Bifidobacterium for increasing lean body mass

Abstract

The present invention relates to bifidobacteria for increasing lean body mass. The present invention relates to the use of a composition comprising bacteria of the genus Bifidobacterium, in particular, but not limited to, bacteria of Bifidobacterium animalis lactis subspecies (strain) 420 (B420), and one or more prebiotics and / or fibers for increasing lean body mass in a mammal.

Description

[0001] This application is a divisional application of the international application PCT / EP2017 / 058203, filed on April 6, 2017, which entered into China with application number 201780023342.7 and entitled "Bifidobacteria for increasing lean body mass". Technical Field

[0002] This invention relates to Bifidobacterium (Bifidobacterium) Bifidobacterium Bacteria of the genus Bifidobacterium, especially but not limited to Bifidobacterium animalis (Bifidobacterium spp.) Bifidobacterium animalis ) lactic acid ( lactis The invention relates to the use of bacteria of subspecies (strain) 420 (B420), and compositions of one or more prebiotics and / or fibers. The invention also relates to food products, dietary supplements, and pharmaceutically acceptable formulations containing said bacteria. Background Technology

[0003] Lean body mass is a component of the body, calculated by subtracting body fat from total body weight. The percentage of lean body mass is typically between 60% and 90%. Lean body mass is primarily muscle.

[0004] Muscles play a central role in systemic protein metabolism by serving as the primary reservoir of amino acids to sustain protein synthesis in vital tissues and organs when amino acids are not absorbed from the intestines, and by providing gluconeogenic precursors.

[0005] Furthermore, altered muscle metabolism plays a crucial role in the development of these conditions and thus prevents many common pathological conditions and chronic diseases. However, the maintenance of adequate muscle mass, strength, and metabolic function is rarely (if any) targeted as a relevant endpoint for dietary intake recommendations. Am. J. Clin. Nutr. [American Journal of Clinical Nutrition], In September 2006, the first Volume 84, Issue 3, pp. 475-482 ).

[0006] A major change associated with human aging is the gradual decline in muscle mass, a spiral decline that can lead to a reduction in strength and function.

[0007] In 1989, the term "sarcopenia" was coined to describe this age-related loss of muscle mass. Sarcopenia is a condition characterized by a loss of skeletal muscle mass and function. While it is primarily an age-related disease, its development can be associated with conditions uncommon in older adults. Sarcopenia is a syndrome characterized by a progressive and systemic loss of skeletal muscle mass and strength, and this syndrome is strongly associated with physical disability, poor quality of life, and death. Santilli et al. , Clinical Cases in Mineral and Bone Metabolism [Clinical Cases of Mineral and Bone Metabolism] 2014; 11(3): 177-180 ).

[0008] Geriatric syndromes are common, complex, and highly detrimental to health in older individuals. They arise from the interplay of multiple systemic diseases and incomplete understanding of age, producing a range of signs and symptoms. Delirium, falls, and incontinence are examples of geriatric syndromes.

[0009] Sarcopenia is prevalent among older adults. It has several contributing factors: the aging process throughout life, early developmental impacts, suboptimal diets, a bedridden or sedentary lifestyle, chronic diseases, and certain medications. Sarcopenia represents a health impairment with high personal costs – impaired mobility, increased risk of falls and fractures, impaired ability to perform daily activities, disability, loss of independence, and increased risk of death. Age Ageing [Age and Aging], July 2010; 39(4); 412-423 ).

[0010] Although sarcopenia is primarily observed in older adults, it can also develop in younger adults, as is the case with dementia and osteoporosis. In some individuals, a clear and singular cause of sarcopenia can be identified. In others, no obvious cause can be isolated. Therefore, the classification of primary and secondary sarcopenia may be useful in clinical practice. When no other cause is apparent besides aging itself, sarcopenia can be considered "primary" (or age-related), and when one or more other causes are apparent, sarcopenia can be considered "secondary." In many older adults, the etiology of sarcopenia is multifactorial, making it impossible to characterize each individual as having a primary or secondary condition. This situation is consistent with viewing sarcopenia as a multifaceted geriatric syndrome.

[0011] Prado et al. , J. Parental and Enteral Nutr. [Journal of Parenteral and Enteral Nutrition] , 2014 This study demonstrated the importance of lean body mass and its relationship with mortality and morbidity.

[0012] Ruiz et al. BMJ [British Medical Journal] , 2008 It describes the link between muscle strength and mortality.

[0013] The primary treatment for sarcopenia is exercise. Specifically, resistance training or strength training—exercises that increase muscle strength and endurance using weights or resistance bands—has been shown to be effective in preventing and treating sarcopenia. However, for older adults or those with physical impairments, it may be difficult or even impossible to perform the exercises necessary to increase lean body mass or minimize the consequences of lean body mass loss.

[0014] The present invention aims to provide a solution to the problems of the prior art. Summary of the Invention

[0015] In one aspect, the present invention relates to compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers, for increasing lean body mass in mammals.

[0016] In particular, the present invention relates to a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, for increasing lean body mass in mammals.

[0017] In particular, the present invention relates to a composition of Bifidobacterium animalis subsp. lactis (strain) 420 (B420) and one or more prebiotics and / or fibers for increasing lean body mass in mammals.

[0018] In another aspect, the present invention relates to compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers, for therapeutic use in increasing lean body mass in mammals.

[0019] In particular, the present invention relates to a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, for therapeutic use in increasing lean body mass in mammals.

[0020] In particular, the present invention relates to a composition comprising Bifidobacterium animalis subsp. lactis (strain) 420 (B420), and one or more prebiotics and / or fibers for therapeutic use in increasing lean body mass in mammals.

[0021] In another aspect, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for increasing lean body mass in mammals.

[0022] In particular, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for increasing lean body mass in mammals, wherein the Bifidobacterium is the probiotic Bifidobacterium or mixtures thereof.

[0023] In another aspect, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for increasing lean body mass in mammals, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0024] In another aspect, the invention includes compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for non-therapeutic use in increasing lean body mass in mammals.

[0025] In particular, the present invention relates to the non-therapeutic use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for increasing lean body mass in mammals, wherein the Bifidobacterium is the probiotic Bifidobacterium or mixtures thereof.

[0026] In another aspect, the present invention relates to compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for non-therapeutic use in increasing lean body mass in mammals, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0027] In another aspect, the present invention relates to a method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition in the mammal increases lean body mass.

[0028] In a specific aspect, the present invention relates to a method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition in the mammal increases lean body mass, and wherein the Bifidobacterium is the probiotic Bifidobacterium or a mixture thereof.

[0029] In another aspect, the present invention relates to a method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition increases lean body mass in the mammal, and wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0030] In another aspect, the present invention relates to a non-therapeutic method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition increases lean body mass in the mammal.

