AU2012245002A1

AU2012245002A1 - Weight loss composition

Info

Publication number: AU2012245002A1
Application number: AU2012245002A
Authority: AU
Inventors: Kate BARRY; Sean HALL; Evan Hayes
Original assignee: Fit Bioceuticals Ltd
Current assignee: FIT-BIOCEUTICALS Ltd
Priority date: 2011-04-21
Filing date: 2012-04-23
Publication date: 2013-11-28
Also published as: WO2012142678A1

Abstract

The present disclosure relates generally to the use of compositions comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol and uses thereof for promoting weight and/or fat loss in a subject.

Description

WO 2012/142678 PCT/AU2012/000427 Weight loss composition Technical Field The present disclosure relates generally to the use of compositions comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol and uses thereof for promoting weight and/or fat loss in a subject. Background of the Disclosure The number of overweight and obese individuals has more than doubled over the past two decades. The health problems and consequences associated with overweight and obese individuals are many and varied, including type 2 diabetes, gall bladder disease, hypertension, dyslipidaemia, insulin resistance, musculoskeletal problems, cardiovascular disease, atherosclerosis, some cancers, sleep apnoea, breathlessness, asthma, social isolation/depression and daytime sleepiness/fatigue. Such health problems cause discomfort and pain and decrease the quality of life to the individual and are a costly clinical problem. Many studies that have shown that there is a clear relationship between overweight and obese individuals and increased mortality. Treatment of overweight or obese individuals includes diet and exercise regimes. Unfortunately not all individuals are able to diet and/or exercise effectively due to factors such as sedentary lifestyles, the ready availability of fast foods and convenience foods leading to poor dietary selection, lack of free time, stress and depression. As a result many individuals are unable to reduce their weight and/or maintain a healthy weight. Some individuals choose to undergo surgery in an attempt to lose weight, for example by undergoing surgery to reduce the size of the stomach or the length of the bowels. Unfortunately, complications from surgery are common and the individual is required to modify their behaviour towards food to enhance the likelihood of a successful outcome. Even individuals who are not categorised as overweight or obese may desire improved physical performance and appearance resulting from decreased weight and/or fat. Accordingly, there is a need for a composition that promotes weight loss and/or fat loss in an individual.

WO 2012/142678 PCT/AU2012/000427 2 The present inventors have found that a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol promotes weight loss and/or fat loss in an individual. Summary According to a first aspect of the present disclosure there is provided a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol. According to a second aspect of the present disclosure there is provided a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol for promoting weight loss and/or fat loss in a subject. In one embodiment the composition according to the first or second aspect may further comprise vitamin K. Typically, the one or more probiotic microorganisms comprises Lactobacillus and/or Bifidobacterium. In one embodiment the probiotic microorganisms comprise Lactobacillus acidophilus. In another embodiment the probiotic microorganisms comprise Bifidobacterium lactis, In yet another embodiment the probiotic microorganisms comprises Lactobacillus acidophilus and Bifidobacterium lactis. The probiotic microorganisms in the composition may be in an amount of from about 1 billion to about 50 billion IU/mg. In one embodiment the probiotic microorganisms in the composition are in an amount of about 3 billion IU/mg. The glutamine in the composition may be in an amount of from about 50 to about 600 IU/mg. In one embodiment the glutamine in the composition is in an amount of about 250 IU/mg. In one embodiment the at least one sugar alcohol is xylitol, mannitol or sorbitol, In particular embodiments the at least one sugar alcohol is xylitol. The xylitol in the composition may be in an amount of from about 10 to about 300 g/kg. In one embodiment the xylitol in the composition is in an amount of about 110 g/kg. In some embodiments the composition further comprises vitamin K. The vitamin K may be vitamin K1 and/or vitamin K2. The vitamin K in the composition may be in an amount of from about WO 2012/142678 PCT/AU2012/000427 3 0.1 pg/mg to about 100 pg/mg. In one embodiment the vitamin K in the composition is in an amount of about 1 pg /mg. In another embodiment the composition further comprises vitamin D. In another embodiment the composition further comprises whey protein. In another embodiment the composition further comprises vitamin B. In another embodiment the composition further comprises polydextrose. In another embodiment the composition further comprises at least one medium chain triglyceride. In another embodiment the composition further comprises one or more enzyme. The enzyme may be selected from the group consisting of protease, bromelain and papain. Typically the composition is in a form suitable for oral administration. In particular embodiments the composition is in the form of a liquid, a powder or a unit dosage form such as a tablet, capsule or caplet. According to a third aspect of the present disclosure there is provided a method of promoting weight loss and/or fat loss in a subject, the method comprising administering to the subject a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol. The composition is typically administered to the subject orally. In one embodiment the composition is in the form of a liquid, a powder or a unit dosage form. The unit dosage form may be a tablet, a capsule or a caplet. Typically between 1 and 5 unit dosage forms are administered per day. According to a fourth aspect of the present disclosure there is provided a method of promoting a healthy immune system in a subject, the method comprising administering to the subject a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol.

