. Am. J. Clinical Nutrition 48, 98-103. Edwards C, Blackburn N, Craigen L, Davison P, Tomlin J, Sugden K, Johnson I & Read N (1987) Viscosity of food gums determined in vitro related to their hypoglycemic actions. Am J Clin Nutr 46, 72-77. Ellis P, Dawoud F & Morris E (1991) Blood glucose, plasma insulin and sensory responses to guar-containing wheat breads: effects of molecular weight and particle size of guar gum. Br J Nutr 66, 363-379. 31 January 2008 Page 1,679 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Ellis P, Kamalanathan T, Dawoud F, Strange R & Coultate T (1988) Evaluation of guar biscuits for use in the management of diabetes: tests of physiological effects and palatability in on-diabetic volunteers. Eur J Clin Nutr 42, 425-435. Gatenby S, Ellis P, Morgan L & Judd P (1996) Effect of partially depolymerized guar gum on acute metabolic variables in patients with non-insulin-dependent diabetes. Diabet Med 13, 358-364. Gulliford M, Bicknell E & Scarpello J (1988) Effect of guar on amino acid absorption and the blood glucose, insulin, C-peptide and glucagon responses to jejunal amino acid and glucose perfusion in man. Eur J Clin Nutr 42, 871-876. Hansen W, Maurer H, Vollmar J & Brauning C (1983) Guar gum and bile: effects on postprandial gallbladder contraction and on serum bile acids in man. Hepatogastroenterology 30, 131-133. Heijnen M, van Amelsvoort J & Weststrate J (1995) Interaction between physical structure and amylose:amylopectin ratio of foods on postprandial glucose and insulin responses in healthy subjects. Eur J Clin Nutr 49, 446-457. Heini A, Lara-Castro C, Schneider H, Kirk K, Considine R & Weinsier R (1998) Effect of hydrolyzed guar fiber on fasting and postprandial satiety and satiety hormones: a double-blind, placebo-controlled trial during controlled weight loss. Int J Obes Relat Metab Disord 22, 906-909. Holman R, Steemson J, Darling P & Turner R 31 January 2008 Page 1,680 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID (1987) No glycemic benefit from guar administration in NIDDM. Diabetes Care 10, 68-71. Jenkins D, Goff D, Leeds A, Alberti K, Wolever T, Gassull M & Hockaday T (1976) Unabsorbable carbohydrates and diabetes: Decreased post-prandial hyperglycaemia. Lancet 2, 172-174. Jenkins D, Leeds A, Gassull M, Cochet B & Alberti G (1977) Decrease in postprandial insulin and glucose concentrations by guar and pectin. Ann Intern Med 86, 20-23. Jenkins D, Taylor R, Nineham R, Goff D, Bloom S, Sarson D & Alberti K (1979) Combined use of guar and acarbose in reduction of postprandial glycaemia. Lancet 2, 924-927. Jenkins DJ, Wolever TM, Leeds AR, Gassull MA, Haisman P, Dilawari J, Goff DV, Metz GL & Alberti KG (1978a) Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. Br Med J. 1, 1392-1394. Jenkins DJ, Wolever TM, Nineham R, Taylor R, Metz GL, Bacon S & Hockaday T (1978b) Guar crispbread in the diabetic diet. BMJ 2, 1744-1746. Jones K, MacIntosh C, Su Y, Wells F, Chapman I, Tonkin A & Horowitz M (2001) Guar gum reduces postprandial hypotension in older people. J Am Geriatr Soc 49, 162-167. Kirsten R, Heintz B, Nelson K, Oremek G & Speck U (1992) Influence of two guar preparations on glycosylated hemoglobin, total 31 January 2008 Page 1,681 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID cholesterol and triglycerides in patients with diabetes mellitus. Int J Clin Pharmacol Ther Toxicol 30, 582-586. Kovacs EM, Westerterp-Plantenga MS, Saris WH, Melanson KJ, Goossens I, Geurten P & Brouns F (2002a) Associations between spontaneous meal initiations and blood glucose dynamics in overweight men in negative energy balance. Br J Nutr 87, 39-45. Kovacs EM, Westerterp-Plantenga MS, Saris WH, Melanson KJ, Goossens I, Geurten P & Brouns F (2002b) The effect of guar gum addition to a semisolid meal on appetite related to blood glucose, in dieting men. Eur J Clin Nutr 56, 771-778. Lalor B, Bhatnagar D, Winocour P, Ishola M, Arrol S, Brading M & Durrington P (1990) Placebo-controlled trial of the effects of guar gum and metformin on fasting blood glucose and serum lipids in obese, type 2 diabetic patients. Diabet Med 7, 242-245. Makkonen M, Simpanen A, Saarikoski S, Uusitupa M, Penttila I, Silvasti M & Korhonen P (1993) Endocrine and metabolic effects of guar gum in menopausal women. Gynecol Endocrinol 7, 135-141. Meyer B, Muller F, Kruger J, Clur B & Grigoleit H (1984) Effects of tendamistate (an alpha-amylase inactivator), guar and placebo on starch metabolism. S Afr Med J 66, 222-223. O'Donovan D, Feinle-Bisset C, Chong C, Cameron A, Tonkin A, Wishart J, Horowitz M & Jones KL (2005) Intraduodenal Guar 31 January 2008 Page 1,682 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Attenuates the Fall in Blood Pressure Induced by Glucose in Healthy Older Adults. J Gerontol A Biol Sci Med Sci 60, 940-946. Parcell A, Ray M, Moss K, Ruden T, Sharp R & King D (1999) The effect of encapsulated soluble fiber on carohydrate metabolism during exercise. Int J Sport Nutr 9, 13-23. Peterson D, Ellis P, Baylis J, Fielden P, Ajodhia J, Leeds A & Jepson E (1987) Low dose guar in a novel food product: improved metabolic control in non-insulin-dependent diabetes. Diabet Med 4, 111-115. Requejo F, Uttenthal L & Bloom S (1990) Effects of alpha-glucosidase inhibition and viscous fibre on diabetic control and postprandial gut hormone responses. Diabet Med 7, 515-520. Russo A, Stevens J, Wilson T, Wells F, Tonkin A, Horowitz M & Jones K (2003) Guar attenuates fall in postprandial blood pressure and slows gastric emptying of oral glucose in type 2 diabetes. Dig Dis Sci 48, 1221-1229. Shah P, Lakhotia M, Purohit A, Jain S, Gupta S & Bhandari P (1993) Modification in sucrose tolerance test with acarbose, guargum and their combination in patients with non-insulin dependent diabetes. J Assoc Physicians India 41, 703-705. Sierra M, Garcia J, Fernandez N, Diez M, Calle A & Sahagun A (2001) Effects of ispaghula husk and guar gum on postprandial glucose and insulin concentrations in healthy subjects. Eur J Clin Nutr 55, 235-243. 31 January 2008 Page 1,683 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Trinick T, Laker M, Johnston D, Keir M, Buchanan K & Alberti K (1986) Effect of guar on second-meal glucose tolerance in normal man. Clin Sci (Lond) 71, 49-55. Trinidad T, Perez E, Loyola A, Mallillin A, Encabo R, Yokawa T, Aoyama N & Juneja L (2004) Glycemic index of Sunfibre (Cyamoposis tetragonolobus) products in normal and diabetic subjects. International Journal of Food Science & Technology 39, 1093-1098. Uusitupa M, Sodervik H, Silvasti M & Karttunen P (1990) Effects of a gel forming dietary fiber, guar gum, on the absorption of glibenclamide and metabolic control and serum lipids in patients with non-insulin-dependent (type 2) diabetes. Int J Clin Pharmacol Ther Toxicol 28, 153-157. Uusitupa M, Tuomilehto J, Karttunen P & Wolf E (1984) Long term effects of guar gum on metabolic control, serum cholesterol and blood pressure levels in type 2 (non-insulin-dependent) diabetic patients with high blood pressure. Ann Clin Res 16 Suppl 43, 126-131. Vaaler S, Hanssen K, Dahl-Jorgensen K, Frolich W, Aaseth J, Odegaard B & Aagenaes O (1986) Diabetic control is improved by guar gum and wheat bran supplementation. Diabet Med 3, 230-233. Vuorinen-Markkola H, Sinisalo M & Koivisto V (1992) Guar gum in insulin-dependent diabetes: effects on glycemic control and serum lipoproteins. Am J Clin Nutr 56, 1056-1060. 31 January 2008 Page 1,684 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Wahren J, Juhlin-Dannfelt A, Bjorkman O, DeFronzo R & Felig P (1982) Influence of fibre ingestion on carbohydrate utilization and absorption. Clin Physiol 2, 315-321. Williams JA, Lai C-S, Corwin H, Ma Y, Maki KC, Garleb KA & Wolf BW (2004) Inclusion of Guar Gum and Alginate into a Crispy Bar Improves Postprandial Glycemia in Humans. J. Nutr. 134, 886-889. Wolever T, Jenkins D, Nineham R & Alberti K (1979) Guar gum and reduction of post-prandial glycaemia: effect of incorporation into solid food, liquid food, and both. Br J Nutr 41, 505-510. Wolf B, Wolever T, Lai C, Bolognesi C, Radmard R, Maharry K, Garleb K, Hertzler S & Firkins J (2003) Effects of a beverage containing an enzymatically induced-viscosity dietary fiber, with or without fructose, on the postprandial glycemic response to a high glycemic index food in humans. Eur J Clin Nutr 57, 1120-1127. Satiety 31 January 2008 Provide at least 3,25 g/day 823 Page 1,685 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative bodies Review Human studies References Claim ID Authoritative bodies AFSSA Opinion, 23 September 2002. AVIS de l’Agence française de sécurité sanitaire des aliments relatif à l’évaluation sur l’emploi, dans des denrées destinées à une alimentation particulière, de la gomme de guar (actuellement considérée comme additif technologique conformément à l’arrêté du 2 octobre 1997), en tant qu’additif à but nutritionnel (23 septembre 2002, Saisine n° 2002-SA-0069). Review Slavin J and Green H (2007) Dietary fibre and satiety. Nutrition Bulletin 32, 32-42. Human studies Adam, TCM, Westererp-Plantenga, MS. (2005) Glucagon-like peptide-1 release and satiety after a nutrient challenge in normal-weight and obese subjects. Br J Nutr 93, 845-851 Adam, TCM, Westererp-Plantenga, MS. (2005) Nutrient-stimulated GLP-1 release in normal-weight men and women. Horm Metab Res. 37, 111-117 Ellis PR, Apling EC & Leeds AR (1981) Guar bread: acceptability and efficacy combined. Studies on blood glucose, serum insulin and satiety in normal subjects. British Journal of Nutrition 46, 267-276. Evans E., and Miller, D.S. (1975) Bulking agents in the treatment of obesity. Nutr Metab 18:199-203. French S & Read N (1994) Effect of guar gum on hunger and satiety after meals of differing fat content: relationship with gastric emptying. Am J Clin Nutr 59, 87-91. 31 January 2008 Page 1,686 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hoad CL, Rayment P, Spiller RC, Marciani L, Alonso BdC, Traynor C, Mela DJ, Peters HPF & Gowland PA (2004) In Vivo Imaging of Intragastric Gelation and Its Effect on Satiety in Humans. J. Nutr. 134, 2293-2300. Jones K, MacIntosh C, Su Y, Wells F, Chapman I, Tonkin A & Horowitz M (2001) Guar gum reduces postprandial hypotension in older people. J Am Geriatr Soc 49, 162-167. Kovacs EM, Westerterp-Plantenga MS, Saris WH, Goossens I, Geurten P & Brouns F (2001) The effect of addition of modified guar gum to a low-energy semisolid meal on appetite and body weight loss. Int J Obes Relat Metab Disord 25, 307-315. Kovacs EM, Westerterp-Plantenga MS, Saris WH, Melanson KJ, Goossens I, Geurten P & Brouns F (2002) The effect of guar gum addition to a semisolid meal on appetite related to blood glucose, in dieting men. Eur J Clin Nutr 56, 771-778. Krotkiewski M (1984) Effect of guar gum on body-weight, hunger ratings and metabolism in obese subjects. British Journal of Nutrition 52, 97-105. Lavin J & Read N (1995) The effect on hunger and satiety of slowing the absorption of glucose: relationship with gastric emptying and postprandial blood glucose and insulin responses. Appetite 25, 89-96. Russo A, Stevens J, Wilson T, Wells F, Tonkin A, Horowitz M & Jones K (2003) Guar attenuates fall in postprandial blood pressure and slows gastric emptying of oral glucose in type 2 diabetes. Dig Dis Sci 48, 1221-1229. Wilmshurst P and Crawley J. (1980) The measurement of gastric transit time in obese subjects using 24Na and the effects of energy 31 January 2008 Page 1,687 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID content and guar gum on gastric emptying and satiety. Br J Nutr. 44: 1-6. Wolf B, Wolever T, Lai C, Bolognesi C, Radmard R, Maharry K, Garleb K, Hertzler S & Firkins J (2003) Effects of a beverage containing an enzymatically induced-viscosity dietary fiber, with or without fructose, on the postprandial glycemic response to a high glycemic index food in humans. Eur J Clin Nutr 57, 1120-1127. Cholesterol lowering 31 January 2008 10 g/day 821 Page 1,688 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Meta-analysis Review Human studies References Claim ID Meta-analysis Brown L, Rosner B, Willett WW & Sacks FM (1999) Cholesterol-lowering effects of dietary fiber: a meta-analysis. Am J Clin Nutr 69, 30-42. Review Truswell AS & Beynen AC (1992) Dietary fibre and plasma lipids: potential for prevention and treatment of hyperlipidaemias. In Dietary Fibre-A Component of Food Nutritional Function in Health and Disease., pp. 295-332 [TF Schweizer and CA Edwards, editors]: Springer Verlag, London,UK. Human studies Anderson J & Tietyen-Clark J (1986) Dietary fiber: hyperlipidemia, hypertension, and coronary heart disease. Am J Gastroenterol 81, 907-919. Aro A, Uusitupa M, Voutilainen E, Hersio, K & Korhonen T. (1981) Improved diabetes control and hypocholesterolaemic effect induced by long-term dietary supplementation with guar gum in type 2 diabetes (insulin-dependant) diabetes. Diabetologia 21:29-33. Aro A, Uusitupa M, Voutilainen E & Korhonen T (1984) Effects of guar gum in male subjects with hypercholesterolemia. Am J Clin Nutr 39, 911-916. Chuang L, Jou T, Yang W, Wu H, Huang S, Tai T & Lin B (1992) Therapeutic effect of guar gum in patients with non-insulin-dependent diabetes mellitus. J Formos Med Assoc 91, 15-19. Fuessl, HS, Williams, G., Adrian, TE., Bloom SR (1987) Guar sprinkled on food; effect on glycaemic control, plasma lipids and gut hormonesin non-insluin dependant diabetic patients. Diabet. Med. 4:463-468. Holman R, Steemson J, Darling P & Turner R 31 January 2008 Page 1,689 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID (1987) No glycemic benefit from guar administration in NIDDM. Diabetes Care 10, 68-71. Jenkins D, Newton C, Leeds A & Cummings J (1975) Effect of pectin, guar gum, and wheat fibre on serum-cholesterol. Lancet 1, 1116-1117. Khan, AR., Khan, GY., Mitchel, A., Qadeer, MA. (1981) Effect of guar gum on blood lipids. Am J Clin Nutr. 34:2446-2449 Lalor B, Bhatnagar D, Winocour P, Ishola M, Arrol S, Brading M & Durrington P (1990) Placebo-controlled trial of the effects of guar gum and metformin on fasting blood glucose and serum lipids in obese, type 2 diabetic patients. Diabet Med 7, 242-245. Landin, K., Holm, G., Tenborn, L., Smith U. (1992) Guar gum improves insulin sensitivity, blood lipids, blood pressure, and fibrinolysis in healthy men. Am J Clin Nutr 56:1061-1065 McIvor, ME., Cummings, CC., Van Duyn, MA., Leo, TH., Margolis, S., Behall, KM., Michnowski, JE., Mendeloff, AI. (1986) Long term effects of guar gum on blood lipids. Atheroschlerosis 60:7-13 Niemi, MK., Keinanen-Kiukaanniemi, SM., Salmela PI. (1988) Long-term effects of guar gum and microcrystalline cellulose on glycaemic control and serum lipids in type 2 diabetes. Eur J Pharmacol 34:427-429. Penagini R, Velio P, Vigorelli R, Bozzani A, Castagnone D, Ranzi T & Bianchi P (1986) The effect of dietary guar on serum cholesterol, intestinal transit, and fecal output in man. Am J Gastroenterol 81, 123-125. Requejo F, Uttenthal L & Bloom S (1990) Effects of alpha-glucosidase inhibition and viscous fibre on diabetic control and postprandial gut hormone responses. Diabet Med 7, 515-520. 31 January 2008 Page 1,690 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Suprko HR, Haskell, WL., Sawrey-Kubicek, L., Farquhar, JW. (1988) Effect of solid and liquid guar gum on plasma cholesterol and triglyceride concentrations in moderate hypercholesterolemia. Am J Cardiol 62:51-55. Tuomilehto, J., Silvasti, M,., Manninen, V., Uusitupa, M., Aro, A., (1989) Guar gum and gemfibrozil – an effective combnination in the treatment of hypercholesterolemia. Atheroschlerosis 76:71-77. Turner, PR., Tuomilehto, J., Happonen, P., La Ville, AE., Shaikh, M., Lewis, B. (1990) metabolic studies on the hypolipidaemic effect of guar gum. Atheroschlerosis 81:145-150. Uusitupa M, Tuomilehto J, Karttunen P & Wolf E (1984) Long term effects of guar gum on metabolic control, serum cholesterol and blood pressure levels in type 2 (non-insulin-dependent) diabetic patients with high blood pressure. Ann Clin Res 16 Suppl 43, 126-131. Uusitupa M, Siitonen, O., Savolainen, K., Silvastri, M., Penttila, I., Parvianen, M. (1989) metabolic and nutritional effects of long-term use of guar gum in the treatment of noninsulin-dependant diabetes of poor metabolic control. Am J Ciln Nutr 49:345-351 Vaaler S, Hanssen K, Dahl-Jorgensen K, Frolich W, Aaseth J, Odegaard B & Aagenaes O (1986) Diabetic control is improved by guar gum and wheat bran supplementation. Diabet Med 3, 230-233. Vuorinen-Markkola H, Sinisalo M & Koivisto V (1992) Guar gum in insulin-dependent diabetes: effects on glycemic control and serum lipoproteins. Am J Clin Nutr 56, 1056-1060 31 January 2008 Page 1,691 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Guar gum partially hydrolyzed Prebiotic/Bifidogenic Must meet minimum requirements for use of the claim "Source of fibre" as per Annex to Regulation 1924/2006. 3- 22 g/day Human study 31 January 2008 2.5 – 20g/day 1,715 Tuohy KM, Kolida S, Lustenberger AM, Gibson GR. 2001. The prebiotic effects of biscuits containing partially hydrolysed guar gum and fructo-oligosaccharides. a human volunteer study. Br. J. Nutr. 86; 341-348. In vitro study Glycemic response Takahashi H, Wako N, Okubo T, Ishihara N, Yamanaka J, Yamamoto T. 1994. Influence of partially hydrolyzed guar gum on constipation in women. J. Nutr. Sci. Vitaminol. 40; ,251-259. Effect of Oligosaccharides and Fibre Substitutes on Short-chain Fatty Acid Production by Human Faecal Microflora Velázquez M, Davies C, Marett R, Slavin JL, Feirtag JM Anaerobe 6(2):87-92, 2000 1,717 Page 1,692 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human study References Claim ID Golay A, Schneider H, Bloise D, Vadas L, Assal JPh. 1995. The effect of a liquid supplement containing guar gum and fructose on glucose tolerance in non-insulin-dependent diabetic patients. Nutr. Metab. Cardiovasc. Dis. 5; 141-148. Trinidad T, Perez E, Loyola A, Mallillin A, Encabo R, Yokawa T, Aoyama N, Juneja L. 2004. Glycemic index of Sunfiber (Cyamoposis tetragonolobus) products in normal and diabetic subjects. Int. J. Food Sci. Technol. 39(10); 1093-1098. Gu YH, Yamashita T, Suzuki I, Juneja LR, Yokawa T. 2003. Effect of enzyme hydrolyzed guar gum on the elevation of blood glucose levels after meal. Medicine and Biology. 147 (2); 19-24. Improved intestinal conditions (pH, SCFA production) and intestinal function. Mineral (calcium and Megnesium) absorption 31 January 2008 Must meet minimum requirements for use of the claim "Source of fibre" as per Annex to Regulation 1924/2006. In vitro Velazquez M, Davies C, Marett R, Slavin JL, Feirtag JM. 2000. Effect of commercial oligosaccharides and fiber substitutes on short-chain fatty acid production by human fecal microflora and the growth of probiotic organisms during in vitro fermentation. Anaerobe 6; 87-92. 1,716 1,719 Page 1,693 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human study Animal study References Claim ID Takahashi H, Yang SI, Hayashi C, Kim M, Yamanaka J, Yamamoto T. 1993.Effect of partially hydrolyzed guar gum on fecal output in human volunteers. Nutr. Res.13(6); 649-657. Takahashi H, Yang SI, Ueda Y, Kim M, Yamamoto T. 1994. Influence of intact and partially hydrolyzed guar gum on iron utilization in rats fed on iron-deficient diets. Comp. Biochem. Physiol. 109A(1); 75-82. Karine de Cássia Freitasa, Olga Maria Silvério Amancioa, Neil Ferreira Novob, c, Ulysses Fagundes-Netoa and Mauro Batista de Morais. Partially hydrolyzed guar gum increases intestinal absorption of iron in growing rats with iron deficiency. Clinical Nutrition N.H. Alam, R. Meier, T. Rausch, B. Meyer-Wyss, P. Hildebrand, H. Schneider, C. Bachmann, E. Minder, B. Fowler and K. Gyr. Effects of a partially hydrolyzed guar gum on intestinal absorption of carbohydrate, protein and fat: a double-blind controlled study in volunteers . Clinical Nutrition 17 (3):125-129. Hara H, Nagata M, Ohta A, Kasai T. 1996. Increases in calcium absorption with ingestion of soluble dietary fibre, guar-gum hydrolysate, depend on the caecum in partially nephrectomized and normal rats. Br. J. Nutr. 76; 773-784. Lipid management 31 January 2008 4 – 15g/day 1,718 Page 1,694 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human study References Claim ID Takahashi H, Yang SI, Hayashi C, Kim M, Yamanaka J, Yamamoto T. 1993. Effect of partially hydrolyzed guar gum on fecal output in human volunteers. Nutr. Res. 13(6); 649-657.. Yamatoya K, Kuwano K, Suzuki J. 1997. Effects of hydrolyzed guar gum on cholesterol and glucose in humans. Food Hydrocolloids. Food Hydrocoloids 11; 239-242. Kondo S, Xiao JZ, Takahashi N, Miyaji K, Iwatsuki K, Kokubo S.2004. Suppressive effects of dietary fiber in yogurt on the postprandial serum lipid levels in healthy adult male volunteers. Biosci. Biotechnol. Biochem. 68; 1135-1138. 31 January 2008 Page 1,695 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Hydroxypropyl methylcellulose (HPMC) Dietary fibre Bowel function Conditions of "source of" (3g/100g) from Health Claims regulation 1924/2006, specific conditions of use are listed in the list of references. There is no upper safe limit. HPMC Acceptable Daily Intake (ADI) is “not specified” as adopted in 1994 by the Scientific Committee on Food for five closely related cellulose derivatives, including hydroxypropyl methyl cellulose. Authoritative Body JHCI – Joint Health Claims Initiative – Final Technical Report – A List of Well Established Nutrient Function Statements http://www.food.gov.uk/multimedia/pdfs/jhci_he althreport.pdf 1,147 NFA – Terveysvaitteiden valvontaopas, Finnish Food Authority Control guides number 2/2002 http://www.palvelu.fi/evi/evi_material.php NHPD – Health Canada Permitted Health Claims http://laws.justice.gc.ca/en/F-27/C.R.C. -c.870/236932.html#Section-B.01.603 SNF – Swedish Nutrition Foundation http://www.snf.ideon.se/snf/en/rh/Healh_claims _FF.htm A 2007 ‘Safety assessment of hydroxypropyl methylcellulose as a food ingredient’ by G.A. Burdock published in Food and Chemical Toxicology (Elsevier) states that "These data indicate that at the current level of intake, HPMC does not pose a health risk to humans." 31 January 2008 Page 1,696 of 3,931 Category Food Component Health Relationship Uniform blood sugar levels Suggested Conditions of Use Products carrying the claim should contain a single serving of 1 gram per serving. Recommended daily use is 2 grams per day. There is no upper safe limit. HPMC Acceptable Daily Intake (ADI) is “not specified” as adopted in 1994 by the Scientific Committee on Food for five closely related cellulose derivatives, including hydroxypropyl methyl cellulose. A 2007 ‘Safety assessment of hydroxypropyl methylcellulose as a food ingredient’ by G.A. Burdock published in Food and Chemical Toxicology (Elsevier) states that "These data indicate that at the current level of intake, HPMC does not pose a health risk to humans." Nature of Evidence Human Intervention Study Supporting Study (Animal) References D.J.A. Jenkins, T.M.S. Wolever, A.R. Leeds, M.A. Gassull, P. Haisman, J. Dilawari, D.V. Goff, G.L. Metz, K.G. Alberti, Dietary Fibres, Fibre Analogues, And Glucose Tolerance: Importance Of Viscosity, Br. Med. J. 1978, 1, 1392-1394. Claim ID 1,145 C. Reppas, C.H. Adair, J.L. Barnett, R.R. Berardi, D. DuRoss, S.Z. Swidan, P.F. Thill, S.W. Tobey, J.B. Dressman, High Viscosity Hydroxypropylmethylcellulose Reduces Postprandial Blood Glucose Concentrations In NIDDM Patients, Diabetes Res. Clin. Pract. 1993, 22/1, 61-69. D.L. Topping, D. Oakenfull, R.P. Trimble, R.J. Illman, A Viscous Fibre (Methylcellulose) Lowers Blood Glucose And Plasma Triacylglycerols And Increases Liver Glycogen Independently Of Volatile Fatty Acid Production In The Rat, British Journal of Nutrition 1988, 59, 21-30. C. Reppas, J.B. Dressman, Viscosity Modulates Blood Glucose Response To Nutrient Solutions In Dogs, Diabetes Res. Clin. Pract. 1992, 17, 81-88. C. Reppas, J.H. Meyer, P.J. Sirois, J.B. Dressman, Effect Of Hydroxypropylmethylcellulose On Gastrointestinal Transit And Luminal Viscosity In Dogs, Gastroenterology 1991, 100, 1217-1223. C. Reppas, D.E. Greenwood, J.B. Dressman, Longitudinal Versus Radial Effects Of Hydroxypropylmethylcellulose On Gastrointestinal Glucose Absorption In Dogs, 31 January 2008 Page 1,697 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Eur. J. Pharm. Sci. 1999, 8, 211-219. K.C. Maki, M.L. Carson, M.P. Miller, M. Turowski, M. Bell, D.M.Wilder, M.S. Reeves, High-Viscosity Hydroxypropylmethylycellulose Blunts Postprandial Glucose and Insulin Responses, Diabetes Care., Vol. 30, No. 5, May 2007, 1039-1043. EFSA Report Published toxicology summary EU Scientific Committee on Food (SCF), Reports of the Scientific Committee for Food, 32nd series, Re-evaluation of 5 modified celluloses (Opinion expressed on 13 March 1992), 1994. Burdock, G.A. Safety assessment of hydroxypropyl methylcellulose as a food ingredient, Food Chem. Toxicol. (2007), doi:10.1016/j.fct.2007.07.001 Maintenance of normal cholesterol levels Products carrying the claim should contain a single serving of 1.25 grams per serving. Recommended daily use is 2.5 grams per day. There is no upper safe limit. HPMC Acceptable Daily Intake (ADI) is “not specified” as adopted in 1994 by the Scientific Committee on Food for five closely related cellulose derivatives, including hydroxypropyl methyl cellulose. Human Intervention Study (Efficacy Trial: DBPC*, randomised, cross-over) (Dose Response Study: open, escalating dose) (Tolerance Study: DBPC, randomised, cross-over) J.B. Dressman, C.H. Adair, J.L. Barnett, R.R. Berardi, V.A. Dunn-Kucharski, K.M. Jarvenpaa, D.D. Parr, C.A. Sowle, S.Z. Swidan, S.W. Tobey, High-Molecular-Weight Hydroxypropylmethylcellulose. A Cholesterol-Lowering Agent, Arch. Intern. Med. 1993, 153, 1345-1353 Human Intervention Study (DBPC, randomised, cross-over) S.Z. Swidan, C. Reppas, J.L. Barnett, D.E. Greenwood, A.M. Tallman, S.W. Tobey, J.B. Dressman, Ability Of Two Comestible Formulations Of Hydroxypropylmethylcellulose To Lower Serum Cholesterol Concentrations, Eur. J. Pharm. Sci. 1996, 4, 239-245. 1,146 A 2007 ‘Safety 31 January 2008 Page 1,698 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use assessment of hydroxypropyl methylcellulose as a food ingredient’ by G.A. Burdock published in Food and Chemical Toxicology (Elsevier) states that "These data indicate that at the current level of intake, HPMC does not pose a health risk to humans." Nature of Evidence References Human Intervention Study (randomised, open-label, parallel) K.C. Maki, M.H. Davidson, S. Torri, K.A. Ingram, J. O’Mullane, B.P. Daggy, H.H. Albrecht, High-Molecular-Weight Hydroxypropylmethylcellulose Taken With Or Between Meals Is Hypocholesterolemic In Adult Men, J. Nutr. 2000, 130, 1705-1710. Human Intervention Study (DBPC, randomised, parallel) K.C. Maki, M.H. Davidson, K.C. Malik, H.H. Albrecht, J. O’Mullane, B.P. Daggy, Cholesterol Lowering With High-Viscosity Hydroxypropylmethylcellulose, Am. J. Cardiol. 1999, 84, 1198–1203. Supporting Study (Animal) D.D. Gallaher, C.A. Hassel, K.J. Lee, Relationships Between Viscosity Of Hydroxypropyl Methylcellulose And Plasma Cholesterol In Hamsters, J. Nutr. 1993, 123, 1732-1738. Claim ID T.P. Carr, D.D. Gallaher, C.H. Yang, C.A. Hassel, Increased Intestinal Contents Viscosity Reduces Cholesterol Absorption Efficiency In Hamsters Fed Hydroxypropyl Methylcellulose, J. Nutr. 1996 126, 1463-1469. 31 January 2008 EFSA Report EU Scientific Committee on Food (SCF), Reports of the Scientific Committee for Food, 32nd series, Re-evaluation of 5 modified celluloses (Opinion expressed on 13 March 1992), 1994. Published toxicology summary Burdock, G.A. Safety assessment of hydroxypropyl methylcellulose as a food ingredient, Food Chem. Toxicol. (2007), doi:10.1016/j.fct.2007.07.001 Page 1,699 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Inulin / FOS (beta 2-1 linked fructans) Prebiotic/ Bifidogenic; Digestive Health 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 5g/ day Books and Review Papers Roberfroid, M B. Inulin-Type Fructans, Functional Food Ingredients. CRC Press, Boca Raton, FL, 2005. Books and Review Papers Boeckner LS, Schnepf MI, Tungland BC. Inulin: a review of nutritional and health implications. In: Advances in Food and Nutrition Research, volume 43. Edited by Steve L. Taylor. Academic Press, USA. Pages 1-62, 2001. Books and Review Papers Bornet FRJ. Undigestible sugars in food products. Am J Clin Nutr 59:763S-769S, 1994. Books and Review Papers Bornet FRJ, Brouns F. Immune-stimulating and gut health-promoting properties of short chain fructo-oligosaccharides. Nutr Reviews, 60:326-334, 2002. Books and Review Papers Carabin IG, Flamm WG. Evaluation of safety of inulin and oligofructose as dietary fiber. Reg Tox Pharm, 30:268-282, 1999. Books and Review Papers Cherbut C. Inulin and oligofructose in the dietary fibre concept. Br J Nutr, 87:S159-S162, 2002. Books and Review Papers Egan SK, Petersen BJ. Estimated consumption of inulin and oligofructose by the US population. Technical Assessment Systems Inc. Washington DC, USA, 1992. Books and Review Papers Flamm G, Glinsmann W, Kritchevsky D, Prosky L, Roberfroid M. Inulin and oligofructose as dietary fiber: a review of the evidence. Crit Rev Food Sci Nutr, 41:353-362, 2001. Books and Review Papers Gibson GR and Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr, 125:1401-1412, 1995. 