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Flora pro-activ with plant sterols. Clinically proven to lower cholesterol. Information for Healthcare Professionals Contents 02 Introduction 03 Diet and lifestyle play a key role in reducing risk of cardiovascular disease 04 Plant sterols -proven doseresponse reduction of LDL cholesterol 05 Plant sterols reduce cholesterol absorption in the gut 06 Plant sterols occur naturally in everyday foods 07 The optimum intake of plant sterols is 2g/day 08 National and International Recommendations 10 Plant Sterol Safety 11 Plant sterols – effective in combination with statins 12 Clinical Applications 13 Flora pro-activ spreads 14 References 16 Summary Introduction Globally, cardiovascular disease (CVD) is the leading cause of morbidity and mortality. However, about 80% of heart disease and stroke could be prevented by positive lifestyle changes, such as eating a healthy diet, exercise and abstinence from smoking1. Elevated LDL-cholesterol is widely accepted as one of the major modifiable risk factors. There are many diet and lifestyle changes that may help control elevated LDL-cholesterol and therefore help in reducing the risk of coronary heart disease (CHD). They include recommendations for the use of specific foods with cholesterol lowering benefits, such as plant sterol enriched foods2,3. These additional options can enhance the effectiveness of a typical healthy diet low in saturated fat, rich in polyunsaturated fat and controlled in energy intake. Flora pro-activ spreads contain plant sterols, in many human studies it has been shown that plant sterols significantly lower LDL-cholesterol. Combined with other diet and lifestyle changes plant sterolenriched foods can contribute to increasing the effectiveness of diet, in lowering cholesterol and offer a valuable addition to reduce CHD risk reduction strategies. This brochure contains information on plant sterols and Flora pro-activ spreads for health care professionals. 02 Diet and lifestyle play a key role in reducing risk of Cardiovascular Disease Elevated LDL-cholesterol is widely accepted as a key modifiable risk factor for CHD, the main form of CVD, and is prevalent in the Australian and New Zealand population. Many dietary factors affect LDL-cholesterol levels. Making positive dietary changes like replacing saturated fats with polyunsaturated fats are well known to lower LDL-cholesterol.4 Every year heart disease is responsible for around 40% of deaths in New Zealand and around 15% of deaths in Australia5,6. It was recently estimated that lowering the mean LDL-cholesterol of the Australian adult population by 10% would reduce the number of cardiovascular deaths by approximately 3000 annually.7 Several diet and lifestyle factors affect serum LDL-cholesterol factors (Table 1). The single most effective way to lower LDL-cholesterol with dietary change is to include plant sterols or stanols. Eating 2-2.5 g of plant sterols daily can lower LDL-cholesterol by up to 15% when combined with the move to a healthy diet and lifestyle.†8 † Average 10% reduction over 3 weeks based on daily consumption of 2g plant sterols and an additional 5% from the move to a healthy diet and lifestyle. Table 1: Effect of diet and lifestyle factors on LDL- cholesterol 4, 8-11. Component LDL-reduction (%) Recommendation 10 2 – 2.5g/day 5 – 10 <7% energy 3 5 – 10% energy 5 <200mg/day Soluble dietary fibres 5 5 – 10g/day Body weight reduction 5 Lose ~5kg 3–5 25g/day Plant sterols Saturated fatty acids reduction in intake Polyunsaturated fatty acids Dietary cholesterol reduction in intake Soy protein 03 Plant sterols proven dose-response reduction of LDL cholesterol The cholesterol lowering effect of plant sterols has been known since the early 1950’s. A large body of scientific evidence of more than 120 studies has proven plant sterols significantly lower LDL-cholesterol. Since the late 1980s, Unilever, in collaboration with many independent scientific investigators, has researched the cholesterol-lowering properties of plant sterols in Flora pro-activ spreads in over 30 clinical trials. A meta-analysis shows the continuous dose-response relationship between plant sterol intake and LDL-cholesterol levels8 (figure 1). There is a continuous dose-response relationship between the intake of plant sterols and their effect on LDL-cholesterol levels.12,13 The more plant sterol consumed, the greater the reduction in LDL-cholesterol up to about 2-2.5g plant sterol per day. Intakes above 2.5g/day are not recommended as this provides little further benefit.8 Figure 1: The effect of plant sterols on LDL-cholesterol levels8 Plant sterols (grams per day) LDL-cholesterol lowering (%reduction) 0 0.5 1 1.5 2 2.5 33.5 -5 -10 - 15 95% confidence interval Optimal intake Consuming more than 3g of plant sterols per day does not provide additional benefits. 