WO 2012/142678 PCT/AU2012/000427 4 The composition is typically administered to the subject orally. In one embodiment the composition is in the form of a liquid, a powder or a unit dosage form. The unit dosage form may be a tablet, a capsule or a caplet. Typically between 1 and 5 unit dosage forms are administered per day. In some embodiments the oral composition as defined above may be in the form of a food stuff or beverage, or suitable for administering with a food stuff or beverage. According to a fifth aspect of the present disclosure there is provided a use of a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol in the manufacture of a medicament for promoting weight loss and/or fat loss in a subject. According to a sixth aspect of the present disclosure there is provided a use of a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol in the manufacture of a medicament for promoting a healthy immune system in a subject. Definitions Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. In the context of this specification, the terms "a" and "an" are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, "an element" means one element or more than one element. In the context of this specification, the term "about," is understood to refer to a range of numbers that a person of skill in the art would consider equivalent to the recited value in the context of achieving the same function or result. In the context of this specification, the term "sugar alcohol" or "sugar alcohols" is understood to refer to those compounds with the general formula H(HCHO)o.

1 H and which can be administered to a subject. A person skilled in the art will appreciate that the term does not include the sugar alcohol glycol.

WO 2012/142678 PCT/AU2012/000427 5 In the context of this specification, the term "probiotic microorganisms" is to be given its broadest construction and is understood to refer to any live microorganisms which when administered in an effective amount promotes a health benefit. In the context of this specification, the term "prebiotic" is to be given its broadest construction and is understood to refer to any non-digestible substance that stimulates the growth and/or activity of bacteria, in particular probiotic bacteria, in the digestive system. In the context of this specification, the terms "promote" and "promoting" and variations thereof as used herein refer to the ability of a composition of the present disclosure to achieve or assist in achieving a benefit, either directly or indirectly, in relation to weight loss and/or fat loss, the health of the gastrointestinal tract, the health of the immune system and/or diseases associated therewith; or to improve the ability to achieve or assist in achieving a measurable benefit, either directly or indirectly, in relation to weight loss and/or fat loss, the health of the gastrointestinal tract, the health of the immune system and/or diseases associated therewith; or otherwise prevent, hinder, retard, or reverse the deterioration in the health of a subject in any way whatsoever. Thus the terms "promote", "promoting" and the like are to be considered in their broadest context. In the context of this specification, the term "derivative" or "derivatives" is understood to include compounds that are formed from a parent compound by chemical reaction(s). For example a derivative of vitamin D 3 is a compound formed by a chemical reaction with vitamin D 3 . In the context of this specification, the term "precursor" or precursors" is understood to refer to a compound that forms a parent compound by chemical reaction(s) or metabolic process(es). For example a precursor of vitamin D3 forms vitamin D3 via chemical reaction(s) or metabolic process(es). In the context of this specification, "food", "foods", "beverage" or "beverages" includes but is not limited to health foods, functional foods and foods for specified health use. When such food or beverage of the present disclosure is used for subjects other than humans, the term can be used to include a feedstuff.