182 Page 1,700 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Books and Review Papers Gibson GR, Probert HM, Van Loo J, Rastall RA, Roberfroid MB. Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr Res Rev, 17:259-275, 2004 Books and Review Papers Moshfegh AJ, Friday JE, Goldman JP, Ahuja JKC. Presence of inulin and oligofructose in the diets of Americans. J Nutr, 129:1407S-1411S, 1999. Books and Review Papers Niness KR. Inulin and oligofructose: what are they? J Nutr 129:1402S-1406S, 1999. Books and Review Papers Roberfroid, M. B. 2005. Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL. Books and Review Papers Roberfroid M, Gibson GR, Delzenne N. The biochemistry of oligofructose, a nondigestible fiber : an approach to calculate its caloric value. Nutr Rev, 51:137-146, 1993. Books and Review Papers Roberfroid M, van Loo JAE, Gibson G. The bifidogenic nature of chicory inulin and its hydrolysis products. J Nutr. 128:11-19, 1998. Books and Review Papers Van Loo J. The specificity of the interaction with intestinal bacterial fermentation by prebiotics determines their physiological efficacy. Nutr Res Rev 17:89-98, 2004. Books and Review Papers Van Loo J, Coussement P, de Leenheer L, Hoebregs H, Smits G. On the presence of inulin and oligofructose as natural ingredients in the Western diet. Crit Rev Food Science and Nutr, 35:525-552, 1995. Human Studies Bach Knudsen KE and Hessov I. Recovery of inulin from Jerusalem artichoke (Helianthus tuberosus L.) in the small intestine of man. Br J Nutr, 74:101-113, 1995. Claim ID Page 1,701 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Studies Bouhnik Y, Flourie B, Riottot M, Bisetti N, Gailing M, Guibert A, Bornet F, Rambaud J. Effects of fructo-oligosaccharides ingestion on fecal bifidobacteria and selected metabolic indixes of colon carcinogenesis in healthy humans. Nutr Cancer 26:21-29, 1996. Human Studies Bouhnik Y, Raskine L, Simoneau G, Paineau D, Bornet FR. The capacity of short-chain fructo¬oligosaccharides to stimulate faecal bifidobacteria : a dose- response relationship study in healthy humans. Nutr J, 5:8-14, 2006. Human Studies Bouhnik Y, Raskine L, Simoneau G, Vicaut E, Neut C, Flourie B, Brouns F, Bornet FR. The capacity of nondigestible carbohydrates to stimulate fecal bifidobacteria in healthy humans: a double-blind, randomized, placebo-controlled, parallel-group, dose-response relation study. Am J Clin Nutr, 80:1658-1664, 2004. Human Studies Bouhnik Y, Vahedi K, Achour L, Attar A, Salfati J, Pochart P, Marteau P, Flourie B, Bornet F, Rambaud J. Short-chain fructo-oligosaccharide administration dose-dependently increasese fecal bifidobacteria in healthy humans. J Nutr, 129:113-116, 1999. Human Studies Boutron-Ruault M, Marteau P, Lavergne-Slove A, Myara A, Gerhardt M, Franchisseur C, Bornet F, and the Eripolyp Study Group. Nutr and Cancer, 53:160-168, 2005. Human Studies Buddington RK, Williams CH, Chen S, Witherly SA. Dietary supplement of neosugar alters the fecal flora and decreases activities of some reductive enzymes in human subjects. Am J Clin Nutr, 63:709-716, 1996. Claim ID Page 1,702 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Studies Clavel T, Fallani M, Lepage P, Levanez F, Mathey J, Fochet V, Serezat M, Sutren M, Henderson G, Bennetau-Pelissero C, Tondu F, Blaut M, Dore J, Coxam V. Isoflavones and functional foods alter the dominant intestinal microbiota in postmenopausal women. J Nutr, 135:2786-2792, 2005. Human Studies Rumessen JJ, Bode S, Hamberg O, Gudmand-Hoyer E. Fructans of Jerusalem artichokes: intestinal transport, fermentation, and influence on blood glucose, insulin, and C-peptide responses in healthy subjects. Am J Clin Nutr, 52:675-681, 1990. Human Studies Wada T, Sugatani J, Terada E, Ohguchi M, Miwa M. Physicochemical characterization and biological effects of inulin enzymatically synthesized from sucrose. J Agric Food Chem 53:1246-1253, 2005. Animal and In-Vitro Studies Coudray C, Tressol JC, Gueux E, and Rayssiguier Y. Effects of inulin-type fructans of different chain length and type of branching on intestinal absorption and balance of calcium and magnesium in rats. Eur J Nutr 42: 91-98, 2003. Animal and In-Vitro Studies Lopez-Molina D, Navarro-Martinez MD, Melgarejo FR, Hiner ANP, Chazarra S, Rodriguez-Lopez JN. Molecular properties and prebiotic effect of inulin obtained from artichoke (Cynara scolymus L.). Phytochemistry 66:1476-1484, 2005. Animal and In-Vitro Studies Marx SP, Winkler S, Hartmeier W. Metabolization of 0-(2,6)-linked fructose-oligosaccharides by different bifidobacteria. Microbiol Letters 182:163-169, 2000. Claim ID Page 1,703 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal and In-Vitro Studies Probert HM, Apajalahti JHA, Rautonen N, Stowell J, Gibson GR. Polydextrose, lactitol, and fructo¬oliogosaccharide fermentation by colonic bacteria in a three-stage continuous culture system. App Env Microbiol, 70:4505-4511, 2004. Animal and In-Vitro Studies Rao DS, Murthy KSK, Srinivasan M. Effect of polyfructosan from Agave vera-cruz mill and inulin on cholesterol levels in plasma and liver of albino rats. Indian J Exp Biology 3:103-105, 1965. Animal and In-Vitro Studies Yamamoto Y, Takahashi Y, Kawano M, Iizuka M, Matsumoto T, Saeki S, Yamaguchi H. In vitro digestibility and fermentability of levan and its hypocholesterolemic effects in rats. J Nutr Biochemm, 10:13-18, 1999. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) AOAC Official Method 997.08. Fructans in Food Products. JAOAC Int. 80:1029-1033, 1997. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) AOAC Official Method 997.08. Fructans in Food Products. AOAC Official Methods of Analysis (2005). Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Beck, RHF, and Praznik, W. Molecular characterization of fructans by high-performance gel chromatography. J. Chormat. 369:208-212, 1986. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Besemer, AC, and van Bekkum, H. The hypochlorite oxidation of inulin. Recueil des Travaux Chimiques des Pays-Bas113:398-402, 1994. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Carpita, NC, Housley, TL, Hendrix, JE. New features of plant fructan structure revealed by methylation analysis and C13 NMR-Spectroscopy. Carbohydr. Res. 217:127-136, 1991. Claim ID Page 1,704 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) DeLeenheer, L., and Hoebregs, H. Progress in the elucidation of the composition of chicory inulin. Starch. 46: 193-196, 1994. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Egan SK, Petersen BJ. Estimated consumption of inulin and oligofructose by the US population. Technical Assessment Systems Inc. Washington DC, USA, 1992. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Jamie, L., Martin-Cabrejas, MA, Molia, E., Lopez-Andreu, F., and Esteban, RM. Effect of storage on fructan and fructooligosaccharide of onion (Allium cepa L.). J.Agric. Food Chem. 49:982-988, 2001. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Lopez, MG, Mancilla-Margalli, NA, and Mendoza-Diaz, G. Molecular structure of fructans from Agave tequilana Weber var. azul. J. Agric. Food. Chem. 51:7835-7840, 2003. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Losso, JN, and Nakai, S. Molecular size of garlic fructooligosaccharides and fructopolymers by matrix-assisted laserdesorption ionization mass spectrometry. J. Agric. Food Chem. 45:4342-4346, 1997. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Moerman, FT, VanLeeuwen, MB, and Delcour, JA. Enrichment of higher molecular weight fractions in inulin. J.Agric.Food Chem. 52: 3780-3783, 2004. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Praznik, W., and Beck, RHF. Application of gel permeation chromatographic systems to the determination of the molecular weight of inulin. J.Chromat. 348:187-197, 1985. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Praznik, W., Huber, A., Loppert, R. Occurence and potential of fructan plants. IP: Renewable Biomaterials. Ghent, 2006. Claim ID Page 1,705 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Schutz, K., Muks, E., Carle, R., and Schieber, A. Separation and quantification of inulin in selected artichoke (Cynara scolymus L.) cultivars and dandelion (Taraxacum officinale WEB. ex WIGG.) roots by high-performance anion exchange chromatography with pulsed amperometric detection. Biomed. Chromat. 20:1295-1303, 2006. Chemical Structure of Inulin / FOS (82--+1 Linked Fructans) Wack, M, and Blaschek, W. Determination of the structure and degree of polymerization of fructans from Echinacea purpurea roots. Carbohydr.Res. 241:1147-1153, 2006. Claim ID Page 1,706 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Inulin / oligofructose / Oligofructose-enriched inulin (specific selection of short & long chains) from chicory Prebiotic / Bifidogenic 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 5g/ day Authoritative/Scientific Bodies AFSSA. 2005. Effects of probiotics and prebiotics on flora and immunity in adults. ISBN 2-11-095439-6 http://www.isapp.net/PDF/AFFSAprobioticprebi oticfloraimmunity05.pdf Authoritative/Scientific Bodies AFSSA Advice (France) 2004-SA-0365 http://www.afssa.fr/Object.asp?IdObj=29810&P ge=0&CCH=060512092005:26:4&cwSID=E193 076 4922A4D3C8D41649348D811D0&AID=0 Authoritative/Scientific Bodies AFSSA (CSHPF) Advice (France) 2000-SA-0118 http://www.afssa.fr/ftp/afssa/basedoc/2000sa11 8.pdf Authoritative/Scientific Bodies VC (the Netherlands): Assessment report of VC on Vitaalbrood Flora http://www.voedingscentrum.nl/NR/rdonlyres/85 938396-FFD6-44B0-8143-769E3B25A14C/0/be oordelingsrapport_vitaalbrood_florapdf.pdf Book Roberfroid, M. B. 2005. Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL. ISBN 0-8493-0059-2. Reviews Biedrzycka, E., and M. Bielecka. 2004. Prebiotic effectiveness of fructans of different degrees of polymerization. Trends in Food Science and Technology 15:170-175 Reviews Conway, P. 2001. Prebiotics and human health : The state-of-the-art and future perspectives. Scan. J. Nutr. 45:13-21 Reviews Cummings, J. H., G. T. Macfarlane, and H. N. Englyst. 2001. Prebiotic digestion and fermentation. Am J Clin Nutr 73:(2) 415S-420. 181 Page 1,707 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews Gibson, G. R., H. Probert, J. van Loo, R. A. Rastall, and M. B. Roberfroid. 2004. Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. Reviews Gibson, G. R., McCartney, A. L., and Rastall, R. A. Prebiotics and resistance to gastrointestinal infections British Journal of Nutrition 2005;93:S31-S34. Reviews Gibson, G., and M. Roberfroid. 1995. Dietary modulation of the human colonic microbiota: Introducing the concept of prebiotics. J. Nutr. 125:(6) 1401-1412. Reviews Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. Reviews Roberfroid, M. B. 2001. Prebiotics: Preferential substrates for specific germs? Am J Clin Nutr 73:(2) 406S-409 Reviews Schrezenmeir, J., and M. deVrese. 2001. Probiotics, prebiotics, and synbiotics -approaching a definition. 73:(suppl 1) 361S-364S. Reviews Tuohy KM, Rouzaud GC, Bruck WM, Gibson GR. Modulation of the human gut microflora towards improved health using prebiotics-assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. Clinical Studies Bouhnik Y, Raskine L, Champion K, Andrieux C, Penven S, Jacobs H, Simoneau G. 2007. Prolonged administration of low-dose inulin stimulates bifidobacteria growth in humans. Nutr Res 27(4): 187-193. Claim ID Page 1,708 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies Brighenti F.; Casiraghi MC.; Canzi E.; Ferrari A.; 1999; “Effect of consumption of a ready-to-eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy volunteers”; Eur. J. Clin. Nutr., 53, pp. 726-733. Clinical Studies Gibson, G.R., Beatty, E.R., Wang, X. and Cummings, J.H. 1995. Selective stimulation of bifidobacteria in the human colon by oligofructose and inulin. Gastroenterolgy 108, 975-982. Clinical Studies Harmsen H, 2002; The Effect of the Prebiotic Inulin and the Probiotic Bifidobacterium longum on theFaecal Microflora of Healthy Volunteers Measured by FISH and DGGE; Microbial Ecology in Health and Disease, 2002; 14; 212 220. Clinical Studies Kim SH, Lee da H, Meyer D. 2007. Supplementation of baby formula with native inulin has a prebiotic effect in formula-fed babies. Asia Pac J Clin Nutr. 16(1):172-7. Clinical Studies Kleessen B., Sykura B., Zunft H., Blaut M., 1997; “Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons”; Am. J; Clin. Nutr., 65, 1397-1402. Clinical Studies Kolida S, Meyer D, Gibson GR. 2007. A double-blind placebo-controlled study to establish the bifidogenic dose of inulin in healthy humans. Eur J Clin Nutr advance online publication, 31 January 2007. Clinical Studies Kruse H., Kleessen B., Blaut M., 1999; “Effects of inulin on faecal bifidobacteria in human subjects”; BJN, 82, 375-382. Claim ID Page 1,709 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies Langlands S.; Hopkins M.; Coleman N.; Cummings J. 2004 “Prebiotic carbohydrates modify the mucosa associated microflora of the human large bowel"; Gut; 53; 1610-1616. Clinical Studies Menne E., Guggenbuhl N., Roberfroid M., 2000; “Fn-type Chicory Inulin Hydrolysate Has a Prebiotic Effect in Humans”; J. Nutr., 130, pp. 1197-1199. Clinical Studies Rao V., 2001; “The prebiotic properties of oligofructose at low intake levels”; Nutrition Research, 21, pp. 843-848. Clinical Studies Tuohy K.; Finlay R.; Wynne A.; Gibson G.; 2001; “A Human Volunteer Study on the Prebiotic Effects of HP-Inulin – Faecal Bacteria Enumerated Using Fluorescent In Situ Hybridisation (FISH)”; Anaerobe, 7, pp. 113-118. Clinical Studies Waligora-Dupriet AJ, Campeotto F, Nicolis I, Bonet A, Soulaines P, Dupont C, Butel MJ. 2007. Effect of oligofructose supplementation on gut microflora and well-being in young children attending a day care centre. Int J Food Microbio 1;113(1):108-13. In Vitro Studies Durieux, A., Fougnies, C., Jacobs, H., Simon, J.-P. (2001). Metabolism of chicory fructooligosaccharides by bifidobacteria. Biotechnology Letters 23, 1523-1527. In Vitro Studies Gibson G.R. and Wang X (1994b), "Regulatory effects of Bifidobacteria on the growth of other colonic bacteria.", J. Appl. Bacteriology, 77, 412-420. In Vitro Studies Gibson G.R. and Wang X (1994c), “Bifidogenic properties of different types of fructo¬oligosaccharides.”, Food Microbiology, 11; 491-498. Claim ID Page 1,710 of 3,931 Category Food Component Health Relationship Improves digestive/ bowel function 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 8g/day Nature of Evidence References In Vitro Studies Gibson G.R. and Wang X. (1994a), “Enrichment of Bifidobacteria from human gut contents by oligofructose using continuous culture.”, FEMS microbiology ecology, 118, 121-128. In Vitro Studies Perrin, S., Fougnies, C., Grill, J.-P., Jacobs, H., Schneider, F. (2002). Fermentation of chicory fructo-oligosaccharides in mixtures of different degrees of polymerization by three strains of bifidobacteria. Can. J. Microbiol. 48: 759-763 In Vitro Studies Rycroft, C. E., M. R. Jones, G. R. Gibson, and R. A. Rastall. 2001. A comparative in vitro evaluation of the fermentation properties of prebiotic oligosacharides. J. Appl. Microbiol. 91:878-887. In Vitro Studies Van de Wiele T., Boon, N., Possemiers, S., Jacobs, H.,Verstraete, W. (2004). Prebiotic effects of chicory inulin in the Simulator of the Human Intestinal Microbial Ecosystem. FEMS Microbiology Ecology 51, 143-153. DIETARY FIBRE Inulin from Chicory 3 Book -Ashwell M.; 2002: "Concepts of functional foods"; ILSI Concise Monograph Series; ISBN 1-57881-145-7 Book -Roberfroid M.; 2005; "The Digestive functions: inulin-type fructans as non-digestible oligosaccharides, as fermentable carbohydrates, as dietary fibre, as low-calory carbohydrates, Conclusions; Inulin-type fructans; CRC Series in Modern Nutrition; ISBN 0-8493-0059-2; 61-150. Reviews -Kaur N., Gupta A.; 2002; "Applications of inulin and oligofructose in health and nutrition"; J. Bioscience.; 27; 7; 703-714. Claim ID 184 Page 1,711 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews -Losada M.; Olleros T; 2002; "Towards a healthier diet for the colon: the influence of fructooligosaccharides and lactobacilli on intestinal health"; Nutrition Research; 22; 71-84. Reviews -Van Loo J.; 2004; "Prebiotics promote good health; the basis, the potential and the emerging evidence"; J. Clin. Gastroenterol.; 38; 2; S70-S75. Human Intervention Studies -Bettler J.; Euler A.; 2005; "An evaluation of the growth of term infants fed formula supplemented with fructo-oligosaccharide"; Int. J. of Probiotics and Prebiotics; 1; 1; 19-26. Human Intervention Studies -Castiglia-Delavaud C., Verdier E., Besle J., Vernet J., Boirie Y., Beaufrere B., de Baynast R., Vermorel M.; 1998; "Net energy value of non-starch polysaccharide isolates (sugarbeet fibre and commercial inulin) and their impact on nutrient digestive utilization in healthy human subjects"; BJN., 80, pp. 343-352. Human Intervention Studies -Causey J.; Feirtag J.; Gallaher D.; Tungland B.; Slavin J.; 2000; "Effects of dietary inulin on serum lipids, blood glucose and the gastrointestinal environment in hypercholesterolic men"; Nut Res. 20, 2, pp. 191-201. Human Intervention Studies -Chen H.; Lu Y.; Lin J.; Ko L.; 2000; "Effects of fructooligosaccharide on bowel function and indicators of nutritional status in constipated elderly men"; Nut. Res. 20, 12, pp. 1725-1733 Human Intervention Studies -Clausen M.; Jorgensen J.; Mortensen P.; 1998; "Comparison of Diarrhoea Induced by Ingestion of Fructooligosaccharide Idolax and Disaccharide Lactulose"; Dig. Dis. And Sc., 43, 12, pp. 2696-2707. Claim ID Page 1,712 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies -Cummings J.; Christie S.; Cole T.; 2001; "A study of fructo oligosaccharides in the prevention of travellers’ diarrhoea"; Aliment. Pharmacol. Ther.; 15; 1139-1145. Human Intervention Studies -Den Hond E.; Geypens B.; Ghoos Y.; 2000;"Effect on high performance chicory inulin on constipation"; Nut. Res. 20,5, pp. 731-736. Human Intervention Studies -Euler A.; Mitchell D.; Kline R.; Pickering L.; 2005;"Prebiotic effect of fructo-oligosaccharide supplemented term infant formula at two concentrations compared with unsupplemented formula and human milk"; J Pediatric Gastroenterology and Nutrition;40; 157-164. Human Intervention Studies -Gibson G.; Beatty E.; Wang X.; Cummings J.; 1995; "Selective Stimulation of Bifidobacteria in the Human Colon by Oligofructose and Inulin"; Gastroenterology, 108, pp. 975-982. Human Intervention Studies -Kleessen B.; Sykura B.; Zunft H.; Blaut M.; 1997; "Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons"; Am. J; Clin. Nutr., 65, 1397-1402. Human Intervention Studies -Menne E.; Guggenbuhl N.; Roberfroid M.; 2000; "Fn-type Chicory Inulin Hydrolysate Has a Prebiotic Effect in Humans"; J. Nutr., 130, pp. 1197-1199. Human Intervention Studies -Moore N.; Chao C.; Yang L.; Storm H.; Oliva-Hemker M.; Saavedra J.; 2003; "Effects of fructo¬oligosaccharide-supplemented infant cereal: a double-blind, randomized trial"; BJN., 90, pp. 581-587. Human Intervention Studies -Saavedra J. M.; Tschernia A..; 2002; "Human studies with probiotics and prebiotics: clinical implications"; BJN; 87; Suppl. 2; S241-S246. Claim ID Page 1,713 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human Intervention Studies 31 January 2008 References Claim ID -Waligora-Dupriet A.; Campeotto F.; Nicolis I.; Bonet A.; Soulaines P.; Dupont C.; Butel M.; 2006; "Effects of oligofructose supplementation on gut microflora and well-being in young children attending a day care centre"; Int J of Food Microbiology; doi:10.1016/ijffoodmicro.2006.07.009. Page 1,714 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Inulin/oligofructose from chicory Improved Calcium absorption 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 8g/day DIETARY FIBRE- Inulin from Chicory 5 Reviews -Coxam V. Inulin-type fructans and bone health: state of the art and perspectives in the management of osteoporosis. Br J Nutr. 2005 Apr;93 Suppl 1:S111-23 Reviews -Meyer D. & Stasse-Wolthuis M. Inulin and bone health. 2006 Current Topics in Nutraceutical Research; 4(3/4), 211-226 Reviews -Scholz-Ahrens, K.E., Ade, P, Marten, B., Weber, P., Timm, W., Asil, Y., Glueer, C.C. and Schrezenmeir, J. 2007. Prebiotics, probiotics, and synbiotics affect mineral absorption, bone mineral content, and bone structure. J Nutr 137 (3) S838-S846 Reviews -Scholz-Ahrens KE, Schaafsma G, van den Heuvel EG, Schrezenmeir J. Effects of prebiotics on mineral metabolism. Am J Clin Nutr. 2001 Feb;73(2 Suppl):459S-464S. Clinical Studies -Abrams SA, Griffin IJ, Hawthorne KM, Liang L, Gunn SK, Darlington G, Ellis KJ. A combination of prebiotic short- and long-chain inulin-type fructans enhances calcium absorption and bone mineralization in young adolescents. Am J Clin Nutr. 2005 Aug;82(2):471-6 Clinical Studies -Coudray C, Bellanger J, Castiglia-Delavaud C, Remesy C, Vermorel M, Rayssignuier Y. Effect of soluble or partly soluble dietary fibres supplementation on absorption and balance of calcium, magnesium, iron and zinc in healthy young men. Eur J Clin Nutr. 1997 Jun;51(6):375-80. 186 Page 1,715 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Griffin I, Hicks P, Heaney R, Abrams S. Enriched chicory inulin increases calcium absorption mainly in girls with lower calcium absorption. Nutrition research 2003; 23(7):901-909. Clinical Studies -Griffin IJ, Davila PM, Abrams SA. Non-digestible oligosaccharides and calcium absorption in girls with adequate calcium intakes. Br J Nutr. 2002 May;87 Suppl 2:S187-91 Clinical Studies -Holloway L, Moynihan S, Abrams S, Kent K, Hsu A, Fiedlander A. Effect of oligofructose enriched inulin on calcium and magnesium absorption and bone turnover markers in postmenopausal women. Brit J Nutr 2006; 97(2): 365-372 . Clinical Studies -Kim Y-Y, Jang K-H, Lee E-Y, Cho Y, Kang S, Ha W-K, Choue R. The effect of chicory fructan fiber on calcium absorption and bone metabolism in korean postmenopausal women. Nutritional Sciences 2004; (73): 151-157. Clinical Studies -Maki, K.C., Dicklin, M.R., Cyrowski, M., Umporowicz, D.M., Nagata, Y., Moon, G., Forusz, S., Davidson, M.H. 2002. Improved calcium absorption from a newly formulated beverage compared with a calcium carbonate tablet. Nutr. Res. 22, 1163-1176. Clinical Studies -Van den Heuvel EG, Muys T, van Dokkum W, Schaafsma G. Oligofructose stimulates calcium absorption in adolescents. Am J Clin Nutr. 1999 Mar;69(3):544-8. Clinical Studies -Van den Heuvel E, Schaafsma G, Muys T, van Dokkum W. 1998; Nondigestible oligosaccharides do not interfere with calcium and nonheme-iron absorption in young, healthy men. Am J Clin Nutr 67, 445-451 Claim ID Page 1,716 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal Studies -Coudray C, Rambeau M, Feillet-Coudray C, Tressol JC, Demigne C, Gueux E, Mazur A, Rayssiguier Y. 2005. Dietary inulin intake and age can significantly affect intestinal absorption of calcium and magnesium in rats: a stable isotope approach. Nutr J. Oct 27;4:29. Animal Studies -Coudray C, Tressol JC, Gueux E, Rayssiguier Y. 2003. Effects of inulin-type fructans of different chain length and type of branching on intestinal absorption and balance of calcium and magnesium in rats. Eur J Nutr. Apr;42(2):91-8. Animal Studies -Delzenne N, Aertssens J, Verplaetse H, Roccaro M, Roberfroid M. 1995. Effect of fermentable fructo-oligosaccharides on mineral, nitrogen and energy digestive balance in the rat. Life Sci. 57(17):1579-87. Animal Studies -Levrat MA, Remesy C, Demigne C. High propionic acid fermentations and mineral accumulation in the cecum of rats adapted to different levels of inulin. J Nutr. 1991 Nov;121(11):1730-7. Animal Studies -Lopez HW, Coudray C, Levrat-Verny MA, Feillet-Coudray C, Demigne C, Remesy C. 2000. Fructooligosaccharides enhance mineral apparent absorption and counteract the deleterious effects of phytic acid on mineral homeostasis in rats. J Nutr Biochem. Oct;11(10):500-8 Animal Studies -Nzeusseu A, Dienst D, Haufroid V, Depresseux G, Devogelaer JP, Manicourt DH. Inulin and fructo-oligosaccharides differ in their ability to enhance the density of cancellous and cortical bone in the axial and peripheral skeleton of growing rats. Bone. 2006 Mar;38(3):394-9. Claim ID Page 1,717 of 3,931 Category Food Component Health Relationship Cholesterol lowering/ maintenance 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 9g/day Nature of Evidence References Animal Studies -Raschka L, Daniel H. Mechanisms underlying the effects of inulin-type fructans on calcium absorption in the large intestine of rats. Bone. 2005 Nov;37(5):728-35. Animal Studies -Roberfroid MB, Cumps J, Devogelaer JP. 2002. Dietary chicory inulin increases whole-body bone mineral density in growing male rats. J Nutr. Dec;132(12):3599-602. Animal Studies -Scholz-Ahrens KE, Acil Y, Schrezenmeir J. 2002. Effect of oligofructose or dietary calcium on repeated calcium and phosphorus balances, bone mineralization and trabecular structure in ovariectomized rats. Br J Nutr 88(4):365-77 DIETARY FIBRE Inulin from Chicory 4 Review -Delzenne, N.M. and Williams, C.M. (2002) Prebiotics and lipid metabolism. Curr. Opinion Lipidol. 13 (1): 61-67. Review -Delzenne NM, Kok N. Effects of fructans-type prebiotics on lipid metabolism. Am J Clin Nutr. 2001 Feb;73(2 Suppl):456S-458S. Clinical Studies -Alles, M.S., de Roos, N.M., Baks, J.C., van de Lisdonk, E., Zock, P.L., Hautvast, J.G. 1999. Consumption of fructooligosaccharides does not favorably affect blood glucose and serum lipid concentrations in patients with type 2 diabetes. Am. J. Clin. Nutr. 69, 64-69 Clinical Studies -Brighenti, F., Casiraghi, M.C., Canzi, E. and Ferrari, A. 1999. Effect of consumption of a ready-to¬eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy male volunteers. Eur. J. Clin. Nutr. 53, 726-733 Claim ID 185 Page 1,718 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Canzi, E., Brighenti, F., Casiraghi, M.C., Del Puppo, E., Ferrari, A. 1995. Prolonged consumption of inulin in ready-to-eat breakfast cereals: effects on intestinal ecosystem, bowel habits and lipid metabolism. p. 280-284 in 'Dietary fibre and fermentation in the colon', Proc. COST action 92 workshop, Finland. Clinical Studies -Causey, J.L., Feirtag, J.M., Gallaher, D.D., Tungland, B.C., Slavin, J.L. 2000. Effects of dietary inulin on serum lipids, blood glucose and the gastrointestinal environment in hypercholesterolemic men. Nutr. Res. 20, 191-201 Clinical Studies -Davidson, M.H., Maki, K.C., Synecki, C., Torri, S.A., Drennan, K.B. 1998. Effects of dietary inulin on serum lipids in men and women with hypercholesterolemia. Nutr. Res. 18, 503-517 Clinical Studies -Jackson, K.G., Taylor, G.R.J., Clohessy, A.M., Williams, C.M. 1999. The effect of daily intake of inulin on fasting lipid, insulin and glucose concentrations in middle-aged men and women. Br. J. Nutr. 82, 23-30 Clinical Studies -Letexier D, Diraison F, Beylot M. Addition of inulin to a moderately high-carbohydrate diet reduces hepatic lipogenesis and plasma triacylglycerol concentrations in humans. Am J Clin Nutr. 2003 Mar;77(3):559-64. Clinical Studies -Pedersen, A., Sandstrom, B., van Amelsfoort, J.M.M. 1997. The effect of inulin on blood lipids and gastrointestinal symptoms in healthy females. Br. J. Nutr. 78, 215-222. Claim ID Page 1,719 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Van Dokkum, W., Wezendonk, B., Srikumar, T.S., van den Heuvel, E.G. 1999. Effect of nondigestible oligosaccharides on large-bowel functions, blood lipid concentrations and glucose absorption in young healthy male subjects. Eur. J. Clin. Nutr. 53, 1-7 Animal Studies -Delzenne N, Kok N, Fiordaliso M. 1993 Dietary fructooligosaccharides modify lipid metabolism in rats. Am J Clin Nutr 5:820S. Animal Studies -Diez, M., Hornick, J.L., Baldwin, P., van Eenaeme, C., Istasse, L. 1998. Study of dietary fibre in dog's diet: results of 7 experimental trials. Ann. Med. Vet. 142, 185-201 Animal Studies -Fiordaliso, M., Kok, N., Desager, J.-P., Goethals, F., Deboyser, D., Roberfroid, M., Delzenne, N. 1995. Dietary oligofructose lowers triglycerides, phospholipids and cholesterol in serum and very low density lipoproteins in rats. Lipids 30, 163-167. Animal Studies -Kok, N.N., Taper, H.S., Delzenne, N.M. 1998. Oligofructose modulates lipid metabolism alterations induced by a fat-rich diet in rats. J. Appl. Toxicol. 