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1 PRODUCT TECHNICAL INFORMATION 2 Index VOLUME 1 1. An Introduction To B-Imune 2. The Objectives in B-Imune as a Food Supplement 3. Nutrition in Health and Immune System i. Nutritional Requirements ii. The Impact of Malnutrition iii. Proteins iv. Fats v. Vitamins vi. Minerals vii. Soya Components 4. Gastrointestinal (GI) Tract 5. Bacteria 6. Probiotics i. Probiotics as a Disease Fighter ii. Probiotics in Food Digestion iii. Probiotics in Short-chain Fatty Acid (SCFA) Production iv. Probiotics in Immune Enhancement v. Probiotics in Food Allergy Reduction vi. Probiotics and Anticarcinogenic Activity 7. Prebiotics 8. L-Glutamine 9. Taurine 10. Carnitine 11. Nutraceuticals 12. Summary of Features and Benefits of B-Imune 13. Ingredients in B-Imune 14. Preparation Instructions of B-Imune 15. B-Imune Usage Recommendations 16. B-Imune Portion Evaluation Annexure A: ABSTRACT OF RESEARCH THESIS 3 3 3 8 8 9 11 11 11 12 12 13 13 13 13 13 14 3 1. An Introduction to B-Imune. B-Imune is arguably the most advanced, yet totally natural food supplement regarding the boosting and supporting of the immune system. Formulated to rapidly revive the intestine for ultimate immune response, B-Imune includes a maize/soy (Maize Drink) or a soy base( Energy Drink) food base, which is fortified with Vitamins and Minerals and includes Probiotics, Prebiotics, L-Glutamine and Antioxidants. B-Imune enhances the immune response by way of providing balanced nutrition together with health promoting microorganisms. The natural bacteria included in B-Imune are recognised by the body as ‘friendly’ and are rapidly accepted into the system, so achieving natural balance and improved wellbeing. By enhancing and supporting the immune system, B-Imune effectively reduces the risk of opportunistic diseases and other illnesses. Whether an immune system is ‘down’ because of stress or because of a terminal disease, B-Imune will prove of benefit in restoring immune response and achieving improved ‘quality of life’. B-Imune is defined as a ‘functional food’, that is a food that can be health promoting beyond its nutritional value. 2. The Objectives in B-Imune as a Food Supplement. B-Imune is formulated as a food supplement for the following specific reasons: The digestive tract plays an important role in building a strong immune system, and regular food intake keeps the digestive tract working. B-Imune with its’ food component therefore offers the digestive tract the opportunity to actively partake during ‘treatment’. B-Imune is typically taken as a drink (alternatively a porridge), and as such when consumed by sick or elderly people, it offers easy absorption by the intestinal tract, with higher and quicker absorption of nutrients than is the case with pills or normal food stuffs. B-Imune therefore assists to prevent a condition called malabsortion, malabsortion being the inability to absorb nutrients due to factors such as diarrhoea and an inflamed intestinal tract. Many people in need of B-Imune do not have the luxury of regular food intake, let alone access to nutritious foods, and as such it serves to feed as well as support the needs of an effective immune system. 3. Nutrition in Health and the Immune System. i. Nutritional Requirements In achieving general good health, energy providing nutrients (protein, fat and carbohydrate), vitamins, minerals and water are required. The required amounts of these essential nutrients differ by age and physiologic state. Conditionally essential nutrients are not required in the diet but must be supplied to individuals who do not synthesise them in adequate amounts, such as those having pathologic states with nutritional implications. For body weight to remain stable, energy intake must match energy output. Illness often alters energy needs e.g. intestinal malabsorption may decrease net utilisable energy whereas fever increases energy expenditure. The most important nutritional priority for people at the AIDS (Acquired Immunodeficiency Syndrome) infection stage is fluid intake. The majority of HIV-related hospital admissions are for dehydration, with the most obvious fluid losses from diarrhoea, vomiting and perspiration. Weight loss will often follow, given the nature of hospital life; therefore energy is the next concern. Of the diet’s energy providers, fat, carbohydrate and protein, the best energy source is from fat, followed by carbohydrate and protein. Vitamins and minerals are essential in everyone’s diet B-Imune as a beverage, contributes to the fluid losses associated with AIDS infection. Energy is derived from its balanced source of protein, fat and carbohydrate. It is fortified with conditionally essential amino acids, to support the immune system and as are also required in HIV/AIDS nutrition. It contains nutraceuticals of which antioxidants components are: Ascorbic acid, Alpha-Tocopherol, 4 Isoflavonoids Selenium. Patients living with HIV-I are nearly 20 times more likely to die of the AIDS virus if they also have a selenium deficiency, as compared to those with adequate selenium levels. ii. The