WO 2012/142678 PCT/AU2012/000427 6 In the context of this specification, the term "subject" includes humans, primates, livestock animals (eg. sheep, pigs, cattle, horses, donkeys), laboratory test animals (eg. mice, rabbits, rats, guinea pigs), companion animals (eg. dogs, cats) and captive wild animals (eg. foxes, kangaroos, deer). Typically, the subject is a human or a laboratory test animal. Even more typically, the subject is a human. Detailed Description Embodiments of the present disclosure provide compositions comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol. The compositions promote weight loss and/or fat loss in a subject. The compositions may be used as meal replacements or alternatively in addition to meals as part of a calorie controlled diet/weight loss regime. The compositions of the disclosure are also useful for managing diseases and/or disorders that are associated with excessive calorie intake, such as obesity, metabolic syndrome and diseases and conditions related thereto. In some embodiments the compositions may promote a healthy immune system thereby reducing the risk of autoimmune disease, reducing inflammation, and promoting the health of the gastrointestinal tract thereby promoting healthy digestion and absorption of nutrients in a subject. In some embodiments the compositions may promote an improved mood state and/or boost the metabolism and assist in balancing the appetite of a subject. In other embodiments the compositions may promote the health of a subject by reducing the risk of hypothyroidism. The compositions of the present disclosure may also assist in reducing or inhibiting bone decay in a subject, thereby decreasing the pain associated with the effects of carrying extra weight. Currently available weight loss and fat loss products seek to address the issue of weight loss and fat loss by simply reducing the calorie intake of a subject or by or increasing the loss of calories in a subject. The deficiency of the currently available products is that they do not address the overall health of the subject or address the health issues associated with overweight or obese individuals.

WO 2012/142678 PCT/AU2012/000427 7 The compositions of the present disclosure seek to not only address the issue of weight loss and or fat loss but also to reduce systematic inflammation and stress in the gastrointestinal tract thereby promoting an improvement in the health of the gastrointestinal tract, promoting weight loss and/or fat loss and promoting additional health benefits. Compositions comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol work synergistically promoting bacterial growth in the gut because the glutamine and at least one sugar alcohol nourish the probiotic microorganisms during proliferation. According to the World Health Organisation Global Database on Body Mass Index (BMI), in 2011 the current classification for BMI indicates that, the term "overweight" refers a subject having a BMI of between 25 and 29.9 and the term "obese" refers to a subject having a body mass index of greater than 30. Whilst not wishing to be bound by theory, it is suggested that overweight and obese individuals may experience systemic inflammation due to the release of pro-inflammatory signals by fat cells. Systemic inflammation is a major problem in overweight and obese individuals and can result in insulin resistance which leads to type 2 diabetes; and in leptin resistance which can lead to poor appetite control due to a decreased feeling of satiety and suppressed metabolism. Systemic inflammation can also cause oestrogen-dominant conditions, joint pain, cardiovascular disease, adrenal fatigue, depression and gastrointestinal problems. In accordance with embodiments of the present disclosure the compositions may reduce systemic inflammation and promote the health of the gastrointestinal tract and therefore assist in preventing and/or promoting the improvement of conditions associated with systemic inflammation. Overweight and obese individuals may also have increased risk of dysbiosis (or dysbacteriosis) which is a condition that causes microbial imbalances on or within the body. Dysbiosis can cause major problems in the gastrointestinal tract or on the skin, and has been associated with inflammatory bowel disease, chronic fatigue syndrome, poor oestrogen clearance and compromised digestion which can reduce the absorption of nutrients. Dysbiosis can also lead to leaky gut and can comprise vitamin K in a subject. The probiotic microorganisms in accordance with embodiments of the present disclosure may reduce dysbiosis thereby promoting absorption of B vitamins and vitamin K.