04 Little further benefit Plant sterols reduce cholesterol absorption in the gut The key benefit of plant sterols lies in their ability to reduce the absorption of cholesterol from the gut into the blood stream. Cholesterol is an essential building block in the human body and plays a key role in maintaining cell membranes. It is naturally produced in the liver but is also delivered through foods containing cholesterol in the diet. As a part of normal metabolism, cholesterol in the gut mixes with bile salts, lecithin and triglycerides to form micelles. Micelles then deliver cholesterol to the cells lining the gut wall where the cholesterol is re-packaged and released into the bloodstream. Plant sterols have a similar chemical structure to cholesterol. It is thought that when plant sterols reach the gut they displace cholesterol from the micelles14. In this way, less cholesterol reaches the lining of the gut wall in a form that can be absorbed. Consuming 2g of plant sterols a day reduces the absorption of cholesterol by 30-40%15. The cholesterol that is not incorporated into the micelles is then excreted (along with virtually all the plant sterols). In this way, cholesterol is removed from the body. Subsequently, levels of LDL-cholesterol are lowered but HDLcholesterol and triglyceride levels remain unaffected. The effects of plant sterols on cholesterol absorption Without plant sterols Cholesterol With plant sterols liver liver Plant Sterols More cholesterol absorbed = higher blood cholesterol levels Less cholesterol absorbed = lower cholesterol levels micelle micelle gutgut blood blood Plant sterols partially block the absorption of cholesterol from the gut, significantly lowering blood cholesterol levels 05 Plant sterols occur naturally in everyday foods Plant sterols are found naturally in everyday foods like vegetable oils, nuts, seeds, grain products, fruit and vegetables, however, only in very small quantities. The average daily intake of plant sterols from regular foods is about 0.3g per day. Western populations consume 0.15-0.31g plant sterols per day.16,17,18 Diets that contain plant sterol-rich foods in abundance, such as vegetarian diets, provide 0.6g plant sterols per day.19 The optimal intake of plant sterols for significant cholesterol lowering is 2-2.5g/day. To reach this recommended intake, very large quantities of regular foods would need to be consumed. The quantity of regular foods required to provide 2g plant sterols 20,21,22 2g plant sterols = 150 apples* 83 oranges* *where each individual item weighs 100g. 06 425 tomatoes* 70 slices of wholemeal bread* 210 carrots* 11 cups of peanuts* The optimum intake of plant sterols is 2g/day To achieve optimal results, and lower LDL-cholesterol by 10% (on average), at least 2g of plant sterols per day is required. This equates to 1 rounded tablespoon (25g) of Flora pro-activ per day, the amount typically spread on 2-3 slices of bread. Plant sterol spreads may also be melted over vegetables and used in cooking and baking. Consuming more than 2.5g of plant sterols provides little additional cholesterol lowering benefit. Plant sterol-enriched foods start to lower cholesterol absorption soon after consumption. If consumed regularly, the cholesterol lowering benefit can be achieved in about 3 weeks13, 23. Longer term studies have shown that this benefit can be sustained, providing regular consumption continues24. If plant sterolenriched foods are not consumed, the cholesterol-lowering effect is lost. For optimum benefit, Flora pro-activ spreads should be consumed as part of a healthy diet and lifestyle. It is recommended that plant sterols are consumed every day for continued cholesterol-lowering effects. 