[0031] In a specific aspect, the present invention relates to a non-therapeutic method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition in the mammal increases lean body mass, and wherein the Bifidobacterium is the probiotic Bifidobacterium or a mixture thereof.

[0032] In another aspect, the present invention relates to a non-therapeutic method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition increases lean body mass in the mammal, and wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0033] In another aspect, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers in the manufacture of food products, dietary supplements or pharmaceutically acceptable compositions for increasing lean body mass.

[0034] In another aspect, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers in the manufacture of food products, dietary supplements or pharmaceutically acceptable compositions for increasing lean body mass, wherein the Bifidobacterium is the probiotic Bifidobacterium or mixtures thereof.

[0035] In a still specific aspect, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers in the manufacture of food products, dietary supplements or pharmaceutically acceptable compositions for increasing lean body mass, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0036] advantage The inventors have unexpectedly discovered that treatment with a composition comprising bacteria of the genus Bifidobacterium or mixtures thereof (especially Bifidobacterium animalis subsp. lactis (strain) 420 (B420)), and one or more prebiotics and / or fibers has shown an increase in lean body mass in mammals. This gives the potential of combining bacteria of the genus Bifidobacterium or mixtures thereof (especially Bifidobacterium animalis subsp. lactis (strain) 420 (B420)) with one or more prebiotics and / or fibers for the treatment and / or prevention of many diseases associated with lean body mass loss. Detailed Implementation

[0037] bacteria The bacteria used in this invention are selected from bacteria of the genus Bifidobacterium or mixtures thereof. Preferably, the Bifidobacterium used in this invention is generally considered safe and, more preferably, GRAS-approved. Generally considered safe (GRAS) is a marker data from the U.S. Food and Drug Administration (FDA): experts consider a chemical or substance added to food to be safe and therefore exempt from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerability requirements.

[0038] In one embodiment, the present invention relates to a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber.

[0039] In another embodiment, the present invention relates to a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, for increasing lean body mass in mammals.

[0040] In another embodiment, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers for increasing lean body mass in mammals.

[0041] In another embodiment, the present invention relates to a method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition increases lean body mass in the mammal.

[0042] In yet another embodiment, the present invention relates to the use of compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fibers in the manufacture of food products, dietary supplements or pharmaceutically acceptable compositions for increasing lean body mass.

[0043] Bacteria can be used in any form that enables them to perform the functions described herein. For example, bacteria can be viable, dormant, inactive, or dead bacteria. Preferably, the bacteria are viable bacteria.

[0044] Bacteria can consist of whole bacteria or bacterial components. Examples of such components include bacterial cell wall components (e.g., peptidoglycan), bacterial nucleic acids (e.g., DNA and RNA), bacterial membrane components, and bacterial structural components (e.g., proteins, carbohydrates, lipids, and combinations thereof (e.g., lipoproteins, glycolipids, and glycoproteins)).

[0045] Bacteria may also contain, or alternatively contain, bacterial metabolites. In this specification, the term "bacterial metabolite" includes all molecules produced or modified by (probiotic) bacteria as a result of bacterial metabolism during the growth, survival, persistence, transport, or presence of bacteria during the manufacture and storage of probiotic products and during their transit through the gastrointestinal tract in mammals. Examples include all organic acids, inorganic acids, bases, proteins and peptides, enzymes and coenzymes, amino acids and nucleic acids, carbohydrates, lipids, glycoproteins, lipoproteins, glycolipids, vitamins, all bioactive compounds, metabolites containing inorganic components, and all small molecules, such as nitrite molecules or molecules containing sulfurous acid.

[0046] Preferably, the bacteria comprise whole bacteria, more preferably whole, viable bacteria.

[0047] Preferably, the Bifidobacterium used according to the present invention is a Bifidobacterium suitable for human and / or animal consumption. Those skilled in the art will readily recognize specific Bifidobacterium species and / or strains from the genera described herein that are used in the food and / or agricultural industries and are generally considered suitable for human and / or animal consumption.

[0048] In this invention, the Bifidobacteria used may be of the same type (species and strains) or may contain a mixture of species and / or strains.

[0049] Suitable bacteria were selected from the following species: Bifidobacterium lactis ( Bifidobacterium lactis Bifidobacterium bifidum ( Bifidobacterium bifidium Bifidobacterium longum ( Bifidobacterium longum Bifidobacterium animalis, Bifidobacterium breve ( Bifidobacterium breve ), Bifidobacterium infantis ( Bifidobacterium infantis ), Bifidobacterium chain ( Bifidobacterium catenulatum Bifidobacterium pseudosporidis ( ), Bifidobacterium pseudosporidis ( ) Bifidobacterium pseudocatenulatum Bifidobacterium adolescentis ( ) Bifidobacterium adolescentis ), and Bifidobacterium angularis ( Bifidobacterium angulatum ), and any combination thereof.

[0050] Preferably, the Bifidobacterium used in this invention is Bifidobacterium animalis. More preferably, the Bifidobacterium used in this invention is Bifidobacterium animalis subsp. lactis.

[0051] In a particularly preferred embodiment, the bacteria used in this invention is Bifidobacterium animalis subsp. lactis (strain) 420 (B420). This strain is commercially available from DuPont Nutrition Biosciences ApS.

[0052] This strain of *Bifidobacterium animalis* subsp. *lactam* has also been deposited by DuPont Nutritional Biosciences (Langebrogade 1, DK-1411 Copenhagen K, Denmark) on June 30, 2015, at the German Collection of Microorganisms and Cell Cultures at the Leibniz Institute (DSMZ) (Inhoffenstrasse 7B, 38124 Braunschweig, Germany) under reference number DGCC420, which is recorded under registration number DSM 32073. It is required that the biological material be provided only by means of samples issued to experts designated by the requester.

[0053] In one embodiment, the bacteria used in this invention are probiotic bacteria. In this specification, the term 'probiotic bacteria' is defined as encompassing any non-pathogenic bacteria that, when administered in sufficient live quantities, confer health benefits to the host. These probiotic strains typically possess the ability to survive through the upper digestive tract. They are non-pathogenic, non-toxic, and exert beneficial effects on health, on the one hand through ecological interactions with the resident flora in the digestive tract, and on the other hand through the ability to positively influence the immune system via GALT (gut-associated lymphoid tissue). By definition, these bacteria have the ability to live through the intestine when administered in sufficient quantities; however, they do not cross the intestinal barrier, and thus their primary action is induced within the lumen and / or wall of the gastrointestinal tract. They then form part of the resident flora during administration. This colonization (or temporary colonization) allows the probiotic bacteria to exert beneficial effects, such as inhibiting potentially pathogenic microorganisms present in the flora and interacting with the intestinal immune system.

[0054] In a preferred embodiment, the bacteria used in this invention are probiotics such as Bifidobacterium or a combination thereof.