WO 2012/142678 PCT/AU2012/000427 8 The compositions of the present disclosure may comprise any one or more probiotic microorganisms. The one or more probiotic microorganisms may be present in the composition as specially selected strains as a culture concentrate or as part of a multiple strain blend with a variety of excipients. The one or more probiotic microorganisms may include but are not limited to one or more of a strain of Lactobacillus, Bifidobacterium, Streptococcus Saccharomyces, Bacillus, Enterococcus, Bacteroides or Propionibacterium The Lactobacillus may be one or more of, but is not limited to, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Lactobacillus salivarius, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus helveticus, Lactobacillus reuteri, Lactobacillus johnsonii, Lactobacillus paracasei, Lactobacillus gasseri or Lactobacillus sporogenes. In one embodiment the Lactobacillus is Lactobacillus acidophilus. The Bifidobacterium may be one or more of, but is not limited to, Bifidobacterium animals, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis, Bifidobacterium Lafti, Bifidobacterium breve or Bifidobacterium lactis. In one embodiment the Bifidobacterium is Bifidobacterium lactis. The Streptococcus may be one or more of, but is not limited to, Streptococcus thermophilus, Streptococcus faecium, or Streptococcus salivarius. The Saccharomyces may be one or more of, but is not limited to, Saccharomyces cerevisiae or Saccharomyces boulardii. The Bacillus may be one or more of, but is not limited to, Bacillus coagulans, Bacillus cereus, Bacillus clausii, or Bacillus pumilus. The Enterococcus may be, but is not limited to, Enterococcus faecium. In accordance with particular embodiments of the present disclosure the amount of one or more probiotic microorganisms present in the compositions may be between about 1 billion to about 100 billion IU/mg, or more typically between about 2 billion to about 5 billion IU/mg. Alternatively, the WO 2012/142678 PCT/AU2012/000427 9 composition may comprise about 2.5 billion IU/mg, 3.0 billion IU/mg, 3.5 billion IU/mg, 4.0 billion IU/mg or 4.5 billion IU/mg of the one or more probiotic microorganisms. The glutamine may be present in the composition in the form of a salt or derivative. In accordance with particular embodiments the amount of glutamine present in the composition may be between about 1 IU/mg and about 1000 IU/mg, or more typically between about 50 lU/mg and about 600 IU/mg. Alternatively, the composition may comprise about 100 IU/mg, 150 IU/mg, 200 IU/mg, 250 IU/mg, 300 IU/mg, 350 IU/mg, 400 IU/mg, 450 IU/mg, 500 IU/mg or 550 of glutamine. The compositions of the present disclosure comprise at least one sugar alcohol. The at least one sugar alcohol is typically selected from a sugar alcohol that also functions as a sweetener. The at least one sugar alcohol may include, but is not limited to, one or more of glycerol, erythritol, xylitol, mannitol, sorbitol, isomalt, maltitol, lactitol or polyglycitol. In one embodiment the at least one sugar alcohol is sorbitol. In another embodiment the at least one sugar alcohol is mannitol. In yet another embodiment the at least one sugar alcohol is xylitol. When present, the xylitol may be present in the composition in the form of a salt or derivative. In accordance with particular embodiments the amount of xylitol present in the composition may be between about 1 g/kg and about 1000 g/kg, or more typically between about 10 g/kg and about 300 g/kg. Alternatively, the composition may comprise about 20 g/kg, 30 g/kg, 40 g/kg, 50 g/kg, 60g/kg, 70g/kg, 80g/kg, 90g/kg, 100g/kg, 110g/kg, 120g/kg, 130g/kg, 140g/kg, 150g/kg, 160 g/kg, 170 g/kg, 180 g/kg, 190 g/kg, 200 g/kg, 210 g/kg, 220 g/kg, 230 g/kg, 240 g/kg, 250 g/kg, 260 g/kg, 270 g/kg, 280 g/kg or 290 g/kg of xylitol. In some embodiments the composition may further comprise vitamin K. The vitamin K may be vitamin Ki and/or vitamin K 2 . Typically the vitamin K is vitamin K2. Those skilled in the art will appreciate that the vitamin K may be present in the form of suitable precursors, derivatives or analogues thereof. The body does not store vitamin K and therefore it is an essential vitamin that needs to be continuously ingested. Vitamin K2 is produced by probiotics and some vegetables such as broccoli, however vitamin K2 produced by probiotics is not always readily absorbed in the gut and the harmful bacteria in the gut does not permit vegetables to be digested effectively enough to extract sufficient vitamin K 2 from such foods. As well are producing vitamin K, the one or more probiotic microorganisms in the compositions of the present disclosure harmonise the gut of an WO 2012/142678 PCT/AU2012/000427 10 overweight or obese individual thereby allowing vitamin K to be more effectively extracted from food. Whilst not wishing to be bound by theory the inventors of the subject application believe that the combination of one or more probiotic microorganisms and vitamin K (in particular vitamin K 2 ) in the compositions promote the proliferation of the beneficial bacteria and promote the absorption of vitamin K 2 . In accordance with particular embodiments of the present disclosure the amount of vitamin K present in the composition may be between about 0.1 pg/mg and about 100 pg/mg, or more typically between about 0.2 p/mg and about 5 p/mg w/w. Alternatively, the composition may comprise about 0.4 pg/mg, 0.6 pg/mg, 0.8 pg/mg, 1.0 pg/mg, 1.2 pg/mg, 1.4 pg/mg, 1.6 pg/mg, 1.8 pg/mg, 2.0 pg/mg, 2.2 pg/mg, 2.4 pg/mg, 2.6 pg/mg, 2.8 pg/mg, 3.0 pg/mg, 3.2 pg/mg, 3.4 pg/mg, 3.6 pg/mg, 3.8 pg/mg, 4.0 pg/mg, 4.2 pg/mg, 4.4 pg/mg, 4.6 pg/mg or 4.8 pg/mg of vitamin K. Fat cells can sequester vitamin D3 which can result in overweight and obese individuals suffering from vitamin D3 deficient related conditions, for example low bone density, inflammation, autoimmune diseases, poor immunity to colds and flu, depression, and cancer. Accordingly, in some embodiments vitamin D is added to the compositions to assist in replacing the vitamin D sequestered by fat cells. The vitamin D may be present as vitamin D2 and/or D 3 . In some embodiments the compositions comprise vitamin D3 (cholecalciferol). However, a person skilled in the art will appreciate that the vitamin D3 may be in the form of any suitable precursor, derivative or analogue thereof. In some embodiments the composition comprises vitamin D 2 (ergocalciferol), or metabolites, analogues or derivatives thereof. In some embodiments the compositions may further comprise a fibre and/or a prebiotic. In some embodiments the compositions further comprise