07 National and International Recommendations Australia New Zealand The Heart Foundation of Australia produced a ‘Summary of evidence. Dietary fats and dietary cholesterol for cardiovascular health’ in 200925. Its key findings are based on the scientific literature and include: The New Zealand Cardiovascular Guidelines Handbook recommends considering the addition of plant sterol or stanolfortified spreads for lipid modification. • • • • Phytosterols lower LDL-cholesterol in people with normocholesterolemia, hypercholesterolaema and diabetes. For people with increased risk of CVD, consuming phytosterol/stanol enriched foods provides an additional option for risk reduction through lowering the level of cholesterol. A daily intake of approximately 2g of phytosterol/stanol enriched margarine reduces LDL-C levels by approximately 10% but has little effect on HDL-cholesterol (HDL-C) or triglycerides. Phytosterol/stanol enriched foods have an additive effect in lowering LDL-C when combined with statins. International recommendations Evidence-based dietary recommendations for the management of cholesterol and the prevention of coronary heart disease have now been developed by several international authorities. Many of these now include plant sterols, including the recommendations of the US National Cholesterol Education Program Adult Treatment Panel III2, 3, the International Atherosclerosis Society, American Heart Association, Dutch Heart Foundation, Finnish Nutrition Association, Finnish Medical Society and Spanish Atherosclerosis Society who have all included plant sterols in their dietary recommendations for cholesterol management. The Heart Foundation concludes26 that people at high absolute risk for coronary disease benefit from the cholesterol-lowering effect of consuming 2-3g of plant sterols naturally occurring in plant foods and food products enriched with plant sterols.* * People using phytosterols should also choose at least one daily serve of fruit or vegetable high in beta-carotene (GOR A; 2007p)26 08 To improve cardiovascular health in all Australians the Heart Foundation makes the following recommendations with respect to dietary fats and dietary sterols.26 All Australians: 1. Reduce their intake of saturated fatty acids (SFA) to < 7% of total energy intake and trans fatty acids (tFA) to < 1% of total energy intake 2. Replace SFA with monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA) as a strategy for reducing the intake of SFA 3. Consume 500 mg per day of combined docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) through a combination of the following: 2–3 serves (150 g per serve) of oily fish per week, fish oil capsules or liquid and food and drinks enriched with marine n-3 PUFA* 4. Consume at least 2 g per day ALA by including foods, such as canola- or soybean-based oils and margarine spreads, seeds (especially linseeds), nuts (particularly walnuts), legumes (including soybeans), eggs and green leafy vegetables (GOR A; 2008f) 5. Consume 8–10% of total energy intake as n-6 PUFA 6. May consume up to six eggs per week within a cardio protective eating pattern (reduced SFA) without increasing their risk of CVD Those with high absolute risk of CVD, elevated LDL-C, familial hypercholesterolaemia or type 2 diabetes 1. Consume 2–3 g of phytosterols per day from margarine, breakfast cereal, reduced fat yoghurt or reduced fat milk enriched with phytosterols (approximately 2–3 serves per day of these enriched foods). *People using phytosterols should also choose at least one daily serve of fruit or vegetable high in beta-carotene. 2. Include phytosterol enriched foods in addition to statin therapy 3. Continue compliance with cholesterol-lowering medication * women who are pregnant, women planning pregnancy and children should follow the advice from Food Standards Australia and New Zealand on mercury in fish (2008f). 09 Plant Sterols Safety As components of whole plant foods, plant sterols are natural components of a normal diet. The safety of consuming high intakes of plant sterols to lower cholesterol has been studied extensively since the 1950s and reviewed by independent experts and regulatory authorities internationally. Despite the absence of any adverse effects in previously published trials, before launching plant sterol-enriched Flora pro-activ spread, Unilever conducted a thorough safety program researching the effect of an increased consumption of plant sterols 27,28,29. No significant adverse effects were seen in these clinical trials, even with high intakes of plant sterols. Safety tests of up to a 100-fold safety factor indicated a lack of toxicity and no significant effects on gut flora, bile acids, oestrogen metabolism, clinical chemistry, haematology or urinary analysis. Clinical studies confirmed that very low levels of plant sterols are absorbed and that serum plant sterol levels are only modestly increased, remaining within the normal range obtained with healthy diets (less than 1% of total sterol concentration)23. Some studies show decreases of 10-20% in blood carotenoids (alpha- and beta-carotene and lycopene)30. These reductions are considered to be biologically insignificant and serum levels remain well within the typical range of seasonal variation, which is around 30%. This reduction in blood carotenoid levels can be prevented by following dietary advice to consume an extra serve of carotenoid-rich fruit or vegetables each day31 , such as carrots, sweet potatoes, tomatoes or spinach. The results of the above studies were an important part of the dossier submitted for independent review by food regulators in many countries. Plant sterol-enriched foods are approved for sale in Australia, New Zealand, United States, European Union, Japan, South Africa, Brazil, Israel, Iceland and Switzerland. 