18, 47-53 Animal Studies -Levrat, M.A., Favier, M.L., Moundras, C., Remesy, C., Demigne, C., Morand, C. 1994. Role of dietary propionic acid and bile acid excretion in the hypocholesterolemic effects of oligosaccharides in rats. J. Nutr. 124, 531-538. Animal Studies -Levrat, M.A., Remesy, C., Demigne, C. 1991. High propionic acid fermentations and mineral accumulation in the cecum of rats adapted to different levels of inulin. J. Nutr. 121, 1730-1737 Claim ID Page 1,720 of 3,931 Category Food Component Health Relationship Improved intestinal conditions (pH, SCFA production) and intestinal functions 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 5g/day Nature of Evidence References Animal Studies -Trautwein, E.A., Rieckhoff, D., Erbersdobler, H.F. 1998. Dietary inulin lowers plasma cholesterol and triacylglycerol and alters biliary bile acid profile in hamsters. J. Nutr. 128, 1937-1943 Animal Studies -Vanhoof K., De Schrijver R. Effect of unprocessed and baked inulin on lipid metabolism in normo and hypercholesterolemic rats. Nutr. Res. 1995; 15:1637-1646 Dietary Fibre - Inulin from Chicory 2 Authoritative/Scientific Bodies -AFSSA. 2005. Effects of probiotics and prebiotics on flora and immunity in adults. ISBN 2-11-095439-6 http://www.isapp.net/PDF/AFFSAprobioticprebi oticfloraimmunity05.pdf Authoritative/Scientific Bodies -VC (the Netherlands): Assessment report of VC on Vitaalbrood Flora http://www.voedingscentrum.nl/NR/rdonlyres/85 938396-FFD6-44B0-8143-769E3B25A14C/0/be oordelingsrapport_vitaalbrood_florapdf.pdf Book -Ashwell M.; 2002: Concepts of functional foods; ILSI Concise Monograph Series; ISBN 1-57881-145-7 Book -Roberfroid, M. B. 2005. Inulin-type fructans, functional food ingredients. CRC Press, Boca Raton, FL. ISBN 0-8493-0059-2. Reviews -Cummings, J. H., G. T. Macfarlane, and H. N. Englyst. 2001. Prebiotic digestion and fermentation. Am J Clin Nutr 73:(2) 415S-420. Reviews -Gibson, G. R., H. Probert, J. van Loo, R. A. Rastall, and M. B. Roberfroid. 2004. Dietary modulation of the human colonic microbiota: Updating the concept of prebiotics. Nutr. Res. Rev. 17:(2) 259-275. Claim ID 183 Page 1,721 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Reviews -Gibson, G., and M. Roberfroid. 1995. Dietary modulation of the human colonic microbiota: Introducing the concept of prebiotics. J. Nutr. 125:(6) 1401-1412. Reviews -Guarner F. Inulin and oligofructose: impact on intestinal diseases and disorders. Br J Nutr. 2005 Apr;93 Suppl 1:S61-5. Reviews -Kaur N., Gupta A.; 2002; Applications of inulin and oligofructose in health and nutrition; J. Bioscience.; 27; 7; 703-714. Reviews -Losada M.; Olleros T; 2002; Towards a healthier diet for the colon: the influence of fructooligosaccharides and lactobacilli on intestinal health; Nutrition Research; 22; 71-84. Reviews -Macfarlane S, Macfarlane GT, Cummings JH. Review article: prebiotics in the gastrointestinal tract. Aliment Pharmacol Ther. 2006 Sep 1;24(5):701-14. Reviews -Nyman M. Fermentation and bulking capacity of indigestible carbohydrates: the case of inulin and oligofructose. Br J Nutr. 2002 May;87 Suppl 2:S163-8. Reviews -Roberfroid MB. Introducing inulin-type fructans. Br J Nutr. 2005 Apr;93 Suppl 1:S13-25 Reviews -Saavedra J. M.; Tschernia A..; 2002; Human studies with probiotics and prebiotics: clinical implications; BJN; 87; Suppl. 2; S241-S246. Reviews -Van Loo J.; 2004; Prebiotics promote good health; the basis, the potential and the emerging evidence; J. Clin. Gastroenterol.; 38; 2; S70-S75. Claim ID Page 1,722 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Brighenti F.; Casiraghi MC.; Canzi E.; Ferrari A.; 1999; Effect of consumption of a ready-to-eat breakfast cereal containing inulin on the intestinal milieu and blood lipids in healthy volunteers; Eur. J. Clin. Nutr., 53, pp. 726-733. Clinical Studies -Castiglia-Delavaud C., Verdier E., Besle J., Vernet J., Boirie Y., Beaufrere B., de Baynast R., Vermorel M.; 1998; Net energy value of non-starch polysaccharide isolates (sugarbeet fibre and commercial inulin) and their impact on nutrient digestive utilization in healthy human subjects; BJN., 80, pp. 343-352. Clinical Studies -Causey J.; Feirtag J.; Gallaher D.; Tungland B.; Slavin J.; 2000; Effects of dietary inulin on serum lipids, blood glucose and the gastrointestinal environment in hypercholesterolic men; Nut Res. 20, 2, pp. 191-201. Clinical Studies -Cummings J.; Christie S.; Cole T.; 2001; A study of fructo oligosaccharides in the prevention of travellers’ diarrhoea”; Aliment. Pharmacol. Ther.; 15; 1139-1145. Clinical Studies -Gibson, G.R., Beatty, E.R., Wang, X. and Cummings, J.H. 1995. Selective stimulation of bifidobacteria in the human colon by oligofructose and inulin. Gastroenterolgy 108, 975-982. Clinical Studies -Kleessen B., Sykura B., Zunft H., Blaut M., 1997; Effects of inulin and lactose on fecal microflora, microbial activity, and bowel habit in elderly constipated persons; Am. J; Clin. Nutr., 65, 1397-1402. Claim ID Page 1,723 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Kruse H., Kleessen B., Blaut M., 1999; Effects of inulin on faecal bifidobacteria in human subjects; BJN, 82, 375-382. Clinical Studies -Menne E., Guggenbuhl N., Roberfroid M., 2000; Fn-type Chicory Inulin Hydrolysate Has a Prebiotic Effect in Humans”; J. Nutr., 130, pp. 1197-1199. Clinical Studies -Moore N.; Chao C.; Yang L.; Storm H.; Oliva-Hemker M.; Saavedra J.; 2003; Effects of fructo¬oligosaccharide-supplemented infant cereal: a double-blind, randomized trial; BJN., 90, pp. 581-587. Clinical Studies -Waligora-Dupriet AJ, Campeotto F, Nicolis I, Bonet A, Soulaines P, Dupont C, Butel MJ. 2007. Effect of oligofructose supplementation on gut microflora and well-being in young children attending a day care centre. Int J Food Microbio 1;113(1):108-13. Animal Studies -Campbell JM, Fahey GC Jr, Wolf BW. Selected indigestible oligosaccharides affect large bowel mass, cecal and fecal short-chain fatty acids, pH and microflora in rats. J Nutr. 1997 Jan;127(1):130-6. Animal Studies -Djouzi Z, Andrieux C. Compared effects of three oligosaccharides on metabolism of intestinal microflora in rats inoculated with a human faecal flora. Br J Nutr. 1997 Aug;78(2):313-24. Animal Studies -Levrat MA, Remesy C, Demigne C. 1991. High propionic acid fermentations and mineral accumulation in the cecum of rats adapted to different levels of inulin. J Nutr. 1991 Nov;121(11):1730-7 Claim ID Page 1,724 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal Studies -Roland N, Nugon-Baudon L, Andrieux C, Szylit O. Comparative study of the fermentative characteristics of inulin and different types of fibre in rats inoculated with a human whole faecal flora.Br J Nutr. 1995 Aug;74(2):239-49. In Vitro Studies -Rycroft, C. E., M. R. Jones, G. R. Gibson, and R. A. Rastall. 2001. A comparative in vitro evaluation of the fermentation properties of prebiotic oligosacharides. J. Appl. Microbiol. 91:878-887. In Vitro Studies -Van de Wiele T., Boon, N., Possemiers, S., Jacobs, H.,Verstraete, W. (2004). Prebiotic effects of chicory inulin in the Simulator of the Human Intestinal Microbial Ecosystem. FEMS Microbiology Ecology 51, 143-153. In Vitro Studies -van Nuenen MH, Meyer PD, Venema K. 2003 The effect of various inulins and Clostridium difficile on the metabolic activity of the human colonic microbiota in vitro. Microbial Ecol. Health Dis. 15: 137-144. Claim ID Page 1,725 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Isomalto-oligosaccharides Low Glycemic Index The recommended dosage for Vitasugar (Bioneutra Inc. Isomalto-oligosaccharide product) is 15 to 20 g per day. No adverse effects reported. Women who are pregnant or planning a pregnancy should consult a healthcare professional before taking any food supplements. Hesta et al (2001) The effect of a commercial high-fibre diet and an isomalto-oligosaccharide diet on post-prandial glucose concentrations in dogs. Journal of Animal Physiology and Animal Nutrition 85 (7-8) pp 217-221 784 Normal bowel function/gastrointest inal function/colonic function The recommended dosage for Vitasugar (Bioneutra Inc. Isomalto-oligosaccharide product) is 30g per day. No adverse effects reported. Women who are pregnant or planning a pregnancy should consult a healthcare professional before taking any food supplements. Chen et al, (2001) Effects of isomalto-oligosaccharides on bowel functions and indicators of nutritional status in constipated elderly men. Journal of the American College of Nutrition 20 (1) pp 44-49 787 Wang et al (2001) Use of isomalto-oligosaccharide in the treatment of lipid profiles and constipation in haemodialysis patients. Journal of Renal Nutrition 11 (2) pp 73-79 The recommended dosage for Vitasugar (Bioneutra Inc. Isomalto-oligosaccharide product) is 15 to 20 g per Kohmoto et al (1988) Effect of isomalto-oligosaccharides on human fecal flora. Bifidobacteria Microflora 7 (2) pp 61-69 Prebiotic 31 January 2008 785 Page 1,726 of 3,931 Category Food Component Health Relationship Help to reduce cholesterol levels 31 January 2008 Suggested Conditions of Use Nature of Evidence References day. No adverse effects reported. Women who are pregnant or planning a pregnancy should consult a healthcare professional before taking any food supplements. Kohmoto et al (1991) Dose-response test of isomaltooligosaccharides for increasing fecal bifidobacteria. Agricultural and Biololgical Chemistry 55 (8) pp 2157-2159. The recommended dosage for Vitasugar (Bioneutra Inc. Isomalto-oligosaccharide product) is 30g per day. No adverse effects reported. Women who are pregnant or planning a pregnancy should consult a healthcare professional before taking any food supplements. Chen et al, (2001) Effects of isomalto-oligosaccharides on bowel functions and indicators of nutritional status in constipated elderly men. Journal of the American College of Nutrition 20 (1) pp 44-49 Wang et al (2001) Use of isomalto-oligosaccharide in the treatment of lipid profiles and constipation in haemodialysis patients. Journal of Renal Nutrition 11 (2) pp 73-79 Claim ID 786 Page 1,727 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Nutrim® Oat Bran Contribution to the maintenance of healthy blood glucose levels 7.5 grams of Nutrim® Oat Bran per serving provides 0.75 grams of beta-glucan oat soluble fiber 30 grams of Nutrim® Oat Bran per day provides 3 grams of beta-glucan oat soluble fiber Federal Register U.S. Department of Health and Human Services Food and Drug Administration Scientific Dossier submitted to JCHI U.S. Patent #6,060,519 Oat Beta Glucan Soluble Fiber = 10% Insoluble Fiber = 16% Total Dietary Fiber = 26% Scientific References 1,896 “Food Labeling: Health Claims; Oats and Coronary Heart Disease, Final Rule.” United States Federal Register 62:15 (23 January 1997) p. 15343 “The inclusion of at least 3 grams of oat beta glucan per day as part of a diet low in saturated fat and a health lifestyle can help reduce blood cholesterol.” Scientific Dossier Submitted to the UK Joint Health Claims Initiative. (29 January 2004). http://www.uspto.gov/ Hallfrisch J, Scholfield DJ & Behall KM (1995) Diets containing soluble oat extracts improve glucose and insulin responses of moderately hypercholesterolemic men and women. Am J Clin Nutr 61, 379-384. Jenkins AL, Jenkins DJ, Zdravkovic U, Wursch P & Vuksan V (2002) Depression of the glycemic index by high levels of beta-glucan fiber in two functional foods tested in type 2 diabetes. Eur J Clin Nutr 56, 622-628. 31 January 2008 Page 1,728 of 3,931 Category Food Component Health Relationship Contribution to the maintenance of healthy blood cholesterol levels Suggested Conditions of Use 7.5 grams of Nutrim® Oat Bran per serving provides 0.75 grams of beta-glucan oat soluble fiber 30 grams of Nutrim® Oat Bran per day provides 3 grams of beta-glucan oat soluble fiber Oat Beta Glucan Soluble Fiber = 10% Insoluble Fiber = 16% Total Dietary Fiber = 26% Nature of Evidence Federal Register U.S. Department of Health and Human Services Food and Drug Administration Scientific Dossier submitted to JCHI References References Claim ID 1,895 “Food Labeling: Health Claims; Oats and Coronary Heart Disease, Final Rule.” United States Federal Register 62:15 (23 January 1997) p. 15343 U.S. Patent #6,060,519 Scientific Journal “The inclusion of at least 3 grams of oat beta glucan per day as part of a diet low in saturated fat and a health lifestyle can help reduce blood cholesterol.” Scientific Dossier Submitted to the UK Joint Health Claims Initiative. (29 January 2004). http://www.uspto.gov/ Barter PJ, Brewer HB, Jr., Chapman MJ, Hennekens CH, Rader DJ & Tall AR (2003) Cholesteryl ester transfer protein: a novel target for raising HDL and inhibiting atherosclerosis. Arterioscler Thromb Vasc Biol 23, 160-167. Behall KM, Scholfield DJ & Hallfrisch J (1997) Effect of beta-glucan level in oat fiber extracts on blood lipids in men and women. J Am Coll Nutr 16, 46-51. Maki KC, Galant R, Samuel P, Tesser J, Witchger MS, Ribaya-Mercado JD, Blumberg JB & Geohas J (2006) Effects of consuming foods containing oat [beta]-glucan on blood pressure, carbohydrate metabolism and biomarkers of oxidative stress in men and women with elevated blood pressure. Eur J Clin 31 January 2008 Page 1,729 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Nutr 61, 786-795. Naumann E, van Rees AB, Onning G, Oste R, Wydra M & Mensink RP (2006) Beta-glucan incorporated into a fruit drink effectively lowers serum LDL-cholesterol concentrations. Am J Clin Nutr 83, 601-605. Queenan KM, Stewart ML, Smith KN, Thomas W, Fulcher RG & Slavin JL (2007) Concentrated oat beta-glucan, a fermentable fiber, lowers serum cholesterol in hypercholesterolemic adults in a randomized controlled trial. Nutr J 6, 6. Reyna-Villasmil N, Bermudez-Pirela V, Mengual-Moreno E, et al. (2007) Oat-derived beta-glucan significantly improves HDLC and diminishes LDLC and non-HDL cholesterol in overweight individuals with mild hypercholesterolemia. Am J Ther 14, 203-212. 31 January 2008 Page 1,730 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Oats/ Oats beta-glucan Blood cholesterol Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated Whole oats,/rolled oats/whole oat flour (min 4% beta-glucan), oat bran ( min 5.5% beta glucan) 3g beta glucan/ day - a portion or in an amount that is customarily consumed in a day should contain at least 0,75g of beta-glucan. The claim should be set in the context of a diet that is low saturated fat and a healthy lifestyle The claim relates to whole oats, oat bran, rolled oats and whole oat flour as long as oat bran provides at least 5.5%, rolled oats and whole oats flour at least 4% beta-glucan soluble fibre Products carrying the claim should contain at least 0.75 g oat beta-glucan soluble fibre per serving, or in an 31 January 2008 Authoritative Bodies FDA - Final rule Federal Register: January 23, 1997 (Volume 62, Number 15, Pages 3584-) http://www.fda.gov/ohrms/dockets/dockets/06p 0393/06p-0393-cp00001-038-Tab-F-FR-RulesRegulations-1997-vol2.pdf Authoritative Bodies Federal Office of Public Health Switzerland (BAG) (CH) http://www.bag.admin.ch/index.html?lang=en Authoritative Bodies Ministry for Health Czech Republic 333/1997 amended by decree 936/2000. Czech Republic SZU – Ministry for Health Authoritative Bodies NL Profit/OatWell oat bran bread 177 http://www.voedingscentrum.nl/voedingscentru m/Private/Nieuws/2005/Nieuw%20cholesterolv erlag end%20brood.htm http://www.voedingscentrum.nl/voedingscentru m/Public/Dynamisch/productinformatie/function ele %20voeding/aanbod.htm Authoritative Bodies SNF Sweden - Health claims in the labelling and marketing of food products. The food sector’s code of practice. Revised version September 2004. http://www.hp-info.nu/SweCode_2004_1.pdf Authoritative Bodies UK JHCI Expert Committee - October 04-Approved Claim by the Joint Health Claim Initiative http://www.jhci.co.uk/ Submitter CreaNutrition AG Switzerland Meta-Analysis Brown L, Rosner B, Willett WW, Sacks FM. Cholesterol-lowering effects of dietary fibre: a meta-analysis. Am J Clin Nutr. 1999 Jan;69(1):30-42. Page 1,731 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use amount that is customarily consumed in a day that makes a reasonable contribution to a healthy diet. Products carrying the claim should state what constitutes a serving; the amount of oat beta-glucan soluble fibre provided in each serving, expressed as grams; and the proportion it contributes to a 3 gram suggested daily intake. 31 January 2008 Nature of Evidence References Meta-Analysis Ripsin CM, Keenan JM, Jacobs DR Jr, Elmer PJ, Welch RR, Van Horn L, Liu K, Turnbull WH, Thye FW, Kestin M, et al. Oat products and lipid lowering. A meta-analysis. JAMA. 1992 Jun 24;267(24):3317-25. Reviews Glore SR, van Treeck D, Kehans AW, Giuld M. Soluble fiber and serum lipids: A litterature review. J Am Diet Assoc. 1994; 94:425-436 Reviews Wood PJ, Beer MU. Functional oat products. In book Mazza G (ed.). Functional Foods, Lancaster, USA: Technomic publishing Co. Inc. 1998:1-37 Human Intervention Studies 1984 - 2007 Anderson JW, Story L, Sieling B, Chen WJ, Petro MS, Story J. Hypocholesterolemic effects of oat-bran or bean intake for hypercholesterolaemic men. Am J Clin Nutr. 1984 Dec;40(6):1146-55. Human Intervention Studies 1984 - 2007 Anderson JW, Spencer DB, Hamilton CC, Smith SF, Tietyen J, Bryant CA, Oeltgen P. Oat-bran cereal lowers blood total and LDL cholesterol in hypercholesterolaemic men. Am J Clin Nutr. 1990 Sep;52(3):495-9. Human Intervention Studies 1984 - 2007 Anderson JW, Gilinsky NH, Deakins DA, Smith SF, O'Neal DS, Dillon DW, Oeltgen PR. Lipid responses of hypercholesterolaemic men to oat-bran and wheat-bran intake. Am J Clin Nutr. 1991 Oct;54(4):678-83. Human Intervention Studies 1984 - 2007 Bartram P, Gerlach S, Scheppach W, Keller F, Kasper H. Effect of a single oat bran cereal breakfast on blood cholesterol, lipoproteins, and apolipoproteins in patients with hyperlipoproteinemia type IIa. JPEN J Parenter Enteral Nutr. 1992 Nov-Dec;16(6):533-7. Claim ID Page 1,732 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Beer MU, Arrigoni E, Amado R. Effects of oat gum on blood cholesterol levels in healthy young men. Eur J Clin Nutr. 1995 Jul;49(7):517-22. Human Intervention Studies 1984 - 2007 Behall KM, Scholfield DJ, Hallfrisch J. Effect of beta-glucan level in oat fibre extracts on blood lipids in men and women. J Am Coll Nutr. 1997 Feb;16(1):46-51. Human Intervention Studies 1984 - 2007 Berg A, Konig D, Deibert P, Grathwohl D, Berg A, Baumstark MW, Franz IW. Effect of an oat bran enriched diet on the atherogenic lipid profile in patients with an increased coronary heart disease risk. A controlled randomized lifestyle intervention study. Ann Nutr Metab. 2003;47(6):306-11. Human Intervention Studies 1984 - 2007 Berg A, Konig D, Deibert P, Grathwohl D, Berg A, Baumstark MW, Franz IW. Effect of an oat bran enriched diet on the atherogenic lipid profile in patients with an increased coronary heart disease risk. A controlled randomized lifestyle intervention study. Ann Nutr Metab. 2003;47(6):306-11. Human Intervention Studies 1984 - 2007 Biorklund M, van Rees A, Mensink RP, Onning G. Changes in serum lipids and postprandial glucose and insulin concentrations after consumption of beverages with beta-glucans from oats or barley: a randomised dose-controlled trial. Eur J Clin Nutr. 2005 Nov;59(11):1272-81. Human Intervention Studies 1984 - 2007 Braaten JT, Wood PJ, Scott FW, Wolynetz MS, Lowe MK, Bradley-White P, Collins MW. Oat beta¬glucan reduces blood cholesterol concentration in hypercholesterolaemic subjects. Eur J Clin Nutr. 1994 Jul;48(7):465-74. Claim ID Page 1,733 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Bridges SR, Anderson JW, Deakins DA, Dillon DW, Wood CL. Oat bran increases blood acetate of hypercholesterolaemic men. Am J Clin Nutr. 1992 Aug;56(2):455-9. Human Intervention Studies 1984 - 2007 Cara L, Dubois C, Borel P, Armand M, Senft M, Portugal H, Pauli AM, Bernard PM, Lairon D. Effects of oat bran, rice bran, wheat fibre, and wheat germ on postprandial lipemia in healthy adults. Am J Clin Nutr. 1992 Jan;55(1):81-8. Human Intervention Studies 1984 - 2007 Davidson MH, Dugan LD, Burns JH, Bova J, Story K, Drennan KB. The hypocholesterolemic effects of beta-glucan in oatmeal and oat bran. A dose-controlled study. JAMA. 1991 Apr 10;265(14):1833-9. Human Intervention Studies 1984 - 2007 Davy BM, Davy KP, Ho RC, Beske SD, Davrath LR, Melby CL. High-fibre oat cereal compared with wheat cereal consumption favorably alters LDL-cholesterol subclass and particle numbers in middle-aged and older men. Am J Clin Nutr. 2002 Aug;76(2):351-8. Human Intervention Studies 1984 - 2007 Demark-Wahnefried W, Bowering J, Cohen PS. Reduced blood cholesterol with dietary change using fat-modified and oat bran supplemented diets. J Am Diet Assoc. 1990 Feb;90(2):223-9. Human Intervention Studies 1984 - 2007 Dubois C, Armand M, Senft M, Portugal H, Pauli AM, Bernard PM, Lafont H, Lairon D. Chronic oat bran intake alters postprandial lipemia and lipoproteins in healthy adults. Am J Clin Nutr. 1995 Feb;61(2):325-33. Human Intervention Studies 1984 - 2007 Gerhardt AL, Gallo NB. Full-fat rice bran and oat bran similarly reduce hypercholesterolaemia in humans. J Nutr. 1998 May;128(5):865-9. Claim ID Page 1,734 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Gold K, Wong N, Tong A, Bassin S, Iftner C, Nguyen T, Khoury A, Baker S. Blood apolipoprotein and lipid profile effects of an oat-bran-supplemented, low-fat diet in children with elevated blood cholesterol. Ann N Y Acad Sci. 1991;623:429-31. No abstract available. Human Intervention Studies 1984 - 2007 Gold KV, Davidson DM. Oat bran as a cholesterol-reducing dietary adjunct in a young, healthy population. West J Med. 1988 Mar;148(3):299-302. No abstract available. Human Intervention Studies 1984 - 2007 Hallfrisch J, Scholfield DJ, Behall KM. Diets containing soluble oat extracts improve glucose and insulin responses of moderately hypercholesterolaemic men and women. Am J Clin Nutr. 1995 Feb;61(2):379-84. Human Intervention Studies 1984 - 2007 Hegele RA, Zahariadis G, Jenkins AL, Connelly PW, Kashtan H, Stern H, Bruce R, Jenkins DJ. Genetic variation associated with differences in the response of blood apolipoprotein B levels to dietary fibre. Clin Sci (Lond). 1993 Sep;85(3):269-75. Human Intervention Studies 1984 - 2007 Jenkins DJ, Hegele RA, Jenkins AL, Connelly PW, Hallak K, Bracci P, Kashtan H, Corey P, Pintilia M, Stern H, et al. The apolipoprotein E gene and the blood low-density lipoprotein cholesterol response to dietary fibre. Metabolism. 1993 May;42(5):585-93. Human Intervention Studies 1984 - 2007 Kabir M, Oppert JM, Vidal H, Bruzzo F, Fiquet C, Wursch P, Slama G, Rizkalla SW. Four-week low-glycaemic index breakfast with a modest amount of soluble fibres in type 2 diabetic men. Metabolism. 2002 Jul;51(7):819-26. Human Intervention Studies 1984 - 2007 Kahn RF, Davidson KW, Garner J, McCord RS. Oat bran supplementation for elevated blood cholesterol. Fam Pract Res J. 1990 Fall;10(1):37-46. Claim ID Page 1,735 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Karmally W, Montez MG, Palmas W, Martinez W, Branstetter A, Ramakrishnan R, Holleran SF, Haffner SM, Ginsberg HN. Cholesterol-lowering benefits of oat-containing cereal in Hispanic americans. J Am Diet Assoc. 2005 Jun;105(6):967-70. Human Intervention Studies 1984 - 2007 Kashtan H, Stern HS, Jenkins DJ, Jenkins AL, Hay K, Marcon N, Minkin S, Bruce WR. Wheat-bran and oat-bran supplements' effects on blood lipids and lipoproteins. Am J Clin Nutr. 1992 May;55(5):976-80. Human Intervention Studies 1984 - 2007 Keenan JM, Pins JJ, Frazel C, Moran A, Turnquist L. Oat ingestion reduces systolic and diastolic blood pressure in patients with mild or borderline hypertension: a pilot trial. J Fam Pract. 2002 Apr;51(4):369. Human Intervention Studies 1984 - 2007 Keenan JM, Wenz JB, Ripsin CM, Huang Z, McCaffrey DJ. A clinical trial of oat bran and niacin in the treatment of hyperlipidemia. J Fam Pract. 1992 Mar;34(3):313-9. Human Intervention Studies 1984 - 2007 Keenan JM, Wenz JB, Myers S, Ripsin C, Huang ZQ. Randomized, controlled, crossover trial of oat bran in hypercholesterolaemic subjects. J Fam Pract. 1991 Dec;33(6):600-8. Human Intervention Studies 1984 - 2007 Kelley MJ, Hoover-Plow J, Nichols-Bernhard JF, Verity LS, Brewer H. Oat bran lowers total and low-density lipoprotein cholesterol but not lipoprotein(a) in exercising adults with borderline hypercholesterolaemia. J Am Diet Assoc. 1994 Dec;94(12):1419-21. No abstract available. Human Intervention Studies 1984 - 2007 Kerckhoffs DA, Hornstra G, Mensink RP. Cholesterol-lowering effect of beta-glucan from oat bran in mildly hypercholesterolaemic subjects may decrease when beta-glucan is incorporated into bread and cookies. Am J Clin Nutr. 2003 Aug;78(2):221-7. Claim ID Page 1,736 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Kestin M, Moss R, Clifton PM, Nestel PJ. Comparative effects of three cereal brans on blood lipids, blood pressure, and glucose metabolism in mildly hypercholesterolaemic men. Am J Clin Nutr. 1990 Oct;52(4):661-6. Human Intervention Studies 1984 - 2007 Leadbetter J, Ball MJ, Mann JI. Effects of increasing quantities of oat bran in hypercholesterolaemic people. Am J Clin Nutr. 1991 Nov;54(5):841-5. Human Intervention Studies 1984 - 2007 Lepre F, Crane S. Effect of oatbran on mild hyperlipidaemia. Med J Aust. 1992 Sep 7;157(5):305-8. Human Intervention Studies 1984 - 2007 Lia Amundsen A, Haugum B and Andersson H. Changes in blood cholesterol and sterol metabolites after intake of products enriched with oat bran concentrate within a controlled diet. Scan. J. Nutr. (2003) 47 (2): 68-74. Human Intervention Studies 1984 - 2007 Lovegrove JA, Clohessy A, Milon H, Williams CM. Modest doses of beta-glucan do not reduce concentrations of potentially atherogenic lipoproteins. Am J Clin Nutr. 2000 Jul;72(1):49-55. Human Intervention Studies 1984 - 2007 Mackay S, Ball MJ. Do beans and oat bran add to the effectiveness of a low-fat diet? Eur J Clin Nutr. 1992 Sep;46(9):641-8. Human Intervention Studies 1984 - 2007 Marlett JA, Hosig KB, Vollendorf NW, Shinnick FL, Haack VS, Story JA. Mechanism of blood cholesterol reduction by oat bran. Hepatology. 1994 Dec;20(6):1450-7. Human Intervention Studies 1984 - 2007 Naumann E, van Rees AB, Onning G, Oste R, Wydra M, Mensink RP. Beta-glucan incorporated into a fruit drink effectively lowers serum LDL-cholesterol concentrations. Am J Clin Nutr. 2006 Mar;83(3):601-5. Claim ID Page 1,737 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Noakes M, Clifton PM, Nestel PJ, Le Leu R, McIntosh G. Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia. Am J Clin Nutr. 1996 Dec;64(6):944-51. Human Intervention Studies 1984 - 2007 O'Kell RT, Duston AA. Lack of effect of dietary oats on blood cholesterol. Mo Med. 1988 Nov;85(11):726-8. No abstract available. Human Intervention Studies 1984 - 2007 Onning G, Wallmark A, Persson M, Akesson B, Elmstahl S, Oste R. Consumption of oat milk for 5 weeks lowers blood cholesterol and LDL cholesterol in free-living men with moderate hypercholesterolaemia. Ann Nutr Metab. 1999;43(5):301-9. Human Intervention Studies 1984 - 2007 Onning G, Akesson B, Oste R, Lundquist I. Effects of consumption of oat milk, soya milk, or cow's milk on blood lipids and antioxidative capacity in healthy subjects. Ann Nutr Metab. 1998;42(4):211-20. Human Intervention Studies 1984 - 2007 Pick ME, Hawrysh ZJ, Gee MI, Toth E, Garg ML, Hardin RT. Oat bran concentrate bread products improve long-term control of diabetes: a pilot study. J Am Diet Assoc. 1996 Dec; 96(12):1254-61. Human Intervention Studies 1984 - 2007 Pins JJ, Geleva D, Keenan JM, Frazel C, O'Connor PJ, Cherney LM. Do whole-grain oat cereals reduce the need for antihypertensive medications and improve blood pressure control? J Fam Pract. 2002 Apr;51(4):353-9. Human Intervention Studies 1984 - 2007 Poulter N, Chang CL, Cuff A, Poulter C, Sever P, Thom S. Lipid profiles after the daily consumption of an oat-based cereal: a controlled crossover trial. Am J Clin Nutr. 1994 Jan;59(1):66-9. Claim ID Page 1,738 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Redard CL, Davis PA, Schneeman BO. Dietary fibre and gender: effect on postprandial lipemia. Am J Clin Nutr. 1990 Nov;52(5):837-45. Human Intervention Studies 1984 - 2007 Robitaille J, Fontaine-Bisson B, Couture P, Tchernof A, Vohl MC. Effect of an oat bran-rich supplement on the metabolic profile of overweight premenopausal women. Ann Nutr Metab. 2005 May-Jun;49(3):141-8. Epub 2005 May 24. Human Intervention Studies 1984 - 2007 Romero AL, Romero JE, Galaviz S, Fernandez ML. Cookies enriched with psyllium or oat bran lower blood LDL cholesterol in normal and hypercholesterolaemic men from Northern Mexico. J Am Coll Nutr. 1998 Dec;17(6):601-8. Human Intervention Studies 1984 - 2007 Saltzman E, Das SK, Lichtenstein AH, Dallal GE, Corrales A, Schaefer EJ, Greenberg AS, Roberts SB. An oat-containing hypocaloric diet reduces systolic blood pressure and improves lipid profile beyond effects of weight loss in men and women. J Nutr. 2001 May;131(5):1465-70. Human Intervention Studies 1984 - 2007 Saudia TL, Barfield BR, Barger J. Effect of oat bran consumption on total blood cholesterol levels in healthy adults. Mil Med. 1992 Nov;157(11):567-8. Human Intervention Studies 1984 - 2007 Spiller GA, Farquhar JW, Gates JE, Nichols SF. Guar gum and blood cholesterol. Effect of guar gum and an oat fibre source on blood lipoproteins and cholesterol in hypercholesterolaemic adults. Arterioscler Thromb. 