polydextrose which acts both as a source of a fibre and a prebiotic. In other embodiments the fibre and prebiotic may be inulin, fructooligosaccharides (FOS), xylooligosaccharides (XOS) and/or galactooligosaccharides (GOS). Those skilled in the art will appreciate that other sources of fibre and/or prebiotics may be added to the compositions. In some embodiments of the present disclosure at least one enzyme, such as but not limited to, protease (peptidase), bromelain and papain and/or at least one medium chain triglyceride (medium chain (6 to 12 carbons) fatty acid esters of glycerol) may be added to the compositions. The at least WO 2012/142678 PCT/AU2012/000427 11 one medium chain triglyceride may be selected from the group consisting of caproic acid (C6), caprylic acid (C8), capric acid (C10) and lauric acid (C12). Whilst not wishing to be bound by theory, in overweight or obese individuals medium chain triglycerides are not always effectively utilised as such individuals often have a deficiency of stomach acid or pancreatic enzymes. Accordingly, a combination of at least one medium chain triglyceride and at least one enzyme in the compositions of the invention promotes the digestion of the at least medium chain triglyceride and ensures that the medium chain triglyceride is effectively utilised as energy thereby further promoting weight loss and/or fat loss. In yet further embodiments the compositions may comprise protein. The protein may be whey protein, however a person skilled in the art will appreciate that other protein sources may also be used. The whey protein may be in the form of a concentrate, an isolate, and/or a hydrolysate. The whey protein is typically obtained from cow's milk, however those skilled in the art will appreciate that whey protein sourced from other milk may be used. The whey protein may comprise at least one of alpha lactalbumin, beta lactoglobulin, bovine serum albumin immunoglobulins and glycomacropeptides or mixtures thereof. The compositions of the present disclosure may further comprise vitamins and/or minerals and/or amino acids. The vitamins and/or minerals may be one or more vitamins or minerals indicated for weight loss and/or appetite control. The vitamins and minerals may be selected from, but not limited to: vitamins A, B1, B2, B 3 , B 5 , B 6 , 89, B12, C, D, E and calcium, chromium, copper, fluorine, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, sodium and zinc. The amino acids may be selected from, but are not limited to: alanine, arginine, aspartic acid, cystine, glycine, histidine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan and tyrosine. The compositions may be used as meal replacements or supplements. Alternatively, the compositions may form part of a calorie controlled diet. The methods and compositions of the disclosure may form part of a weight management program in a subject in need thereof. The compositions may be taken before, during, or after a meal and/or in between meals where necessary.. In some embodiments the serving size of the composition may be between about 1 g and about 100 g, or between about 5 g and about 50 g, or between about 25 g and about 35 g, or about 26 g, 27 g, 28 g, 29 g, 30 g, 31 g, 32 g, 33 g or 34 g. Those skilled in the art will however WO 2012/142678 PCT/AU2012/000427 12 appreciate that the exact amounts and rates of administration of the compositions will depend on a number of factors such as the particular composition being administered, the age, body weight, general health, sex and dietary requirements of the subject, as well as any drugs or agents used in combination or coincidental with the compositions. Based on the teaching herein those skilled in the art will, by routine trial and experimentation, be capable of determining suitable dosage regimes on a case-by-case basis. The compositions may be provided to the user, for example, in a liquid form, a powder form or as a solid unit dosage form such as a tablet, capsule or caplet. The compositions may be added in powder form by the user to any type of drink or food product (for example water, fruit juice or yoghurt) and consumed there after. In another embodiment, the compositions may simply be consumed as a powder in the absence of a drink or additional food product. In yet another embodiment the composition may be conveniently presented and consumed in a dosage form prepared by any of the methods well known in the art. The method may include the step of bringing the components of the oral composition into association with a carrier which constitutes one or more accessory ingredients. In general, oral compositions are prepared by uniformly and intimately bringing into association the components of the composition with a liquid carrier or finely divided solid carrier, or both and then, if necessary, shaping the product into the desired composition. The present disclosure also contemplates that the composition may be conveniently incorporated in a variety of food and/or beverage products, nutraceutical products, pharmaceuticals and over-the counter formulations. The food may be a solid form such as a powder, or a liquid form. Specific examples of the types of beverages or foods include, but are not limited to water-based, milk-based, yoghurt-based, other dairy-based, milk-substitute based such as soy milk or oat milk, or juice-based beverages, water, soft drinks, carbonated drinks, and nutritional beverages, (including a concentrated stock solution of a beverage and a dry powder for preparation of such a beverage); baked products such as crackers, breads, muffins, rolls, bagels, biscuits, cereals, bars such as muesli bars, health food bars and the like, dressings, sauces, custards, yoghurts, puddings, pre packaged frozen meals, soups and confectioneries. The compositions of the disclosure may be used in conjunction with other treatments directed to WO 2012/142678 PCT/AU2012/000427 13 other diseases. As such, the compositions of the invention may be used as part of a treatment regime or combination therapy, wherein the role of the composition is to promote weight loss and/or fat loss. For example, the composition may be administered to a subject undergoing drug treatment for heart disease, wherein the composition assists in weight loss and/or fat loss. The reference in this specification to any prior publication (or information derived from it), or to -any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates. The present disclosure will now be described with reference to the following specific examples, which should not be construed as in any way limiting the scope of the invention.