Impact of Malnutrition Malnutrition significantly impairs the immune function, and reduces the ability to fight off infections and disease. Often resultant intestinal infections further compound the situation in that nutrient absorption and utilisation become impaired. Each day, in developing countries, over 30 000 children die from preventable diseases. Malnutrition is associated with over half of these deaths (WHO). The role of nutrition and diet in promoting health and reducing the effects of chronic diseases, ranging from: - the preventing low birth weight to weight reduction, - diabetes mellitus, - cardiovascular disease, - stunted growth and early death in children, - resistance to infection, - disrupt cognition and - dietary intervention in cancer prevention and control, have been well established and documented. B-Imune and its’ function in addressing intestinal infections is discussed later in this document under Probiotcs and LGlutamine. B-Imune is per portion of product, also fortified with vitamins from 50% to 100% of the RDA (Recommended Daily Allowance) for vitamins, for people of the age group 10 years and older, as well as with chelated minerals to 15% of the RDA. iii. Proteins Protein is made of amino acids. Essential amino acids cannot be synthesised by humans and must be supplied by the diet. The nine essential amino acids are histidine, isoleucine, leucine, lysine, methionine/cystine, phenylalanine/tyrosine, threonine, tryptophan, and valine. The recommended dietary allowance for protein is about 0.6 g/body mass/day, assuming that energy needs are met and that the protein is of relatively high biological value. The World Health Organisation (WHO) established this in 1985 in a report on energy and protein requirements for humans. The protein fraction of B-Imune is mainly derived from soy, although some is also obtained from maize. Soy protein is particularly valuable because its amino acid composition complements that of other cereals. Soy proteins contain limited sulphur containing amino acids, cystine and methionine, but contain sufficient lysine to overcome the deficiency of cereals. The protein quality or “pattern of amino acids” is more important than the absolute content of each essential amino acid. The amino acids whose levels equal or exceed the reference pattern are termed “non-limiting” because they are present in sufficient amounts. Cereal based diets containing mixed sources of protein are most likely to be limiting in lysine, tryptophan and threonine. Adding soy protein to these diets will increase the amount of the latter amino acids and thus improve the amino acid profile, as well as the protein quality, which is measured as Amino Acid Score. Protein is: Essential for normal growth of children Essential for building and regeneration of body tissues Important for normal immune function Lack of protein intake leads to malnutrition (kwashiorkor) iv. Fats Fats are a concentrated source of energy. The fat fraction of B-Imune is mainly from soy oil. Soybean oil is highly digestible, high in polyunsaturated fatty acids and contains no cholesterol. Soybean oil is composed of about 85% unsaturated fat with oleic- and linoleic acid being predominant, and 15% saturated fatty acids. It is generally recognised that unsaturated oil is beneficial to health as opposed to saturated fat. Soybean oil also contain about 7-9 % of the triunsaturated linolenic acid, which happens to be the parent fatty acid of the Omega-3 configuration of which much literature has been published in recent times, with regards to their health benefits. 5 v. Vitamins Vitamin A: Maintains healthy skin. Essential for normal growth of children Important for night vision Helps to combat infections Promotes normal growth of bones and teeth, especially in children This vitamin is essential for the physical integrity of mucosal surfaces such as the GI track, a critical part of immune defence. In HIV patients, higher mortality rates have been associated with Vitamin A deficiency. Vitamin B-complex: Although not antioxidants, B vitamins are also important for optimal immune functioning and slowing AIDS development in HIV positive patients. In epidemiological studies of nutrition and HIV, high intakes of B3, B2 and B1 have been associated with a reduced risk of developing Aids] Vitamin B1 (thiamin), B2 (riboflavin), B3 (niacin), B6 (piridoxine) B5 (Pantothenic Acid): Important for normal digestion of food Play an essential role in energy production in the body Essential for normal functioning of the nervous system Necessary for normal growth in children Maintain healthy skin and hair Important for normal appetite Deficiency leads to fatigue, irritability, anxiousness, beri-beri and pellagra (serious diseases of malnutrition) Folic Acid (Vitamin B9): Plays a role in red blood cell production Folic Acid deficiency can cause anaemia and neural tube defects during pregnancy Protects against intestinal parasites and food poisoning Acts as an analgesic for pain Vitamin B12: Plays a role in red blood cell production and regeneration Promotes growth and increase