1991 Sep-Oct;11(5):1204-8. Human Intervention Studies 1984 - 2007 Stevens J, Burgess MB, Kaiser DL, Sheppa CM. Outpatient management of diabetes mellitus with patient education to increase dietary carbohydrate and fibre. Diabetes Care. 1985 Jul-Aug;8(4):359-66. Claim ID Page 1,739 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Stewart FM, Neutze JM, Newsome-White R. The addition of oatbran to a low fat diet has no effect on lipid values in hypercholesterolaemic subjects. N Z Med J. 1992 Oct 14;105(943):398-400. Human Intervention Studies 1984 - 2007 Swain JF, Rouse IL, Curley CB, Sacks FM. Comparison of the effects of oat bran and low-fibre wheat on blood lipoprotein levels and blood pressure. N Engl J Med. 1990 Jan 18;322(3):147-52. Human Intervention Studies 1984 - 2007 Theuwissen E and Mensink RP, Simultaneous Intake of R-Glucan and Plant Stanol Esters Affects Lipid Metabolism in Slightly Hypercholesterolemic Subjects, J Nutr. 2007, 137;583-588 Human Intervention Studies 1984 - 2007 Torronen R, Kansanen L, Uusitupa M, Hanninen O, Myllymaki O, Harkonen H, Malkki Y. Effects of an oat bran concentrate on blood lipids in free-living men with mild to moderate hypercholesterolaemia. Eur J Clin Nutr. 1992 Sep;46(9):621-7. Human Intervention Studies 1984 - 2007 Trinidad TP, Loyola AS, Mallillin AC, Valdez DH, Askali FC, Castillo JC, Resaba RL, Masa DB. The cholesterol-lowering effect of coconut flakes in humans with moderately raised serum cholesterol. J Med Food. 2004 Summer;7(2):136-40. Human Intervention Studies 1984 - 2007 Uusitupa MI, Miettinen TA, Sarkkinen ES, Ruuskanen E, Kervinen K, Kesaniemi YA. Lathosterol and other non-cholesterol sterols during treatment of hypercholesterolaemia with beta-glucan-rich oat bran. Eur J Clin Nutr. 1997 Sep;51(9):607-11. Claim ID Page 1,740 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Human Intervention Studies 1984 - 2007 Uusitupa MI, Ruuskanen E, Makinen E, Laitinen J, Toskala E, Kervinen K, Kesaniemi YA. A controlled study on the effect of beta-glucan-rich oat bran on blood lipids in hypercholesterolaemic subjects: relation to apolipoprotein E phenotype. J Am Coll Nutr. 1992 Dec;11(6):651-9. Human Intervention Studies 1984 - 2007 Van Horn L, Moag-Stahlberg A, Liu KA, Ballew C, Ruth K, Hughes R, Stamler J. Effects on blood lipids of adding instant oats to usual American diets. Am J Public Health. 1991 Feb;81(2):183-8. Human Intervention Studies 1984 - 2007 Van Horn L, Emidy LA, Liu KA, Liao YL, Ballew C, King J, Stamler J. Blood lipid response to a fat-modified, oatmeal-enhanced diet. Prev Med. 1988 May;17(3):377-86. Human Intervention Studies 1984 - 2007 Van Horn LV, Liu K, Parker D, Emidy L, Liao YL, Pan WH, Giumetti D, Hewitt J, Stamler J. Blood lipid response to oat product intake with a fat-modified diet. J Am Diet Assoc. 1986 Jun;86(6):759-64. Human Intervention Studies 1984 - 2007 Vorster HH, Lotter AP, Odendaal I. Effects of an oats fibre tablet and wheat bran in healthy volunteers. S Afr Med J. 1986 Mar 29;69(7):435-8. Human Intervention Studies 1984 - 2007 Whyte JL, McArthur R, Topping D, Nestel P. Oat bran lowers blood cholesterol levels in mildly hypercholesterolaemic men. J Am Diet Assoc. 1992 Apr;92(4):446-9. Human Intervention Studies 1984 - 2007 Winblad I, Joensuu T, Korpela H. Effect of oat bran supplemented diet on hypercholesterolaemia. Scand J Prim Health Care. 1995 Jun;13(2):118-21. Claim ID Page 1,741 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human Intervention Studies 1984 - 2007 31 January 2008 References Claim ID Zhang JX, Hallmans G, Andersson H, Bosaeus I, Aman P, Tidehag P, Stenling R, Lundin E, Dahlgren S. Effect of oat bran on blood cholesterol and bile acid excretion in nine subjects with ileostomies. Am J Clin Nutr. 1992 Jul;56(1):99-105. Page 1,742 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Oligofructose-enriched inulin (specific selection of short & long chains) from chicory Increased calcium absorption 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 8g/day DIETARY FIBRE Inulin from Chicory 6 Oligofructose-enriched inulin: Increased Ca absorption 1. Scientific support for oligofructose-enriched inulin Book -Roberfroid M.; 2005; "Inulin-type fructans and the intestinal absorption of minerals"; Inulin-type fructans; CRC Series in Modern Nutrition; ISBN 0-8493-0059-2; 183-238. Clinical Studies -Abrams S.; Griffin I.; Hawthorne K.; Liang L.; Gunn S.; Darlington G.; Ellis K.; 2005; "A combination of prebiotic short- and long-chain inulin-type fructans enhances calcium absorption and bone mineralisation in young adolescents"; Am J Clin Nut; 82; 471-476. Clinical Studies -Griffin I.; Davila P.; Abrams S.; 2002; "Non-digestible oligosaccharides and calcium absorption in girls with adequate calcium intakes"; BJN; 87; S187-S191. Clinical Studies -Griffin I.; Hicks P.; Heaney R.; Abrams S.; 2003; "Enriched chicory inulin increases calcium absorption mainly in girls with lower calcium absorption"; Nutrition Research; 23; 901-909. Clinical Studies -Holloway L.; Moynihan S.; Abrams S.; Kent K.; Hsu A.; Friedlander A.; 2007; "Effects of oligofructose enriched inulin on calcium and magnesium absorption and bone turnover markers in postmenopausal women"; BJN; 97(2); 365-372. 187 Page 1,743 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal Studies -Coudray C.; Tressol J.; Gueux E.; Rayssiguier Y. ; 2003; « Effects of inulin-type fructans of different chain length and type of branching on intestinal absorption and balance of calcium and magnesium in rats; Eur. J. Nutr.; 42;91-98. Animal Studies -Coudray C.; Feillet-Coudray C.; Tressol J.; Gueux E.; Thien S.; Jaffrelo L.; Mazur A.; Rayssiguier; 2005a; "Stimulatory effect of inulin on intestinal absorption of calcium and magnesium in rats is modulated by dietary calcium intakes: Short- and long-term balance studies" Eur J Nutr 44, 293-302. Animal Studies -Coudray C.; Rambeau M.; Feillet-Coudray C.; Tressol J.; Demigne C.; Gueux E.; Mazur A.; Rayssiguier; 2005b; "Dietary inulin intake and age can significantly affect intestinal absorption of calcium and magnesium in rats: a stable isotope approach" Nutrition Journal 4:29. 2. Scientific support: Inulin & oligofructose Expert Review & Opinion -Cashman K.; Dept. of Food and Nutritional Sciences, and Medicine, University College, Cork, Ireland; 2004; "Prebiotics and Calcium bioavailability"; Curr. Issues Intest. Microbiol.; 4; 21-32. Clinical Studies -Coudray C.; Bellanger J.; Castiglia-Delavaud C.; Remesy C.; Vermorel M.; Rayssignuier Y.; 1997; "Effect of soluble or partly soluble dietary fibres supplementation on absorption and balance of calcium, magnesium, iron and zinc in healthy young men."Eur. J. Clin. Nutr., 51(6); pp. 375-380. Clinical Studies -Kim Y.; Jang K.; Lee E.; Cho Y.; Kang A.; Ha W.; Choue R.; 2004; "The effect of chicory fructan fiber on calcium absorption and bone metabolism in Korean Postmenopausal women"; Nutritional Sciences; 7(3); 151-157. Claim ID Page 1,744 of 3,931 Category Food Component Health Relationship Increased bone mineral density 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 8g/day Nature of Evidence References Clinical Studies -Van den Heuvel E.; Muys T.; van Dokkum W.; Schaafsma G.; 1999; "Oligofructose stimulates calcium absorption in adolescents." Am. J. Clin. Nutr., 69; pp. 544-548. Clinical Studies -Van den Heuvel E.; Schaafsma G.; Muys T.; van Dokkum W.; 1998; "Nondigestible oligosaccharides do not interfere with calcium and nonheme-iron absorption in young, healthy men" Am J Clin Nutr 67, 445-451. Animal Studies -Delzenne N.; Aertssens J.; Verplaetse N.; Roccaro M.; Roberfroid M.; 1995; "Effect of fermentable fructo-oligosaccharides on energy and nutrients absorption in the rat." Life Science, 57(17); pp. 1579-1587. Animal Studies -Levrat, M-A.; Remesy, C.; Demigne C.; 1991; "High propionic acid fermentations and mineral accumulation in the cecum of rats adapted to different levels of inulin." J. Nutr., 121; pp. 1730-1737. DIETARY FIBRE Inulin from Chicory 7 Oligofructose-enriched inulin: Increased bone mineral density 1. Scientific support for oligofructose-enriched inulin Book -Roberfroid M.; 2005; "Inulin-type fructans and the intestinal absorption of minerals"; Inulin-type fructans; CRC Series in Modern Nutrition; ISBN 0-8493-0059-2; 183-238 Review -Cashman K.; 2006; "A prebiotic substance persistently enhances intestinal calcium absorption and increases bone mineralisation in young adolescents"; ILSI; Nutrition Reviews; 64; 4. Review -Coxam V.; 2005; "Inulin-type fructans and bone health: state of the art and perspectives in the management of osteoporosis"; BJN; 93; S1; S111-S123. Claim ID 188 Page 1,745 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Review -Franck A.; 2006;"Oligofructose-enriched inulin stimulates calcium absorption and bone mineralisation"; British Nutrition Foundation Nutrition Bulletin; 31; 341-345. Review -Weaver C.; 2005; "Inulin, oligofructose and bone health: experimental approaches and mechanisms"; BJN;93; S1; S99-S103. Clinical Studies -Abrams S.; Griffin I.; Hawthorne K.; Liang L.; Gunn S.; Darlington G.; Ellis K.; 2005; "A combination of prebiotic short- and long-chain inulin-type fructans enhances calcium absorption and bone mineralisation in young adolescents"; Am J Clin Nut; 82; 471-476. Clinical Studies -Griffin I.; Davila P.; Abrams S.; 2002; "Non-digestible oligosaccharides and calcium absorption in girls with adequate calcium intakes"; BJN; 87; S187-S191. Clinical Studies -Griffin I.; Hicks P.; Heaney R.; Abrams S.; 2003; "Enriched chicory inulin increases calcium absorption mainly in girls with lower calcium absorption"; Nutrition Research; 23; 901-909. Clinical Studies -Holloway L.; Moynihan S.; Abrams S.; Kent K.; Hsu A.; Friedlander A.; 2007; "Effects of oligofructose enriched inulin on calcium and magnesium absorption and bone turnover markers in postmenopausal women"; BJN; 97(2); 365-372. Animal Studies -Coudray C.; Tressol J.; Gueux E.; Rayssiguier Y. ; 2003; « Effects of inulin-type fructans of different chain length and type of branching on intestinal absorption and balance of calcium and magnesium in rats"; Eur. J. Nutr.; 42;91-98. Claim ID Page 1,746 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal Studies -Coudray C.; Feillet-Coudray C.; Tressol J.; Gueux E.; Thien S.; Jaffrelo L.; Mazur A.; Rayssiguier; 2005a; "Stimulatory effect of inulin on intestinal absorption of calcium and magnesium in rats is modulated by dietary calcium intakes: Short- and long-term balance studies" Eur J Nutr 44, 293-302. Animal Studies -Coudray C.; Rambeau M.; Feillet-Coudray C.; Tressol J.; Demigne C.; Gueux E.; Mazur A.; Rayssiguier; 2005b; "Dietary inulin intake and age can significantly affect intestinal absorption of calcium and magnesium in rats: a stable isotope approach" Nutrition Journal 4:29. Animal Studies -Zafar T.; Weaver C.; Zhao., Martin B.; Wastney E.; 2003; "Nondigestible oligosaccharides increase calcium absorption and suppress bone resorption in ovariectomised rats"; J. Nutr.; 134; 399-402. 2. Scientific support for inulin and oligofructose Animal Studies -Delzenne N.; Aertssens J.; Verplaetse N.; Roccaro M.; Roberfroid M.; 1995; "Effect of fermentable fructo-oligosaccharides on energy and nutrients absorption in the rat."Life Science, 57(17); pp. 1579-1587. Animal Studies -Levrat, M-A.; Remesy, C.; Demigne C.; 1991; "High propionic acid fermentations and mineral accumulation in the cecum of rats adapted to different levels of inulin." J. Nutr., 121; pp. 1730-1737. Animal Studies -Lobo A.; Colli C.; Filisetti T.; 2006; "Fructooligosaccharides improve bone mass and biomechanical properties in rats"; Nutr Res 26, 413-420. Animal Studies -Roberfroid M.; Cumps J.; Devogelaer J.; 2002; "Dietary Chicory Inulin Increases Whole-Body Bone Mineral Density in Growing Male Rats"; J. Nutr.; 132; 3599-3602. Claim ID Page 1,747 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Animal Studies -Scholz-Ahrens K..; Acil Y.; Schrezenmeir J.; 2002; "Effect of oligofructose or dietary calcium on repeated calcium and phosphorous balances, bone mineralization and trabecular structure in ovariectomised rats"; BJN; 88; 365-377. 3. Scientific support: BMD as a predictor for bone fracture risk & bone strength Individual Studies -Cummings S.; Black D.; Nevitt M.; Browner W.; Cauly J.; Ensrud K.; Genant H.; Palermo L.; Scott J.; Vogt T.; 1993; "Bone density at various sites for prediction of hip fractures" The Lancet, 341, 72-75. Individual Studies -Goulding A.; Cannan R.; Williams S.; Gold E.; Taylor R.; Lewis-Barned N.; 1998; "Bone mineral density in girls with forearm fractures"; J Bone & Min Res, 13, 143-148. Individual Studies -Goulding A.; Jones I.; Taylor R.; Manning P.; Williams S.; 2000;"More broken bones: a 4-year double cohort study of young girls with and without distal forearm fractures" J Bone & Min Res, 15, 10, 2011. Individual Studies -Marshall D., Johnell O., Wedel H., 1996; "Meta-analysis of how well measures of bone mineral density predict occurrence of osteoporotic fractures" BMJ 312, 1254-1259. Individual Studies -Schott A.; Cormier C.; Hans D.; Favier F.; Hausherr E.; Dargent-Molina P.; Delmas P.; Ribot C.; Sebert J.; Breart G.; Meunier P.; 1998; "How hip and whole-body bone mineral density predict hip fracture in elderly women: the EPIDOS prospective study"; Osteoporosis Int 8, 247-254. Claim ID Page 1,748 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Partially Hydrolysed Guar Gum (PHGG) General bowel health Digestive health Bowel movement Laxation and regularity 31 January 2008 AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) PHGG general: 5–10 g/day 631 Page 1,749 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Publication IOM guideline 31 January 2008 References Claim ID Uneddu et al. European Bulletin of Drug Research 2005;13(1):1-6 Giaccari S, Grasso G, Tronci S, Allegretta L, Sponziello G, Montefusco A, Siciliano IG, Guarisco R, Candiani C, Chiri S. Clin Ter. 2001 152(1):21-5 Parisi GC, Zilli M, Miani MP, Carrara M, Bottona E, Verdianelli G, Battaglia G, Desideri S, Faedo A, Marzolino C, Tonon A, Ermani M, Leandro G. Dig Dis Sci. 2002 (8):1697-704 Parisi G, Bottona E, Carrara M, Cardin F, Faedo A, Goldin D, Marino M, Pantalena M, Tafner G, Verdianelli G, Zilli M, Leandro G. Dig Dis Sci. 2005 50(6):1107-12 Giannini EG, Mansi C, Dulbecco P, Savarino V. Nutrition. 2006 22(3):334-42 Nakamura S, Hongo R, Moji K, Oku T. Eur J Clin Nutr. 2007 Alam NH, Meier R, Sarker SA, Bardhan PK, Schneider H, Gyr N. Arch Dis Child. 2005 90(2):195-9 Spapen H, Diltoer M, Van Malderen C, Opdenacker G, Suys E, Huyghens L. Clin Nutr. 2001 20(4):301-5 Alam NH, Meier R, Schneider H, Sarker SA, Bardhan PK, Mahalanabis D, Fuchs GJ, Gyr N. J Pediatr Gastroenterol Nutr. 2000 31(5):503-7 Homann HH, Kemen M, Fuessenich C, Senkal M, Zumtobel V. J Parenter Enteral Nutr. 1994 18(6):486-90 Patrick PG, Gohman SM, Marx SC, DeLegge MH, Greenberg NA. J Am Diet Assoc. 1998 98(8):912-4 Takahashi H, Wako N, Okubo T, Ishihara N, Yamanaka J, Yamamoto T. J Nutr Sci Vitaminol (Tokyo). 1994 40(3):251-9 Takahashi H, Yang S, Hayashi C, Kim M, Yamanaka J, Yamamoto T. Nutr Res. 1993 13:649-657 Yamatoya K, Kuwano K, Suzuki J, Mitamura T, Page 1,750 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Sekiya K. Oyo Toshitsu Kagaku 1995 42(3):251-257 DeLegge MH et al. Gastroenterology 1995, 108/4: A722 Naito Y, Takagi T, Katada K, Uchiyama K, Kuroda M, Kokura S, Ichikawa H, Watabe J, Yoshida N, Okanoue T, Yoshikawa T. J Nutr Biochem. 200617(6):402-9 (animal study) Institute of Medicine (IOM). Dietary, Functional, and Total Fiber. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D. C., National Academies Press; 2002: 265-334 Bowel health/SCFA production AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) Publication Valazquez M, Davies C, Marett R, Slavin JL, and Feirtag J. Anaerobe 2000;6:87 Weaver GA, Tangel C, Krause JA, Alpern HD, Jenkins PL, Parfitt MM, Stragand JJ. J Nutr. 1996 126(8):1979-91 (animal study) Slavin JL. Dietary fiber and Irritable Bowel Syndrome (submitted) Stewart ML et al. Digestive Disease Week, May 19-24, 2007 in Washington DC (submitted). Wisker E; Daniel M; Rave G; Feldheim W. Fermentation of non-starch polysaccharides in mixed diets and single fibre sources: Comparative studies in human subjects and in vitro. Br J Nutr 80[3], 253-261. 1998 632 Bowel health/prebiotic effect AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) Publication Okubo T, Ishihara N, Takahashi H, Fujisawa T, Kim M, Yamamoto T, Mitsuoka T. Bios Biotech Biochem 1994;58:1364 633 PHGG: 3-11 g/day 31 January 2008 Page 1,751 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human and in vitro studies References Claim ID Takahashi et al Reported PHGG increase the production of short chain fatty acids (SCFA) and lower intestinal pH, which provides an ideal environment for the growth of beneficial bacteria and reducing the formation of harmful bacteria metabolites. J Nutr Sci Vitaminol 40: 251-259, 1994. Tuohy et al reported that the supplementation PHGG (3.4g/day) in 31 people in a 21 day cross over study, increased the number of Bifidobacterial count in the gut. Br J Nutr. 86:341-348, 2001 Ohkubo et al reported that the intake of PHGG (21g/day for 2 weeks) increased the number of Bifidobacterium spp. and Lactobacillus spp in 9 healthy men. Biosci Biotechnol Biochem. 58:1364-1369, 1994. Velazquez et al. reported significant high levels SCFA production and Butyrate production by PHGG over other dietary fibres. Anaerobe 6:87-92, 2000. Glycemic response 31 January 2008 AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) 634 Page 1,752 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Publication FDA regulation Suzuki T, Hara H. J Nutr 2004;134:1942-1947 (animal study) Chandalia M et al. N Engl J Med 2000;342(19):1392-1398 Salmeron J et al. Diabetes Care 1997;20(4):545-550 Salmeron J et al. JAMA 1997;277(6):472-477 Schafer G et al. Am J Clin Nutr 2003;78(1):99-103 Kabir M et al. Metabolism 2002;51(7):819-826 Williams JA et al. J Nutr 2004;134(4):886-889 Sierra M et al. Eur J Clin Nutr 2001;55(4):235-243 Wolever TM, Jenkins DA. Effect of Dietary Fiber and Foods on Carbohydrate Metabolism. In: Spiller GA, ed. CRC Handbook of Dietary Fiber in Human Nutrition. 3rd ed. Boca Raton: CRC Press; 2001:321-360 Sugar Content Claims, Food and Drug Administration, CFR, 101.60 Human intervention Golay et al reported in a randomized double blind three phase cross-over study with 6 non-insulin dependent diabetic patients that the intake of PHGG reduced plasma glucose levels. Nutr Metab Cardiovasc Dis. 5: 141-148, 1995. Claim ID Trinidad et al reported in a randomized cross over study with 11 normal and 9 diabetic patients, PHGG reduced the glycemic index of the white bread and rice. Int J Food Sci and Tec. 39:1093-1098, 2004. Gu et al reported in a cross-over study with 30 healthy subjects significantly lower Post-prandial blood sugar levels after consuming 300g of rice with 2.5 of PHGG. Medicine and Biology. 147:19-24; 2003. 31 January 2008 Page 1,753 of 3,931 Category Food Component Health Relationship Heart Health/cholesterol lowering effect 31 January 2008 Suggested Conditions of Use AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) Nature of Evidence Publications References Minekus M, Jelier M, Xiao JZ, Kondo S, Iwatsuki K, Kokubo S, Bos M, Dunnewind B, Havenaar R. Biosci Biotechnol Biochem. 2005 69(5):932-8 Kondo S, Xiao JZ, Takahashi N, Miyaji K, Iwatsuki K, Kokubo S. Biosci Biotechnol Biochem. 2004 68(5):1135-8 Takahashi H, Yang S, Hayashi C, Kim M, Yamanaka J, Yamamoto T. Nutr Res. 1993 13:649-657 Yamada K, Tokunaga Y, Ikeda A, Ohkura K, Mamiya S, Kaku S, Sugano M, Tachibana H. Biosci Biotechnol Biochem. 1999 63(12):2163-7 (animal study) Anderson JW, Major AW. Br J Nutr. 2002;88 Suppl 3:S263-271 Ripsin CM, Keenan JM, Jacobs DR, Jr., et al. JAMA. 1992;267(24):3317-3325 Brown L, Rosner B, Willett WW, Sacks FM. Am J Clin Nutr. 1999;69(1):30-42. Food and Drug Administration. Food labeling: health claims; soluble dietary fiber from certain foods and coronary heart disease. Final rule. Fed Regist. 2003;68(144):44207-44209 Anderson JW, Allgood LD, Lawrence A, et al. Am J Clin Nutr. 2000;71(2):472-479 Anderson JW, Gilinsky NH, Deakins DA, Smith SF, O-Neal DS, Dillon DW, Oeltgen PR. Am J Clin Nutr 1991;54:678-683 Fraser GE, Sabate J, Beeson WL, Strahan TM. Arch Intern Med. 1992;152(7):1416-1424 Humble CG, Malarcher AM, Tyroler HA. Am J Prev Med. 1993;9(4):197-202 Jacobs DR, Jr., Meyer KA, Kushi LH, Folsom AR. Am J Clin Nutr. 1998;68(2):248-257 Khaw KT, Barrett-Connor E. Am J Epidemiol. 1987;126(6):1093-1102 Pietinen P, Rimm EB, Korhonen P, et al. Circulation. 1996;94(11):2720-2727 Rimm EB, Ascherio A, Giovannucci E, Claim ID 635 Page 1,754 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Spiegelman D, Stampfer MJ, Willett WC. JAMA. 1996;275(6):447-451 Todd S, Woodward M, Tunstall-Pedoe H, Bolton-Smith C. Am J Epidemiol. 1999;150(10):1073-1080 Wolk A, Manson JE, Stampfer MJ, et al. JAMA. 1999;281(21):1998-2004 Bazzano LA, He J, Ogden LG, Loria CM, Whelton PK. Arch Intern Med. 2003;163(16):1897-1904 Mozaffarian D, Kumanyika SK, Lemaitre RN, Olson JL, Burke GL, Siscovick DS. JAMA. 2003;289(13):1659-1666 Pereira MA, O'Reilly E, Augustsson K, et al. Arch Intern Med. 2004;164(4):370-376 Liu S, Willett WC. Curr Atheroscler Rep. 2002;4(6):454-461 Ford ES, Liu S. Arch Intern Med. 2001;161(4):572-576 Liu S, Manson JE, Stampfer MJ, et al. Am J Clin Nutr. 2001;73(3):560-566 Ascherio A, Hennekens C, Willett WC, et al. Hypertension. 1996;27(5):1065-1072 Ascherio A, Rimm EB, Giovannucci EL, et al. Circulation. 1992;86(5):1475-1484 Keenan JM, Pins JJ, Frazel C, Moran A, Turnquist L. J Fam Pract. 2002;51(4):369 He J, Streiffer RH, Muntner P, Krousel-Wood MA, Whelton PK. J Hypertens. 2004;22(1):73-80 Lupton JR, Turner ND. Curr Atheroscler Rep. 2003;5(6):500-505 Immune health 31 January 2008 AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) 637 Page 1,755 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Publications Mineral absorption 31 January 2008 References Claim ID Bengmark S. Curr Opin Crit Care 2002;8:145-51 Schley PD, Field CJ. Br J Nutr. 2002;87 Suppl 2:S221-30 Felippe CR et al. Lipids 1997;32:587-591 Valazquez M, Davies C, Marett R, Slavin JL, and Feirtag J. Anaerobe 2000;6:87 Slavin JL. Dietary fiber and Irritable Bowel Syndrome (submitted) Stewart ML et al. Digestive Disease Week, May 19-24, 2007 in Washington DC (submitted) Takahashi H, Wako N, Okubo T, Ishihara N, Yamanaka J, Yamamoto T. J Nutr Sci Vitaminol (Tokyo). 1994 40(3):251-9 Tuohy KM, Kolida S, Lustenberger AM, Gibson GR. Br J Nutr. 2001 86(3):341-8 Okubo T, Ishihara N, Takahashi H, Fujisawa T, Kim M, Yamamoto T, Mitsuoka T. Bios Biotech Biochem 1994;58:1364 688 Page 1,756 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Individual studies References Claim ID REFERENCE 22 Takahashi et al reported that unlike other fibre rich diets, the consumption of high amounts of PHGG (36g/day) did not reduce or influence the absorption of calcium, iron and zinc in men. Nutr Res. 13: 649-657, 1993. REFERENCE 23 Takahashi et al reported that PHGG intake significantly improved the iron absorption in the rats grown in iron-deficient diets. Comp Biochem Physical 109: 75-82, 1994. REFERENCE 24 Freitasa et al reported that PHGG led to greater intestinal absorption of iron, regeneration of haemoglobin and hepatic levels of iron than diet with cellulose and diet control in rats. Clinical Nutrition. REFERENCE 25 Alam et al reported in a double blind cross over study with 10 healthy volunteers, that PHGG apparently not interfere with the normal absorption of glucose, amino acid and fat. Clinical Nutrition 17 (3):125-129. REFRENCE 26 Hara et al reported that PHGG promoted calcium and magnesium absorption and reduced excretion in rats. Br. J. Nutr 76: 773-784; 1996. Energy and vitality 31 January 2008 AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) 638 Page 1,757 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Publication Textbook Weight management, obesity and satiety 31 January 2008 AI for total fiber (IOM): 26-38 g/day (ideally 8.5-12.5 g/day soluble fiber) References Claim ID Schafer G et al. Am J Clin Nutr 2003;78(1):99-103 Kabir M et al. Metabolism 2002;51(7):819-826 Williams JA et al. J Nutr 2004;134(4):886-889 Sierra M et al. Eur J Clin Nutr 2001;55(4):235-243 Wolever TM, Jenkins DA. Effect of Dietary Fiber and Foods on Carbohydrate Metabolism. In: Spiller GA, ed. CRC Handbook of Dietary Fiber in Human Nutrition. 3rd ed. Boca Raton: CRC Press; 2001:321-360 636 Page 1,758 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Publications 31 January 2008 References Claim ID Howarth NC, Saltzman E, Roberts SB. Nutr Rev. 2001;59(5):129-139 Appleby PN, Thorogood M, Mann JI, Key TJ. Int J Obes Relat Metab Disord. 1998;22(5):454-460 Miller WC, Niederpruem MG, Wallace JP, Lindeman AK. J Am Diet Assoc. 1994;94(6):612-615 Liu S, Willett WC, Manson JE, Hu FB, Rosner B, Colditz G. Am J Clin Nutr. 2003;78(5):920-927 Lissner L, Lindroos AK, Sjostrom L. Swedish obese subjects (SOS): An obesity intervention study with a nutritional perspective. Eur J Clin Nutr, 1998;52; 316-322. Alfieri M, Pomerleau J, Grace DM, Anderson L. Obesity Research 1995;3:541-547 Appleby PM, Thorogood M, Mann JI, Key TJ. Int J Obesity 1998;22:454-460 Nelson LH, Tucker LA. J Am Diet Assoc 1996;96:771-777 Kromhout D, Bloemberg B, Seidell JC, Nissinen A, Menotti A. Int J Obesity 2001;25:301-306 Birketvedt GS, Aaseth J, Florholmen JR, Ryttig K. Acta Medica 2000;43:129-132 Mueller-Cunningham WM, Quintana R, Kasim-Karakas SE. J Am Diet Assoc 2003;103:1600-1606 Hays NP, Starling RD, Liu X, Sullivan DH, Trappe TA, Fluckey JD, Evans WJ. Arch Intern Med. 2004;164: 210-217 Jenkins DJ et al. N Eng J Med 1993;329:21-26 Pasman WJ, Saris WHM, Wauters MAJ, Westerterp-Plantenga MS. Appetite 1997;29:77-87 Page 1,759 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Pectins Blood cholesterol lowering/maintenan ce 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 6g/ day DIETARY FIBRE Pectins 1 Individual Studies -Brown L, Rosner B, Willett W W, Sacks F M, Cholesterol-lowering effects of dietary fiber: a meta-analysis, Am. J. Clin. Nutr. 1999, 69, 30-42 Individual Studies -Behall K, Reiser S, Effects of Pectin on Human Metabolism, in Fishmen, Yen (Eds) Chemistry and Function of Pectins, ACS Symposium Series 310 Washington DC 1986, pp 248-65 Individual Studies -Reiser S, Metabolic effects of dietary pectins related to human health, Food Technol. 1987, 41, 91-99 201 Page 1,760 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID PHGG Lipid management Must meet minimum requirements for use of the claim "fibre" as per Annex to Regulation 1924/2006. Individual studies Takahashi et al reported reduction of serum cholesterol in 8 subjects after consumption of PHGG (36g/Day) in a beverage for 4 weeks. Nutr. Res. 13: 649-657, 1993. 1,120 Yamatoya et al also reported a reduction in serum cholesterol with intake of PHGG (15g/day) in 6 female subjects. Food Hydrocolloids. 11: 239-242; 1997. Yamatoya et al also reported post-prandial reduction in serum cholesterol 4 h after the consumption of 15g PHGG with food. J Jpn Soc Nutr Food Sci. 46:199-203; 1993. Kondo et al reported that a yogurt sample (200g) with PHGG (6g) along with high fat food (100g) significantly reduce the post-prandial serum triglycerides and RLP cholesterol in a single, placebo controlled crossover study. Biosci Biotechnol Biochem. 68: 1135-1138, 2004. Kajimoto et al also reported that the yogurt drink with 4g of PHGG along with fat-rich meal significantly reduced post-prandial triglyceride within 2-3 hours in 20 adults. J Nutr Food. 7:1-17; 2004. 31 January 2008 Page 1,761 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Polydextrose Improves the bowel function 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 4g/ day DIETARY FIBREPolydextrose and Bowel Function Authoritative/Scientific Bodies -Ostereichische Agentur fur Gesundheit und Ernahrungssicherheit GMBH. Institut for Lebensmitteluntersuchung. November 18, 2005 Reviews -Craig, SAS, Holden, JF, Troup, JP, Auerbach, MH, Frier, HI. (1998) Polydextrose as soluble fibre: physiological and analytical aspects. Cereal Foods World 43, 370-376. Reviews -Craig, SAS, Holden, JF, Troup, JP, Auerbach, MH, Frier, HI. (1999) Polydextrose as soluble fibre and complex carbohydrate. In: Compley Carbohydrates in Foods, S.S. Cho, L. Prosky, M. Dreher, eds. Marcel Dekker Inc., New York. Reviews -Craig, SAS. (2001) Polydextrose: Analysis and Physiological Benefits In: Advanced dietary Fibre Technology B.V. McCleary, L. Prosky, Eds Blackwell Science, Oxford. Animal Studies -Ishizuka, S., Nagai, T., Hara, H. (2003) Reduction of aaberrant crypt foci by ingestion of polydextrose in the rat colorectum.Nutr Res 23, 117-122. Animal Studies -Peuranen, S., Tiihonen, K., Apajalahti, J., Kettunen, A., Saarinen, M., Rautonen, (2004) Combination of polydextrose and lactitol affects microbial ecosystem and immune responses in rat gastrointestinal tract. Br J Nutr 91, 905-914. 