10 Eating plant sterol enriched foods in combination with statins Complementary cholesterol lowering effects of plant sterols with statins33 Clinical evidence shows that eating plant sterol enriched foods in combination with statins, can have a greater cholesterollowering effect than statins alone1. Cumulative benefits • • Statins reduce LDL-cholesterol levels by an average of 25%3. • Including a plant sterol-enriched spread can help lower cholesterol by a further 10%. Moving to a healthy diet and lifestyle can lower cholesterol by 5%; and This combination of statins, plant sterols and a healthy diet and lifestyle can lead to a greater reduction in cholesterol levels. Doubling a statin dose has been shown to achieve just a 6% further reduction4. % LDL-cholesterol lowering A combination of statins, plant sterols, diet and lifestyle changes can work together to help patients achieve targets for cholesterol reduction2. They work in different ways and therefore the effect is additive: 0 10 Statins Statins 20 Diet and lifestyle 30 Plant Sterols 40 Flora pro-activ spread has been shown to be a useful adjunct to statins and fibrates, offering additional cholesterol lowering benefits 32. However, dietary approaches should not be a substitute for lipid lowering medications and vice versa. If people are taking statins and/or fibrates and consuming plant sterol enriched foods as part of a heart healthy diet, the dosage of medication may need to be adjusted. 11 Clinical Applications Eating a diet where saturated fats are replaced with polyunsaturated fats is an established way to lower cholesterol. However, the cholesterol lowering benefits of plant sterols is additional to that of a healthy diet. Plant sterol enriched foods significantly lower cholesterol in: Patients at moderate absolute risk of CHD Plant sterol spread should be considered as part of comprehensive dietary intervention for patients at moderate coronary risk irrespective of their initial cholesterol levels.34 Although plant sterols lower LDL-cholesterol in individuals with both moderate and elevated blood cholesterol levels, in absolute terms the LDL-lowering effect will be more pronounced in individuals with higher cholesterol levels. People with type II diabetes and familial hypercholesterolaemia (FH) Individuals with type 2 diabetes are at increased risk of developing CVD and most will benefit from cholesterol lowering. Clinical studies have shown that plant sterol spreads lower serum LDL-cholesterol in this group35. Children with family history and their parents who participated in a free living setting trial experienced 11% LDL-cholesterol lowering after consuming plant sterols for 6 months24. Plant sterol spread may be considered as an integral part of the dietary management of people with type 2 diabetes and children and adults with family history. 12 Pregnant or breast-feeding women and children Plant sterol-enriched foods are generally not recommended for pregnant or breastfeeding women or for normal children under 5 years of age as they have different nutritional needs. Sitosterolaemia: a contraindication Homozygous sitosterolaemia is a very rare condition (c. 1 in 6 million) characterised by excessive plant sterol absorption, reduced excretion and elevated serum levels of plant sterols. Individuals with homozygous sitosterolemia should avoid eating all foods rich in plant sterols, including plant sterol spreads. Plant sterol-enriched foods are safe for individuals heterozygous for sitosterolaemia.36 Flora pro-activ spreads Flora pro-activ spread, the first plant sterol-enriched food launched in Australia and New Zealand, was developed for individuals who want to actively lower their LDL-cholesterol levels through dietary changes. The Flora pro-activ range now includes 5 variants with varying oil blends and total fat contents: Flora pro-activ Original (64%), Flora pro-activ Buttery (65%), Flora pro-activ Olive (48%), Flora pro-activ Light (40%) and Flora pro-activ Ultralight (22.7%). All variants of Flora pro-activ contain the same amount of plant sterols per gram of spread. Flora