[0055] dose The Bifidobacteria used according to the present invention (e.g., strains of Bifidobacterium animalis subsp. lactis, such as Bifidobacterium animalis subsp. lactis (strain) 420 (B420)) may contain from 10 6 Up to 10 12 CFU of bacteria / g support, and more specifically from 10 8 Up to 10 12CFU of bacteria / g of support, preferably for lyophilized form 10 9 Up to 10 12 CFU / g.

[0056] Suitable, Bifidobacteria (e.g., strains of Bifidobacterium animalis subsp. lactis (e.g., Bifidobacterium animalis subsp. lactis (strain) 420 (B420))) can be obtained from about 10 6 To about 10 12 The microbial content / dosage of CFU is preferably about 10. 8 To about 10 12 The CFU of microorganisms / dosage is administered in doses. The term "per dose" means that the amount of microorganisms provided to the subject is given daily or per ingestion (preferably daily). For example, if the microorganisms will be administered in a food product (e.g., in yogurt), the yogurt will preferably contain from about 10 8 Up to 10 12 CFU of microorganisms. However, alternatively, this amount of microorganisms can be administered in multiple doses, each consisting of a smaller microbial load – as long as the total amount of microorganisms received by the subject at any given time (e.g., every 24-hour period) is less than approximately 10. 6 To about 10 12 CFU microorganisms, preferably 10 8 To about 10 12 Microorganisms in CFU.

[0057] According to the present invention, at least one strain of the effective amount of microorganisms may be at least 10 6 The microbial / dosage of CFU is preferably from about 10 6 To about 10 12 The microbial content / dosage of CFU is preferably about 10. 8 To about 10 12 CFU microbiology / dosage.

[0058] In one embodiment, preferably, Bifidobacteria (e.g., strains of Bifidobacterium animalis subsp. lactis (e.g., Bifidobacterium animalis subsp. lactis (strain) 420 (B420))) can be derived from about 10 6 To about 10 12 CFU microorganisms / day, preferably around 10 8 To about 10 12 The CFU is administered at a dose of microorganisms per day. Therefore, the effective amount in this embodiment can be from approximately 10 6 To about 10 12 CFU microorganisms / day, preferably around 10 8 To about 10 12 CFU microorganisms / day.

[0059] CFU stands for "colony-forming unit". "Support" refers to food products, dietary supplements, or pharmaceutically acceptable preparations.

[0060] In one embodiment, the present invention relates to compositions in the form of food products, dietary supplements, or pharmaceutically acceptable compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fiber. Compositions comprising bacteria of the genus Bifidobacterium or mixtures thereof (e.g., strains of Bifidobacterium animalis subsp. lactis (e.g., Bifidobacterium animalis subsp. lactis (strain) 420 (B420)) are in the form of food products, dietary supplements, or pharmaceutically acceptable compositions.

[0061] In another embodiment, lean body mass is increased in the trunk, legs, android region, and gynoid region.

[0062] Lean body mass is a component of the body, calculated by subtracting body fat from total weight. Total weight is lean muscle plus fat. In the mathematical equation: Lean body mass (LBM) = Body weight (BW) - Body fat (BF).

[0063] In yet another embodiment, lean body mass is muscle mass.

[0064] "Muscle" refers to tissue composed of cells that can contract and relax to produce movement in an organ or part of an organ.

[0065] Effects / Subjects / Medical Indications The compositions involved in this invention are administered to mammals, including, for example, livestock (including cattle, horses, pigs, and sheep) and humans. In some aspects of this invention, the mammal is a companion animal (including pets), such as a dog or cat. In some aspects of this invention, the subject may suitably be a human.

[0066] The compositions involved in this invention are applicable to increasing lean body mass in mammals.

[0067] Although birds and poultry (including chickens) are not technically mammals, the present invention is also applicable to birds and any type of poultry, such as chickens.

[0068] In this specification, the term "increase in lean body mass" refers to any application of the composition according to the invention, and includes increasing lean body mass in mammals, birds or poultry.

[0069] In particular, the compositions according to the invention are suitable for mammals, birds, and poultry that are reducing lean body mass or exhibiting a need to increase lean body mass. This aspect is discussed in more detail below.

[0070] Lean body mass As described above, subjects, mammals, birds, or poultry treated with the composition according to the invention can increase their lean body mass, thereby mitigating the consequences of lean body mass loss.

[0071] In a condition known as sarcopenia, lean body mass declines with age in adults. Sarcopenia is an age-related loss of lean body mass that is accelerated by malnutrition and lack of physical activity. To counteract this muscle loss, patients should consume adequate amounts of protein at appropriate times.

[0072] Adult lean body mass also decreases with certain diseases (such as kidney disease).

[0073] Composition Although the composition can be administered alone according to the invention (i.e., without any support, diluent, or excipient), it is typically and preferably administered as part of a product (particularly as a component of a food product, dietary supplement, or pharmaceutical composition or formulation) on or within a support. These products typically contain additional components well known to those skilled in the art.

[0074] "Composition" should be understood as a combination of two or more substances. Substances can be chemical substances or biological substances, such as bacteria, including substances that have the desired effect.

[0075] "Formulation" should be understood as a method or composition of combining different chemical and / or biological substances (including substances having the desired effect) to produce a final product. Composition and formulation are used interchangeably.

[0076] Any product that can benefit from the composition can be used in this invention. These include, but are not limited to, foods, particularly fruit conserves and dairy products, as well as dairy-derived products and pharmaceuticals.

[0077] food In one embodiment, the composition according to the invention is used in a food product (e.g., a food supplement, beverage, or milk-based powder). Here, the term "food" is used broadly—and encompasses food for humans as well as food for animals (i.e., animal feed). In a preferred aspect, the food is intended for human consumption.

[0078] Food can be in the form of a solution or as a solid – depending on the use and / or mode of application and / or mode of administration.

[0079] When used or in the preparation of food (e.g., functional food), the compositions of the present invention may be used in combination with one or more of the following: a nutritionally acceptable carrier, a nutritionally acceptable diluent, a nutritionally acceptable excipient, a nutritionally acceptable adjuvant, or a nutritionally active ingredient.

[0080] For example, the compositions of the present invention can be used as ingredients in soft drinks, juices, or beverages containing whey protein, health tea, cocoa beverages, milk beverages and lactic acid bacteria beverages, yogurt and drinking yogurt, cheese, ice cream, sorbets and desserts, pastries and confectionery, biscuits, cakes and cake mixes, snack foods, balanced foods and beverages, fruit fillings, health glazes, chocolate bread fillings, cheesecake-flavored fillings, fruit-flavored cake fillings, cake and donut icings, instant baking fillings, biscuit fillings, ready-to-eat bread fillings, low-calorie fillings, adult nutritional beverages, acidified soy / juice beverages, aseptic / distilled chocolate beverages, bar mixes, beverage powders, calcium-fortified soy / yogurt and chocolate milk, and calcium-fortified coffee beverages.