199 Page 1,762 of 3,931 Category Food Component Health Relationship Prebiotic/ Bifidogenic 31 January 2008 Suggested Conditions of Use Where a daily value is indicated the amount per serving is typicaly 25% Nature of Evidence References Human Studies -Endo, K., Kumemura, M., Nakamura, K., Fujisawa, T., Suzuku, K., Benno, Y., Mitsuoka, T. (1991) Effect of high cholesterol diet and polydextrose supplementation on the microflora, bacterial enzyme activity, putrefactive products, volatile fatty acid (VFA) profile, weight, and pH of the feces in healthy colunteers. Bifidobact Microflora 10, 53 Human Studies -Jie, Z., Bang-yao, L., Ming-jie, X., Hai-wie, L., Ting-song, W. Craig, SAS (2000) Studies on the effects of polydextrose intake on physiological functions in Chinese people. Am J Clin Nutr 72, 503-9 Human Studies -Saku K, Yoshinaga K, Okura Y, Ying H, Harada R, Arakawa K (1991). Effects of polydextrose on serum lipids, lipoproteins, and apolipoproteins in healthy subjects. Clin Therapeutics; 13/2: 254-258. 1. POLYDEXTROSE and Butyrogenic Action Human Study -Liu S, Tsai CE (1994). Effects of biotechnically synthetized oligosaccharides and polydextrose on serum lipids in the human. J. Chinese Nutr Soc; 20:1-12. In Vitro Study -Probert, H.M., Apajalahti, J., Rautonen, N., Stowell, J., Gibson, G. (2004) Polydextrose, lactitol and fructo-oligosaccharide fermentation by colonic bacteria in a three stage continous culture system. Appl Environ Microbiol 70, 4504-4511 Authoritative bodies Approvals as a dietary fibre from -Belgium dated October 8, 2001, -Finland dated October 10 2003, -Italy dated September 28, 2006, -France dated March 24, 2004 -Austria dated November 18, 2005 Claim ID 200 Page 1,763 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use unless otherwise stated 4g/ day Nature of Evidence References DIETARY FIBREPolydextrose and Prebiotic Action Review -Mitchell Helen (2005) Prebiotics: The use of speciality carbohydrates. AgroFOOD, 2005, 4, 25-27 Human Study -Jie, Z., Bang-yao, L., Ming-jie, X., Hai-wie, L., Ting-song, W. Craig, SAS (2000) Studies on the effects of polydextrose intake on physiological functions in Chinese people. Am J Clin Nutr 72, 503-9 Claim ID Liu S, Tsai CE (1994). Effects of biotechnically synthetized oligosaccharides and polydextrose on serum lipids in the human. J. Chinese Nutr Soc; 20:1-12. Endo, K., Kumemura, M., Nakamura, K., Fujisawa, T., Suzuku, K., Benno, Y., Mitsuoka, T. (1991) Effect of high cholesterol diet and polydextrose supplementation on the microflora, bacterial enzyme activity, putrefactive products, volatile fatty acid (VFA) profile, weight, and pH of the feces in healthy volunteers. Bifidobact Microflora 10, 53 31 January 2008 In Vitro Study -Probert, H.M., Apajalahti, J., Rautonen, N., Stowell, J., Gibson, G. (2004) Polydextrose, lactitol and fructo-oligosaccharide fermentation by colonic bacteria in a three stage continous culture system. Appl Environ Microbiol 70, 4504-4511 Authoritative bodies Approvals as a dietary fibre from -Belgium dated October 8, 2001, -Finland dated October 10 2003, -Italy dated September 28, 2006, -France dated March 24, 2004 -Austria dated November 18, 2005 Page 1,764 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human studies Animal studies In vitro studies 31 January 2008 References Claim ID Oku T, Fuji Y and Okamatsu H (1991). Polydextrose as dietary fiber: hydrolysis by digestive enzymes and its effect on gastrointestineal transit time in rats. J Clin Biochem Nutr 11: 31-40. Kobayashi T and Yoshino H (1989) Enzymatic hydrolysis of “Polydextrose”, Denpun Kagaku, 36:283-286. Stumm I and Baltes W (1997). Analysis of the linkage positions in polydextrose by the reductive cleavage method, Food Chemistry 59:291-297 Figdor SK and Rennhard HH (1981). Caloric utilization and disposition of [14C]polydextrose in the rat. J Agric Food Chem 29: 1181. Fava F, Mäkivuokko H, Siljander-Rasi H, Putaala H, Tiihonen K, Stowell J, Tuohy K, Gibson G and Rautonen N (2007). Effect of polydextrose and intestinal microbes and immune functions in pigs. B J Nutr 98: 123. Figdor SK and Bianchine JR (1983). Caloric utilization and disposition of [14C]polydextrose in man. J Agric Food Chem 31: 389. Achour L, Flourie B, Briet F, Pellier P, Marteau P and Rambaud J (1994). Gastro-intestinal effects and energy value of polydextrose in healthy non-obese men. Am J Clin Nutr 59: 1362. Juhr N and Franke J (1992). A method for estimating the available energy of incompletely digested carbohydrates in rats. J Nutr 122: 1425. Solomons NW and Rosenthal A (1985). Intestinal metabolism of random-bonded polyglucose bulking agent in humans: in vitro and in vivo studies of hydrogen evolution. J Lab Clin Med 105: 585-592. Mäkivuokko H, Nurmi J, Nurminen P, Stowell J, and Rautonen N (2005). In vitro effects on polydextrose by colonic bacteria and Caco-2 Page 1,765 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID cell cyclooxygenase gene expression. Nutrition and Cancer 52: 94. Wang X and Gibson GR (1993). Effects of the in vitro fermentation of oligofructose and inulin by bacteria growing in the human large intestine. J Appl Bacteriol 75: 373. Zhong J, Luo B, Xiang M, Liu H, Zhai Z, Wang T, Craig SAS (2000). Studies on the effects of polydextrose on physiological function in Chinese people. Am J Clin Nutr 72: 1503-9. Tiihonen K, Suomalainen T, Tynkkynen S and Rautonen N. Effect of a probiotic bacteria mixture with polydextrose or galacto-oligosaccharide supplementation on intestinal microbiota and immune responses. Comparison between a rat model and clinical trials. Brit J Nutr In press. 31 January 2008 Page 1,766 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Psyllium Bowel movement and stool characteristics 31 January 2008 Drink at least 6 to 8 full glasses of water throughout the day or constipation may develop. Medications should be taken at least one hour before or between two and four hours after taking psyllium. 1,080 Page 1,767 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Monograph Discussion/review Review RCT Systematic review Human trial References Claim ID Psyllii semen: Psyllium seed. European Scientific Cooperative on Phytotherapy (ESCOP). Monographs on the Medicinal Uses of Plant Drugs. 1997. Singh B. Psyllium as therapeutic and drug delivery agent. Int J Pharm. 2007 Apr. 4;334(1-2):1-14. Chang HY, Kelly EC, Lembo AJ. Current gut directed therapies for irritable bowel bowel syndrome. Curr Treat Options Bastroenterol. 2006 Jul;9(4):314-23. Fernandez-Banares F. Nutritional care of the patient with constipation. Best Pract Res Clin Gastroenterol. 2006;20(3):575-87. McRorie JW, Daggy BP, Morel JG, Diersing PS et al. Psyllium is superior to docusate sodium for treatment of chronic constipation. Aliment Pharmacol Ther. 1998 May; 12(5):491-7. Washington N, Harris M, Mussellwhite A, Spiller RC. Modulation of lactulose-induced diarrhea by psyllium:effects on motility and fermentation. Am J Clin Nutr. 1998 Feb;67(2):317-21 Ramkumar D, Rao SS. Efficacy and safety of traditional medical therapies for chronic constipation: systematic review. Am J Gastroenterol. 2005 Apr; 100(4):936-71. Burton R, Manninen V. Influence of a psyllium-based fibre preparation on faecal and serum parameters. Acta Med Scand Suppl. 1982;668:91-4. 31 January 2008 Page 1,768 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Psyllium (Plantago ovata, Plantago isphagula) seed husk Blood cholesterol 31 January 2008 Adults dosage: typically 2 – 45 g per day, usually in 2 or 3 divided doses. The product label should indicate that psyllium seed husk is a form of soluble dietary fibre and therefore the product’s fibre content makes a contribution to total dietary fibre intake. Government recommended daily intake for dietary fibre should be indicated. 1,837 Page 1,769 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Meta-analysis (including 17 studies on psyllium) RCTs References Claim ID Brown L, Rosner B, Willett WW, et al. Cholesterol-lowering effects of dietary fiber: a meta-analysis. Am J Clin Nutr 1999;69(1):30-42. Davidson MH, Dugan LD, Burns JH, et al. A psyllium-enriched cereal for the treatment of hypercholesterolemia in children: a controlled, double-blind, crossover study. Am J Clin Nutr 1996;63(1):96-102. Davidson MH, Maki KC, Kong JC, et al. Long-term effects of consuming foods containing psyllium seed husk on serum lipids in subjects with hypercholesterolemia. Am J Clin Nutr 1998;67(3):367-376. Anderson JW, Zettwoch N, Feldman T, et al. Cholesterol-lowering effects of psyllium hydrophilic mucilloid for hypercholesterolemic men. Arch Intern Med 1988;148(2):292-296. Anderson JW, Floore TL, Geil PB, et al. Hypocholesterolemic effects of different bulk-forming hydrophilic fibers as adjuncts to dietary therapy in mild to moderate hypercholesterolemia. Arch Intern Med 1991;151(8):1597-1602. Anderson JW, Riddell-Mason S, Gustafson NJ, et al. Cholesterol-lowering effects of psyllium-enriched cereal as an adjunct to a prudent diet in the treatment of mild to moderate hypercholesterolemia. Am J Clin Nutr 1992;56(1):93-98. Bell LP, Hectorne K, Reynolds H, et al. Cholesterol-lowering effects of psyllium hydrophilic mucilloid. Adjunct therapy to a prudent diet for patients with mild to moderate hypercholesterolemia. JAMA 1989;261(23):3419-3423. Everson GT, Daggy BP, McKinley C, et al. Effects of psyllium hydrophilic mucilloid on 31 January 2008 Page 1,770 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID LDL-cholesterol and bile acid synthesis in hypercholesterolemic men. J Lipid Res 1992;33(8):1183-1192. MacMahon M, Carless J. Ispaghula husk in the treatment of hypercholesterolaemia: a doubleblind controlled study. J Cardiovasc Risk 1998;5(3):167-172. Neal GW, Balm TK. Synergistic effects of psyllium in the dietary treatment of hypercholesterolemia. South Med J 1990;83(10):1131-1137. Spence JD, Huff MW, Heidenheim P, et al. Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia. Ann Intern Med 1995;123(7):493-499. Sprecher DL, Harris BV, Goldberg AC, et al. Efficacy of psyllium in reducing serum cholesterol levels in hypercholesterolemic patients on high- or low-fat diets. Ann Intern Med 1993;119(7 Pt 1):545-554. Levin EG, Miller VT, Muesing RA, et al. Comparison of psyllium hydrophilic mucilloid and cellulose as adjuncts to a prudent diet in the treatment of mild to moderate hypercholesterolemia. Arch Intern Med 1990;150(9):1822-1827. Bell LP, Hectorn KJ, Reynolds H, et al. Cholesterol-lowering effects of soluble-fiber cereals as part of a prudent diet for patients with mild to moderate hypercholesterolemia. Am J Clin Nutr 1990;52(6):1020-1026. Summerbell CD, Manley P, Barnes D, et al. The effects of psyllium on blood lipids in hypercholesterolaemic subjects. Journal of Human Nutrition and Dietetics 1994;7:147-151. Wolever TM, Jenkins DJ, Mueller S, et al. Method of administration influences the serum cholesterol-lowering effect of psyllium. Am J Clin Nutr 1994;59(5):1055-1059. 31 January 2008 Page 1,771 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Wolever TM, Jenkins DJ, Mueller S, et al. Psyllium reduces blood lipids in men and women with hyperlipidemia. Am J Med Sci 1994;307(4):269-273. Roberts DC, Truswell AS, Bencke A, et al. The cholesterol-lowering effect of a breakfast cereal containing psyllium fibre. Med J Aust 1994;161(11-12):660-664. Stoy DB, LaRosa JC, Brewer BK, et al. Cholesterol-lowering effects of ready-to-eat cereal containing psyllium. J Am Diet Assoc 1993;93(8):910-912. Anderson JW, Allgood LD, Turner J, et al. Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia. Am J Clin Nutr 1999;70(4):466-473. 31 January 2008 Page 1,772 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Resistant starch Favours a normal colon metabolism 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 17g/day DIETARY FIBRE Resistant Starch 1 Individual Studies -Bauer-Marinovic M, Florian S, Muller-Schmehl K, Glatt H, Jacobasch G. Dietary resistant starch type 3 prevents tumor induction by 1,2-dimethylhydrazine and alters proliferation, apoptosis and dedifferentiation in rat colon. Carcinogenesis 2006;27:1849-59. Individual Studies -Birkett A, Muir J, Phillips J, Jones G, O'Dea K. Resistant starch lowers fecal concentrations of ammonia and phenols in humans. Am J Clin Nutr 1996;63:766-72. Individual Studies -Cassand P, Maziere S, Champ M, Meflah K, Bornet F, Narbonne JF. Effects of resistant starch-and vitamin A-supplemented diets on the promotion of precursor lesions of colon cancer in rats. Nutr Cancer 1997;27:53-9. Individual Studies -Champ MM. Physiological aspects of resistant starch and in vivo measurements. J AOAC Int 2004;87:749-55. Individual Studies -Cummings JH, Beatty ER, Kingman SM, Bingham SA, Englyst HN. Digestion and physiological properties of resistant starch in the human large bowel. Br J Nutr 1996;75:733-47. Individual Studies -Dongowski G, Jacobasch G, Schmiedl D. Structural stability and prebiotic properties of resistant starch type 3 increase bile acid turnover and lower secondary bile acid formation. J Agric Food Chem 2005;53:9257-67. 196 Page 1,773 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Ferguson LR, Zhu S, Kestell P. Contrasting effects of non-starch polysaccharide and resistant starch-based diets on the disposition and excretion of the food carcinogen, 2-amino-3-methylimidazo[4,5-f]quinoline (IQ), in a rat model. Food Chem Toxicol 2003;41:785-92. Individual Studies -Grubben MJ, van den Braak CC, Essenberg M et al. Effect of resistant starch on potential biomarkers for colonic cancer risk in patients with colonic adenomas: a controlled trial. Dig Dis Sci 2001;46:750-6. Individual Studies -Heijnen ML, Beynen AC. Consumption of retrograded (RS3) but not uncooked (RS2) resistant starch shifts nitrogen excretion from urine to feces in cannulated piglets. J Nutr 1997;127:1828-32. Individual Studies -Heijnen ML, van Amelsvoort JM, Deurenberg P, Beynen AC. Limited effect of consumption of uncooked (RS2) or retrograded (RS3) resistant starch on putative risk factors for colon cancer in healthy men. Am J Clin Nutr 1998;67:322-31. Individual Studies -Jacobasch G, Dongowski G, Schmiedl D, Muller-Schmehl K. Hydrothermal treatment of Novelose 330 results in high yield of resistant starch type 3 with beneficial prebiotic properties and decreased secondary bile acid formation in rats. Br J Nutr 2006;95:1063-74. Individual Studies -Jacobasch G, Schmiedl D, Kruschewski M, Schmehl K. Dietary resistant starch and chronic inflammatory bowel diseases. Int J Colorectal Dis 1999;14:201-11. Individual Studies -Jenkins DJ, Vuksan V, Kendall CW et al. Physiological effects of resistant starches on fecal bulk, short chain fatty acids, blood lipids and glycemic index. J Am Coll Nutr 1998;17:609-16. Claim ID Page 1,774 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Le Leu RK, Brown IL, Hu Y et al. A synbiotic combination of resistant starch and Bifidobacterium lactis facilitates apoptotic deletion of carcinogen-damaged cells in rat colon. J Nutr 2005;135:996-1001. Individual Studies -Maziere S, Meflah K, Tavan E, Champ M, Narbonne JF, Cassand P. Effect of resistant starch and/or fat-soluble vitamins A and E on the initiation stage of aberrant crypts in rat colon. Nutr Cancer 1998;31:168-77. Individual Studies -Morita T, Hayashi J, Motoi H et al. In Vitro and In Vivo Digestibility of recrystallized Amylose and Its Application for Low Glycemic Foods. J Food Sci 2005;70:S179-S185. Individual Studies -Muir JG, Yeow EG, Keogh J et al. Combining wheat bran with resistant starch has more beneficial effects on fecal indexes than does wheat bran alone. Am J Clin Nutr 2004;79:1020-8. Individual Studies -Noakes M, Clifton PM, Nestel PJ, Le LR, McIntosh G. Effect of high-amylose starch and oat bran on metabolic variables and bowel function in subjects with hypertriglyceridemia. Am J Clin Nutr 1996;64:944-51. Individual Studies -Nugent A 2005 Health Properties of Resistant Starch. British Nutrition Foundation Nutrition Bulletin, 30: 27-54 Individual Studies -Pierre F, Perrin P, Champ M, Bornet F, Meflah K, Menanteau J. Short-chain fructo¬oligosaccharides reduce the occurrence of colon tumors and develop gut-associated lymphoid tissue in Min mice. Cancer Res 1997;57:225-8. Claim ID Page 1,775 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Perrin P, Pierre F, Patry Y et al. Only fibres promoting a stable butyrate producing colonic ecosystem decrease the rate of aberrant crypt foci in rats. Gut 2001;48:53-61. Individual Studies -Phillips J, Muir JG, Birkett A et al. Effect of resistant starch on fecal bulk and fermentation-dependent events in humans. Am J Clin Nutr 1995;62:121-30. Individual Studies -Raben A, Tagliabue A, Christensen NJ, Madsen J, Holst JJ, Astrup A. Resistant starch: the effect on postprandial glycemia, hormonal response, and satiety. Am J Clin Nutr 1994;60:544-51. Individual Studies -Raghupathy P, Ramakrishna BS, Oommen SP et al. Amylase-resistant starch as adjunct to oral rehydration therapy in children with diarrhea. J Pediatr Gastroenterol Nutr 2006;42:362-8. Individual Studies -Sakamoto J, Nakaji S, Sugawara K, Iwane S, Munakata A. Comparison of resistant starch with cellulose diet on 1,2-dimethylhydrazine-induced colonic carcinogenesis in rats. Gastroenterology 1996;110:116-20. Individual Studies -Silvi S, Rumney CJ, Cresci A, Rowland IR. Resistant starch modifies gut microflora and microbial metabolism in human flora-associated rats inoculated with faeces from Italian and UK donors. J Appl Microbiol 1999;86:521-30. Individual Studies -Thorup I, Meyer O, Kristiansen E. Effect of potato starch, cornstarch and sucrose on aberrant crypt foci in rats exposed to azoxymethane. Anticancer Res 1995;15:2101-5. Claim ID Page 1,776 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Individual Studies -Toden S, Bird AR, Topping DL, Conlon MA. Resistant starch attenuates colonic DNA damage induced by higher dietary protein in rats. Nutr Cancer 2005;51:45-51. Individual Studies -Van M, I, Tangerman A, Nagengast FM. Effect of resistant starch on colonic fermentation, bile acid metabolism, and mucosal proliferation. Dig Dis Sci 1994;39:834-42. Individual Studies -Wacker M, Wanek P, Eder E, Hylla S, Gostner A, Scheppach W. Effect of enzyme-resistant starch on formation of 1,N(2) -propanodeoxyguanosine adducts of trans-4-hydroxy-2-nonenal and cell proliferation in the colonic mucosa of healthy volunteers. Cancer Epidemiol Biomarkers Prev 2002;11:915-20. Individual Studies -Weststrate JA, van Amelsvoort JM. Effects of the amylose content of breakfast and lunch on postprandial variables in male volunteers. Am J Clin Nutr 1993;58:180-6. Individual Studies -Williamson SL, Kartheuser A, Coaker J et al. Intestinal tumorigenesis in the Apc1638N mouse treated with aspirin and resistant starch for up to 5 months. Carcinogenesis 1999;20:805-10. Individual Studies -Young GP, Le Leu RK. Resistant starch and colorectal neoplasia. J AOAC Int 2004;87:775-86. Individual Studies -Young GP, McIntyre A, Albert V, Folino M, Muir JG, Gibson PR. Wheat bran suppresses potato starch-potentiated colorectal tumorigenesis at the aberrant crypt stage in a rat model. Gastroenterology 1996;110:508-14. Claim ID Page 1,777 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Soluble Fibre (from oat, psyllium, pectin or guar gum) Lipid Metabolism Inclusion in a healthy diet Must meet the minimum requirements for use of the claim source of fibre as per Annex to 1924/2006 31 January 2008 Meta Analysis Brown, L., Rosner, B., Willet, W.W. and Sacks, F. Cholesterol-lowering effects of dietary fiber: a meta-analysis Am. J. Clin. Nutr. 69:30- 42, 1999. 804 Page 1,778 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Sugar beet fibre Bowel function 15-20 g/day Human studies Animal studies Must meet minimum requirements for use of the claim "source of fibre" as per Annex to Regulation 1924/2006. Human studies Hagander, B., Asp, N-G., Efendic, S., Nilsson-Ehle, P., Lundqvist, I., Schersten, B. 1986. Reduced glycemic response to beet-fibre meal in non-insulin-dependent diabetics and its relation to plasma levels of pancreatic and gastrointestinal hormones. Diabetes Res. 3, 91-96 820 Langkilde, A-M., Andersson, H., Bosaeus, I. (1993). Sugar beet fibre increases cholesterol and reduces bile acid excretion from the small bowel. Br J of Nutrition 70, 757-766. Hamberg, O; Rumessen, J; Gudmand-Høyer, E (1989): Inhibition of starch absorption by dietary fibre. A comparative study of wheat bran, sugar-beet fibre and pea fibre. Scandinavian Journal of Gastroenterology, 24, 103-109. Animal studies Nyman, M; Asp, N G (1982): Fermentation of dietary fibre components in the rat intestinal tract. British Journal of Nutrition, 47, 357-366. Contributes to lower cholesterol levels Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 25-40g/ day DIETARY FIBRE Sugar Beet Fibre 2 Human Studies -Cossack, Z T; Musaiger, A O (1991): Effect on lipid metabolism of beet fibre in desert nomads with low habitual fibre intake. European Journal of Clinical Nutrition, 45, 105-110. 198 Must meet minimum requirements for use of the claim "source of fibre", as per Annex to 31 January 2008 Page 1,779 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Regulation 1924/2006. Impact on blood glucose / Glycemic control / Glycemic response Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 10g/ day Must meet minimum requirements for use of the claim "source of fibre", as per Annex to Regulation 1924/2006. 31 January 2008 Nature of Evidence References Human Studies -Hagander, B; Asp, N G; Ekman, R; Nilsson-Ehle, P; Schersten, B (1989): Dietary fibre enrichment, blood pressure, lipoprotein profile and gut hormones in NIDDM patients. European Journal of Clinical Nutrition, 43, 35-44. Human Studies -Israelsson, B; Jarnblad, G; Persson, K (1993): Serum Cholesterol Reduced with FIBREX®, a sugar-beet fibre preparation. Scandinavian Journal of Nutrition/Naringsforskning, 37, 146-149. Human Studies -Langkilde, A-M; Andersson, H; Bosaeus, I (1993): Sugar-beet fibre increases cholesterol and reduces bile acid excretion from the small bowel. British Journal of Nutrition, 70, 757-766. Animal Studies -Klopfenstein, C (1990): Nutritional properties of coarse and fine sugar-beet fibre and hard red wheat bran. I. Effects on rat serum and liver cholesterol and triglycerides and on fecal characteristics. Cereal Chemistry, 67, 538-541. DIETARY FIBRE Sugar Beet Fibre 1 Human Studies -Hagander, B; Holm, J; Asp, N G; Efendic, S; Lundquist, I; Nilsson-Ehle, P; Schersten, B (1988): Metabolic response to beet fibre test meals. Journal of Human Nutrition and Dietetics, 1, 239-246. Human Studies -Hagander, B; Holm, J; Asp, N G; Efendic, S; Lundquist, I; Nilsson-Ehle, P; Schersten, B (1988): Dietary fibre decreases fasting blood glucose levels and plasma LDL concentration in non-insulin¬dependent diabetes mellitus patients. American Journal of Clinical Nutrition, 47, 852-858. Claim ID 197 Page 1,780 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human Studies 31 January 2008 References Claim ID -Hagander, B; Asp, N G; Efendic, S; Nilsson-Ehle, P; Lundquist, I; Schersten, B (1986): Reduced glycemic response to beet fibre meal in non-insulin-dependent diabetics and its relation to plasma levels of pancreatic and gastrointestinal hormones. Diabetes Research, 3, 91-96. Page 1,781 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Xylo-oligosaccharides Prebiotic/ Bifidogenic 31 January 2008 Where a daily value is indicated the amount per serving is typicaly 25% unless otherwise stated 2.6g/day DIETARY FIBRE Xylooligosaccharides and Prebiotic Action Authoritative/Scientific Body -AFSSA Report - Effects of prebiotics and prebiotics on flora and immunity in adults, Report, February 2005:25 Reviews -Drakoularakou A., McCartney A.L., Rastall R.A. and Gibson G.R. Established and emerging prebiotics and their effects on the gut microflora. Agro Food Ind Hi Tec 15, 18-20 (2004) Reviews -Tuohy KM, Rouzaud GC, Bruck WM, Gibson GR. Modulation of the human gut microflora towards improved health using prebiotics-assessment of efficacy. Curr Pharm Des. 2005;11(1):75-90. Clinical Studies -Iino T, Nishijima Y, Sawada S, Sasaki H, Harada H, Suwa Y, Kiso Y. Improvement of Constipation by a Small Amount of xylooligosaccharides Ingestion in Adult Women. Jounal of Japanese Association for Dietary Fiber Research, 1997 Vol.1 No.1 19-24 Clinical Studies -Kobayashi T, Okasaki M. Fujikawa S, Koka K. Effects of xylooligosaccharides on feces of men. J. Jap. Soc. Food Sci. Nutr. (1991) 43(6):395-401 Clinical Studies -Mikio Kajihara. Shinzo Kato, Masahiro Konishi, Yoshinori Yamagishi, Yoshinori Horie, and Hiromasa Ishii. Xylooligosaccharide decreases blood ammonia levels in patients with liver cirrhosis. The American journal of Gastroenterology - September 2000, Vol 95, n°9 195 Page 1,782 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References Clinical Studies -Okazaki M, Fujikawa S, Matsutomo N. Effects of xylooligosaccharides on growth of Bifidobacteria. Bifidobacteria Microflora (1990) 9, 77-86 Clinical Studies -Tateyama I, Hashii K, Johno I, Iino T, Hirai K, Suwa Y, Kiso Y. Effect of xylooligosaccharide intake on severe constipation in pregnant women. J Nutr Sci Vitaminol (Tokyo). 2005 Dec;51(6):445-8. Animal Studies -Campbell JM, Fahey GC Jr, Wolf BW. Selected indigestible oligosaccharides affect large bowel mass, cecal and fecal short-chain fatty acids, pH and microflora in rats. J Nutr. 1997 Jan;127(1):130-6. Animal Studies -Howard MD, Gordon DT, Garleb KA, Kerley MS. Dietary fructooligosaccharide, xylooligosaccharide and gum arabic have variable effects on cecal and colonic microbiota and epithelial cell proliferation in mice and rats. J Nutr. 1995 Oct;125(10):2604-9. Animal Studies -Hsu CK, Liao JW, Chung YC, Hsieh CP, Chan YC. Xylooligosaccharides and fructooligosaccharides affect the intestinal microbiota and precancerous colonic lesion development in rats. J Nutr. 2004 Jun;134(6):1523-8. Animal Studies -Santos, A; M. San Mauron, D Marquina Diaz. Prebiotics and their long term influence on the microbial populations of the mouse bowel. Food Microbiology 23 ( 2006) 498-503 In Vitro Studies -Katrien M. J. Van Laere, Ralf Hartemink, Margaret Bosveld, Henk A. Schols, and Alphons G. J. Voragen. Fermentation of Plant Cell Wall Derived Polysaccharides and Their Corresponding Oligosaccharides by Intestinal Bacteria. J. Agric. Food Chem., 48 (5), 1644 -1652, 2000. Claim ID Page 1,783 of 3,931 Category Food Component 31 January 2008 Health Relationship Suggested Conditions of Use Nature of Evidence References In Vitro Studies -Palframan RJ, Gibson GR, Rastall RA. Carbohydrate preferences of Bifidobacterium species isolated from the human gut. Curr Issues Intest Microbiol. 2003 Sep;4(2):71-5. In Vitro Studies -Rycroft CE, Jones MR, Gibson GR, Rastall RA. A comparative in vitro evaluation of the fermentation properties of prebiotic oligosaccharides. J Appl Microbiol. 2001 Nov;91(5):878-87. In Vitro Studies -Smiricky-Tjardes MR, Flickinger EA, Grieshop CM, Bauer LL, Murphy MR, Fahey GC Jr. In vitro fermentation characteristics of selected oligosaccharides by swine fecal microflora. J Anim Sci. 2003 Oct;81(10):2505-14. Claim ID Page 1,784 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID FOODS AND BEVERAGES 31 January 2008 Page 1,785 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID (Cow’s) Milk And dairy products for which milk is the principle ingredient and no sugar has been added – e.g. yogurt, cheese. Dental Health 31 January 2008 (Cow’s) Milk (to which no sugar has been added) 709 Page 1,786 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Scientific body International Scientific Report Reviews Observational Study Clinical Trial Cross-over study References Claim ID British Nutrition Foundation (1999) Oral health, diet and other factors. In Task Force report. British Nutrition Foundation, London WHO Technical Report Series: Diet, Nutrition and the prevention of chronic diseases; Report of a joint WHO/FAO Expert Consultation (2003) Levine RS (2001) Milk, flavoured milk products and caries. Briefing paper. British Nutrition Foundation. 191; 20. Touger-Decker R & van Loveren C (2003) Sugars and dental caries. American Journal of Clinical Nutrition 78; 881S-892S. Al-Zahrani MS (2006) Increased intake of Dairy Products is related to Lower Peridonitis Prevalence. Journal of Periodontology 77; 289-294. Gedalia I et al (1991) Enamel softening with Coca-Cola and rehardening with milk or saliva. American Journal of Dentistry 4; 120-122. Gedalia I et al (1991) Tooth enamel softening with a cola type drink and rehardening with hard cheese or stimulated saliva in situ. Journal of Oral Rehabilitation 18, 501-6. Gedalia I, Ben-Mosheh S, Biton J & Kogan D (1994) Dental caries protection with hard cheese consumption. Am J Dent 7, 331-332. Jensen ME, Donly K & Wefel JS (2000) Assessment of the effect of selected snack foods on the remineralization/ demineralization of enamel and dentin. The Journal of Contemporary Dental Practice 1; 1-12. 