Compositions and methods for improving gastrointestinal health

Abstract

Methods and compositions for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort in an individual in need thereof, the composition comprising a low sugar, low lactose, milk-based composition comprising galactooligosaccharide (GOS).

Description

TITLE COMPOSITIONS AND METHODS FOR IMPROVING GASTROINTESTINAL HEALTHTECHNICAL FIELD

[0001] The present disclosure generally relates to compositions and methods treating and / or preventing gastrointestinal disorders and / or improving digestive comfort. Some embodiments are directed to a composition comprising milk protein and further comprising a mixture of lactose, glucose, galactose and galactooligosaccharide (GOS).BACKGROUND

[0002] Gut microbiota metabolites play an important role in host health and nutrient metabolism. More and more scientific evidence suggests that metabolites produced by gut microbiota are important mediators of benefits for the host. Supplementation with galactooligosaccharides (GOS) has been previously linked to several health benefits, predominantly via gut microbiome modulation. While many studies are focused on beneficial metabolites originating from gut carbohydrate fermentation, it appears that bacterial metabolites from protein metabolisms also play an important role in host physiology.

[0003] Moreover, lactose malabsorption is a condition in which the body is unable to fully digest lactose, a sugar found in milk and dairy products. This occurs due to a deficiency or absence of lactase, an enzyme produced in the small intestine that breaks down lactose into simpler sugars for absorption into the bloodstream. As a result, undigested lactose passes into the large intestine, where it is fermented by bacteria, leading to symptoms such as bloating, gas, diarrhea, and abdominal discomfort. Lactose malabsorption is different from lactose intolerance, which refers to the development of symptoms after consuming lactose-containing foods.

[0004] It is important for lactose malabsorbers to manage their condition by adjusting their diet to limit or avoid lactose-containing foods and beverages. Lactose-free or low lactose alternatives or non-dairy sources of calcium exist that are suitable for individuals with lactose malabsorption, however, there remains a need for a composition for easy and convenient administration to any individual resulting in an increase in beneficial microbial metabolites.SUMMARY

[0005] Embodiments of the disclosure concern methods and / or compositions for improving gastrointestinal health and / or digestive comfort.

[0006] In particular embodiments, a method for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort includes administering to an individual in need thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharide. In some embodiments, the composition comprises milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 35-55% or 32-55%, by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.

[0007] The prevention and / or treatment of gastrointestinal disorders and / or improvement of digestive comfort comprises at least one result selected from the group consisting of: (a) preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartburn, acid reflux and / or gastric ulcers (b) preventing and / or attenuating abdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness; (c) reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / or constipation, abnormal stool consistency (to put in transit); (d) reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease and / or gastritis (e) prevent gastrointestinal motility related disorders and / or transit related disorders and combinations thereof.

[0008] Another aspect of the present disclosure is a method for preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartbum, acid reflux and / or gastric ulcers, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein.

[0009] Yet another aspect of the present disclosure is a method for preventing and / or attenuating abdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein.

[0010] Yet another aspect of the present disclosure is a method for reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / orconstipation, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein.

[0011] Yet another aspect of the present disclosure is a method for reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein.

[0012] In a last aspect of the present disclosure is a method for preventing gastrointestinal motility related disorder and / or transit related disorder, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein.

[0013] Additional features and advantages are described herein and will be apparent from the following Figures and Detailed Description.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 shows the increase in production of valerate metabolite after 24h fermentation of the active composition (MLG-H) by comparison to GOS alone or negative control (NSC) using batch fermentation.

[0015] FIG. 2 shows the increase in production of propionate metabolite after 24h fermentation of the active composition (MLG-H) by comparison to GOS alone or negative control (NSC) using batch fermentation.

[0016] FIG. 3 shows the increase in production of N,N-Dimethylglycine metabolite after 24h fermentation of the active composition (MLG-H) by comparison to GOS alone or negative control (NSC) using batch fermentation.

[0017] FIG. 4 shows the decrease in gas production after 24h fermentation of the Active Composition (composition - LM) by comparison to regular milk (regular milk - LM) using batch fermentation with simulated lactose malabsorption.

[0018] FIG. 5 shows total SCFA production after 24h fermentation of the Active Composition (composition - LM) by comparison to regular milk (regular milk - LM) using batch fermentation with simulated lactose malabsorption.