[0081] This composition can be further used as an ingredient in the following food products: such as American cheese sauce, anti-caking agents for grated and shredded cheese, dessert platters, cream cheese, dry-mix whipped nonfat cream, frozen / thawed dairy whipped cream, frozen / thawed stable whipped cream, low-fat and light natural cheddar cheese, low-fat Swiss yogurt, aerated frozen desserts, hard-pack ice cream, label-friendly economical and indulgent hard-pack ice cream, low-fat ice cream: soft-serve ice cream, barbecue sauce, cheese dip, soft cheese dressing, dry-mix Alfredo sauce, mixed cheese sauce, dry-mix tomato sauce, etc.

[0082] As used herein, the term "dairy product" is intended to include a culture medium containing milk of animal and / or plant origin. Milk of animal origin may refer to milk from cows, sheep, goats, or buffalo. Milk of plant origin may refer to any plant-derived fermentable material that can be used according to the invention, particularly fermentable materials derived from soybeans, rice, or grains.

[0083] More preferably, the food product used according to the present invention is fermented milk or humanized milk.

[0084] In some respects, preferably, the present invention can be used in relation to yogurt production, such as fermented yogurt beverages, yogurt, drinking yogurt, cheese, fermented cream, milk-based desserts, etc.

[0085] Suitable, the composition may be further used as an ingredient in one or more cheese applications, meat applications, or applications containing protective cultures.

[0086] The present invention also provides a method for preparing food or food ingredients, the method comprising mixing a composition according to the invention with another food ingredient.

[0087] Advantageously, the present invention relates to products that have been in contact with the composition of the present invention (and optionally with other components / ingredients), wherein the composition is used in an amount capable of improving the nutritional and / or health benefits of the product.

[0088] As used herein, the term "contact" means applying the composition of the invention, whether directly or indirectly, to the product. Examples of possible application methods include, but are not limited to: treating the product in a material containing the composition, applying it directly by mixing the composition with the product, spraying the composition onto the surface of the product, or immersing the product in a formulation of the composition.

[0089] When the product of the present invention is food, the composition of the present invention is preferably mixed with the product. Alternatively, the composition may be included in the emulsion or original ingredients of the food. In other alternative embodiments, the composition may be used as a seasoning, glaze, colorant mixture, etc.

[0090] For some applications, it is important that the composition is available on or can be used on the surface of the product to be affected / treated. This allows the composition to impart one or more of the following advantageous properties: nutritional and / or health benefits.

[0091] The compositions of the present invention can be applied to garnished, coated and / or impregnated products with controlled amounts of microorganisms.

[0092] Preferably, the composition is used in fermented milk or sucrose-fortified milk or lactic acid culture medium containing sucrose and / or maltose, wherein the resulting culture medium containing all the components of the composition—i.e., the microorganisms according to the invention—can be used as an ingredient at a suitable concentration—for example, to provide 10 in the final product. 6 - 10 10 The daily dose concentration of CFU is added to the yogurt. The microorganisms according to the invention can be used before or after yogurt fermentation.

[0093] In some respects, the compositions according to the invention are used or used in the preparation of animal feed, such as livestock feed, particularly poultry (e.g., chicken) feed or pet food.

[0094] Advantageously, when the product is a food product, the composition containing bacteria of the genus Bifidobacterium or mixtures thereof, and one or more prebiotics and / or fiber, should remain effective by the normal "latest sale" date or "end" date (during which the food product is sold by the retailer). Preferably, the effective period should extend beyond such a date until the normal freshness period ends when food spoilage becomes apparent. The desired length of time and normal shelf life will vary depending on the food, and those skilled in the art will recognize that shelf life varies depending on the type of food, its size, storage temperature, processing conditions, packaging materials, and packaging equipment.

[0095] Food ingredients The compositions of the present invention can be used as food ingredients and / or feed ingredients.

[0096] As used herein, the terms “food ingredient” or “feed ingredient” include preparations that are added to or may be added to functional foods or foods as nutritional supplements.

[0097] Food ingredients can be in solution form or as a solid – depending on the use and / or application and / or delivery method.

[0098] food supplements The compositions of the present invention may be or may be added to dietary supplements, also referred to herein as food supplements.

[0099] Here, the term "dietary supplement" refers to a product intended for consumption that contains "dietary ingredients" designed to add additional nutritional value to a (supplementary) diet. "Dietary ingredients" can be one or any combination of the following substances: vitamins, minerals, herbs or other plants, amino acids, dietary substances, concentrates, metabolites, components, or extracts intended to supplement a person's diet by increasing their total dietary intake.

[0100] Dietary supplements can exist in many forms, such as tablets, capsules, softgels, gel caps, liquids, or powders. Some dietary supplements can help ensure you get enough of the essential nutrients you need from your diet; others can help reduce your risk of disease.

[0101] Functional foods The compositions of the present invention may be or may be added to functional foods.

[0102] As used in this article, the term "functional food" refers to food that not only provides nutritional benefits but also delivers additional beneficial effects to consumers.

[0103] Therefore, functional foods are ordinary foods with incorporated components or ingredients (such as those described herein) that impart specific functional effects—such as medical or physiological benefits—rather than purely nutritional effects.

[0104] Although there is no legal definition for functional foods, most parties concerned with this area agree that they are foods marketed as having specific health benefits beyond basic nutritional effects.

[0105] Some functional foods are health supplements. Here, the term "health supplement" refers to foods that not only provide nutritional benefits and / or taste satisfaction, but also deliver therapeutic (or other beneficial) effects to consumers. Health supplements cross the traditional line between food and medicine.

[0106] Medical food In one embodiment, the composition of the present invention is in the form of a medical food. Preferably, the composition of the present invention (containing a strain of Bifidobacterium animalis subsp. lactis (e.g., Bifidobacterium animalis subsp. lactis (strain) 420 (B420))) is in the form of a medical food.

[0107] "Medical food" means food that is formulated for consumption or administration with or without a physician and is intended for a specific dietary management or condition for which unique nutritional needs are established through medical evaluation based on recognized scientific principles.

[0108] drug The compositions of the present invention can be used as—or for the preparation of—pharmaceutical formulations or pharmaceutical compositions. Here, the term "pharmaceutical" is used broadly—and encompasses pharmaceuticals for human use as well as pharmaceuticals for animal use (i.e., veterinary applications). In a preferred aspect, the pharmaceutical is for human use and / or for livestock production.

[0109] Medications can be used for therapeutic purposes—they can be therapeutic, palliative, or preventative in nature. Medications may even be used for diagnostic purposes.