WO 2012/142678 PCT/AU2012/000427 14 Examples Example I - Oral powder composition By way of example only a suitable oral composition for use in accordance with the disclosure is outlined below. The following is to be construed as merely an illustrative example of a composition and not as a limitation of-the scope of the present disclosure in any way. A typical powder composition for oral administration is prepared by combining the following components: Lactobacillus acidophilus LA 14 0.469 g/Kg (150 billion per gram) Bifidobacterium lactis BI-04 0.052 g/Kg (450 billion per gram) Glutamine 7.813 g/Kg Xylitol 101.563 g/Kg Vitamin K 0.156 g/Kg (optional) Whey protein isolate 15.625 g/Kg Whey protein concentrate 562.50 g/Kg Enzyme blend 3.125 g/Kg (protease (peptidase), bromelain, protease 6.0, protease 4.5, papain) Medium chain triglyceride powder 54.688 g/Kg (alpha lactalbumin, beta lactoglobulin, bovine serum albumin, immunoglobulins (IgG) and glycomacropeptides) Polydextrose (Litesse) 101.563 g/Kg Vitamin A 0.060 g/Kg Vitamin B 1 (as thiamine hydrochloride) 0.017 g/Kg Vitamin B2 (as riboflavin) 0.027 g/Kg Vitamin B3 (as nicotinamide) 0.156 g/Kg Vitamin B6 (as pyridoxine hydrochloride) 0.030 g/Kg Vitamin B7 (as biotin) 0.047 g/Kg Vitamin B9 (as folic acid) 0.031 g/Kg Vitamin B 1 2 0.003 g/Kg Vitamin C (ascorbic acid) 0.625 g/Kg Vitamin D 3 0.016 g/Kg WO 2012/142678 PCT/AU2012/000427 15 Vitamin E (d-alpha tocopheryl succinate) 0.189 g/Kg Calcium d-pantothenate 0.027 g/Kg Calcium carbonate 21.094 g/Kg Zinc (zinc oxide) 0.233 g/Kg Copper (cupric sulphate pentahydrate) 0.046 g/Kg Iron (ferrous fumarate) 0.570 g/Kg Manganese (manganese sulphate monohydrate) 0.120 g/Kg Potassium (potassium iodide 1%) 0.154 g/Kg Selenium (selenomethionine 1.25%) 0.031 g/Kg Magnesium (magnesium oxide heavy) 12.555 g/Kg Potassium (potassium citrate) 9.256 g/Kg Chromium (Chromium Picolinate 2%) 0.318 g/Kg Xanthan Gum 5.469 g/Kg Vanilla Flavour 12.350 g/Kg Cream Flavour 13.547 g/Kg Maltodextrin 75.634 g/Kg In particular exemplary compositions the dosage is 32 g of the resulting powder (typically dissolved in 200 mL water or other liquid) to be taken once to three times daily.