31 January 2008 Page 1,787 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Jenkins GN & Ferguson DB (1966) Milk and dental caries. Br Dent J 120; 472-477 31 January 2008 Page 1,788 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Acidic water - based, non alcoholic flavoured beverages Dental health - low erosion 31 January 2008 In the beverage ready for consumption in accordance with the manufacturer’s instructions - calcium is present in the range of 0.3 to 0.8 mol per mol of acid and the amount of calcium and acidulant in the composition being selected so that the pH of the composition is at least 3.7 561 Page 1,789 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT In vitro evidence References Claim ID 1. Hughes JA., West NX., Parker DM, Newcombe RG, Addy M. (1999) Development and evaluation of a low erosive blackcurrant juice drink in vitro and in situ 1. Comparison with orange juice. Journal of Dentistry 27: 285 - 289 2. West NX, Hughes JA, Parker DM, Newcombe EG, Addy M. (1999) Development and evaluation of a low erosive blackcurrant juice drink 2. Comparison with a conventional blackcurrant juice drink and orange juice. Journal of Dentistry 27: 341-344 3. Hughes JA, West NX, Parker DM, Newcombe RG, Addy, M. (1999) Development and evaluation of a low erosive blackcurrant juice drink. 3. Final Drink and Concentrate, formulae comparisons in situ and overview of the concept. Journal of Dentistry, 27: 345 350. 4. Hughes JA, Jandt KD, Baker N, Parker D, Newcombe RG, Eisenburger M, Addy M. (2002) Further Modification to Soft Drinks to Minimise Erosion. Caries Research 36: 70 - 74 5. West NX, Hughes JA, Parker D, Weaver, LJ., Moohan, M., De’ath, J, Addy M (2004) Modification of soft drinks with xanthan gum to minimise erosion: a study in situ. British Dental Journal 196: 478-481 6. Hunter ML, Hughes JA., Parker DM, West NX, Newcombe RG, Addy, M. (2003) Development of low erosive carbonated fruit drinks. 1. Evaluation of two experimental orange drinks in vitro and in situ. Journal of Dentistry 31: 253 – 260 7. West NX, Hughes JA, Parker DM, Moohan M, Addy, M. (2003) Development of low erosive carbonated fruit drinks. 2. Evaluation of an experimental carbonated blackcurrant drink compared to a conventional carbonated drink. 31 January 2008 Page 1,790 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Journal of Dentistry 31: 361 – 365 8. Hooper S, West NX, Sharif N, Smith S, North M, De’Ath, J, Parker DM, Roedig-Penman A, Addy M. (2004) A comparison of enamel erosion by a new sports drink compared to two proprietary products: a controlled, crossover study in situ. Journal of Dentistry 32: 541 – 545 9. Venables MC, Shaw L, Jeukendrup AE, Roedig-Penman A, Finke M, Newcombe RG, Parry J, Smith AJ. (2005) Erosive effect of a new sports drink on dental enamel during exercise. Medicine and Science in Sports and Exercise 37(1): 39-44 10. Finke M, Hughes JA, Parker DM, Jandt KD. (2001) Mechanical properties of in situ demineralised human enamel measured by AFM nanoindentation. Surface Science 491: 465-467 11. Bartlett DW, Bureau GP, Anggiansah A. (2003) Evaluation of the pH of a new carbonated soft drink beverage: an in vivo investigation. Journal of Prosthodontics 12(1): 21-25 12. Finke M, Jandt KD, Parker DM. (2000) The early stages of native enamel dissolution studied with atomic force microscopy. Journal of Colloid Interface Science 232: 156-164 13. Barbour ME, Finke M, Parker DM, Hughes JA, Allen GC, Addy M. (2006) The relationship between enamel softening and erosion caused by soft drinks at a range of temperatures. Journal of Dentistry 34(3): 207 – 213 14. Hemingway CA, Parker DM, Addy M Barbour ME. (2006) Erosion of enamel by non-carbonated soft drinks, with and without toothbrushing abrasion. British Dental Journal 201: 447 – 450 15. Shellis RP, Finke M, Eisenburger M, Parker DM, Addy M. (2005) Relationship between 31 January 2008 Page 1,791 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID enamel erosion and liquid flow rate. European Journal Oral Science 113: 232-238 16. Mahoney E, Beattie J, Swain M, Kilpatrick N. (2003) Preliminary in vitro assessment of erosive potential using the ultra-micro-indentation system Caries Research 37: 218-224 17. Ramalingam L, Messer LB, Reynolds EC. (2005) Adding casein phosphopeptide-amorphous calcium phosphate to sports drinks to eliminate in vitro erosion. Pediatric Dentistry 27: 61-67 31 January 2008 Page 1,792 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Almonds Maintains healthy blood total and LDL cholesterol and heart health 31 January 2008 28g raw or roasted almonds with skin per day 28g raw or roasted almonds with skin per day in conjuction with a varied and balanced diet that is low in saturated fat and a healthy lifestyle. 299 Page 1,793 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human, randomised crossover Human, randomised, crossover design Human, randomised crossover design References Claim ID Meta-Analysis Fulgoni V, Abbey M, Davis P, Hyson D, Jenkins D, Lovejoy J, Most M, Sabate J, Spiller G. 2002. Almonds significantly lower elevated blood cholesterol and LDL-cholesterol but not HDL cholesterol or triglycerides in human subjects. FASEB Journal. 16(5):A961 (manuscript in preparation) Human Clinical Trials Abbey M, Noakes M, Belling G, Nestel PJ. 1994. Partial replacement of saturated fatty acids with almonds or walnuts lowers total plasma cholesterol and low-density-lipoprotein cholesterol. Amer J Clin Nutr. 59:995-999. Hyson D, Schneerman BO, Davis PA. 2002. Almonds and almond oil have similar effects on plasma lipids with LDL oxidation in healthy men and women. J Nutr. 132 (4):703-7. Jambazian P, Haddad E, Rajaram S, Tanzman J, Sabate J. 2005. Almonds in the diet simultaneously improve plasma a-tocopherol concentrations and reduce plasma lipids. JADA. 105:449-454. Jenkins DJ, Kendall CW, Marchie A, Parker TL, Connelly PW, Qian W, Haight JS, Faulkner D, Vidgen E, Lapsley KG, Spiller GA. 2002. Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial. Circulation. 106.11:1327-32. Jenkins, D.J.A., C.W.C. Kendall, A. Marchie, D.A. Faulkner, J.M.W. Wong, R. de Souza, A. Emam, T.L. Parker, E. Vidgen, K.G. Lapsley, E.A. Trautwein, R.G. Josse, L.A. Leiter, PhW. Connelly, 2003. Effects of a dietary portfolio of cholesterol-lowering foods 31 January 2008 Page 1,794 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID vs. lovastatin on serum lipids and C-reactive protein. J. Am. Med. Assn. 290 (4): 502-510. Jenkins, D.J.A., Kendall, A. D. Faulkner, Nguyen, N., Kemp, T., Marchie, A., Wong, J.M.W., de Souza, R., Emam, A., Vidgen, E., Trautwein, E.A., Lapsley, KG., Homes, A., Josse, R.G., Leiter, L.A., Connelly, P.W and Singer, W. 2006. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am. J. Clin. Nutr.83:582–91. Jenkins, D.J.A., Kendall, A. D. Faulkner, Nguyen, N., Kemp, T., Marchie, A., Wong, J.M.W., de Souza, R., Emam, A., Vidgen, E., Trautwein, E.A., Lapsley, KG., Homes, A., Josse, R.G., Leiter, L.A., Connelly, P.W and Singer, W. 2007 Long-term effects of a plant-based dietary portfolio of cholesterol-lowering foods on blood pressure. Accepted for publication – European Journal of Clinical Nutrition Manuscript Number: 2006EJCN0079R. Lovejoy JC, Most MM, Lefevre M, Greenway FL, Reed JC. 2003. Effect of diets enriched in almonds on insulin action and serum lipids in adults with normal glucose tolerance or type 2 diabetes. J Nutr. 76(5):1000 -6. Sabate JE, Haddad E, Tanzman JS, Jambazian P, Rajaram S. 2003. Serum lipid response to the graduated enrichment of a Step I diet with almonds. Am J Clin Nutr. 77(6):1379-84. Spiller G, Miller A, Olivera K, Reynolds J, Miller B, Morse J, Dewell A, Farquhar J. 2003. Effect of plant based diets high in raw or roasted almonds or roasted almond butter on serum lipoproteins in humans. J Amer Coll of Nutr. Vol 22 (3):195-200. 31 January 2008 Page 1,795 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Spiller G, Jenkins DJ, Bosello O, Gates J, Cragen L, Bruce B. 1998. Nuts and plasma lipids: an almond based diet lowers LDL-C while preserving HDL-C. J Amer Coll Nutr. Vol 17(3):285-290. Spiller G, Jenkins DJ, Cragen N, Gates JE, Bosello O, Rudd C, Stevenson M, Superko R. 1992. Effect of diet high in monounsaturated fat from almonds on plasma cholesterol and lipoproteins. J. Amer Coll Nutr. Vol 11(2):126130. Tamizifar B, Rismankarzadeh M, Vosoughi AA, Rafieeyan M, Tamizifar B, Aminzade A. 2005. A low dose almond based diet decreases LDL-C while preserving HDL. Arch Iranian Med. 8(1):45-51. Wien MA, Sabate JM, Ikle DN, Cole SE, Kandeel FR. 2003. Almonds vs complex carbohydrates in a weight reduction program. Intl J Obes. 27:1365-1372. Xiao Y, Wang JB, Yan SF, Lian XJ, Tang Y, Liu Y. 2002. Effect of nut rich in monounsaturated fatty acid on serum lipids in hyperlipidemia. J of China Public Health. 18(8):931-932. Longer-term, free-living human randomized controlled dose response cross-over trial 31 January 2008 Jenkins, D.J.A., Kendall, A. D. Faulkner, Nguyen, N., Kemp, T., Marchie, A., Wong, J.M.W., de Souza, R., Emam, A., Vidgen, E., Trautwein, E.A., Lapsley, KG., Homes, A., Josse, R.G., Leiter, L.A., Connelly, P.W and Singer, W. 2006. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am. J. Clin. Nutr.83:582–91. Page 1,796 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Beef and beef products Antioxidant to prevent oxidative stress,Proper thyroid function,Maintenanc e of cellular redox status 31 January 2008 The product must state that the source of selenium-enrichment is via the animal’s feed, and is by means of an approved source of organic selenium (e.g. selenomethionine and other organic selenium molecules from an approved selenium yeast). Pavlata L, Illek A, & Pechova A (2001) Guyot H, Sprin P, Andrieu S, & Rollin F (2007) Pavlata et al 2001 Acta Vet Brno 70:19-26 Blood and tissue selenium concentrations in calves treated with inorganic or organic selenium compounds a comparison. http://jinfo.lub.lu.se/jinfo?func=fullRecord&jId=1 0315&issn=00017213 Sel-Plex@ supplementation of calves results in significantly higher tissue selenium in comparison to other forms of selenium. Guyot et al (2007) Livestock Science 111:259-263 Comparative responses to sodium selenite and organic selenium supplements in Belgian Blue cows and calves. www.elsevier.com/locate/livsci Sel-Plex@ supplementation of beef cows and calves results in significantly higher selenium status in comparison with sodium selenite supplementation. 2,359 Page 1,797 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Bilberry British pilots during World War II ate bilberries before night flights to support their vision. 31 January 2008 No RDA/RNI 2,463 Page 1,798 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Belleoud L, Leluan D, Boyer YS. Study on the effects of anthocyanin glycosides on the nocturnal vision of air controllers. Rev Med Aeronaut Spatiale 1966;18:3–7. 1. Natural Medicines Comprehensive Database 2000 2. 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Reyner LA, Horne JA Physiol Behav. 75(3):331-5, 2002 31 January 2008 Page 1,803 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID The effects of red bull energy drink on human performance and mood. Alford C, Cox H, Wescott R. Amino Acids. 21(2):139-50, 2001 A taurine containing drink stimulates cognitive performance and well-being. Seidl R, Peryl R. Amino acids 19:635-642, 2000 Effects of low doses of caffeine on cognitive performance, mood and thirst in low and higher caffeine consumers. Smit HJ, Rogers PJ Psychopharmacology (Berl). 152(2):167-73, 2000 The effects of low doses of caffeine on human performance and mood. Lieberman HR, Wurtman RJ, Emde GG, Roberts C, Covielle IL Psychopharmacology 92(3):308-12, 1987 A naturalistic investigation of the effects of day-long consumption of tea, coffee and water on alertness, sleep onset and sleep quality. Hindmarch I, Rigney U, Stanley N, Quinlan P, Rycroft J, Lane J Psychopharmacology (Berl). 149(3):203-16, 2000 Caffeine, fatigue, and cognition. Lorist MM &Tops M Brain Cognition 53(1):82-94, 2003 The effects of a low dose of caffeine on cognitive performance. Durlach PJ 31 January 2008 Page 1,804 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Psychopharmacology (Berl). 140(1):116-9, 1998 31 January 2008 Page 1,805 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Camelia sinensis (Common Name : Tea) Protection of body tissues and cells from oxidative damage 31 January 2008 Leaf / 300 ml of brewed tea (1.5 cups or a large mug). 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Leung LK, Su Y, Chen R, Zhang Z, Huang Y, Chen ZY, "Theaflavins in black tea and catechins in green tea are equally effective antioxidants", J Nutr. 2001 Sep;131(9):2248-51 Lewis,J.R., Davis,A.L., Cai,Y., Davies,A.P., Wilkins,J.P.G., and Pennington,M. (1998) Theaflavate B, isotheaflavin-3 '-O-gallate and neotheaflavin-3- O-gallate: Three polyphenolic pigments from black tea. Phytochemistry 49, 2511-2519. Maxwell, S.; Thorpe, G. (1996) Tea flavonoids have little short term impact on serum antioxidant activity. BMJ. 27;313(7051):229. Miller,N.J., Castelluccio,C., Tijburg,L., and Rice-Evans,C. (1996) The antioxidant properties of theaflavins and their gallate esters--radical scavengers or metal chelators? FEBS Lett. 392, 40-44. Miller,N.J., Rice-Evans,C., Davies,M.J., Gopinathan,V., and Milner,A. 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J Hypertens 2005; 23:47-54. Hodgson JM et al. Regular ingestion of black tea improves branchial artery vasodilator function. Clinical Science 2002;102:195-201. Hodgson, J.M., et al., Acute effects of ingestion of black and green tea on lipoprotein oxidation. Am J Clin Nutr, 2000. 71(5): p. 11037. Hodgson, J.M., et al., Acute effects of ingestion of black tea on postprandial platelet aggregation in human subjects. Br J Nutr, 2002. 87(2): p. 141-5. Hodgson, J.M., et al., Can black tea influence plasma total homocysteine concentrations? Am J Clin Nutr, 2003. 77(4): p. 907-11. Hodgson, J.M., et al., Effects of regular ingestion of black tea on haemostasis and cell adhesion molecules in humans. Eur J Clin Nutr, 2001. 55(10): p. 881-6. Hodgson, J.M., et al., Regular ingestion of black tea improves brachial artery vasodilator function. Clin Sci (Lond), 2002. 102(2): p. 195201. Hodgson,J.M., Puddey,I.B., Mori,T.A., et al. 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Int J Food Sci Nutr, 2000. 51(5): p. 309-15. Leenen, R., et al., A single dose of tea with or without milk increases plasma antioxidant activity in humans. Eur J Clin Nutr, 2000. 54(1): p. 87-92. Loktionov, A., et al., Apolipoprotein E genotype modulates the effect of black tea drinking on blood lipids and blood coagulation factors: a pilot study. Br J Nutr, 1998. 79(2): p. 133-9. Mennen, L.I., et al., Consumption of Foods Rich in Flavonoids Is Related to a Decreased Cardiovascular Risk in Apparently Healthy French Women. J. Nutr., 2004. 134(4): p. 923926. Menotti A, Kromhout D, Blackburn H, Fidanza F, Buzina R,Nissinen A. Food intake patterns and 25-year mortality from cornonary heart disease: cross-cultural correlations in the Seven Countries Study. The Seven Countries Study Research Group. Eur J Epidemiol 1999;15:507-15. Mukamal, K.J., et al., Tea consumption and mortality after acute myocardial infarction. Circulation, 2002. 105(21): p. 2476-81. O'Reilly, J.D., T.A. Sanders, and H. Wiseman, Flavonoids protect against oxidative damage to LDL in vitro: use in selection of a flavonoid rich diet and relevance to LDL oxidation resistance ex vivo? Free Radic Res, 2000. 33(4): p. 419-26. Sampson, L., et al., Flavonol and flavone 31 January 2008 Page 1,821 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID intakes in US health professionals. J Am Diet Assoc, 2002. 102(10): p. 1414-20. Serafini, M., A. Ghiselli, and A. Ferro-Luzzi, In vivo antioxidant effect of green and black tea in man. Eur J Clin Nutr, 1996. 50(1): p. 28-32. Sesso et al., Coffee and tea intake and the risk of myocardial infarction. 1999 Am J Epidemiol, 1999. 149(2): p. 162-7. Sesso, H.D., et al., Flavonoid intake and the risk of cardiovascular disease in women. Am J Clin Nutr 2003;77(6):1400-1408 Stensvold I, Tverdal A, Solvoll K, Foss OP, "Tea consumption. relationship to cholesterol, blood pressure, and coronary and total mortality", Prev Med. 1992 Jul;21(4):546-53 Vita, J.A., Tea consumption and cardiovascular disease: effects on endothelial function. J Nutr, 2003. 133(10): p. 3293S3297S. Vorster, H., et al., Tea drinking and haemostasis: a randomized, placebo-controlled, crossover study in free-living subjects. Haemostasis, 1996. 26(1): p. 58-64. Weisburger, J.H. and F.L. Chung, Mechanisms of chronic disease causation by nutritional factors and tobacco products and their prevention by tea polyphenols. Food Chem Toxicol, 2002. 40(8): p. 1145-54. Yang TTC, Koo MWL, "Chinese green tea lowers cholesterol level through an increase in fecal lipid excretion", Life Sciences 2000;66(5):411-423 Yochum, L., et al., Dietary flavonoid intake and risk of cardiovascular disease in postmenopausal women. Am J Epidemiol, 1999. 149(10): p. 943-9. Physical and mental 31 January 2008 200ml (1 cup) of black 1,276 Page 1,822 of 3,931 Category Food Component Health Relationship stimulation (hydration and caffeine) Suggested Conditions of Use tea (equivalent to 0.40.5g/serving tea solids) Nature of Evidence In vivo Human clinical studies References Claim ID Reviews Gardner, E.J.; Ruxton, CHS.; Leeds, AR. Black tea - helpful or harmful? A review of the evidence European Journal of Clinical Nutrition (2007) 61: 3-18. Individual Studies Hindmarch I, Rigney U, Stanley N, Quinlan P, Rycroft J, Lane J. “A naturalistic investigation of the effects of day-long consumption of tea, coffee and water on alertness, sleep onset and sleep quality”. Psychopharmacology (Berl) 2000;149(3):20316 Hindmarch I, Quinlan PT, Moore KL, Parkin C. “The effects of black tea and other beverages on aspects of cognition and psychomotor performance”. Psychopharmacology (Berl) 1998;139(3):230-8 Quinlan PT, Lane J, Moore KL, Aspen J, Rycroft JA, O'Brien DC. “The acute physiological and mood effects of tea and coffee: the role of caffeine level”. Pharmacol Biochem Behav 2000;66(1):19-28 Quinlan P, Lane J, Aspinall LT. “Effects of hot tea, coffee, and water ingestion on physiological responses and mood: the role of caffeine, water and beverage type.” Psychopharmacol (Berl) 1997;134(2):164-73 Scott, D.; Rycroft, J.A.; Aspen, J.; Chapman, C.; Brown, B. The effect of drinking tea at high altitude on hydration status and mood. European Journal of Applied Physiology (2004) 91: 493-498. Steptoe, A.; Wardle, J. Mood and drinking: a naturalistic diary study of alcohol, coffee and tea. Psychopharmacology (1999) 141: 315-321. Skin health 31 January 2008 Leaf / Usual consumption as 1,283 Page 1,823 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use traditional foodstuff in a normal diet / The equivalent of 1-3 cups of tea per day delivering 360-1080 mg tea solids Oral health 31 January 2008 200ml (1 cup) of tea (equivalent to 0.40.5g/serving tea solids) no added sugar Nature of Evidence individual studies, review References Claim ID Individual Studies Morley N, Clifford T, Salter L, Campbell S, Gould D, Curnow A, "The green tea polyphenol (-)-epigallocatechin gallate and green tea can protect human cellular DNA from ultraviolet and visible radiation-induced damage", Photodermatol Photoimmunol Photomed. 2005 Feb;21(1):15-22 Yusuf N, Irby C, Katiyar SK, Elmets CA., "Photoprotective effects of green tea polyphenols", Photodermatol Photoimmunol Photomed. 2007 Feb;23(1):48-56. 1,277 Page 1,824 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Individual studies References Claim ID Reviews Cabrera, C.; Artacho, R.; Gimenez, R. Beneficial effects of green tea--a review. J Am Coll Nutr 2006, 25, 79-99. Hamilton-Miller, J. M. Anti-cariogenic properties of tea (Camellia sinensis). J Med Microbiol 2001, 50, 299-302. Hamilton-Miller, J. M. Antimicrobial properties of tea (Camellia sinensis L.). Antimicrob Agents Chemother 1995, 39, 23752377. Wu, C. D.; Wei, G. X. Tea as a functional food for oral health. Nutrition 2002, 18, 443444. Individual Studies Cao J, et al (1987) Observation of caries incidence among a tea-drinking population. J Dental Health: 31; 86-9. Chan JT, et al (1996) Fluoride content in caffeinated, decaffeinated and herbal teas. Caries Research; 30: 88-92. Cremer HD, et al (1970) Absorption of fluorides, Fluoride and human health. Geneva: WHO, 75-91. Hirasawa, M.; Takada, K.; Makimura, M.; Otake, S. Improvement of periodontal status by green tea catechin using a local delivery system: a clinical pilot study. J Periodontal Res 2002, 37, 433-438. Hirasawa, M.; Takada, K.; Otake, S. Inhibition of acid production in dental plaque bacteria by green tea catechins. Caries Res 2006, 40, 265-270. Iizuka S. (1980) Inhibitory effect of tannic acid on the lactate metabolism in human saliva. Dentistry: 67: 770-778. Itoh T (1991) Inhibition of cariogenic factor of mutans streptococci by tannic acid. Nihon Univ J Oral Sci: 17; 115-126. Jones, C.; Woods, K.; Whittle, G.; 31 January 2008 Page 1,825 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Worthington, H.; Taylor, G. Sugar, drinks, deprivation and dental caries in 14-year-old children in the north west of England in 1995. Community Dent Health 1999, 16, 68-71. Matsumoto, M.; Hamada, S.; Ooshima, T. Molecular analysis of the inhibitory effects of oolong tea polyphenols on glucan-binding domain of recombinant glucosyltransferases from Streptococcus mutans MT8148. FEMS Microbiol Lett 2003, 228, 73-80. Nakahara, K.; Kawabata, S.; Ono, H.; Ogura, K.; Tanaka, T.; Ooshima, T.; Hamada, S. Inhibitory effect of oolong tea polyphenols on glycosyltransferases of mutans Streptococci. Appl Environ Microbiol 1993, 59, 968-973. Okamoto, M.; Sugimoto, A.; Leung, K. P.; Nakayama, K.; Kamaguchi, A.; Maeda, N. Inhibitory effect of green tea catechins on cysteine proteinases in Porphyromonas gingivalis. Oral Microbiol Immunol 2004, 19, 118-120. Onisi M (1985) Analysis of data obtained from 5 years tea drinking program for the caries prevention by means of the linear caries extent/ risk relation J. Dental Health:35; 138-9. Ooshima, T.; Minami, T.; Aono, W.; Tamura, Y.; Hamada, S. Reduction of dental plaque deposition in humans by oolong tea extract. Caries Res 1994, 28, 146-149. Otake S, et al (1991) Anticaries effects of polyphenolic compounds from Japanese green tea. Caries Res, 25(6): 438-43. Paolino VJ, et al (1980) Inhibition of dextran synthesis by tannic acid. Am Assoc Dent Res: 488 (abstract). Ramsey AC, et al (1975) Fluoride intakes and caries increments in relation to tea consumption by British children. Caries Res: 9; 312. Rao GS (1984) Dietary intake and 31 January 2008 Page 1,826 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID bioavailability of fluoride. Ann Rev Nutr 4; 115136. Sakanaka S, et al (1990) Inhibitory effects of green tea polyphenols on glucan synthesis and cellular adherence of cariogenic Streptococci. Agric Biol Chem 54; 2925-9. Sasaki, H.; Matsumoto, M.; Tanaka, T.; Maeda, M.; Nakai, M.; Hamada, S.; Ooshima, T. Antibacterial activity of polyphenol components in oolong tea extract against Streptococcus mutans. Caries Res 2004, 38, 28. Signoretto, C.; Burlacchini, G.; Bianchi, F.; Cavalleri, G.; Caneparil, P. Differences in microbiological composition of saliva and dental plaque in subjects with different drinking habits. New Microbiol 2006, 29, 293-302. Simpson A, et al (2001) the bio-availability of fluoride from black tea. J Dentistry:29; 15-21. Simpson A, et al (2001) Tooth Surface pH during drinking of black tea. British Dental Journal:190; 374-376 . Tachibana Y, et al (1989) The effect of suppression of the tannin fluoride preparation upon the development of dental plaque. J Jpn Endodont: 10; 60-65. Wei SHY, et al (1989) Concentration of fluoride and selected other elements in tea. Nutrition 1989; 5: 237-40. Wu-Yuan CD, et al (1988) Gallotannins inhibit growth, water insoluble glucan synthesis and aggregation of mutans streptococci. J Dent Res: 67; 51-55. Yu H, et al (1995) Effects of several tea components on acid resistance of human tooth enamel. J Dent: 23; 101-105. Zhang J, et al (1998) Inhibition of salivary amylase by black and green teas and their effects on the intraoral hydrolysis of starch. 31 January 2008 Page 1,827 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Caries Research: 32; 233-8. Bone health 31 January 2008 Leaf / Usual consumption as traditional foodstuff in a normal diet / The equivalent of 1-3 cups per day delivering 360-1080 mg tea solids individual studies, review Review Gardner EJ, Ruxton CH, Leeds AR., "Black tea--helpful or harmful? A review of the evidence", Eur J Clin Nutr. 2007 Jan;61(1):3-18. Epub 2006 Jul 19 1,282 Individual Studies Chen CH, Ho ML, Chang JK, Hung SH, Wang GJ., "Green tea catechin enhances osteogenesis in a bone marrow mesenchymal stem cell line", Osteoporos Int. 2005 Dec;16(12):2039-45. Epub 2005 Sep 17 Vali B, Rao LG, El-Sohemy A., "Epigallocatechin-3-gallate increases the formation of mineralized bone nodules by human osteoblast-like cells", J Nutr Biochem. 2007 May;18(5):341-7. Epub 2006 Sep 8 Hegarty VM, May HM, Khaw KT, "Tea drinking and bone mineral density in older women", Am J Clin Nutr. 2000 Apr;71(4):10037 Page 1,828 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Camelia sinensis(Common Name : Tea) Glucose metabolism 31 January 2008 Leaf / Usual consumption as traditional foodstuff in a normal diet / The equivalent of 1-3 cups per day delivering 360-1080 mg tea solids Individual Studies Anderson RA, Polansky MM, "Tea enhances insulin activity", J Agric Food Chem. 2002 Nov 20;50(24):7182-6 Fukino Y, Shimbo M, Aoki N, Okubo T, Iso H, "randomized controlled trial for an effect of green tea consumption on insulin resistance and inflammation markers", Journal of nutritional science and vitaminology 2005;51(5):335-342 Wolfram S, et al., "Epigallocatechin Gallate Supplementation Alleviates Diabetes in Rodents", Journal of Nutrition 2006;136(10):2512-2518 1,280 Page 1,829 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Camellia sinensis Tea (Green, Oolong and Black Tea) Resting metabolic rate and thermogenesis The product must contain at least 200 milligrams Camellia sinensis extract per serving and delivering at least 90 mg EGCG per serving Claim to be used for foods for active individuals Peer-reviewed scientific research articles Peer-reviewed animal study Chantre P, Lairon D. (2002) Recent findings of green tea extract AR25 (Exolise) and its activity for the treatment of obesity. Phytomedicine; Jan;9(1):3- 8. 1,761 Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander. (1999) Efficacy of a Green Tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. J. Am J Clin Nutr; Dec;70(6):1040-5. Dulloo AG, Seydoux J, Girardier L, Chantre P, Vandermander J. (2000) Green tea and thermogenesis: interactions between catechin-polyphenols, caffeine and sympathetic activity. Int J Obes Relat Metab Disord; Feb;24(2):252-8. Rumpler W, Seale J, Clevidence B, Judd J, Wiley E, Yamamoto S, Komatsu T, Sawaki T, Ishikura Y, Hosoda K. (2001) Oolong tea increases metabolic rate and fat oxidation in men. J Nutr; Nov;131(11):2848-52. Han LK, Takaku T, Li J, Kimura Y, Okuda H. (1999) Anti-obesity action of oolong tea. Int J Obes Relat Metab Disord; Jan;23(1):98-105. Murase T, Nagasawa A, Suzuki J, Hase T, Tokimitsu I. (2002) Beneficial effects of tea catechins on diet-induced obesity: stimulation of lipid catabolism in the liver. Int J Obes Relat Metab Disord; Nov;26(11):1459-64. Antioxidant 31 January 2008 The product must 1,760 Page 1,830 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use contain at least 200 milligrams Camellia sinensis extract per serving and delivering at least 90 mg EGCG per serving Claim to be used for foods for active individuals Nature of Evidence Peer-reviewed scientific review articles References Claim ID Cooper R, Moore DJ, Morre DM. (2005) Medicinal benefits of green tea: Part I. Review of noncancer health benefits. J Altern Complement Med; Jun, 11(3): 521-8. Cooper R, Moore DJ, Morre DM. (2005) Medicinal benefits of green tea: Part II. Review of anticancer properties. J Altern Complement Med; Aug, 11(4): 639-652. Nagel DG, Ferreira D, Zhou YD. (2006) Epigallocatcechin-3-gallate (EGCG): chemical and biomedical perspectives. Phytochemistry; Sept: 67(17): 1849-55. 31 January 2008 Page 1,831 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Carbohydrate foods and beverages ENDURANCE Increased endurance capacity; Increased endurance performance; Delayed Fatigue. 31 January 2008 Claim to be only used for Foods for sportpeople under the Dir. 89/398/EEC. Metabolisable carbohydrates: = 65% of total energy (for foods). Metabolisable carbohydrates: = 75% of total energy (for beverages). 1,615 Page 1,832 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence SCF Review FAO/WHO Review Nutrition Society Textbook Consensus statement RCT References Claim ID Report of the SCF on the Composition and Specification of Food Intended to Meet the Expenditure of Intense Muscular Effort, especially for Sportsmen (2001) SCF/CS/NUT/SPORT/5 Final. Report of a joint FAO/WHO Expert Consultation (1997). Carbohydrates in human nutrition (FAO Food and Nutrition Paper – 66). Nutritional considerations in triathlon. Jeukendrup A, Jentjens R & Molesey L. Sports Med 35 (2) 163-181, 2005 Carbohydrate intake during exercise and performance Jeukendrup AE. Nutrition 20(7-8):669-77, 2004 Nutrition on Match Day Williams and Serratosa J Sp Sci 24 (7) 687-697, 1991 Exercise performance. Jeukendrup AE and Burke LM. Chapter 18. In: Nutrition and Metabolism. (Gibney MJ MacDonald I, Roche HM eds). London. 