[0110] Pharmaceutically acceptable formulations, supports, or compositions may be in the form of, for example, compressed tablets, tablets, capsules, ointments, suppositories, or drinkable solutions. Other suitable forms are provided below.

[0111] When used or in the preparation of a medicine, the compositions of the present invention may be used in combination with one or more of the following: a pharmaceutically acceptable carrier, a pharmaceutically acceptable diluent, a pharmaceutically acceptable excipient, a pharmaceutically acceptable adjuvant, or a pharmaceutically active ingredient.

[0112] Medications may be in solution or as a solid – depending on the use and / or mode of application and / or mode of administration.

[0113] The compositions of the present invention can be used as pharmaceutical ingredients. Here, the composition may be a single active ingredient, or it may be at least one of a plurality of active ingredients (i.e., two or more).

[0114] The drug ingredient may be in solution form or as a solid – depending on the use and / or mode of application and / or mode of administration.

[0115] According to the present invention, the composition can be used in any suitable form – whether alone or in combination with other components or ingredients. Combinations containing the composition of the present invention with other components and / or ingredients (i.e., ingredients – such as food ingredients, functional food ingredients, or pharmaceutical ingredients) can be used in any suitable form.

[0116] According to the present invention, the composition may be used in the form of a solid or liquid formulation or alternatives thereof. Examples of solid formulations include, but are not limited to, wettable, spray-dried or freeze-dried tablets, capsules, dusts, granules and powders. Examples of liquid formulations include, but are not limited to, aqueous, organic or aqueous-organic solutions, suspensions and emulsions.

[0117] For immediate-release, delayed-release, modulated-release, sustained-release, pulsatile-release, or controlled-release applications, suitable examples of the form include one or more of tablets, pills, capsules, beads, solutions, or suspensions, which may contain flavoring agents or coloring agents.

[0118] For example, if the compositions of the present invention are used in tablet form—for example, as a functional ingredient—then these tablets may also contain one or more of the following: excipients, such as microcrystalline cellulose, lactose, sodium citrate, calcium carbonate, calcium hydrogen phosphate, and glycine; disintegrants, such as starch (preferably corn, potato, or cassava starch), sodium glycolate starch, croscarmellose sodium, and certain complex silicates; granulating binders, such as polyvinylpyrrolidone, hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), sucrose, gelatin, and gum arabic; and lubricants, such as magnesium stearate, stearic acid, glyceryl behenate, and talc, may be included.

[0119] Examples of materials used to prepare these nutritionally acceptable carriers include, for example, water, salt solutions, alcohols, silicones, waxes, petrolatum, vegetable oils, polyethylene glycol, propylene glycol, liposomes, sugars, gelatin, lactose, amylose, magnesium stearate, talc, surfactants, silicic acid, viscous paraffin, aromatic oils, monoglycerides and diglycerides of fatty acids, petroleum ether fatty acid esters, hydroxymethyl cellulose, polyvinylpyrrolidone, etc.

[0120] Preferred excipients for these forms include lactose, starch, cellulose, milksugar, or high molecular weight polyethylene glycol.

[0121] For aqueous suspensions and / or elixirs, the compositions of the present invention can be combined with various sweeteners or flavorings, colorants or dyes, emulsions and / or suspending agents, and diluents (e.g., water, propylene glycol and glycerin and combinations thereof).

[0122] Forms may also include gelatin capsules; fiber capsules, fiber tablets, etc.; or even fiber beverages.

[0123] Other examples of the form include creams. For some aspects, the microorganisms used in this invention can be used in pharmaceutical and / or cosmetic creams, such as sunscreen creams and / or after-sun creams.

[0124] In one aspect, the composition according to the invention can be administered in the form of an aerosol, for example by nasal spray, for example for administration into the respiratory tract.

[0125] drug In one embodiment, the composition of the present invention is in the form of a pharmaceutical.

[0126] As used herein, the term "drug" encompasses medicines intended for use in both humans and animals in both human and veterinary medicine. Furthermore, as used herein, the term "drug" refers to any substance that provides therapeutic and / or beneficial effects. As used herein, the term "drug" is not necessarily limited to substances requiring marketing approval, but can include substances that can be used in cosmetics, health supplements, foods (including, for example, animal feed and beverages), probiotic cultures, and natural remedies. Additionally, as used herein, the term "drug" encompasses products designed for inclusion in animal feed (e.g., livestock feed and / or pet food).

[0127] prebiotics In one embodiment, the composition of the present invention comprises bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber.

[0128] Prebiotics are a class of functional foods defined as indigestible food components that beneficially influence the host by selectively stimulating the growth and / or activity of one or a limited number of bacteria (particularly, but not limited to, probiotics, bifidobacteria, and / or lactobacilli) in the colon, thereby improving the host's health. Typically, prebiotics are carbohydrates (e.g., oligosaccharides), but this definition does not exclude non-carbohydrates. The most common form of prebiotics is nutritionally classified as soluble fiber. To some extent, many forms of dietary fiber exhibit some level of prebiotic activity.

[0129] In one embodiment, the prebiotic is a selectively fermented ingredient that allows for specific alterations in the composition and / or activity of the gut microbiota, conferring tranquility and health benefits to the host.

[0130] Suitablely, according to the present invention, prebiotics can be used in amounts of 0.01 to 100 g / day, preferably 0.1 to 50 g / day, more preferably 0.5 to 20 g / day. In one embodiment, according to the present invention, prebiotics can be used in amounts of 1 to 10 g / day, preferably 2 to 9 g / day, more preferably 3 to 8 g / day. In another embodiment, according to the present invention, prebiotics can be used in amounts of 5 to 50 g / day, preferably 10 to 25 g / day.

[0131] Examples of dietary sources of prebiotics include soybeans, inulin sources (such as Jerusalem artichoke, jicama, and chicory root), raw oats, unprocessed wheat, unprocessed barley, and yacon.

[0132] Examples of suitable prebiotics include alginate, xanthan gum, pectin, locust bean gum (LBG), inulin, guar gum, galacto-oligosaccharides (GOS), fructooligosaccharides (FOS), and poly-dextrose (i.e., Litesse). ® Lactitol, lactose, soybean oligosaccharides, isomaltulose (Palatinose™), isomaltulose, glucose oligosaccharides, xylooligosaccharides, mannan oligosaccharides, β-glucan, cellobiose, raffinose, gentiobiose, melibiose, xylobiose, cyclodextrin, isomaltose, trehalose, stachyose, panose, budding pachymannan, mustachyose, galactomannan, and all forms of resistant starch.

[0133] A particularly preferred example of prebiotics is polydextrose.

[0134] The combination of Bifidobacteria present in the compositions according to the invention, along with one or more prebiotics and / or fiber, exhibits a synergistic effect (i.e., greater than the additive effect of the bacteria when used alone). Without wishing to be bound by theory, it is believed that such combinations can selectively stimulate the growth and / or activity of Bifidobacteria in the colon, thereby improving their efficacy and host health.