WO 2012/142678 PCT/AU2012/000427 16 Example 2 - Oral powder composition An exemplary oral composition in accordance with the present disclosure comprises: PER SERVE (32g) PER 100g Unit Unit Energy 468.906 kJ 1465.332 kJ Protein 15.158 g 47.369 g Carbohydrates Total 7.517 g 23.491 g Sugars 1.488 g 4.651 g Lactose 0.779 g 2.434 g Unavailable 3.250 g 10.156 g Xylitol 3.250 g 10.156 g Dietary Fibre 3.065 g 9.578 g Fat Total 2.537 g 7.929 g Saturated 0.800 g 2.500 g Litesse . 3.250 g 10.156 g Vitamin A 625.000 IU 1953.125 IU Retinol Equivalent 187.500 mcg 585.938 mcg Vitamin D3 50.000 IU 156.250 IU Cholecalciferol 1.250 mcg 3.906 mcg Folic Acid 100.000 mcg 312.500 mcg Thiamine Hydrochloride 0.550 mg 1.179 mg Riboflavin 0.850 mg 2.656 mg Nicotinamide 5.000 mg 15.625 mg Pyridoxine Hydrochloride 0.973 mg 3.040 mg Equivalent to Pyridoxine 0.800 mg 2.500 mg Vitamin B12 (Cyanocobalamin) 1.000 mcg 3.125 mcg Biotin 15.000 mcg 46.875 mcg Pantothenic Acid (Vitamin B5) 0.800 mg 2.500 mg WO 2012/142678 PCT/AU2012/000427 17 Ascorbic Acid 20.000 mg 62.500 mg Vitamin E 5.000 mg 15.625 mg Zinc 6.000 mg 18.750 mg Copper 375.000 mcg 1171.875 mcg Iron 6.000 mg 18.750 mg Manganese 1.250 mg 3.906 mg Iodine 37.500 mcg 117.188 mcg Selenium 12.500 mcg 39.063 mcg Magnesium 229.596 mg 717.487 mg Calcium 341.172 mg 1066.164 mg Sodium 45.168 mg 141,151 mg Potassium 231.405 mg 723.141 mg Chromium 25.000 mcg 78.125 mcg Glutamine 250.000 mg 781.250 mg NATURALLY OCCURING COMPONENTS Alpha lactalbumin 1941.000 mg 6065.625 mg Beta lactoglobulin 6820.000 mg 21256.250 mg Bovine Serum Albumin 236.000 mg 737.500 mg Immunoglobulins (IgG) 586.000 mg 1831.250 mg Glycomacropeptides 2792.000 mg 8725.000 mg Lactoferrin - 253.818 mg 793.182 mg Lactoperoxidase 93.067 mg 290.833 mg Isoleucine 1.143 g 3.570 g Leucine 2.179 g 6.809 g Lysine 1.876 g 5.861 g Methionine 0.390 g 1.217 g Phenylalanine 0.716 g 2.236 g Threonine 1.386 g 4.330 g Trytophan 0.386 g 1.205 g Valine 1.176 g 3.675 g WO 2012/142678 PCT/AU2012/000427 18 Histidine 0.374 g 1.169 g Alanine 1.064 g 3.323 g Arginine 0.532 g 1.663 g Aspartic Acid 2.032 g 6.350 g Cysteine/cystine 0.460 g 1.438 g Glutamic Acid 3.487 g 10.895 g Glycine 0.467 g 1.458 g Proline 1.221 g 3.814 g Serine 0.978 g 3.056 g Tyrosine 0.631 g 1.970 g Lactobacillus acidophilus LA 14 2,250,000,000 per mg Bifidobacterium lactis'BI-04 750,000,000 per mg