appetite in children Maintains a healthy nervous system Improves concentration, memory and balance Relieves irritability Vitamin C: Acts as an anti-oxidant in the body Is needed to strengthen the blood vessel walls Is needed to repair scar tissue Strengthens the body for resistance to infections Increases absorption of iron from plant foods Deficiency results in a disease called scurvy Epidemiological studies have shown vitamin C deficiencies in the HIV positive population. Vitamin D: Important for building of bones and teeth Regulates absorption of calcium and phosphorus Lack of vitamin D can lead to rickets (malformation of bones) Vitamin E: Acts as an anti-oxidant Plays a role in the reproductive system Several studies show that patients with high dietary intake and serum levels of Vitamin E have reduced risk of developing AIDS 6 Vitamin K: Necessary for blood coagulation Lack of vitamin K can cause prolonged bleeding that may result in anaemia vi. Minerals Calcium: Major component of bone and teeth Essential for building and maintaining strong bones and teeth Necessary for the central nervous system Important for normal heart function Deficiency leads to osteomalacia (soft bones that fracture easily) or osteoporosis (porous bone that fracture easily) Iron: Essential component of red blood cells Transports oxygen in the body Enhances physical work capacity and productivity Sufficient iron levels in children combats fatigue, irritability and lack of concentration Deficiency leads to anaemia Zinc: Assists in more than 100 enzymatic functions in the body Essential for digestion and processing of the food we eat Important for wound healing Promotes growth and mental alertness Aids in treatment of infertility Is essential for foetal development Promotes growth and development in children Magnesium: Essential for normal functioning of the muscles and nervous system Essential for normal functioning of the heart Important in production of energy in the body Important part of the bone structure Aids in fighting depression vi. Soya Components Lechitin: Lechitin is a complex fatty substance known as a phospholipid. It is composed of Phosphoric Acid, Choline and Inositol. It is found in blood, bile, brain, serous fluids, nerves, semen, pus and white corpuscles. 3% of the 18% of oil in the soybean contains Lecithin. Possibly the greatest benefit of Lecithin is that it regulates metabolism and helps break down fat and cholesterol. Because animal fats have the highest percentage of cholesterol, the more animal fats one eats, the more conscientious one has to be about the amount of Lecithin in one’s dietary intake. Lecithin and Cholesterol: Lecithin is a complex fatty substance that helps break down cholesterol. Excessive cholesterol is responsible for clogging of arteries and for gallstones. Lecithin assists in reducing the cholesterol level in the blood and helps to dissolve plaques already laid down in the arteries. Lecithin lowers the level of harmful low-density lipids in the system without lowering the level of the high-density lipids, which have a positive controlling effect on the system’s fat levels. Lecithin is important for women in controlling cholesterol, especially after menopause. 7 Lecithin and Brain function: Lecithin is found in the brain cells in the form of neurolecithins and has been shown to be vital for the correct and efficient functioning of the brain and in the rebuilding of brain cells. Because Lecithin is found in the brain and nerve cells, it is thought to help in cases of nervous exhaustion and impaired memory. Lecithin other: Lecithin is useful for various skin disturbances such as acne or ageing skin. Lecithin also assists in removing the yellow-brown plaques (which are caused by fatty deposits) found on the skin particularly around the eyes. Lecithin has also been used for addressing eczema and psoriasis. Enzyme Inhibitors Trypsin is an enzyme secreted in pancreatic juice, which breaks down dietary protein, thereby enabling it to be absorbed. An anti-trypsin inhibitor is a plant protein, which inhibits this action of trypsin. In raw beans there are two growth or anti-trypsin inhibitors namely the Kunitz and Bowman-Birk inhibitors. Anti-trypsin inhibitors can have harmful effects on humans where the beans from which they originated were not properly cooked. By proper heating during the processing of soybeans the chymotrysin and anti - trypsin inhibitor Bowman Birk were not destroyed in full. This small remaining portion seems to have a very positive effect in the human body to stimulate the lowering of cholesterol. Phytic Acid Nositol hexaphosphate or phytic acid is found in plant cells. It binds with metals such as iron. Phytic Acid has a positive effect on the lowering of cholesterol. Has anti-oxidant effects Lowers the risk of colon cancer Isoflavones Recent excitement has focused on soy-foods as a rich and unique dietary source of hormones called isoflavones or phyto-estrogens, that enhance the body’s immune system, prevent major diseases and improve the quality of life. Isoflavones are components of phyto-chemicals or plant