[0135] In one embodiment, the Bifidobacterium or a mixture thereof used in combination with one or more prebiotics and / or fiber is Bifidobacterium animalis or a mixture thereof. More preferably, the Bifidobacterium or a mixture thereof used in combination with one or more prebiotics and / or fiber is Bifidobacterium animalis subsp. lactis or a mixture thereof.

[0136] In a particularly preferred embodiment, the Bifidobacterium or a mixture thereof used in combination with one or more prebiotics and / or fiber is Bifidobacterium animalis subsp. lactis (strain) 420 (B420) or a mixture thereof.

[0137] Appropriately, the fiber and / or prebiotic used in the combination is polydextrose.

[0138] In another embodiment, the fibers and / or prebiotics used in the combination are Litesse ® .

[0139] In another aspect, the present invention includes food products containing a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber.

[0140] In another aspect, the present invention includes food products containing a composition comprising Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the Bifidobacterium or the mixture thereof is of the species Bifidobacterium animalis or a mixture thereof.

[0141] In another aspect, the present invention includes food products containing a composition comprising Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the Bifidobacterium or the mixture thereof is the species Bifidobacterium animalis lactic acid.

[0142] In another aspect, the present invention includes a food product containing a composition comprising Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the Bifidobacterium or the mixture thereof is Bifidobacterium animalis lactic acid (strain) 420 (B420).

[0143] In another aspect, the present invention includes dietary supplements containing a composition comprising Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber.

[0144] In another respect, Bifidobacteria or mixtures thereof are species of Bifidobacteria, specifically Bifidobacteria or mixtures thereof.

[0145] In another respect, Bifidobacterium or a mixture thereof is Bifidobacterium animalis subsp. lactis or a mixture thereof.

[0146] In another respect, Bifidobacterium or a mixture thereof is Bifidobacterium animalis subsp. lactis (strain) 420 (B420) or a mixture thereof.

[0147] In another aspect, the present invention includes pharmaceutically acceptable compositions comprising a composition containing Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber.

[0148] In another respect, Bifidobacteria or mixtures thereof are species of Bifidobacteria, specifically Bifidobacteria or mixtures thereof.

[0149] In another respect, Bifidobacterium or a mixture thereof is Bifidobacterium animalis subsp. lactis or a mixture thereof.

[0150] In another respect, Bifidobacterium or a mixture thereof is Bifidobacterium animalis subsp. lactis (strain) 420 (B420) or a mixture thereof.

[0151] Specific numbered embodiments of the present invention: Example 1. A composition comprising Bifidobacterium ( Bifidobacterium Bacteria of the genus (or mixtures thereof), along with one or more prebiotics and / or fiber, are used to increase lean body mass in mammals.

[0152] Example 2. The composition according to Example 1, wherein the Bifidobacterium is the probiotic Bifidobacterium or a mixture thereof.

[0153] Example 3. The composition according to any one of Examples 1 to 2, wherein the Bifidobacterium species is Bifidobacterium animalis.

[0154] Example 4. The composition according to any one of Examples 1 to 3, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis.

[0155] Example 5. The composition according to any one of Examples 1 to 4, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0156] Example 6. The composition according to any one of Examples 1 to 5, wherein the prebiotic and / or fiber is polydextrose.

[0157] Example 7. The composition according to any one of the foregoing examples, wherein the composition is in the form of a food product, a dietary supplement, or a pharmaceutically acceptable composition.

[0158] Example 8. The composition according to Example 7, wherein the pharmaceutically acceptable composition is a drug.

[0159] Example 9. The composition according to Example 7, wherein the food product is a medical food product.

[0160] Example 10. The composition according to any one of the preceding examples, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the abdominal and gluteal regions.

[0161] Example 11. The composition according to any one of Examples 1 to 10, wherein the lean body mass is muscle mass.

[0162] Example 12. A composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, for therapeutic use in increasing lean body mass in mammals.

[0163] Example 13. The composition according to Example 12, wherein the Bifidobacterium is the probiotic Bifidobacterium or a mixture thereof.

[0164] Example 14. The composition according to any one of Examples 12 to 13, wherein the Bifidobacterium species is Bifidobacterium animalis.

[0165] Example 15. The composition according to any one of Examples 12 to 14, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis.

[0166] Example 16. The composition according to any one of Examples 12 to 15, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactic acid (strain) 420 (B420).

[0167] Example 17. The composition according to any one of Examples 12 to 16, wherein the prebiotic and / or fiber is polydextrose.

[0168] Example 18. The composition according to any one of Examples 12-17 above, wherein the composition is in the form of a food product, a dietary supplement or a pharmaceutically acceptable composition.

[0169] Example 19. The composition according to Example 18, wherein the pharmaceutically acceptable composition is a drug.

[0170] Example 20. The composition according to Example 18, wherein the food product is a medical food product.

[0171] Example 21. The composition according to any one of Examples 12-20 above, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the gluteal region.

[0172] Example 22. The composition according to any one of Examples 12 to 21, wherein the lean body mass is muscle mass.

[0173] Example 23. Use of a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber for increasing lean body mass in mammals.

[0174] Example 24. The use according to Example 23, wherein the Bifidobacterium is a probiotic Bifidobacterium or a mixture thereof.

[0175] Example 25. The use according to any one of Examples 23 to 24, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis.

[0176] Example 26. The use according to any one of Examples 23 to 25, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis subsp. lactis.

[0177] Example 27. The use according to any one of Examples 23 to 26, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactic acid (strain) 420 (B420).

[0178] Example 28. The use according to Example 23, wherein the fiber and / or prebiotic is polydextrose.

[0179] Example 29. Use according to any one of Examples 23 to 28, wherein the composition is in the form of a food product, a dietary supplement, or a pharmaceutically acceptable composition.

[0180] Example 30. The use according to Example 29, wherein the pharmaceutically acceptable composition is a drug.

[0181] Example 31. The use according to Example 29, wherein the food product is a medical food product.

[0182] Example 32. The use according to any one of Examples 23 to 31, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the abdominal and gluteal regions.

[0183] Example 33. The use according to any one of Examples 23 to 32, wherein the lean body mass is muscle mass.

[0184] Example 34. A composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber for non-therapeutic use in increasing lean body mass in mammals.

[0185] Example 35. The non-therapeutic use according to Example 34, wherein the Bifidobacterium is the probiotic Bifidobacterium or a mixture thereof.

[0186] Example 36. The non-therapeutic use according to any one of Examples 34 to 35, wherein the Bifidobacterium species is Bifidobacterium animalis.

[0187] Example 37. The non-therapeutic use according to any one of Examples 34 to 36, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis.