Claims

1. A composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol.

2. A composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol for promoting weight loss and/or fat loss in a subject.

3. The composition according to claim 1 or claim 2, wherein the composition further comprises vitamin K.

4. The composition according to any one of claims 1 to 3, wherein the one or more probiotic microorganisms

5. The composition according to any one of claims 1 to 4, wherein the one or more probiotic microorganisms comprises Lactobacillus acidophilus.

6. The composition according to any one of claims 1 to 5, wherein the one or more probiotic microorganisms comprises Bifidobacterium lactis.

7. The composition according to any one of claims 1 to 6, wherein the one or more probiotic microorganisms in the composition is in an amount of from about 1 billion to about 50 billion IU/mg.

8. The composition according to any one of claims 1 to 7, wherein the one or more probiotic microorganisms in the composition is in an amount of about 3 billion IU/mg.

9. The composition according to any one of claim 1 to 8, wherein the glutamine in the composition is in an amount of from about 50 to about 600 IU/mg.

10. The composition according to any one of claim 1 to 9, wherein the glutamine in the composition is in an amount of about 250 IU/mg. WO 2012/142678 PCT/AU2012/000427 20

11. The composition according to any one of claim 1 to 10, wherein the at least one sugar alcohol is selected from the group consisting of xylitol, mannitol and sorbitol.

12. The composition according to any one of claims 1 to 11, wherein the at least one sugar alcohol is xylitol.

13. The composition of claim 11 or claim 12, wherein the xylitol is in an amount of from about 10 to about 300 g/kg.

14. The composition according to any one of claims 11 to 13, wherein the xylitol in the composition is in an amount of about 110 g/kg.

15. The composition according to any one of claims 3 to 14, wherein the vitamin K comprises vitamin K1 and/or vitamin K2.

16. The composition according to any one of claims 3 to 15, wherein the vitamin K in the composition is in an amount of from about 0.1 to about 100 p/mg.

17. The composition according to any one of claims 3 to 16, wherein the vitamin K in the composition is in an amount of about 1 p/mg.

18. The composition according to any one of claim 1 to 17, wherein the composition further comprises vitamin D.

19. The composition according to any one of claim 1 to 18, wherein the composition further comprises whey protein.

20. The composition according to any one of claim 1 to 19, wherein the composition further comprises vitamin B.

21. The composition according to any one of claim 1 to 20, wherein the composition further comprises polydextrose. WO 2012/142678 PCT/AU2012/000427 21

22. The composition according to any one of claim 1 to 21, wherein the composition further comprises at least one medium chain triglyceride.

23. The composition according to any one of claim 1 to 22, wherein the composition further comprises at least one enzyme.

24. The composition according to claim 23, wherein the at least one enzyme is selected from the group consisting of protease, bromelain and papain

25. A method of promoting weight loss and/or fat loss in a subject, the method comprising administering to the subject a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol.

26. A method of promoting a healthy immune system in a subject, the method comprising administering to the subject a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol.

27. The method according to claim 25 or claim 26, wherein the composition is administered to the subject orally.

28. The method according to any one of claims 25 to 27, wherein the composition is in the form of a powder or a unit dosage form.

29. The method according to claim 28, wherein the unit dosage form is a tablet, a capsule or a caplet.

30. The method according to claim 29, wherein between 1 and 5 unit dosage forms are administered per day.

31. The method according to any one of claims 30 to 29, wherein the oral composition is in the form of a food stuff or beverage.

32. Use of a composition comprising one or more probiotic microorganisms, glutamine and at least WO 2012/142678 PCT/AU2012/000427 22 one sugar alcohol in the manufacture of a medicament for promoting weight loss and/or fat loss in a subject.

33. Use of a composition comprising one or more probiotic microorganisms, glutamine and at least one sugar alcohol in the manufacture of a medicament for promoting a healthy immune system in a subject.