chemicals in the soy protein, which makes up a third of the total content of the plant. The structure and effect of isoflavones on the human body are similar to that of the female sex hormone estrogen. Isoflavones have earned intense scientific scrutiny after observations that some major diseases prevalent in Western countries are largely or totally absent in Eastern communities where soy is part of the staple diet. Examples are breast and prostate cancer, heart attacks, hip fractures among menopausal women and the symptoms of menopause. Coronary Heart Disease (CHD) Cancer Menopause Osteoporosis Diabetes 8 4. Gastrointestinal (GI) Tract. The gastrointestinal (GI) tract is exposed to food, water and any other preparations taken orally. It acts as a barrier to harmful substances and invasive infective pathogens. To compliment the GI as a physiological barrier, gut associated lymphoid tissue (GALT) is distributed throughout the GI tract and it is the largest lymphoid or immune organ in the body, accounting for approximately 80% of all immunoglobulin-producing cells in the body. B-Imune stimulates the GALT to produce immunoglobulin (IgA) resulting in an enhanced immune response. Intestinal health is important and a factor when talking about the immune system. The first point is that two-thirds of all of T cells live in close proximity to the GI tract. The reason why two-thirds of white blood cells live in close proximity to the GI tract is because the interior of the tract contains ten billion bacteria. This represents a large quantity of bacteria being very close to the bloodstream. Some of these bacteria are not necessarily ‘good’ bacteria. Occasionally harmful organisms will pass into the blood, and it’s at this stage that the lymph nodes, white blood cells and the T cells monitor what is going on so as to maintain defences and patch any breaches. One of the things that can happen if the ‘bad’ bacteria become dominant, is that the ability to absorb food is reduced. And so the body becomes malnourished because of the lack of nutrients that it’s used to getting, and that it needs to get, to keep the immune system strong. (More about this under the sections on bacteria and probiotics) Similarly, drugs / medication can just pass through the body and not be absorbed. If the drugs / medication does not get to the right blood levels, then they are ineffectual and won’t work, and any virus will have a much easier time developing resistance. This is obviously the last thing that you want if you’re taking antiviral drugs, is to be taking them and have them not be working, and have them wear out too soon. Not only might the body not be absorbing the prescribed drugs / medication, but because the gut is weak and unhealthy, it may cause extended nausea and diarrhoea. One needs to go deeper to the cause of the problem, not just past the symptoms. With a chronically inflamed digestive system the immune system is activated and stressed by an infection, and is going to have less resources to fight the likes of HIV infection. Therefore if the immune system is stressed by what is going on in the gut, which is a 30-foot long tube of bacteria, then less resources and a weaker immune system are going to struggle to keep HIV suppressed. 5. Bacteria Bacteria and intestinal microflora are often miss interrupted. We spend so much time trying to avoid the myriad of harmful varieties around us that it’s easy to forget beneficial bacteria even exist. But, in fact, many strains of ‘friendly’ bacteria are clinging to our intestinal walls right now, helping to protect the gut from invading pathogens, and aiding digestion, among other functions. It is estimated that the human intestine contains more than 400 different bacterial species and approximately [10.sup.14] bacterial cells, which is more than ten times the number of cells comprising the human body. The imagery may not be very appealing, but the benefits are. Supplements of these beneficial bacteria, called ‘probiotics’, help maintain high levels of good bacteria in the gut, encouraging good health in more ways than one. 9 Many factors affect the composition of the bacteria present in the intestines. The age of the individual Their nutritional requirements and immunological status Antibiotic use Stress Alcohol consumption The pH level in the GI tract Transit time and presence of material in the gut Compromised immune system (HIV/Aids, Cancer and TB) Diarrhoea Steroid/Hormone treatment These are just a few factors known to affect the bacterial composition. Diet not only regulates the species and concentration of these micro-organisms in the gut, but also has been reported to influence the metabolic activities of those micro-organisms. When these beneficial resident bacteria are dominant in the digestive tract, they regulate the balance of the intestinal microflora, thus contributing to healthy digestion and overall well being. However, when these bacteria lose their dominant role, pathogenic bacteria, viruses and yeast’s begin to multiply with detrimental effects. 