[0188] Example 38. For non-therapeutic use according to any one of Examples 34 to 37, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

[0189] Example 39. The non-therapeutic use according to Example 34, wherein the fiber and / or prebiotic is polydextrose.

[0190] Example 40. Non-therapeutic use according to any one of Examples 34 to 39, wherein the composition is in the form of a food product, a dietary supplement, or a pharmaceutically acceptable composition.

[0191] Example 41. Non-therapeutic use according to Example 40, wherein the pharmaceutically acceptable composition is a drug.

[0192] Example 42. The non-therapeutic use according to Example 40, wherein the food product is a medical food product.

[0193] Example 43. A non-therapeutic use according to any one of Examples 34 to 31, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the abdominal and gluteal regions.

[0194] Example 44. Non-therapeutic use according to any one of Examples 34 to 43, wherein the lean body mass is muscle mass.

[0195] Example 45. A method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition in the mammal increases lean body mass.

[0196] Example 46. The method according to Example 45, wherein the Bifidobacterium is a probiotic Bifidobacterium or a mixture thereof.

[0197] Example 47. The method according to any one of Examples 45 to 46, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis.

[0198] Example 48. The method according to any one of Examples 45 to 47, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis.

[0199] Example 49. The method according to any one of Examples 45 to 48, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis lactic acid subspecies strain 420 (B420).

[0200] Example 50. The method according to Example 45, wherein the fiber and / or prebiotic is polydextrose.

[0201] Example 51. The method according to any one of Examples 45 to 50, wherein the composition is in the form of a food product, a dietary supplement, or a pharmaceutically acceptable composition.

[0202] Example 52. The method according to Example 51, wherein the pharmaceutically acceptable composition is a drug.

[0203] Example 53. The method according to Example 51, wherein the food product is a medical food product.

[0204] Example 54. The method according to any one of Examples 45 to 53, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the abdominal and gluteal regions.

[0205] Example 55. The method according to any one of Examples 45 to 54, wherein the lean body mass is muscle mass.

[0206] Example 56. A non-therapeutic method for increasing lean body mass, the method comprising administering a composition to a mammal comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein administration of the composition increases lean body mass in the mammal.

[0207] Example 57. The non-treatment method according to Example 56, wherein the Bifidobacterium is the probiotic Bifidobacterium or a mixture thereof.

[0208] Example 58. A non-treatment method according to any one of Examples 56 to 57, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis.

[0209] Example 59. A non-treatment method according to any one of Examples 56 to 58, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis.

[0210] Example 60. A non-treatment method according to any one of Examples 56 to 59, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis strain 420 (B420).

[0211] Example 61. The non-therapeutic method according to Example 56, wherein the fiber and / or prebiotic is polydextrose.

[0212] Example 62. A non-treatment method according to any one of Examples 56 to 61, wherein the composition is in the form of a food product, a dietary supplement, or a pharmaceutically acceptable composition.

[0213] Example 63. The non-treatment method according to Example 62, wherein the pharmaceutically acceptable composition is a drug.

[0214] Example 64. The non-treatment method according to Example 62, wherein the food product is a medical food product.

[0215] Example 65. A non-treatment method according to any one of Examples 56 to 64, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the abdominal and gluteal regions.

[0216] Example 66. A non-treatment method according to any one of Examples 56 to 65, wherein the lean body mass is muscle mass.

[0217] Example 67. Use of a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber in the manufacture of a food product, dietary supplement, or pharmaceutically acceptable composition for increasing lean body mass.

[0218] Example 68. The use according to Example 67, wherein the Bifidobacterium is a probiotic Bifidobacterium or a mixture thereof.

[0219] Example 69. The use according to any one of Examples 67 to 68, wherein the bacteria of the genus Bifidobacterium is Bifidobacterium animalis.

[0220] Example 70. The use according to any one of Examples 67 to 69, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis.

[0221] Example 71. The use according to any one of Examples 67 to 70, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactic acid (strain) 420 (B420).

[0222] Example 72. The use according to Example 67, wherein the fiber and / or prebiotic is polydextrose.

[0223] Example 73. The use according to Example 67, wherein the pharmaceutically acceptable composition is a drug.

[0224] Example 74. The use according to Example 67, wherein the food product is a medical food product.

[0225] Example 75. The use according to any one of Examples 67 to 74, wherein the lean body mass is increased in the trunk, legs, waist and abdomen and the abdominal and gluteal regions.

[0226] Example 76. The use according to any one of Examples 67 to 75, wherein the lean body mass is muscle mass.

[0227] Example Materials and Methods Clinical study design and screening criteria The intervention was a double-blind, randomized, placebo-controlled, multicenter parallel study conducted in accordance with Good Clinical Practice and the Declaration of Helsinki.

[0228] Two hundred and twenty-five of the 263 overweight and obese adults were recruited from four research centers in southern Finland and randomly assigned to one of four groups in a 1:1:1:1 ratio. 1) Placebo (microcrystalline cellulose), 12 g / day; 2) Polydextrose (Pdx), 12 g / day; 3) Probiotic B420 (Bifidobacterium animalis Lactobacillus subsp. Lactobacillus (strain) 420), 10 10 CFU / day; or 4) B420 and Pdx, 10 10 CFU / day + 12 g / day.

[0229] The product used in the study was provided in sachets, which participants mixed with 250 ml of fruit smoothie once a day at their preferred time for six months.

[0230] All randomized participants were aged 18–65 years with a body mass index (BMI, calculated as weight [kg] divided by height [m] squared) between 28.0 and 34.9, and a waist-to-hip ratio ≥ 0.88 for men and ≥ 0.83 for women. The most important exclusion criteria included: a diagnosis of metabolic disease or use of related medications; excessive use of laxatives, fiber supplements, or probiotics within the past 6 weeks; a history of obesity surgery; use of anti-obesity medications within the past 3 months, or recent (past 2 months) use or current use of antimicrobial agents; currently or recently participating in a weight loss program; a weight change of 3 kg within the past 3 months; and pregnancy.

[0231] Recruitment and research groups Prior to unblinding the study, 225 participants were divided into intention-to-treat (ITT) and protocol-compliant (PP) groups. The ITT group included all 209 participants assessed for any parameter after baseline access. The PP group included participants who completed the intervention with 80% adherence to the study product and did not use systemic antimicrobials or high-dose vitamin supplements during the intervention. Additionally, 3 participants were excluded from dual-energy X-ray absorptiometry (DXA) analysis because they did not complete DXA measurements as planned within 10 days after the end of treatment, resulting in a PP group of 131 participants. The PP group includes all participants considered protocol-compliant and therefore better represents the actual efficacy of the study product. Figure 1 ).

[0232] Figure 1This shows that, prior to unblinding the study, participants were divided into the intention-to-treat (ITT) group and the protocol-compliant (PP) group based on adherence to the study protocol (n represents the number of people participating in each step of the process).