2003. Fluid replacement in sport and exercise – a consensus statement Maughan RJ, Goodman R, Griffin J, Irani M, Kirwan JP, Leiper JB, macLaren DP, McLatchie G, Tsintsas K, Willians C, Wellington P, Wilson WM, Wotton S Br J Sp Med 27 (1): 34-35, 1993 Consensus Statement of the IAAF 2007. Nutrition for Athletics. IOC Consensus Statement on Sports Nutrition 31 January 2008 Page 1,833 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 2003. Human muscle glycogen metabolism during exercise. Effect of carbohydrate supplementation. Tsintzas K & Willaims C Sports Med 25 (1): 7-23, 1998 Carbohydrate feedings before, during or in combination improve cycling endurance performance Wright DA, Sherman WM, Dernbach AR J Appl Physiol 71 (3): 1082-1088, 1991 Carbohydrate-loading and exercise performance. An update. Hawley JA, Schabort EJ, Noakes TD, Dennis SC. Sports Med 24 (2); 73-81, 1997 Regulation of endogenous fat and carbohydrate metabolism in relation to exercise intensity and duration Romijn JA, Coyle ET, Sidossis S, Gastaldelli A, Horowitz JF, Endert E, Wolfe RR Am J Physiol 265: E380-E391, 1993. Substrate usage during prolonged exercise following a pre-exercise meal. Coyle EF, Coggan AR, Hemmert MK et al. J Appl Physiol 59 (2): 429-433, 1985 Responses to varying rates of carbohydrate ingestion during exercise Murray R, Paul GL, Seifert JG, Eddy DE. Med Sci Sports Exerc. 23(6):713-8, 1991 RECOVERY Enhanced muscle glycogen synthesis Enhanced recovery. 31 January 2008 Claim to be only used for Foods for sportpeople under the Dir. 1,616 Page 1,834 of 3,931 Category Food Component Health Relationship Enhanced recovery. Suggested Conditions of Use 89/398/EEC. Metabolisable carbohydrates: = 65% of total energy (for foods). Metabolisable carbohydrates: = 75% of total energy (for beverages). Nature of Evidence SCF Review Consensus statement Review RCT References Claim ID Report of the SCF on the Composition and Specification of Food Intended to Meet the Expenditure of Intense Muscular Effort, especially for Sportsmen (2001) SCF/CS/NUT/SPORT/5 Final. Nutrition for football: The FIFA/F-MARC Consensus Conference. Consensus Statement J. Sports Sci. 24 (7): 663 - 664, 2006. Position of the American Dietetic Association, Dietitians of Canada, and the American college of Sports Medicine: Nutrition and athletic performance. Consensus Statement J Am Diet Assoc. 100: 1543-1556, 2000. Carbohydrate intake and recovery from exercise. Williams C. Science & Sports. 19: 239 – 244, 2004. Carbohydrates and fat for training and recovery. Burke LM, Kiens B and Ivy JL. J Sports Sci. 22(1):15-30, 2004. Determinants of post-exercise glycogen synthesis during short-term recovery. Jentjens R and Jeukendrup AE Sports Med. 33 (2): 117 - 144, 2003 Dietary strategies to promote glycogen synthesis after exercise. Ivy J Can. J. Appl. Physiol. 26 (Suppl.): S236 - S245, 2001 Exercise performance. 31 January 2008 Page 1,835 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Jeukendrup AE and Burke LM. Chapter 18. In: Nutrition and Metabolism. (Gibney MJ MacDonald I, Roche HM eds). London, 2003. Post-exercise rehydration and recovery. Shirreffs, S. Chapter 7: In Sports Drinks: Basic Science and Practical Aspects. (Maughan, R. & Murray, R. eds.). CRC Press, 2001. Short-term recovery from prolonged constant pace running in a warm environment: the effectiveness of a carbohydrate-electrolyte solution. Bilzon JLJ, Allsopp AJ, Williams C Eur. J. Appl. Physiol. 82: 305 - 312, 2000. Maximising postexercise muscle glycogen synthesis: carbohydrate supplementation and the application of amino acid or protein hydrolysate mixtures van Loon LJC, Saris WHM, Kruijshoop M, Wagenmakers AJM Am. J. Clin. Nutr. 72: 106 – 111, 2000. The influence of ingesting a carbohydrate-electrolyte beverage during 4 hours of recovery on subsequent endurance capacity. Fallowfield JL, Williams C, Singh R Int. J. Sport Nutr. 5: 285 - 299, 1995. Muscle glycogen synthesis after exercise: effect of time of carbohydrate ingestion. Ivy JL, Katz AL, Cutler CL, Sherman WM, Coyle EF J. Appl. Physiol. 64 (4): 1480 - 1485, 1988. The influence of a high carbohydrate intake 31 January 2008 Page 1,836 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID during recovery from prolonged, constant-pace running. Fallowfield J and Williams C. Int. J. Sport Nutr. 7: 10 - 25, 1997. Attenuation of the perception of effort and reduction in pleasure 31 January 2008 Claim to be only used for Foods for sportpeople under the Dir. 89/398/EEC. Metabolisable carbohydrates: = 65% of total energy (for foods). Metabolisable carbohydrates: = 75% of total energy (for beverages). 1,617 Page 1,837 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence RCT References Claim ID Carbohydrate attenuates perceived exertion during intermittent exercise and recovery Utter AC, Kang J, Nieman DC, Dumke CL, McAnulty SR, McAnulty LS. Med Sci Sports Exerc. 39(5):880-885, 2007 Carbohydrate ingestion during prolonged high-intensity intermittent exercise: impact on affect and perceived exertion. Backhouse SH, Ali A, Biddle SJH, Williams C Scand J Med Sci Sports. 2007 Feb 19; [Epub ahead of print] Effect of carbohydrate and prolonged exercise on affect and perceived exertion. Backhouse SH, Bishop NC, Biddle SJH, Williams C. Med Sci Sports Exerc. 37(10):1768-1773, 2005 Winnick JJ, Davis JM, Welsh RS, Carmichael MD, Murphy EA, Blackmon JA. Carbohydrate feedings during team sport exercise preserve physical and CNS function. Med Sci Sports Exerc. 37(2):306-315, 2005 Carbohydrate supplementation and perceived exertion during prolonged running Achten J, Halson SL, Moseley L, Rayson MP, Casey A, Jeukendrup AE. Med Sci Sports Exerc. 36(6):1036-1041, 2004 Utter AC, Kang J, Nieman DC, Dumke CL, Mcanulty SR, Vinci DM, Mcanulty LS. Carbohydrate supplementation and perceived exertion during prolonged running. Med Sci Sports Exerc. 36(6):1036-1041, 2004 Utter AC, Kang J, Robertson RJ, Nieman DC, Chaloupka EC, Suminski RR, Piccinni CR. Effect of carbohydrate ingestion on ratings of 31 January 2008 Page 1,838 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID perceived exertion during a marathon. Med Sci Sports Exerc. 34(11):1779-1784, 2002 Carbohydrates and physical/mental performance during intermittent exercise to fatigue Welsh RS, Davis JM, Burke JR, Williams HG. Med Sci Sports Exerc. 34(4):723-31, 2002 31 January 2008 Page 1,839 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Catechins – Green tea (camellia sinensis) Eye health Physiological antioxidant properties 31 January 2008 Recommended dosage 100-500 mg EGCG or 200-1000 mg of catechins. Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Recommended dosage 250-1000 mg catechin/day Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which Animal study Review Zhang B, Osborne NN. 2006. Oxidative-induced retinal degeneration is attenuated by epigallocatechin gallate. Brain Res. 1124(1):176-87. 1,742 Bo Zhanga, Rukhsana Safaa, Dario Ruscianob, Neville N. Osbornea, 2007. Epigallocatechin gallate, an active ingredient from green tea, attenuates damaging influences to the retina caused by ischemia/reperfusion. Brain Res 1159(4): 40-53. Zigman S, Rafferty NS, Rafferty KA, Lewis N. 1999. Effects of green tea polyphenols on lens photooxidative stress. Biol Bull. 197(2):285-286 Kaszkin M, Beck KF, Eberhardt W, Pfeilschifter J. 2004. Unravelling green tea's mechanisms of action: more than meets the eye. Mol Pharmacol. 65(1): 15-17. 1,732 Page 1,840 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day.. Nature of Evidence Human study Animal study In vitro Review References Claim ID Nakagawa K, Ninomiya M, Okubo T, Aoi N, Juneja L.R, Kim M, Yamanaka K and Miyazawa T. 1999. Tea Catechin Supplementation Increases Antioxidant Capacity and Prevents Phospholipid Hydroperoxidation in Plasma of Humans. J. Agric. Food Chem.47:3967-3973. Okubo T, Juneja LR, Yokozawa T, Shibata T and Hasegawa M. 2004. Antioxidative effect of Green Tea Catechins and their Clinical Efficacy in Hemodialysis Patients. The 7th Annual Meeting of Japanese society for Complementary and Alternative Medicine. p43. Yokozawa T, Oura H, Shibata T, Ishida K, Kaneko M, Hasegawa M, Sakanaka S.and Kim M. 1996. Effects of Green Tea Tannin in Dialysis Patients, Journal of Traditional Medicines, 13: 124-131. Erba D, Riso P, Bordoni A, Foti P, Biagi PL, Testolin G. 2005. Effectiveness of moderate green tea consumption on antioxidative status and plasma lipid profile in humans. J Nutr Biochem 16(3):144-149. Coimbra S, Castro E, Rocha-Pereira P, Rebelo I, Rocha S, Santos-Silva A. 2006. The effect of green tea in oxidative stress. Clinical Nutrition 25(5):790-796. Hakim IA, Harris RB, Brown S, Chow HH, Wiseman S, Agarwal S, Talbot W. 2003. Effect of increased tea consumption on oxidative DNA damage among smokers: A randomized controlled study. J Nutri. 133: 3303S-3309S. Miyazawa T. 2000 Absorption, metabolism and antioxidative effects of tea catechin in humans. Biofactors 13(1-4): 55-59. 31 January 2008 Page 1,841 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Zhong Z, Froh M, Connor MD, Li X, Conzelmann LO, Mason RP, Lemasters JJ and Thurman RG..2002. Prevention of hepatic ischemia- reperfusion injury by green tea extract, Am J Physiol Gastrointest Liver Physiol, 283, G957-G964. Inagake M, Yamane T, Kitao Y, Oya K, Matsumoto H, Kikuoka N, Nakatani H, Takahashi T, Nishimura H, Iwashima A. 1995. Inhibition of 1,2-Dimethylhydrazine induced Oxidative DNA Damage by Green Tea Extract in Rat. Jpn.J. Cancer Res. 86:1106-1111. Yokozawa T, Oura H, Sakanaka S and Kim M. 1992. Effect of Tannins in Green Tea on the Urinary Methylguanidine Excretion in Rats Indicating a Possible Radical Scavenging Action, Biosci. Biotech. Biochem., 56(6): 896-899. Yokozawa T, Oura H, Hattori M, Hattori M, Dohi K, Sakanaka S and Kim M. 1993. Inhibitory Effect of Tannin in Green Tea on the Proliferation of Mesangial Cells, Nephron, 65: 596-600. Yokozawa T, Oura H, Sakanaka S, Ishigaki S and Kim M. 1994. Depressor Effect of Tannin in Green Tea on Rats with Renal Hypertension. Biosci. Biotech. Biochem., 58(5): 855-858. Yokozawa T, Oura H, Nakagawa H, Sakanaka S and Kim M. 1995. Effects of a Component of Green Tea on the Proliferation of Vascular Smooth Muscle Cells, Biosci. Biotech. Biochem., 59(11): 2134-2136. Yokozawa T, Chung HY, He LQ and Oura H. 31 January 2008 Page 1,842 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 1996. Effectiveness of Green Tea Tannin on Rats with Chronic Renal Failure, Biosci. Biotech. Biochem., 60(6): 1000-1005. Nakagawa T, Yokozawa T, Terasawa T, Shu S and Juneja LR. 2002. Protective Activity of Green Tea against Free Radical- and Glucose-Mediated Protein Damage, J. Agric. Food Chem, 50: 2418-2422. Young JF, Dragstedt LO, Haraldsdóttir J, Daneshvar B, Kal MA, Loft S, Nilsson L, Nielsen SE, Mayer B, Skibsted LH, Huynh-Ba T, Hermetter A, Sandström B. 2002. Green tea extract only affects markers of oxidative status postprandially: lasting antioxidant effect of flavonoid-free diet. British J Nutri 87(4):343-355. Saffari Y, Sadrzadeh SM. 2004. Green tea metabolite EGCG protects membranes against oxidative damage in vitro. Life Sci 74(12):1513-1518. Koketsu M and Satoh Y 1997.Antioxidative Activity of Green Tea polyphenols in Edible Oils. Food Lipids 4: 1-9. Unten L, Koketsu M.and Kim M. 1997. Anti-discoloring activity of green Tea Polyphenols on Beta Carotene. J. Agric. Food Chem. 45: 2009-2012. Luo M, Kannar K, Wahlqvist M.L and O’Brien R.C. 1997. Inhibition of LDL oxidation by Green Tea. Lancet 349: 360-361 Osada K, Takahashi M, Hoshina S, Nakamura M, Nakamura S, Sugano M. 2001. Tea catechins inhibit cholesterol oxidation 31 January 2008 Page 1,843 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID accompanying oxidation of low density lipoprotein in vitro. Comparative Biochemistry and Physiology, Toxicology and Pharmacology 128(2):153-164. Rao T.P, Juneja L.R. and Yokozawa T. 2002. Green Tea Polyphenols Against Renal Disorders.. Int J Tea Sci 2: 51-58. Rao T.P, Yokozawa T and Juneja L.R. 2004. Preventive Effects of Green Tea Polyphenols against Oxidative Stress of Renal Disease. Int J Tea Sci. 3, 239-252.. Cholesterol 31 January 2008 Recommended dosage 400-600 mg catechins. Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day.. 1,734 Page 1,844 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Epidemiology study Human study Animal study In vitro Review References Claim ID Tokunaga S, White IR, Frost C, Tanaka K, Kono S, Tokudome S, Akamatsu T, Moriyama T, Zakouji H. 2002 Green tea consumption and serum lipids and lipoproteins in a population of healthy workers in Japan. Annals of Epidemiology 12(3):157-165. Kono S, Shinchi K, Wakabayashi K, Honjo S, Todoroki I, Sakurai Y, Imanishi K, Nishikawa H, Ogawa S, Katsurada M. 1996. Relation of green tea consumption to serum lipids and lipoproteins in Japanese men. J Epidemiology 6: 128-133. Kim W, Jeong MH, Cho SH, Yun JH, Chae HJ, Ahn YK, Lee MC, Cheng X, Kondo T, Murohara T, Kang JC. 2006. Effect of green tea consumption on endothelial function and circulating endothelial progenitor cells in chronic smokers. Circulation J. 70(8): 1052-1057. Maron DJ, Lu GP, Cai NS, Wu ZG, Li YH, Chen H, Zhu JQ, Jin XJ, Wouters BC, Zhao J. 2003. Cholesterol-lowering effect of a theaflavin-enriched green tea extract: a randomized controlled trial. Arch Intern Med 163(12):1448-1453. Unno T, Tago M, Suzuki Y, Nozawa A, Sagesaka YM, Kakuda T, Egawa K, Kondo K. 2005. Effect of tea catechins on postprandial plasma lipid responses in human subjects. British J Nutri. 93(4):543-547. Lee W, Min WK, Chun S, Lee YW, Park H, Lee DH, Lee YK, Son JE. 2005. Long-term effects of green tea ingestion on atherosclerotic biological markers in smokers. Clin Biochem 38(1): 84-87. 31 January 2008 Page 1,845 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Erba D, Riso P, Bordoni A, Foti P, Biagi PL, Testolin G. 2005. Effectiveness of moderate green tea consumption on antioxidative status and plasma lipid profile in humans. J Nutr Biochem 16(3):144-9. Muramatsu K, Fukuyo M, Hara Y. 1986. Effect of green tea catechins on plasma cholesterol level in cholesterol-fed rats. J Nutr Sci Vitaminol (Tokyo) 32(6):613-22. Raederstorff DG, Schlachter MF, Elste V, Weber P. 2003. Effect of EGCG on lipid absorption and plasma lipid levels in rats. J Nutr Biochem 14(6):326-332. Yang TT, Koo MW. 1997. Hypocholesterolemic effects of Chinese tea. Pharmacol Res 35(6):505-512. Kobayashi M, Unno T, Suzuki Y, Nozawa A, Sagesaka Y, Kakuda T, Ikeda I. 2005. Heat-epimerized tea catechins have the same cholesterol-lowering activity as green tea catechins in cholesterol-fed rats. Biosci. Biotech and Biochem 69(12):2455-2458. Chan PT, Fong WP, Cheung YL, Huang Y, Ho WK, Chen ZY. 1999. Jasmine green tea epicatechins are hypolipidemic in hamsters (Mesocricetus auratus) fed a high fat diet. J Nutri 129:1094-1101. Osada K, Takahashi M, Hoshina S, Nakamura M, Nakamura S, Sugano M. 2001.Tea catechins inhibit cholesterol oxidation accompanying oxidation of low density lipoprotein in vitro. Comparative Biochemistry and Physiology, Toxicol Pharm 128(2):153-164. 31 January 2008 Page 1,846 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Lin JK, Lin-Shaiu SY. 2006. Mechanisms of hypolipidemic and anti-obesity effects of tea and tea polyphenols. Molecular Nutrition and Food Research 50(2):211-217. Weight management 31 January 2008 Recommended dosage 400-600 mg catechins Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. 1,733 Page 1,847 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Human study Animal study Review References Claim ID Dulloo AG, Duret C, Rohrer D, Girardier L, Mensi N, Fathi M, Chantre P, Vandermander J. 1999. Efficacy of a green tea extract rich in catechin polyphenols and caffeine in increasing 24-h energy expenditure and fat oxidation in humans. Am J Clin Nutr. 70(6):1040-50. Nagao T, Komine Y, Soga S, Meguro S, Hase T, Tanaka Y, Tokimitsu I. 2005. Ingestion of a tea rich in catechins leads to a reduction in body fat and malondialdehyde-modified LDL in men. Am J Clin Nutri 81(1): 122-129. Shimotoyodome A, Haramizu S, Inaba M, Murase T, Tokimitsu I. 2005. Exercise and green tea extract stimulate fat oxidation and prevent obesity in mice. Med Sci Sports Exerc. 37(11): 1884-1892. Klaus S, Pültz S, Thöne-Reineke C, Wolfram S. 2005. Epigallocatechin gallate attenuates diet-induced obesity in mice by decreasing energy absorption and increasing fat oxidation. Intl J Obesity (London) 29(6): 615-623. Shimotoyodome A, Haramizu S, Inaba M, Murase T, Tokimitsu I. 2005. Exercise and green tea extract stimulate fat oxidation and prevent obesity in mice. Medicine and Science in Sports and Exercise 37(11):1884-1892. Ashida H, Furuyashiki T, Nagayasu H, Bessho H, Sakakibara H, Hashimoto T, Kanazawa K. 2004. Anti-obesity actions of green tea: possible involvements in modulation of the glucose uptake system and suppression of the adipogenesis-related transcription factors. Biofactors 22(1-4):135-140. Sayama K, Lin S, Zheng G, Oguni I. 2000 31 January 2008 Page 1,848 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Effects of green tea on growth, food utilization and lipid metabolism in mice. In Vivo. 14(4):481-484. Choo JJ. 2003. Green tea reduces body fat accretion caused by high-fat diet in rats through beta-adrenoceptor activation of thermogenesis in brown adipose tissue. J Nutri. Biochem. 14(11):671-676. Zheng G, Sayama K, Okubo T, Juneja LR, Oguni I. 2004. Anti-obesity effects of three major components of green tea, catechins, caffeine and theanine, in mice. In Vivo 18(1):55-62. Juhel C, Armand M, Pafumi Y, Rosier C, Vandermander J, Lairon D. 2000. Green tea extract (AR25) inhibits lipolysis of triglycerides in gastric and duodenal medium in vitro. J Nutr Biochem 11(1):45-51. Dulloo AG, Seydoux J, Girardier L, Chantre P, Vandermander J. 2000 Green tea and thermogenesis: interactions between catechin-polyphenols, caffeine and sympathetic activity. Int J Obes Rel Metab Disord 24(2):252-258. Wolfram S, Wang Y, Thielecke F. 2006. Anti-obesity effects of green tea: from bedside to bench. Mol Nutr Food Res. 50(2):176-187. Lin JK, Lin-Shaiu SY. 2006 Mechanisms of hypolipidemic and anti-obesity effects of tea and tea polyphenols. Molecular Nutrition and Food Research 50(2):211-217. Glucose metabolism 31 January 2008 Recommended dosage 400-600mg Catechins are active and 1,737 Page 1,849 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day.. Nature of Evidence Human study Animal study Review References Claim ID Iso H, Date C, Wakai K, et al. 2006. The relationship between green tea and total caffeine intake and risk for self-reported type 2 diabetes among Japanese adults. Ann Intern Med. 144(8):554-62. Zhong L, Furne JK, Levitt MD. 2006 An extract of black, green, and mulberry teas causes malabasorption of carbohydrate but not of triacylglycerol in healthy volunteers. Am J Clin Nutri. 84(3):551-555 Tsuneki H, Ishizuka M, Terasawa M, Wu JB, Sasaoka T, Kimura I. 2004. Effect of green tea on blood glucose levels and serum proteomic patterns in diabetic (db/db) mice and on glucose metabolism in healthy humans. BMC Pharmacology 4: 18. Arts IC, Jacobs DR Jr, Harnack LJ, Gross M, Folsom AR. 2001. Dietary catechins in relation to coronary heart disease death among postmenopausal women. Epidemiology.12(6):668-675. Wolfram S, Raederstorff D, Preller M, Wang Y, Teixeira SR, Riegger C, Weber P. 2006. Epigallocatechin gallate supplementation alleviates diabetes in rodents. J Nutri. 136(10): 2512-2518. Kim MJ, Ryu GR, Chung JS, Sim SS, Min DS, Rhie DJ, Yoon SH, Hahn SJ, Kim MS, Jo YH. 2003. Protective effects of epicatechin against the toxic effects of streptozotocin on rat pancreatic islets. Pancreas 26(3):292-299. Fukino Y, Ikeda A, Maruyama K, Aoki N, Okubo T, Iso H.2007. Randomized controlled trial for an effect of green tea-extract powder 31 January 2008 Page 1,850 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID supplementation on glucose abnormalities. Eur J Clin Nutr. Hase M, Babazono T, Karibe S, Kinae N, Iwamoto Y. 2006. Renoprotective effects of tea catechin in streptozotocin- induced diabetic rats. Int Urol Nephrol. 38(3-4):693-699. Fukino Y, Shimbo M, Aoki N, Okubo T, Iso H.2005. Randomized controlled trial for an effect of green tea consumption on insulin resistance and inflammation markers. J Nutr Sci Vitaminol (Tokyo). 51(5):335-342. Kim MJ, Ryu GR, Chung JS, Sim SS, Min DS, Rhie DJ, Yoon SH, Hahn SJ, Kim MS, Jo YH. 2003. Protective effects of epicatechin against the toxic effects of streptozotocin on rat pancreatic islets: in vivo and in vitro. Pancreas. 26(3):292-299. Rizvi SI, Zaid MA.2001.Intracellular reduced glutathione content in normal and type 2 diabetic erythrocytes: effect of insulin and (-)epicatechin. J Physiol Pharmacol. 52(3):483-488. Hung PF, Wu BT, Chen HC, Chen YH, Chen CL, Wu MH, Liu HC, Lee MJ, Kao YH.2005. Antimitogenic effect of green tea (-) -epigallocatechin gallate on 3T3-L1 preadipocytes depends on the ERK and Cdk2 pathways. Am J Physiol Cell Physiol. 288(5):C1094-10108. Li C, Allen A, Kwagh J, Doliba NM, Qin W, Najafi H, Collins HW, Matschinsky FM, Stanley CA, Smith TJ. 2006. Green tea polyphenols modulate insulin secretion by inhibiting glutamate dehydrogenase. J Biol Chem. 31 January 2008 Page 1,851 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 281(15): 10214-10221 Li T, Liu J, Zhang X, Ji G. 2007. Antidiabetic activity of lipophilic (-) -epigallocatechin-3-gallate derivative under its role of alpha-glucosidase inhibition. Biomed Pharmacother. 61(1):91-96. Rizvi SI, Zaid MA, Anis R, Mishra N. 2005. Protective role of tea catechins against oxidation-induced damage of type 2 diabetic erythrocytes. Clin Exp Pharmacol Physiol. 32(1-2):70-75. Moon HS, Lee HG, Choi YJ, Kim TG, Cho CS. 2007. Proposed mechanisms of (-) -epigallocatechin-3-gallate for anti-obesity. Chem Biol Interact.167(2):85-98. Kao YH, Chang HH, Lee MJ, Chen CL.2006. Tea, obesity, and diabetes. Mol Nutr Food Res. 50(2):188-210. Crespy V, Williamson G.2004. A review of the health effects of green tea catechins in in vivo animal models.J Nutr.134 (12 Suppl):3431S-3440S. Women health 31 January 2008 Recommended dosage 500 –1000 mg/day Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption 1,744 Page 1,852 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Nature of Evidence Meta analysis Human study References Claim ID Larsson SC, Wolk A. 2005. Tea consumption and ovarian cancer risk in a population-based cohort. Arch Intern Med. 165(22):2683-86. Sun CL, Yuan JM, Koh WP, Yu MC. 2006. Green tea, black tea and breast cancer risk: a meta-analysis of epidemiological studies. Carcinogenesis 27(7):1310-1315. Zhang M, Lee AH, Binns CW, Xie X. 2004. Green tea consumption enhances survival of epithelial ovarian cancer. Int J Cancer. 112(3):465-69. Wu AH, Yu MC, Tseng CC, Hankin J, Pike MC. 2003. Green tea and risk of breast cancer in Asian Americans. Int J Cancer 106(4):574-579. Yuan JM, Koh WP, Sun CL, Lee HP, Yu MC. 2005. Green tea intake, ACE gene polymorphism and breast cancer risk among Chinese women in Singapore. Carcinogenesis 26(8):1389-1394. Wu AH, Tseng CC, Van Den Berg D, Yu MC. 2003. Tea intake, COMT genotype, and breast cancer in Asian-American women. Cancer Research 63(21):7526-7529. Zhang M, Holman CD, Huang JP, Xie X. 2006 Green tea and the prevention of breast cancer: a case-control study in southeast China. Carcinogenesis 28(5):1074-1078. Men health / prostate health 31 January 2008 Recommended dosage 500-1000mg/day Catechins are active and functional polyphenol components of green tea leaves. 1,745 Page 1,853 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Nature of Evidence Human study In vitro Review References Claim ID Jian L, Xie LLP, Lee AH, Binns CW. Protective effect of green tea against prostate cancer: a case-control study in southeast China. International Journal of Cancer 2004;108(1):130-35. Henning SM, Aronson W, Niu Y, Conde F, Lee NH, Seeram NP, Lee RP, Lu J, Harris DM, Moro A, Hong J, Pak-Shan L, Barnard RJ, Ziaee HG, Csathy G, Go VL, Wang H, Heber D. 2006. Tea polyphenols and theaflavins are present in prostate tissue of humans and mice after green and black tea consumption. J Nutri136(7):1839-1843. Bettuzzi S, Brausi M, Rizzi F, Castagnetti G, Peracchia G, Corti A. 2006. Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study. Cancer Res 66(2):1234-1240. Hussain T, Gupta S, Adhami VM, Mukhtar H. 2005. Green tea constituent epigallocatechin-3-gallate selectively inhibits COX-2 without affecting COX-1 expression in human prostate carcinoma cells. Int. J. Cancer. 113(4): 660-69. Adhami VM, Malik A, Zaman N, Sarfaraz S, Siddiqui IA, Syed DN, Afaq F, Pasha FS, Saleem M, Mukhtar H. 2007. Combined inhibitory effects of green tea polyphenols and selective cyclooxygenase-2 inhibitors on the growth of human prostate cancer cells both in vitro and in vivo. Clin Cancer Res. 13:1611-19. Saleem M, Adhami VM, Siddiqui IA, Mukhtar H. 31 January 2008 Page 1,854 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 2003. Tea beverage in chemoprevention of prostate cancer: a mini-review. Nutri. Cancer 47(1):13-23. Colon health Recommended dosage 500-1000mg catechin/day Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Cognitive function 31 January 2008 Recommended dosage 4-6cup/day (200-400mg catechins)54 Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. Animal study In vitro Review Yamane T 1996. Chemoprevention of gastro-intestinal cancer with green tea extract. Molecular Medicine 3: 394. 1,740 Yamane T, Hagiwara N, Tateishi M, Akachi S, Kim M, Okuzumi J, Kitao Y, Inagake M, Kuwata K. and Takahashi T. 1991. Inhibition of Azoxymethane-induced Colon Carcinogenesis in Rat by Green Tea polyphenol Fraction. Jpn.J.Cancer.res 82: 1336-1339. Lee YK, Bone ND, Strege AK, Shanafelt TD, Jelinek DF, Kay NE.. 2004. VEGF receptor phosphorylation status and apoptosis is modulated by a green tea component, epigallocatehcin-3-gallate (EGCG), in B-cell chronic lymphocytic leukemia. Blood. 104(3): 788-794. Juneja LR. 1997. Green Tea Polyphenols-Preventive Effects on Colon Carcinogenesis, Renal Failure and Other Applications”, FIE '97 Conference Proceeding.. 1,739 Page 1,855 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Nature of Evidence Animal study Human study References Claim ID Unno K, Takabayashi F, Yoshida H, Choba D, Fukutomi R, Kikunaga N, Kishido T, Oku N, Hoshino M. 2007. Daily consumption of green tea catechin delays memory regression in aged mice. Biogerontology 8(2):89-95. Chan YC, Hosoda K, Tsai CJ, Yamamoto S, Wang MF. 2006. Favorable effects of tea on reducing the cognitive deficits and brain morphological changes in senescence-accelerated mice. J Nutri. Sci. Vitaminol. 52(4): 266-73. Haque AM, Hashimoto M, Katakura M, Tanabe Y, Hara Y, Shido O. 2006. Long-term administration of green tea catechins improves spatial cognition learning ability in rats. J. Nutri. 136(4):1043-47. Rezai-Zadeh K, Shytle D, Sun N, Mori T, Hou H, Jeanniton D, Ehrhart J, Townsend K, Zeng J, Morgan D, Hardy J, Town T, Tan J. 2005. Green tea epigallocatechin-3-gallate (EGCG) modulates amyloid precursor protein cleavage and reduces cerebral amyloidosis in Alzheimer transgenic mice. J. Neurosci.25(38): 8807-8814. Kuriyama S, Hozawa A, Ohmori K, Shimazu T, Matsui T, Ebihara S, Awata S, Nagatomi R, Arai H, Tsuji I. 2006. Green tea consumption and cognitive function: a cross-sectional study from the Tsurugaya Project 1. Am. J. Clin. Nutri. 83(2):355-61. Ehrnhoefer DE, Duennwald M, Markovic P, Wacker JL, Engemann S, Roark M, Legleiter J, Marsh JL, Thompson LM, Lindquist S, Muchowski PJ, Wanker EE.. 2006. Green tea (-)-epigallocatechin-gallate modulates early 31 January 2008 Page 1,856 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID events in huntingtin misfolding and reduces toxicity in Huntington’s disease models. Hum Mol Genet. 15(18): 2743-2751. Gut flora Dental health 31 January 2008 Recommended dosage 250-500ppm Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Recommended dosage 500 -1000 ppm Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which Human study In vitro Animal study Okubo T, Ishihara N, Oura A, Serit M, Kim M, Yamamoto T and Mitsuoka T. 1992. In Vivo Effects of Tea Polyphenol Intake on Human Intestinal Microflora and Metabolism, Biosci. Biotech. Biochem., 56(4): 588-591 1,738 Ahn YJ, Sakanaka S, Kim M, kawamura T, Fujusawa T and Mitsuoka T. 1990. Effect of Green Tea extract on Growth of Intestinal Bacteria. Microbial Ecology in Health and Disease.3: 335-338. Ahn YJ, Kawamura T, Kim M and Yamamoto T. 1991. Tea Polyphenols: selective Growth Inhibitors of Clostridium spp. Agri.Biol.Chem. 55 (5): 1425-1426. Lee HC, Jenner AM, Low CS, Lee YK. 2006. Effect of tea phenolics and their aromatic fecal bacterial metabolites on intestinal microbiota. Res Microbiol. 