6. Probiotics The word ‘probiotic’ is a compound of a Latin and a Greek word; it means “favourable to life.” Probiotics are microorganisms e.g. Lactobacillus and Bifidobacterium strains that possess health promoting properties and can be defined as live food supplements which beneficially affect the host by improving the balance of intestinal microbial flora. These are essentially ‘friendly’ bacteria of the same family as that already living in our bowel. These bacteria have GRAS status meaning ‘Generally Regarded As Safe’. Probiotics, comprised of the beneficial bacteria in our bodies, fortify our army of good bacteria and help fight invading microbes in three ways: by altering the acidity of the area inhabited by invading microbes, by producing antibiotic substances and by depriving unfriendly microbes of their nutrients. Probiotics stimulate immune response, aid in nutrient absorption and synthesize vitamins. In short, one of the main goals of ingesting probiotics like Lactobacillus acidophilus and Bifidobacterium is to control and suppress existing ‘bad’ bacteria. These ‘bad’ bacteria may consist of pathogenic bacteria, yeast or viruses. One of the objectives of the ingested probiotics is therefore to take over enough space on intestinal walls so that there’s no room for unwanted bacteria to colonize. Another strategy is to decrease the pH (acid-base balance) of the gut, making it an acidic environment in which bad bacteria can’t thrive. In addition to the enhanced functioning of the immune system, other beneficial properties of probiotics include: enhancing absorption of calcium, phosphorous and manganese production of galactosidase (leading to an increased lactose tolerance) detoxification of carcinogens production of vitamins of the B group and vitamin K lowering levels of blood cholesterol lowering levels of blood ammonia Clinical trials have proven the safety and efficacy of the probiotic strain Bifidobacterium . This strain was selected because of its excellent survival during intestinal transit and its adhesion to enterocytes. In another study, the Nestle scientists selected a Lactobacillus acidophilus strain that has exceptional probiotic effects, the clinical evidence for the enhancement of the natural immunity of the gut, was summarized in this report. These two groups of micro-organisms are closely associated with each other. Lactobacilli, which are microaerophilic, reduce the level of oxygen in their immediate surroundings, thus creating a favourable environment for Bifidobacteria, which are anaerobic inhabitants of the large intestine. 10 Successful recolinization and restoration of a balance among the intestinal flora may require regular supplementation of the diet with large quantities of probiotic cultures. Continuous consumption of B-Imune contributes to the reestablishing of these beneficial resident bacteria in the intestine. B-Imune is supplemented with Bifidobacterium bifidum and Lactobacillus acidophilus in equal quantities. The total bacterial count in B-Imune is 1x109 colony forming units/g of product and exceed the proposed concept regulation of 1x10^7 colony forming units/g of product. Both these bacterial strains have been proved to survive the gut’s bile acids and are also commercially also available in capsule form. To understand how probiotics influence health, it is important to understand how they function within the intestinal tract. The following is an overview of several major characteristics and functions of probiotic organisms. i. Probiotics as a Disease Fighter Perhaps the most important function of probiotic organisms is to limit the growth of pathogenic organisms, which cause disease. These potentially harmful microbes naturally reside in the human intestinal tract but do not overpopulate when sufficient numbers of probiotic organisms are present. Probiotic bacteria not only compete with these pathogens for nutrients and space, they also secrete substances - lactic acid and other organic acids, hydrogen peroxide, and potent antibiotic agents known as bacteriocins - that inhibit the growth of harmful organisms.[30,31] Many studies demonstrate the ability of probiotics to fight disease-causing microbes and treat the intestinal infections caused by these harmful organisms. ii. Probiotics in Food Digestion Probiotic organisms contribute to the digestive process by secreting enzymes that help break down foods. Probiotics help digest food in the gut in the same way they partially digest the carbohydrates, proteins and fats in milk to create yoghurt. (In fact, people who are lactose intolerant can often tolerate yoghurt because the lactose has already been partially broken down). By improving digestion, probiotics can benefit those with impaired secretion of hydrochloric acid, bile, and pancreatic or intestinal enzymes. iii. Probiotics in Short-chain Fatty Acid (SCFA) Production Among the most important by-products of probiotic metabolism are SCFAs. SCFAs, such as lactic acid, provide up to 70 percent of the energy required by intestinal cells and have been used therapeutically for disorders such as inflammatory bowel disease. The energy provided by SCFAs appear to