[0019] FIG. 6 shows ratio gas production to total SCFA production after 24h fermentation of the Active Composition (composition - LM) by comparison to regular milk (regular milk - LM) using batch fermentation with simulated lactose malabsorption.

[0020] FIG. 7 represents gas production after 24 h fermentation of the Active composition using batch fermentation with (composition - LM) or without simulated lactose malabsorption (composition).

[0021] FIG. 8 shows fecal cadaverine concentration in 24 healthy individuals in control and intervention groups. Data reported are mean and SD. LMS stands for Least Mean Square analysis based on a linear mixed effects model with product, sequence and period as fixed effects.DETAILED DESCRIPTION

[0022] Definitions

[0023] Some definitions are provided hereafter. Nevertheless, definitions may be located in the “Embodiments” section below, and the above header “Definitions” does not mean that such disclosures in the “Embodiments” section are not definitions.

[0024] All percentages expressed herein are by weight of the total weight of the composition unless expressed otherwise. As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of numerals, for example the range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1% to +1% of the referenced number, most preferably -0.1% to +0.1% of the referenced number. All numerical ranges herein should be understood to include all integers, whole or fractions, within the range. Moreover, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a range of from 1 to 8, from 3 to 7, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

[0025] As used in this disclosure and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a protein” or “the protein” includes two or more proteins.

[0026] The words “comprise,” “comprises” and “comprising” are to be interpreted inclusively rather than exclusively. Likewise, the terms “include,” “including” and “or” should all be construed to be inclusive, unless such a construction is clearly prohibited from the context. Nevertheless, the compositions and methods disclosed herein may lack any element that is not specifically disclosed herein. Thus, a disclosure of an embodiment using the term “comprising” includes a disclosure of embodiments “consisting essentially of’ and “consisting of’ the components or steps identified.

[0027] The terms “at least one of’ and “and / or” used respectively in the context of “at least one of X and Y” and “X and / or Y” should be interpreted as “X without Y,” or “Y without X,” or “both X and Y ” Where used herein, the terms “example” and “such as,” particularly when followed by a listing of terms, are merely exemplary and illustrative and should not be deemed to be exclusive or comprehensive.

[0028] As used herein, “related to,” “associated with” and “linked with” mean occurring concurrently, preferably mean caused by the same underlying condition, more preferably mean that one of the identified conditions is at least indirectly caused by the other identified condition, and most preferably mean that one of the identified conditions is directly caused by the other identified condition.

[0029] The terms “food”, “food supplement”, “food product” and “food composition” mean a product or composition that is intended for ingestion by an individual such as a human and provides at least one nutrient to the individual. The compositions of the present disclosure, including the many embodiments described herein, can comprise, consist of, or consist essentially of the elements disclosed herein, as well as any additional or optional ingredients, components, or elements described herein or otherwise useful in a diet supplement.

[0030] “Prevention” includes reduction of risk, incidence and / or severity of a condition or disorder. The terms “treatment” and “treat” include both prophylactic or preventive treatment (that prevent and / or slow the development of a targeted pathologic condition or disorder) and curative, therapeutic or disease-modifying treatment, including therapeutic measures that cure, slow down, lessen symptoms of, and / or halt progression of a diagnosed pathologic condition or disorder; and treatment of patients at risk of contracting a disease or suspected to have contracted a disease, as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition. The terms “treatment” and “treat” do not necessarily imply that a subject is treated until total recovery. The terms “treatment” and “treat” also refer to the maintenance and / or promotion of health in an individual not suffering from a disease but who may be susceptible to the development of an unhealthy condition. The terms “treatment” and “treat” are also intended to include the potentiation or otherwise enhancement of one or more primary prophylactic or therapeutic measures. As nonlimiting examples, a treatment can be performed by a patient, a caregiver, a doctor, a nurse, or another healthcare professional.

[0031] As used herein, the term “lactose mal-absorber” refers to an individual who has a reduced ability to digest and absorb lactose, which is the sugar found in milk and dairy products. Lactose malabsorption occurs when the body does not produce enough lactase, theenzyme responsible for breaking down lactose into simpler sugars (glucose and galactose) that can be absorbed by the small intestine. Lactose malabsorption can be a result of various factors, including genetic predisposition, certain medical conditions (such as celiac disease or inflammatory bowel disease), or as a temporary condition following an illness or injury to the small intestine.