[0233] Measurement of lean body mass Study participants underwent dual-energy X-ray absorptiometry (DXA) scans at baseline, 2 months, 4 months, 6 months (end of intervention), and one month after the intervention (follow-up + 1 month). DXA scans were performed by trained staff at a private medical center. The device automatically calculates body fat mass, bone mass, and lean body mass from X-ray measurements. Therefore, lean body mass primarily consists of muscle mass, visceral organ mass, and water. Total lean body mass and lean body mass were collected separately for each body region (arms, legs, trunk, waist / abdomen, and hip / buttocks).

[0234] Statistical analysis Mean relative change from baseline in all three activity groups below: - The group that took B420 alone; - The group taking the combination of B420 and polydextrose (Pdx); and - The group that took polydextrose (Pdx) alone, Comparison with placebo (as overall effect) (one-way analysis of covariance, using baseline values ​​as covariates).

[0235] The three active groups were then compared to placebo using the Dunnett test (which corrects for multiple comparisons). All analyses were performed using SAS analysis software (version 9.3) and using relative changes from baseline to the end of treatment (6 months). In the ITT population, missing observations were handled using the Last Observation Carried Forward method. In statistics, the Dunnett test, developed by Canadian statistician Charles Dunnett, is a multiple comparison procedure used to compare each of several treatments to a single control. Multiple comparisons with a control are also called many-to-one comparisons. The Last Observation Carried Forward method means that for missing values, the most recent measurement from a previous time point is used in the analysis. A p-value below 0.05 is considered statistically significant, meaning that the hypothesis of different comparison observations has a 95% probability of being true. A p-value above 0.05 does not prove the absence of difference, but rather lacks sufficient statistical power to draw a confident conclusion.

[0236] result In the PP group, compared with placebo, the group taking the combination of B420 and Pdx had a statistically significant increase in lean body mass (P = 0.012), and there was no marginally significant difference in the ITT group (P = 0.05). Figure 2 A- Figure 2 B).

[0237] The overall difference between the active and placebo groups was not significant (ITT: P = 0.28; PP: P = 0.30), most likely due to the absence of any effect in the B420-only and Pdx-only groups. Figure 2 A- Figure 2 B). Changes in lean body mass occurred gradually during the study in the group taking the combination of B420 and Pdx. Figure 2 C- Figure 2 D).

[0238] There were no statistically significant differences in activity between the placebo and other groups in all areas of the body, although the group taking the combination of B420 and Pdx was the only group to show a significant increase in lean body mass compared to baseline in all areas. Figure 3 In the protocol-compliant PP population, the difference between the B420 and Pdx combination and placebo was observed in the torso (…). Figure 3 A) and legs ( Figure 3 The most significant difference was observed in region C). No similar difference was observed between the B420 and Pdx combination and placebo in the waist and abdomen (waist) lean body mass, suggesting that the increase in lean body mass was not due to any abdominal edema, but rather to an actual increase in muscle mass, which was also supported by the increase in lean body mass in the leg region (where lean tissue mass is primarily composed of muscle mass).

[0239] Figure 2 The relative changes in total lean body mass are shown in the intention-to-treat (A) and compliance (B) groups, as well as the development of lean body mass during the study period in the intention-to-treat (C) and compliance (D) groups. In insets A and B, a p-value less than 0.05 indicates a statistically significant difference from placebo. Results are presented as mean + / - 95% confidence intervals (CI). A 95% CI that does not overlap with baseline (solid line) indicates a significant change from baseline within that group.

[0240] Figure 3 This study shows relative changes in the trunk (A), arms (B), legs (C), and lower abdomen (D) and gluteal region (E) from baseline to 6 months of treatment in both the intention-to-treat and protocol-compliant groups. A p-value less than 0.05 was considered statistically significant compared to placebo. Results are presented as mean + / - 95% confidence intervals (CI). A 95% CI that did not overlap with baseline (solid line) indicated a significant change from baseline within that group.

[0241] Table 1 shows the absolute values ​​of lean body mass in different areas of the body at the beginning and end of the intervention period.

[0242] Table 1. Lean body mass in different areas of each body group.

[0243] *Number of participants (n) at 6-month visit (lower value) and baseline visit (higher value). The mean at baseline in the intention-to-treat group includes participants who withdrew from the study 6 months prior, and therefore changes from baseline do not directly translate to changes from baseline, such as... Figures 2-3 As shown in the figure. However, all numerical values ​​are included in the statistical analysis (last observation carryover technique, as explained above); SD = standard deviation.

[0244] All publications mentioned in the foregoing specification are incorporated herein by reference. Various modifications and variations to the methods and systems described herein will be readily apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in conjunction with specific preferred embodiments, it should be understood that the claimed invention should not be unduly limited to such specific embodiments. In fact, various modifications to the described embodiments for carrying out the invention that are apparent to those skilled in the art of biochemistry and biotechnology or related fields are intended to fall within the scope of the following claims.

Claims

1. A composition comprising Bifidobacterium (Bifidobacterium) Bifidobacterium The composition comprises bacteria of the genus (or mixtures thereof) and one or more prebiotics and / or fiber, and is used to increase lean body mass in mammals.

2. The composition according to claim 1, wherein the Bifidobacterium is a probiotic Bifidobacterium or a mixture thereof.

3. The composition according to any one of claims 1 to 2, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis (Bifidobacterium). Bifidobacterium animalis ) lactic acid ( lactis () subspecies of Bifidobacterium.

4. The composition according to any one of claims 1 to 3, wherein the Bifidobacterium genus is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

5. The composition according to any one of claims 1 to 4, wherein the prebiotic and / or fiber is polydextrose.

6. The composition according to any one of the preceding claims, wherein the composition is in the form of a food product, a dietary supplement, or a pharmaceutically acceptable composition.

7. Use of a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber for increasing lean body mass in mammals.

8. The use according to claim 7, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactic acid (strain) 420 (B420).

9. The use according to claim 7, wherein the fiber and / or prebiotic is polydextrose.

10. A method for increasing lean body mass, the method comprising administering to a mammal a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber, wherein the administration of the composition in the mammal increases lean body mass.

11. The method according to claim 10, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis lactic acid subspecies strain 420 (B420).

12. The method of claim 10, wherein the fiber and / or prebiotic is polydextrose.

13. Use of a composition comprising bacteria of the genus Bifidobacterium or a mixture thereof, and one or more prebiotics and / or fiber in the manufacture of a food product, dietary supplement, or pharmaceutically acceptable composition for increasing lean body mass.

14. The use according to claim 13, wherein the Bifidobacterium genus bacteria is Bifidobacterium animalis subsp. lactis (strain) 420 (B420).

15. The use according to claim 13, wherein the fiber and / or prebiotic is polydextrose.

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