make intestinal cells more capable as a protective barrier. Furthermore, SCFAs keep most intestinal pathogens in check. This is because SCFAs make intestinal pH more acidic, and most intestinal pathogens do not grow well in an acidic environment. In addition, lower intestinal pH facilitates absorption of minerals such as calcium, magnesium and zinc. Lowering intestinal pH may also help lower colon-cancer risk. Studies have shown that low-risk groups typically have a lower fecal pH, while high-risk groups tend to have a higher fecal pH. iv. Probiotics in Immune Enhancement Probiotics have a profound effect on the immune function. Research studies show that probiotic organisms increase numbers of circulating white blood cells, decrease bacteria, elevate antibodies and increase production of some types of cytokines, which help in the production of T cells. One recent study of 4,718 women findings suggest that Lactobacillus acidophilus may be able to inhibit HIV, the virus that leads to AIDS. v. Probiotics in Food Allergy Reduction The intestinal lining keeps toxic/allergenic materials from moving into the bloodstream. An imbalance of intestinal bacteria can contribute to “leaky gut syndrome,” or increased intestinal permeability. Intestinal hyperpermeability— when the intestine allows too much into the blood stream—has been implicated in a variety of diseases including hypersensitive reactions to foods. A recent landmark study in the Journal of Allergy and Clinical Immunology made clear the connection between intestinal flora and food allergy. Using a strain of Lactobacillus rhamnosus, researchers observed clinical improvements in a test group of 10 infants with food-allergy-related dermatitis. After a one-month trial, infants on the probiotic supplement showed significant improvements in their condition compared to infants given placebo. The authors concluded that the improvements were due to the probiotics, which enhanced the intestinal barrier, keeping antigens from erroneously leaking into the blood stream. 11 vi. Probiotics and Anticarcinogenic Activity Research is uncovering anticarcinogenic activities that can be partially explained in terms of functions already discussed, such as lowering intestinal pH, reducing populations of toxin-producing bacteria, and enhancing immune function. The organic acids produced by probiotics also mildly enhance intestinal contractions, hastening the removal of potentially carcinogenic toxins. Recent research has even shown that cell-wall components of certain probiotics may promote specific immunological activity against malignant cells. In one animal study, Bifidobacterium longum was shown to inhibit mammary and liver carcinogenesis. This study is exciting because it suggests the anticarcinogenic activity of probiotics may extend beyond the intestinal tract. 7. Prebiotics A prebiotic is defined as a non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and/or activity of one or more types of bacteria in the colon and that can improve the host’s health. B-Imune contains fructo-oligosaccharides (FOS), which selectively promotes the growth of the above-mentioned bacteria and is supplemented with 3g FOS/100g. 8. L-Glutamine L-glutamine is the most abundant amino acid in the bloodstream and because human cells readily synthesise it, is usually considered a non-essential amino acid. However, during catabolic stress such as trauma, sepsis, starvation and chemotherapy, the intracellular glutamine levels can drop more than 50%, and it is under these circumstances that supplemental glutamine becomes necessary. Glutamine has therefore been re-classified as a conditionally essential amino acid. The gastrointestinal tract is by far the greatest user of glutamine in the body, as enterocytes in the intestinal epithelium use glutamine as their principal metabolic fuel for growth and proliferation. Research has demonstrated glutamine addition to decrease intestinal permeability. It also resulted in an improved gut barrier function, as well as immune activity in the gut. Glutamine is an important fuel for the immune system and the intestinal tract. HIV infection appears to induce glutamine deficiency, with the result of muscle protein wasting, particularly in the AIDS stage of the infection. Approximately 20 % of AIDS patients also have impaired intestinal permeability. Clinical studies have demonstrated glutamine supplementation has significant benefit in these patients. A double-blind, placebo controlled study was conducted with 68 HIV-infected patients having documented weight loss who were given Lglutamine supplement for eight weeks. At 8 weeks, patients taking the glutamine supplement had gained 3.0kg of body weight compared to 0.37kg in the placebo group. An additional benefit in the supplemented group was improved immune status as evidenced by increased CD4 and CD8 cell counts, and decreased HIV viral load. In another doubleblind, placebo controlled study of AIDS patients with abnormal intestinal permeability; glutamine supplementation resulted in stabilisation of intestinal permeability and enhanced intestinal