157(9): 876-84. 1,731 Page 1,857 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day. Nature of Evidence Authoritative body Monograph Human study Animal study Review In vitro References Claim ID FNFC: Ministry of Health and Welfare (FOSHU) Japan Chemistry and Application of Green tea. 1997. Edited by Takehiko Yamamoto, Lekh Raj Juneja, Djoing Chi Chu, Mujo Kim CRC Press LLC, Baca Raton, New York. Irma, L.Parajas; Eufemia, M.Tobias, 2002. Effect of Sunphenon on Periodontal Disease. Vivo study report of Philipine dental association. Preventive effects of tea polyphenols (SunphenonTM) on plaque formation in men, Nihon Univ. Dent. J., 7, 654-659 (in Japanese). Hirasawa, M.;Takada, K.; Makkimura, M.; Otake, S. 2002. Improvement of Periodontal Status by Green Tea Catechin using a Local Delivery System: A clinical pilot study. J.Periodont Res.37: 433-438. Krahwinkel T, Willerhausen B. 2000. The effect of sugar-free green tea chew candies on the degree of inflammation of the gingiva. Eur J Med Res 5(11):463-467. Liu T, Chi Y. 2000. Experimental study on polyphenol anti-plaque effect in humans. Zhonghua Kou Qiang Yi Xue Za Zhi. 35(5):383-384. Sakanaka, S.; Aizawa, M.;Kim, M.; and Yamamoto, T. 1996. Inhibitory Effects of Green Tea Polyphenols on Growth and Cellular Adherence of an Oral Bacterium, Porphyromonas gingivalis, Biosci. Biotech. Biochem., 60(5), 745-749. 31 January 2008 Page 1,858 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Ikematsu, T. 1998. Effect of Green Tea Catechins by Local Delivery System in Periodontitis, Nihon Univ. J. Oral Sci., 24, 21-28. Yamada, H. 1991. The inhibitory effects of Polyphenol Compounds from Camellia sinenis on Collagenase Activity. Nihon Univ.J.oral Sci., 17:508-515. Satoh, S. 1995. 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Anticaries effect of polyphenolic compounds from Japanese green 31 January 2008 Page 1,859 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID tea. Caries Res 25(6):438-443. Sakanaka S, Kim M, Taniguchi M, 1989. Antibacterial substances in Japanese green tea extract against Streptococcus mutans, a cariogenic bacterium. Agric Biol Chem 53(9): 2307-2311. Sakanaka S, Okada Y. 2004. Inhibitory effects of green tea polyphenols on the production of a virulence factor of the periodontal-disease-causing anaerobic bacterium Porphyromonas gingivalis. J Agric Food Chem 52(6):1688-1692. Heart health 31 January 2008 Recommended dosage 500-1000 mg catechins Catechins are active and functional polyphenol components of green tea leaves. One cup (200ml) of brewed green tea may contain 100-150 mg of catechins.or equivalent of 50-60mg of EGCG. The usual consumption of green tea is about 5-10 cups per day, which is equivalent to 500-1200 mg of catechins or 250-600 mg of EGCG per day.. 1,735 Page 1,860 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Epidemiology study Human study Animal study In viro Review References Claim ID Kuriyama S, Shimazu T, Ohmori K, Kikuchi N, Nakaya N, Nishino Y, Tsubono Y, Tsuji I. 2006. Green tea consumption and mortality due to cardiovascular disease, cancer, and all causes in Japan: the Ohsaki study. JAMA 296(10): 1255-65. Yang YC, Lu FH, Wu JS, Wu CH, Chang CJ. 2004. The protective effect of habitual tea consumption on hypertension. Archives of Internal Medicine 164(14):1534-1540. Sano J, Inami S, Seimiya K, Ohba T, Sakai S, Takano T, Mizuno K. 2004. Effects of green tea intake on the development of coronary artery disease. Circulation J 68(7): 665-670. Unno T, Tago M, Suzuki Y, Nozawa A, Sagesaka YM, Kakuda T, Egawa K, Kondo K. 2005. 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Anti-proliferative and proapoptotic effects of (-)-epigallocatchin-3-gallate on human melanoma: possible implications for the chemoprevention of melanoma. Int J Cancer 31 January 2008 Page 1,863 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 114(4):513-521. Chicken and chicken products Antioxidant to prevent oxidative stress,Proper thyroid function Maintenance of cellular redox status 31 January 2008 Selenium-Enriched* Sel-Plex Inside”* Contains x µg Se/100 g Kuricova S, Boldizariva K, Gresakova L, Bobcek R, Levkut M, & Leng L (2003) Kuricova et al 2003. Acta Vet Brno 72:339-346. Chicken selenium status when fed a diet supplemented with Se yeast. http://jinfo.lub.lu.se/jinfo?func=fullRecord&jId=1 0315&issn=00017213 Sel-Plex® supplementation of chickens results in significantly higher meat selenium in comparison with sodium selenite supplementation. 2,357 Page 1,864 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Coffee Glucose homeostasis 31 January 2008 3 cups per day 282 Page 1,865 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Epidemiology studies Animal and In vitro studies References Claim ID Meta-Analysis Dam RM & Hu FR Coffee Consumption and the Risk of Type 2 Diabetes. A systematic Review JAMA 2005; 294:97-104. Critical Reviews Barbagallo M, Dominguez LJ, Galioto A, Ferlisi A et al. Role of magnesium in insulin action, diabetes and cardio-metabolic syndrome X. Mol Aspects Med 2003; 24 : 3952. 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Potential health benefits from the flavonoids in grape products on vascular disease. Adv Exp Med Biol. 2002;505:95-111. 1. Natural Medicines Comprehensive Database 2000 2. The Complete German Commission E Monographs Therapeutic Guide to Herbal Medicines 1998 American Botanical Council 3. PDR for Herbal Medicines 2nd Edition 2000 Medical Economics Co. Inc. 4. The Review of Natural Products Facts and Comparisons Wolters Kluwer Health Inc. 2003 5. A Dictionary of Natural Products George MacDonald Hawking, 1997 Plexus Publishing 6. The Natural Pharmacy 2nd Edition Prima Health 1999 Healthnotes Inc. 7. Pharmacognosy and Pharmacobiotechnology Robbers, Speedie and Tyler. 1996 Williams and Wilkins 31 January 2008 Page 1,879 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 8. Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetics 2nd Ed. Albert Leung and Steven Foster 1996 John Wiley & Sons, Inc. 9. Arch Latinoam Nutr. 2006 Mar;56(1):77-82 Manaca, sweet potato and yam: possible substitutes of wheat in foods for two ethnic population in Venezuelan Amazon 10. J Agric Food Chem. 2006 Jun 14;54(12):4162-7 Total oxidant scavenging capacity of Euterpe oleracea Mart. (açaí) seeds and identification of their polyphenolic compounds. 11. J Ethnopharmacol. 2006 Sep 19;107(2):291-6. Epub 2006 Mar 22. Inhibitory effects of Euterpe oleracea Mart. on nitric oxide production and iNOS expression. 12. J Agric Food Chem. 2006 Feb 22;54(4):1222-9. Açai (Euterpe oleracea Mart.) polyphenolics in their glycoside and aglycone forms induce apoptosis of HL-60 leukemia cells. 13. Int J Food Sci Nutr. 2005 Feb;56(1):53-64. Total oxidant scavenging capacities of Euterpe oleracea Mart. (Açaí) fruits. 14. J Agric Food Chem. 2004 Mar 24;52(6):1539-45 Phytochemical composition and pigment stability of Açai (Euterpe oleracea Mart.). • Kong J. M., Chia L. S., Goh N. K., Chia T. F., Brouillard R. (2003). "Analysis and biological activities of anthocyanins.". Phytochemistry 64 (5): 923-33. 31 January 2008 Page 1,880 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID DOI:10.1016/S0031-9422(03)00438-2. • Gross PM (2007). Scientists zero in on health benefits of berry pigments. Natural Products Information Center. • Wada L, Ou B (2002). Antioxidant activity and phenolic content of Oregon caneberries.. J Agric Food Chem. Jun 5;50(12):3495-500. • Stoner GD, Wang LS, Zikri N, Chen T, Hecht SS, Huang C, Sardo C, Lechner JF (2007). Cancer prevention with freeze-dried berries and berry components.. 1: Semin Cancer Biol. May 10; • Andersen, O.M. Flavonoids: Chemistry, Biochemistry and Applications. CRC Press, Boca Raton FL 2006. • G. M. Robinson, Robert Robinson (1931). "A survey of anthocyanins. I". Biochem J. 25 (5): 1687–1705. 31 January 2008 Page 1,881 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Cranberry Proanthocyanidins may be responsible for beneficial effects on the urinary tract 31 January 2008 No RDA / RNI 2,398 Page 1,882 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Howell AB. Cranberry proanthocyanidins and the maintenance of urinary tract health. Crit Rev Food Sci Nutr. 2002;42(3 Suppl):273-8. Foo LY, Lu Y, Howell AB, Vorsa N. A-Type proanthocyanidin trimers from cranberry that inhibit adherence of uropathogenic P-fimbriated Escherichia coli. J Nat Prod. 2000 Sep;63(9):1225-8. " 1. Natural Medicines Comprehensive Database 2000 2. The Complete German Commission E Monographs Therapeutic Guide to Herbal Medicines 1998 American Botanical Council 3. PDR for Herbal Medicines 2nd Edition 2000 Medical Economics Co. Inc. 4. The Review of Natural Products Facts and Comparisons Wolters Kluwer Health Inc. 2003 5. A Dictionary of Natural Products George MacDonald Hawking, 1997 Plexus Publishing 6. The Natural Pharmacy 2nd Edition Prima Health 1999 Healthnotes Inc. 7. Pharmacognosy and Pharmacobiotechnology Robbers, Speedie and Tyler. 1996 Williams and Wilkins 8. Encyclopedia of Common Natural Ingredients used in Food, Drugs, and Cosmetics 2nd Ed. Albert Leung and Steven Foster 1996 John Wiley & Sons, Inc. 31 January 2008 Page 1,883 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 10. J Agric Food Chem. 2006 Jun 14;54(12):4162-7 Total oxidant scavenging capacity of Euterpe oleracea Mart. (açaí) seeds and identification of their polyphenolic compounds. 11. J Ethnopharmacol. 2006 Sep 19;107(2):291-6. Epub 2006 Mar 22. Inhibitory effects of Euterpe oleracea Mart. on nitric oxide production and iNOS expression. 12. J Agric Food Chem. 2006 Feb 22;54(4):1222-9. Açai (Euterpe oleracea Mart.) polyphenolics in their glycoside and aglycone forms induce apoptosis of HL-60 leukemia cells. 13. Int J Food Sci Nutr. 2005 Feb;56(1):53-64. Total oxidant scavenging capacities of Euterpe oleracea Mart. (Açaí) fruits. 14. J Agric Food Chem. 2004 Mar 24;52(6):1539-45 Phytochemical composition and pigment stability of Açai (Euterpe oleracea Mart.). • Kong J. M., Chia L. S., Goh N. K., Chia T. F., Brouillard R. (2003). "Analysis and biological activities of anthocyanins.". Phytochemistry 64 (5): 923-33. DOI:10.1016/S0031-9422(03)00438-2. • Wada L, Ou B (2002). Antioxidant activity and phenolic content of Oregon caneberries.. J Agric Food Chem. Jun 5;50(12):3495-500. • Stoner GD, Wang LS, Zikri N, Chen T, Hecht SS, Huang C, Sardo C, Lechner JF (2007). Cancer prevention with freeze-dried berries and berry components.. 1: Semin Cancer Biol. May 10; 31 January 2008 Page 1,884 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID • Andersen, O.M. Flavonoids: Chemistry, Biochemistry and Applications. CRC Press, Boca Raton FL 2006. • G. M. Robinson, Robert Robinson (1931). "A survey of anthocyanins. I". Biochem J. 25 (5): 1687–1705. 31 January 2008 Page 1,885 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Cranberry (Lingonberry) juice, (Vaccinium vitis idaea, Vaccinium macrocarpon) Urinary tract 31 January 2008 Product ready-to-drink (diluted juice, nectar or syrup) containing 9,2 g of juice concentrate; used daily over 12 month. 283 Page 1,886 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative body Reviews RCTs References Claim ID AFSSA 2003-SA-0352 and 2003-SA-0214 Authoritative/Scientific Bodies Approval of Agence Frangaise de Securite Sanitaire des Aliments – AFSSA, avis a l’ evaluation des justificatifs concernant l’ allegation « contribue a diminuer la fixation de certaines bacteries E.coli sur les parois des voies urinaires » et sur l’emploi de la « cranberry/canneberg » ou « Vaccinium macrocarpon » dans des jus concentres, des complements alimentaires et un cocktail/nectar de jus, April 6 2004, Afssa - Saisine n° 2003 -SA-0352. Approval of Agence Frangaise de Securite Sanitaire des Aliments – AFSSA, avis relative a l’evaluation des justificatifs concernant l’ allegation « contribue a diminuer la fixation de certaines bacteries E.coli sur les parois urinaires » pour un nectar/cocktail de jus de cranberry, December 3 2004, Afssa - Saisine n° 2003-SA - 0214. Reviews Bruyere F, [Use of cranberry in chronic urinary tract infections.][Article in French], Med Mal Infect. 2006 Jul; 36(7):358-363. Epub 2006 Jul 18; Service d'urologie, CHRU Bretonneau, 2, boulevard Tonnelle, 37044 Tours, France. Donabedian H, Nutritional therapy and infectious diseases: a two-edged sword. Nutr J. 2006 Sep 4; 5(1):21 [Epub ahead of print]. Jepson RG, Mihaljevic L, Craig J, Cranberries for preventing urinary tract infections., Cochrane Database Syst Rev. 2004; (1):CD001321.. Department of General Practice, Edinburgh University, 20 West Richmond Street, Edinburgh, UK, EH8 9DX. Clinical Studies Di Martino P, Agniel R, David K, Templer 31 January 2008 Page 1,887 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID C, Gaillard JL, Denys P, Botto H, Reduction of Escherichia coli adherence to uroepithelial bladder cells after consumption of cranberry juice: a double-blind randomized placebo-controlled cross-over trial, World J Urol. 2006 Feb; 24(1):21-7. Epub 2006 Jan 6.; Laboratoire ERRMECe (EA1391), Universite de Cergy-Pontoise, 2 Avenue A. Chauvin, 95302 Pontoise cedex, France Kontiokari T, Sundqvist K, Nuutinen M, Pokka T, Koskela M, Uhari M., Randomised trial of cranberry-lingonberry juice and Lactobacillus GG drink for the prevention of urinary tract infections in women, BMJ. 2001 Oct 20; 323(7318):936. Evid Based Nurs. 2002 Apr; 5(2):43. Department of Pediatrics, University of Oulu, Oulu, Fin-90220, Finland. Netzel M., Strass G., Herbst M., Dietrich H., Bitsch R., Bitsch I., Frank T., The excretion and biological antioxidant activity of elderberry antioxidants in healthy humans. Food Research International, Volume 38, Issue 8-9, October-November 2005, Pages 905-910; Third international Congress on Pigments in Food. Sobota AE, Inhibition of bacterial adherence by cranberry juice: potential use for the treatment of urinary tract infections, J Urol. 1984 May; 131(5): 1013-6. In Vitro Studies Howell AB, Reed JD, Krueger CG, Winterbottom R, Cunningham DG, Leahy M., A-type cranberry proanthocyanidins and uropathogenic bacterial anti-adhesion activity, Phytochemistry, 2005 Sep; 66(18): 228191; Marucci Center for Blueberry Cranberry Research, Rutgers University, Chatsworth, NJ 08019, USA. Scientific Studies Turner A, Chen SN, Joike MK, Pendland 31 January 2008 Page 1,888 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID SL, Pauli GF, Farnsworth NR., Inhibition of uropathogenic Escherichia coli by cranberry juice: a new antiadherence assay., J Agric Food Chem. 2005 Nov 16; 53(23):8940-7.; UIC/NIH Center for Botanical Dietary Supplements Research for Women's Health, Department of Medicinal Chemistry and Pharmacognosy (MC781), College of Pharmacy, University of Illinois, Chicago, Illinois 60612, USA. Others Natural Standard Research Collaboration, 2005; Cranberry (Vaccinium macrocarpon) http://www.nlm.nih.gov/medlineplus/ druginfo/natural/patient-cranberry.html 31 January 2008 Page 1,889 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Dairy Dental health Lactose the only carbohydrate present in a product, lactose level maximum 5 g/100 g Scientific review Moynihan P. Food and factors that protects against dental caries Nutrition Bulletin 2000 (BNF) 25:281-286 Levine RS. Mlik, flavoured milk products and caries. Br. Dent J 2001 Jul 1;191(1):20 738 Nyvad B The effect of sweetened milk on the pH responce of Dental Plaque Caries Res 29: 321 Thomson ME, Dever JG, Pearce EI Intra-oral testing of flavoured sweetened milk. N Z Dent J 1984 Apr;80(360):44-6 Weight loss 31 January 2008 in an energy restricted diet. 309 Page 1,890 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Review Human intervention study 31 January 2008 References Claim ID Reviews Barba G, Russo P. Dairy foods, dietary calcium and obesity: a short review of the evidence. Nutr Metab Cardiovasc Dis. 2006 Sep;16(6):445-51. Epub 2006 Aug 22. Barr SI. “Increased Dairy Products or Calcium Intake: Is Body Weight and composition Affected in Humans” J Nutr 2003;133:245S-248S Heaney RP. Normalizing calcium intake: projected population effects for body weight. J Nutr. 2003 Jan;133(1):268S-270S. Review. Heaney RP, Davies KM, Barger-Lux MJ. Calcium and weight: clinical studies. J Am Coll Nutr. 2002 Apr;21(2):152S-155S. Review. Huth PJ, DiRienzo DB, Miller GD. Major scientific advances with dairy foods in nutrition and health. J Dairy Sci. 2006 Apr;89(4):120721. Review Pfeuffer M, Schrezenmeir J. Milk and the metabolic syndrome. Obes Rev. 2007 Mar;8(2):109-18. St-Onge M-P “Dietary fats teas, dairy, and nuts: potential functional foods for weight control?” Am J Clin Nutr 2005;81:7-15 Teegarden D. The influence of dairy product consumption on body composition. J Nutr. 2005 Dec;135(12):2749-52. Review. Zemel “Review. The role of dairy Foods in Weight Management” J Am Coll Nutr 2005;24(6):537S-546S Individual Human Studies Barba G, Troiano E, Russo P, Venezia A, Siani A. Inverse association between body mass and frequency of milk consumption in children. Br J Nutr. 2005 Jan;93(1):15-9. Berkey CS, Rockett HRH, Willett WC, Colditz GA. “Milk, Dairy fat, Dietary calcium, and weight gain” Arch Pediatr Adolesc Med 2005;159:543-550 Page 1,891 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Bowen J, Noakes M, Clifton PM “Effect of calcium and dairy foods in high protein, energy-restricted diets on weight loss and metabolic parameters in overweight adults” Int J Obes 2005;29:957-965 Brooks BM, Rajeshwari R, Nicklas TA, Yang SJ, Berenson GS. Association of calcium intake, dairy product consumption with overweight status in young adults (1995-1996): the Bogalusa Heart Study. J Am Coll Nutr. 2006 Dec;25(6):523-32. Chan GM, Hoffman K, McMurry M. Effects of dairy products on bone and body composition in pubertal girls. J Pediatr. 1995 Apr;126(4):551-6. PMID: 7699532 [PubMed indexed for MEDLINE] Cummings NK, James AP, Soares MJ. The acute effects of different sources of dietary calcium on postprandial energy metabolism. Br J Nutr. 2006 Jul;96(1):138-44. Gunther CW, Legowski PA, Lyle RM, McCabe GP, Eagan MS, Peacock M, Teegaarden D. „Dairy products do not lead to alterations in body weight or fat mass in young women in a 1-y intervention“ Am J Clin Nutr 2005;81:751-6 Jacobsen R, Lorenzen JK, Toubo S, Krog-Mikkelsen I, Astrup A “Effect of short-term high dietary calcium intake of 24-h energy expenditure, fat oxidation, and fecal fat excretion” Int J Obes 2005;29:292-301 Major GC, Alarie F, Dore J, Phouttama S, Tremblay A. Supplementation with calcium + vitamin D enhances the beneficial effect of weight loss on plasma lipid and lipoprotein concentrations. Am J Clin Nutr. 2007 Jan;85(1):54-9. Marques-Vidal P, Goncalves A, Dias CM. Milk intake is inversely related to obesity in men 31 January 2008 Page 1,892 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID and in young women: data from the Portuguese Health Interview Survey 1998-1999. Int J Obes (Lond). 2006 Jan;30(1):88-93. Mirmiran P, Esmaillzadeh A, Azizi F. Dairy consumption and body mass index: an inverse relationship. Int J Obes (Lond). 2005 Jan;29(1):115-21. Melanson EL, Donahoo WT, Dong F, Ida T, Zemel MB. Effect of low- and high-calcium dairy-based diets on macronutrient oxidation in humans. Obes Res. 2005 Dec;13(12):2102-12. Nielsen SJ, Popkin BM. Changes in beverage intake between 1977 and 2001. Am J Prev Med. 2004 Oct;27(3):205-10. Erratum in: Am J Prev Med. 2005 May;28(4):413. Novotny R, Daida YG, Acharya S, Grove JS, Vogt TM. Dairy intake is associated with lower body fat and soda intake with greater weight in adolescent girls. J Nutr. 2004 Aug;134(8):1905-9. Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. Ranganathan R, Nicklas TA, Yang SJ, Berenson GS. The nutritional impact of dairy product consumption on dietary intakes of adults (1995-1996): the Bogalusa Heart Study. J Am Diet Assoc. 2005 Sep;105(9):1391-400. Rosell M, Hakansson NN, Wolk A. Association between dairy food consumption and weight change over 9 y in 19,352 perimenopausal women. Am J Clin Nutr. 2006 Dec;84(6):1481-8. Tremblay A| Joanisse DR. Calcium intake, body composition and plasma lipid-lipoprotein concentrations in adults. Aust J Dairy Technol 2005; 60(1): 66-9. 31 January 2008 Page 1,893 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Zemel MB, Richards J, Russel J, Milstead A, Gehardt L, Silvia E. “Dairy argumentation of total and central fat loss in obese subjects” Int J Obes Res 2005; 29(4):391-7 Zemel MB, Thompson W, Milstead A, Morris K, Campbell P. Calcium and dairy acceleration of weight and fat loss during energy restriction in obese adults. Obes Res. 2004 Apr;12(4):582-90. Low GI / blood glucose response GI <35 (ref glucose=100) Only to be used on dairy products containing at least 4 g/100g of carbohydrates. 31 January 2008 Scientific review Foster-Powell K, Holt SH, Brand-Miller JC. International table of glycemic index and glycemic load values: 2002. Am J Clin Nutr. 2002 Jul;76(1):5-56. 737 Page 1,894 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Dairy (low fat dairy) *Dairy refers to cow’s milk, yogurt and cheese Weight loss Fat loss Weight maintenance 31 January 2008 -low fat As part of a healthy balanced diet and lifestyle 869 Page 1,895 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Reviews Individual Human Interventions Studies Longitudinal Study Randomised, parallel study Observational Study Randomized Cross over trial Intervention Study References Claim ID Barba G & Russo P (2006) Dairy foods, dietary calcium and obesity: a short review of the evidence. Nutr Metab Cardiovasc Dis 16; 445-451. Barr SI (2003) Increased dairy product or calcium intake: is body weight or composition affected in humans? J Nutr 133; 245S-248S. Heaney RP (2003) Normalizing calcium intake: projected population effects for body weight. J Nutr 133; 268S-270S. Heaney RP, Davies KM & Barger-Lux MJ (2002) Calcium and weight: clinical studies. J Am Coll Nutr 21; 152S-155S. Huth PJ, DiRienzo DB & Miller GD (2006) Major scientific advances with dairy foods in nutrition and health. J Dairy Sci 89; 1207-1221. Pfeuffer M & Schrezenmeir J (2007) Milk and the metabolic syndrome. Obes Rev 8; 109-118. St-Onge MP (2005) Dietary fats, teas, dairy, and nuts: potential functional foods for weight control? Am J Clin Nutr 81; 7-15. Teegarden D (2005) The influence of dairy product consumption on body composition. J Nutr 135; 2749-2752. Zemel MB (2002) Regulation of adiposity and obesity risk by dietary calcium: mechanisms and implications. J Am Coll Nutr 21; 146S-151S Zemel MB (2003) Mechanisms of dairy modulation of adiposity. J Nutr 133; 252S-256S. Zemel MB (2003) Role of dietary calcium and dairy products in modulating adiposity. Lipids 38; 139-146. 31 January 2008 Page 1,896 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Zemel MB (2004) Role of calcium and dairy products in energy partitioning and weight management. Am J Clin Nutr 79; 907S-912S Zemel MB (2005) The role of dairy foods in weight management. J Am Coll Nutr 24; 537S-546S. Barba G et al (2005) Inverse association between body mass and frequency of milk consumption in children. Br J Nutr 93; 15-19. Berkey CS et al (2005) Milk, dairy fat, dietary calcium, and weight gain: a longitudinal study of adolescents. Arch Pediatr Adolesc Med 159; 543-550. Bowen J, Noakes M & Clifton PM (2005) Effect of calcium and dairy foods in high protein, energy-restricted diets on weight loss and metabolic parameters in overweight adults. Int J Obes 29; 957-965. Bowen J, Noakes M & Clifton PM (2005) Effect of calcium and dairy foods in high protein, energy-restricted diets on weight loss and metabolic parameters in overweight adults. Int J Obes 29; 957-965. Brooks BM et al (2006) Association of calcium intake, dairy product consumption with overweight status in young adults (1995-1996): the Bogalusa Heart Study. J Am Coll Nutr 25; 523-532. Chan GM, Hoffman K & McMurry M (1995) Effects of dairy products on bone and body composition in pubertal girls. J Pediatr 126; 551-556. Cummings NK, James AP & Soares MJ (2006) The acute effects of different sources of dietary calcium on postprandial energy metabolism. Br 31 January 2008 Page 1,897 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID J Nutr 96; 138-144. Gunther CW et al (2005) Dairy products do not lead to alterations in body weight or fat mass in young women in a 1-y intervention. Am J Clin Nutr 81; 751-756. Jacobsen R et al (2005) Effect of short-term high dietary calcium intake on 24-h energy expenditure, fat oxidation, and fecal fat excretion. Int J Obes 29; 292-301. 31 January 2008 Page 1,898 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Randomised double blind trial Cross Sectional Study Randomised crossover study Cross Sectional Study Observational Study Randomised trial References Claim ID Major GC et al (2007) Supplementation with calcium + vitamin D enhances the beneficial effect of weight loss on plasma lipid and lipoprotein concentrations. Am J Clin Nutr 85; 54-59. Marques-Vidal P, Goncalves A & Dias CM (2006) Milk intake is inversely related to obesity in men and in young women: data from the Portuguese Health Interview Survey 1998-1999. Int J Obes 30; 88-93. Melanson EL et al (2005) Effect of low- and high-calcium dairy-based diets on macronutrient oxidation in humans. Obes Res 13; 2102-2112. Mirmiran P, Esmaillzadeh A & Azizi F (2005) Dairy consumption and body mass index: an inverse relationship. Int J Obes 29; 115-121. Nielsen SJ & Popkin BM (2004) Changes in beverage intake between 1977 and 2001. Am J Prev Med 27; 205-10. Novotny R et al (2004) Dairy intake is associated with lower body fat and soda intake with greater weight in adolescent girls. J Nutr 134; 1905-1909. Nowson CA et al (2005) Blood pressure change with weight loss is affected by diet type in men. Am J Clin Nutr 81; 983-989. Pereira MA et al (2002) Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA 287; 2081-2089. Ranganathan R et al (2005) The nutritional impact of dairy product consumption on dietary intakes of adults (1995-1996): the Bogalusa Heart Study. J Am Diet Assoc 105; 1391-1400. Rosell M, Hakansson NN & Wolk A (2006) Association between dairy food consumption and weight change over 9 y in 19,352 perimenopausal women. Am J Clin Nutr 84; 31 January 2008 Page 1,899 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID 1481-1488. Tremblay Al & Joanisse DR (2005) Calcium intake, body composition and plasma lipid-lipoprotein concentrations in adults. Aust J Dairy Technol 60; 66-69. Zemel MB et al (2004) Calcium and dairy acceleration of weight and fat loss during energy restriction in obese adults. Obes Res 12; 582-590. Zemel MB et al (2005) Dairy agumentation of total and central fat loss in obese subjects. Int J Obes Res 29; 391-397. Zemel MB et al (2005) Effects of calcium and dairy on body composition and weight loss in African-American adults. Obes Res 13; 1218-1225. Zemel MB, Thompson W, Milstead A, Morris K & Campbell P (2004) Calcium and dairy acceleration of weight and fat loss during energy restriction in obese adults. Obes Res 12; 582-590. 31 January 2008 Page 1,900 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Authoritative Body COMA Report Food Composition Tables Textbook References Claim ID Dietary Reference Values for Food Energy and Nutrients for the United Kingdom. Report of the Panel on Dietary Values of the Committee on Medical Aspects of Food and Nutrition Policy. Department of Health Report on Health and Social Subjects No. 41. DH: The Stationery Office, 1998. Nutrition and Your Health: Dietary Guidelines for Americans. Backgrounder 2005 Dietary Guidelines Advisory Committee Report. http://www.health.gov/dietaryguidelines/dga200 5/Backgrounder.htm Department of Health Ireland: ‘The Food Pyramid’ France: “National Program Nutrition Health” (PNNS) carried out by the Directorate-General of health: Second National Nutrition and Health Programme 2006-2010, September 2006 http://www.sante.gouv.fr/htm/pointsur/nutrition/ documents_english/pnns2.pdf Food Guide Pyramid. A Guide to Daily Food Choices. Washington, DC: US Dept of Agriculture, Human Nutrition Information Service; 1992. Home and Garden Bulletin No. 252. Higher Education Authority (UK) (1994) Balance of Good Health. The Australian Guide to Healthy Eating Department of Health and Family Services. The Australian guide to healthy eating: background information for nutrition educators. Canberra: DHFS, 1998. Royal Society of Chemistry and Ministry of Agricuture, Fisheries and Food (1991) McCance and Widdowson’s The Composition of Foods, 5th edition. Cambridge: Royal 31 January 2008 Page 1,901 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence References Claim ID Society of Chemistry. Manual of Dietetic Practice Third Edition. [Briony Thomas, editor] Blackwell Science, London. 31 January 2008 Page 1,902 of 3,931 Category Food Component Health Relationship Suggested Conditions of Use Nature of Evidence Cross Sectional Study Specific Diets References Claim ID Fiorito LM et al (2006) Dairy and dairy-related nutrient intake during middle childhood. J Am Diet Assoc 106; 534-542. The WELL diet (Nowson CA et a

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