pro-activ range Why a spread? Enriching a spread with plant sterols helps your patients to ‘kill two birds with one stone’ i.e. to get the cholesterol-lowering benefit of plant sterols and an improved ratio of dietary unsaturated to saturated fatty acids. The type of dietary fat is a key determinant of serum cholesterol levels, contrary to the common misconception that the best dietary means of lowering cholesterol is to eat a diet low in fat. The advantage of incorporating a plant sterol-enriched spread into a cholesterollowering diet was well demonstrated in a trial conducted at the University of Otago in Dunedin, New Zealand37. The serum LDL-cholesterol of subjects on a low saturated fat diet including a plant sterol spread was 8% lower than when they were on a low fat diet. Vegetable oil-based spreads are also major sources of the essential fatty acids, vitamin D and vitamin E.38 What about weight control? 25g of Flora pro-activ Original – the full-fat variant – can easily be incorporated in a reduced-energy, weight-reducing diet. However, if for any reason a lower fat intake is required one of the lower fat variants of Flora pro-activ may be considered. Flora pro-activ Ultralight has 38% of the kilojoules of Flora pro-activ Original. 13 References: 1. World Health Organisation (WHO). Diet, nutrition and the prevention of chronic diseases. Report of a joint WHO/FAO Expert Consultation. WHO Technical Report Series 916. Geneva, 2003. 2. National Cholesterol Education Program. 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 2001; 285: 2486-2497. 3. Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ; for the Coordinating Committee of the National Cholesterol Education Program. Implication of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 2004; 110: 227239. 4. Clarke R, Frost C, Collins R, Appleby P, Peto R. Dietary lipids and blood cholesterol: quantitative meta-analysis of metabolic ward studies. BMJ 1997; 314(7074): 112-117. 5. The New Zealand guidelines group, the national heart foundation of New Zealand and the stroke foundation of New Zealand. The assessment and management of cardiovascular risk. Evidence-based best practice guideline. New Zealand guidelines Group. December 2003. 6. Australian Bureau of Statistics 3303.0 - Causes of Death, Australia, 2010 7. Huxley R, Clifton P, Perkovic V, 7.Woodward M, Neal B. How many Australian deaths from heart disease and stroke could be avoided by a small reduction in population cholesterol levels? Nutr Diet 2009; 66: 158–63. 8. Katan MB, Grundy SM, Jones P, Law M, Miettinen T, Paoletti R; Stresa Workshop Participants. Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels. Mayo Clin Proc 2003 Aug; 78(8): 965-978. Review. 13. 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. 14. Trautwein EA, Duchateau GSMJE, Lin YG, Mel’nikov SM, Molhuizen HOF, Ntanios FY. Proposed mechanisms of cholesterol-lowering action of plant sterols. Eur J Lipid Sci Tech 2003; 105: 171-185. 15. Tikkanen MJ, Hogstrom P, Tuomilehto J 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; 88:1157-1162. 16. Normen AL, Brants HA, Voorrips LE, Andersson HA, van den Brandt PA, Goldbohm RA. Plant sterol intakes and colorectal cancer risk in the Netherlands Cohort Study on Diet and Cancer. Am J Clin Nutr 2001;74(1):141-148. 17. Andersson SW, Skinner J, Ellegard L, Welch AA, Bingham S, Mulligan A, Andersson H, Khaw KT. 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(10):1378-1385. 18. Valsa LM, Lemstrom A, Ovaskainen ML, Lampi AM, Toivo J, Korhonen T, Piironen V. Estimation of plant sterol and cholesterol intake in Finland: quality of new values and their effect on intake. Br J Nutr 2004;92(4):671-678(8). 19. Vuoristo M, Miettinen TA. Absorption, metabolism, and serum concentrations of cholesterol in vegetarians: effects of cholesterol feeding. Am J Clin Nutr 1994;59(6):1325-1331. 20. Normen L, Johnsson M, Andersson H, van Gameran Y, Dutta P. Plant sterols in vegetables and fruits commonly consumed in Sweden. Eur J Nutr 1999;38:84-89. 9. Jenkins DJA, Kendall CWC, Axelson M, Augustin LSA, Vuksan V. Viscous and nonviscous fibres, nonabsorbable and low glycaemic index carbohydrates, blood lipids and coronary heart disease. Curr Opin Lipidol 2000;11:49-56. 21. Normen L, Bryngelsson S, Johnsson M, Evheden P et al. They phytosterol content of some cereal foods commonly consumed in Sweden and in the Netherlands. J Food Comp Analysis 2002;15(6):693-704. 10. Mensink RP, Zock PL, Kester ADM, Katan B. 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. 22. Weihrauch JL, Gardner JM. Sterol content of foods of plant origin. J Am Diet Assoc 1978;73(1):39-47. 