absorption. L-glutamine is thus an essential supplement choice for more chronic conditions of the GI, such as AIDS and cancer patients, where the GI integrity has been compromised. B-Imune Energy Drink is supplimented with 5g L –glutamine per 100g and B-imune Maize Drink supplimented with 2g L-glutamine per 100g 9. Taurine Taurine is a conditionally essential amino acid that is found in the central nervous system, skeletal muscle and is very concentrated in the brain and heart. Taurine is involved in a number of physiological processes. One of its pivotal roles are that it is essential for proper digestion of fats, absorption of fat soluble vitamins and production of bile salts [58,59] It is synthesised in human liver tissue from cysteine and methionine, in conjunction with vitamin B6. Individuals deficient in methionine or cysteine may have difficulty in manufacturing taurine and dietary intake is thought to be important. BImune is supplemented with 140mg Taurine/100g. 12 10. Carnitine Carnitine is a substance related to vitamin B. It holds a chemical structure similar to that of amino acids, which has been found to have a wide range of protective effects and health benefits when consumed in sufficient amounts. Carnitine increases fat metabolism and deficiencies lead to an inability to transport fatty acids into the mitochondria for oxidation. Energy provision from fat sources in the diet is thus enhanced by the addition of carnitine. B-Imune is supplemented with 84 mg L-Carnitine/100g product. 11. Nutraceuticals Nutraceuticals are added ingredients contained within food products that have a health improving effect. Dr Blum from F.Hoffmann-La Roche Ltd, Basel, Switzerland, listed the following degenerative diseases and suggested nutrients that may assist in their prevention (Nutrilit ,1997): Disease Protective nutrients Coronary Heart Disease (CHD) Linoleic- and linolenic acid, omega-3 and omega-6 fatty acids, vitamins C, E, carotenoids, flavonoids, folate, vitamins B6 and B12, potassium and magnesium Cancer Vitamin C (stomach), E (oesophagus), D (colon), calcium (colon), carotenoids (liver) and dietary fibre (colon) Diabetes Foods with a low glycaemic index, vitamin E, chromium Stroke Vitamin E and A, fish oils, flavonoids Cataract & Macular degeneration Vitamin C, E, B complex and carotenoids A combination of nutraceutical antioxidants contained in B-Imune , protect the human body against cell damage caused by free radicals. These components include - Ascorbic acid, Alpha-Tocopherol, Isoflavonoids and Selenium. 12. Summary of Features and Benefits of B-Imune Features Benefits High in protein Provides protein with excellent biological value to help maintain weight Contains soy oil, L - carnitine and taurine. Good source of polyunsaturated fatty acids e.g. Linolenicand linoleic acid. The added essential nutrients are important in fat metabolism to provide the needed energy (calories) L-Glutamine Energy source for cells in gut, having a high turnover rate, involved with the immune system Probiotic intestiflora Contains Bifidobacterium and Lactobacillus species to stimulate immune functions, prevent diarrhoea, aid in mineral absorption and lactose digestion. It also synthesise vitamins Prebiotic Contains fructo-oligosaccharides which selectively stimulates the growth of probiotic intestinal flora in the colon. Nutraceuticals of which Antioxidants components: Ascorbic acid, AlphaTocopherol, Isoflavonoids, Selenium Play a vital protective roll against cell damage caused by free radicals. High levels of vitamins and chelated minerals To meet increased requirements and support the immune system 13 13. Ingredients in B-Imune B-imune Energy Drink: Soy protein, Sugar, Vegetable fat, Fructo-oligosaccharide (Raftilose), L-Glutamine, Salt, Taurine, L-Carnitine, Stabilizer Ascorbic acid (Vitamin C), Nicotinamide ,Vitamin E 50% CWS/S, Calcium D-Pantothenate, Pyridoxine HCL (Vitamin B6), Riboflavin (Vitamin B2), Thiamine mononitrate (Vitamin B1), Vitamin A Acetate 325 CWS/F Folic acid 10% on fructose, Biotin, Vitamin D3 Type 100 CWS, Vitamin B12 0.1% WS, Calcium lactate (28% elemental Ca), Mixture of mirobiological Cultures (Probiotics), Anticaking agent Cultures (Probiotics), Anticaking agent, Iron Ferrochel (20% elemental Fe), Zinc TF Aminoacid Chelate (10% elemental Zn), Selenium Aminoacid Complex (1% elemental Se), Chromium Chelavite Aminoacid Complex (8.5% elemental Chromium), Manganese Chelazome Aminoacid Complex (16% elementa Mn), Flavorants and Colourants B-Imune Maize Drink: Soy protein, Maize starch, Sugar, Fructo-oligosaccharide (Chicory), L-Glutamine, Salt,Taurine, L-Carnitine, Ascorbic Acid (Vitamin C), Nicotineamide Vitamin E 50% CWS/S, Calcium D-Pantothenate, Pyridoxine HCL(Vitamin B6), Riboflavin ( Vitamin B2), Thiamine mononitrate (Vitamin B1), Vitamin A Acetate 325 CWS/F, Folic acid 10% on fructose, Biotin, Vitamin D3 Type100 CWS, Vitamin B12 0.1% WS, Calcium lactate (28% elemental Ca), Mixture of mirobiological cultures (Probiotics), Anticaking agent, Iron Ferrochel (20% elemental Fe), Zinc TF Aminoacid Chelate ), (10% elemental Zn), Selenium