11. Weggemans RM, Trautwein EA. Relation between soy-associated isoflavones and LDL and HDL cholesterol concentrations in humans: a meta-analysis. Eur J Clin Nutr 2003; 57: 940–6. 12. Law M. Plant sterol and stanol margarines and health. BMJ 2000;320:861-864. 14 23. Weststrate JA, Meijer GW. Plant sterol-enriched margarines and reductions in plasma total-and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects. Eur J Clin Nutr 1998;52:334-343. 24. Amundsen Å &, Ntanios F, Put N V.d, Ose L. Long-term compliance and changes in plasma lipids, plant sterols and carotenoids in children and parents with FH consuming plant sterol ester-enriched spread. Eur J Clin Nutr 2004; 58(12): 1612-1620. 25. Summary of evidence. National Heart Foundation of Australia. Dietary fats and dietary cholesterol for cardiovascular health, 2009. 26. National Heart foundation of Australia. Position statement. Dietary fats and dietary sterols for cardiovascular health, 2009. 27. Weststrate JA, Ayesh R, Bauer-Plank C, Drewitt PN. Safety evaluation of phytosterol esters. Part 4. Faecal concentrations of bile acids and neutral sterols in healthy normolipidaemic volunteers consuming a controlled diet either with or a phytosterol esterenriched margarine. Food Chem Toxicol 1999; 37: without 1063–1071. 28. Ayesh R, Weststrate JA, Drewitt PN, Hepburn PA. 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 esterenriched margarine. Food Chem Toxicol 1999; 37: 1127–1138. 36. Stalenhoef AFH, Hectors M, Demacker PNM. Effect of plant sterol-enriched margarine on plasma lipids and sterols in subjects heterozygous for phytosterolaemia. J Intern Med 2001; 249:163–166. 37. Skeaff CM, Thoma C, Mann J, Chisholm A,Williams S, Richmond K. Isocaloric substitution of plant sterol-enriched fat spread for carbohydrate-rich foods in a low-fat, fibre-rich diet decreases plasma low-density lipoprotein cholesterol and increases high density lipoprotein concentrations. Nutr Metab Cardiovasc Dis 2005; 15: 337–344. 38. Shrapnel B, Baghurst K. Adequacy of essential fatty acid, vitamin D and vitamin E intake: implications for the ‘core’ and ‘extras’ food group concept of the Australian Guide to Healthy Eating. Nutr Diet 2007; 64: 78 29. Lea LJ and Hepburn PA. Safety evaluation of phytosterol-esters. Part 9: Results of a European post-launch monitoring programme. Food Chem Toxicol 2006; 44: 1213–1222. 30. Judd JT, Baer DJ, Chen SC, Clevidence BA, Muesing RA, Kramer M, Meijer GW. Plant sterol esters lower plasma lipids and most carotenoids in mildly hypercholesterolemic adults. Lipids 2002; 37: 33–42. 31. Noakes M, Clifton P, Ntanios F, Shrapnel W, Record I,McInerney J. An increase in dietary carotenoids when consuming plant sterols or stanols is effective in maintaining plasma carotenoid concentrations. Am J Clin Nutr 2002; 75: 79–86. 32. Simons LA. Additive effect of plant sterol-ester margarine and cerivastatin in lowering low-density lipoprotein cholesterol in primary hypercholesterolemia. Am J Cardiol 2002; 90:737-740. 33. Scholle JM, Baker WL, Talati R, Coleman CI. The effect of adding plant sterols or stanols to statin therapy in hypercholesterolemic patients: systematic review and metaanalysis. J Am Coll Nutr 2009; 28(5): 517-524. 34. Clifton P, Shrapnel B, Colquhoun D, Hewat C, Jones P, Litt J, Noakes M, O’Brien R, Skeaff M. Comprehensive dietary intervention to lower serum cholesterol: a report from an expert roundtable. Aust Fam Physician 2009 (accepted for publication). 35. Lee YM, Haastert B, Scherbaum W, Hauner H. A phytosterol-enriched spread improves the lipid profile of subjects with type 2 diabetes mellitus - a randomized controlled trial under free-living conditions. Eur J Nutr 2003; 42(2): 111-117. 15 Summary Facts about Flora pro-activ spreads 16 • Flora pro-activ spreads are everyday foods enriched with plant sterols. • Plant sterols lower serum total and LDL-cholesterol by partially blocking cholesterol absorption from the gut. • Daily use of Flora pro-activ lowers LDL-cholesterol by about 10%, based on the findings of over 30 clinical trials. • 25g of Flora pro-activ spread should be included in a heart healthy diet each day. This will ensure plant sterol intake falls in the optimal intake range of 2 - 2.5g per day. • The efficacy of plant sterol-enriched spreads is recognised by international and national health authorities including the National Heart Foundation of Australia and the Heart Foundation of New Zealand. • Plant sterol-enriched spreads are safe, though they are not generally recommended for pregnant and breastfeeding women, and children under 5 years of age. 17