Aminoacid Complex (1% elemental Se), Chromium Chelavite Aminoacid Complex (8.5% elemental Chromium), Manganese Chelazome Aminoacid Complex (16% elementa Mn) , Flavorants and Colourants. B-imune High Protein Energy Drink: Soy fat, Soy protein, Fructo-oligosaccharide (Raftilose), L-Glutamine, Flavorants, Salt, Non nutrititive sweetner, Taurine, L-Carnitine, Stabilizer, Ascorbic acid(Vitamin C), Nicotinamide,Vitamin E 50% CWS/S, Calcium D-Pantothenate, Pyridoxine HCL(Vitamin B6), Riboflavin(Vitamin B2), Thiamine mononitrate(Vitamin B1), Vitamin A Acetate 325 CWS/F, Folic acid 10% on fructose,Ascorbic acid(Vitamin C), Nicotinamide,Vitamin E 50% CWS/S, Biotin, Vitamin D3 Type 100 CWS, Vitamin B12 0.1% WS, Calcium lactate (28% elemental Ca), Iron Ferrochel (20% elemental Fe), Zinc TF Aminoacid Chelate (10% elemental Zn), Selenium Aminoacid Complex(1% elemental Se), Anticaking agent, Chromium Chelavite Aminoacid Complex (8.5% elemental Chromium), Manganese Chelazome Aminoacid Complex (16% elemental Mn), Colourant and Mixture of mirobiological cultures (Probiotics). 14. Preparation Instructions of B-Imune B-imune High Protein Energy- and Energy Drink: To prepare a beverage, add contents of a sachet to 200 ml water, dissolve by stirring/shaking. B-Imune Maize Drink:To prepare a beverage, add contents of a sachet to 250 ml water, dissolve by stirring/shaking. 15. B-Imune Usage Recommendations B-imune High Protein Energy- and Energy Drink 1 portions of 40g per day B-Imune Maize Drink 1 to 2 portions of 50g per day 16. B-Imune Portion Evaluation B-Imune is presented in a box of 30x40g sachets( High Protein Energy – and Energy Drink) and 30x50g sachets (Maize Drink). This equates to 1.2 kg and 1.5kg of product and should be sufficient for 1 month. Most other food supplements available commercially are presented in between 400-450g product and provide between 7-10 servings. 14 Annexure A ABSTRACT OF RESEARCH THESIS EFFECTS OF A MICRONUTRIENT, GLUTAMINE, PRE- AND PROBIOTIC ENRICHED LIQUID SUPPLEMENT ON NUTRITIONAL STATUS AND IMMUNITY OF ADULTS WITH HIV/AIDS: A PILOT STUDY Roy D Kennedy MNutr(Stell), RD(SA) INTRODUCTION: The objective of this pilot study was to evaluate the effects of a new micronutrient, glutamine, pre- and probiotic enriched liquid nutritional supplement on the nutritional status and immunity of adults living with HIV/AIDS. The study was designed as a prospective randomised double-blind placebo-controlled trial. Subjects were HIV-infected male and female adult volunteers (n = 47) from a community-based hospice centre in a peri-urban area in a resource-poor setting and were included irrespective of duration or clinical stage of HIV/AIDS. None of the subjects received antiretroviral therapy. METHOD: The intervention involved the daily ingestion of 40g (200 ml reconstituted) of either the enriched test product or an isocaloric carbohydrate placebo for a period of 12 weeks. Anthropometric assessment (weight, height and triceps skinfold thickness; mid-upper arm, waist and hip circumferences) was performed at baseline and thereafter every 4 weeks (4 times). Biochemical (serum total protein, serum albumin and C-reactive protein) and haematological (full blood count and immunophenotyping) assessment was performed at baseline and again after week 12. RESULTS: Statistical analysis of baseline values was performed with Wilcoxon two-sample tests for comparison between the supplemented and placebo groups. Outcomes were evaluated using analysis of variance with Shapiro-Wilk tests and thereafter either pair-wise t-tests or sign tests (for nonparametric data) were used. Thirty-two subjects completed the trial, 14 in the supplemented group and 18 in the placebo group. Weight increased significantly in the supplemented group (2.73 ± 3.53 kg, p = 0.013). Triceps skinfold thickness increased significantly in both the supplemented (p = 0.047) and placebo group (p = 0.001). No other significant anthropometric change was observed. Serum albumin increased significantly in the supplemented group (p = 0.003) and was associated with a significant decline in C-reactive protein (p = 0.028). Haemoglobin decreased significantly in both groups. A significant decline in CD4+ count was observed in the placebo group while the decline in the supplemented group did not reach significance. CONCLUSION: Oral nutritional supplementation in limited quantities was well tolerated for a period of 3 months. This study demonstrated that an enriched nutritional supplement was able to promote weight gain and ameliorate hypoalbuminaemia and possibly inflammation in adults living with HIV/AIDS in the short to medium term. The enriched nutritional supplement does not appear to have an effect on the immunity of people with HIV/AIDS. The small sample is a limitation of the study and the conclusions pertain to the test product as a whole and not to any of its respective ingredients. Although further studies are required to evaluate long-term feasibility, these findings suggest that the use of an enriched nutritional supplement has a role in the management of weight loss in persons with HIV/AIDS.