[0032] As used herein, the term “low lactose” shall refer to a composition with less than or equal to 30% of lactose.

[0033] As used herein, the term “low sugar” shall refer to a composition with less than or equal to 55% of the composition.

[0034] As used herein, a prophylactically or therapeutically “effective amount” is an amount that prevents a deficiency, treats a disease or medical condition in an individual, or, more generally, reduces symptoms, manages progression of the disease, or provides a nutritional, physiological, or medical benefit to the individual.

[0035] The term “composition” may mean a food, beverage, dietary supplement, complete nutrition or oral nutritional supplement (ONS) or medical food composition, or mixture thereof.

[0036] The composition can be in solid form (e.g., powder) or in liquid form. The amount of the various ingredients can be expressed in g / 100 g of the composition on a dry weight basis when it is in a solid form, e.g. a powder, or as a concentration in g / 100 mL of the composition when it refers to a liquid form (this latter also encompasses liquid composition that may be obtained from a powder after reconstitution in a liquid such as water.)

[0037] The term “unit dosage form,” as used herein, refers to physically discrete units suitable as unitary dosages for human and animal subjects, each unit containing a predetermined quantity of the composition disclosed herein in an amount sufficient to produce the desired effect, in association with an acceptable diluent, carrier or vehicle. The specifications for the unit dosage form depend on the particular compounds employed, the effect to be achieved, and the pharmacodynamics associated with each compound in the host.

[0038] Embodiments

[0039] In an aspect of the present disclosure, a method of treating and / or preventing gastrointestinal disorders and / or improving digestive comfort comprises administering to an individual in need thereof or at risk thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharide.

[0040] In an embodiment, the composition decreases the ratio of gas production to total SCFA by comparison to regular milk.

[0041] In some embodiments, the composition comprises 20-40 % by dry weight of milk protein; and 32-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide.

[0042] In some embodiments, the composition comprises 35-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide.

[0043] In an embodiment, the mixture of lactose, glucose and galactose and galactooligosaccharide comprises: 0.1-30% by weight of lactose.

[0044] In an embodiment, the mixture of lactose, glucose and galactose and galactooligosaccharide comprises: 8-40% by weight of glucose.

[0045] In an embodiment, the mixture of lactose, glucose and galactose and galactooligosaccharide comprises: 0.1-20% by weight of galactose.

[0046] In an embodiment, the mixture of lactose, glucose and galactose and galactooligosaccharide comprises 40-90% by weight of galactooligosaccharide.In an embodiment, the milk-based composition comprises: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.

[0047] In another embodiments, the milk-based composition comprises: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 35-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.

[0048] Some embodiments provide a contribution from each of the components of the composition individually, in combination, and / or synergistically.

[0049] In particular embodiments, treating and / or preventing gastrointestinal disorders and / or improving digestive comfort comprises one or more of the following: (a) preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartbum, acid reflux and / or gastric ulcers (b) preventing and / or attenuatingabdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness; (c) reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / or constipation; (d) reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease and / or gastritis (e) prevent gastrointestinal motility related disorder and / or transit related disorder and combinations thereof.

[0050] The individual may be diagnosed with such condition(s) or may be suspected of having such condition(s) or may be susceptible to such condition(s). The individual may be treated with other therapy or therapies in addition to methods of the disclosure.

[0051] In other embodiment, the individual is healthy but may be experiencing unpleasant gastrointestinal manifestation following the consumption of specific food (e.g. lactose containing product, gluten containing product).

[0052] In another embodiment the individual is lactose mal-absorber.

[0053] In other embodiment, the individual may be of any age or state of health, although in particular embodiments the individual may be susceptible to particular medical conditions or physical states or genetic traits (e.g. lactase deficiency).

[0054] In specific embodiments, treatment and / or prevention of gastrointestinal disorders and / or improvement of digestive comfort is associated with increased and / or decreased levels of certain metabolites, or functional derivatives thereof. In a preferred embodiment, treatment and / or prevention of gastrointestinal disorders and / or improvement of digestive comfort is associated with increased levels of short chain fatty acids e.g. propionate, valerate and / or N,N-Dimethylglycine and / or decreased levels of cadaverine.

[0055] Then, in an embodiment, the individual may be susceptible to particular medical conditions or physical states that would benefit from increased metabolite levels, or the individual may be suspected of having a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels. The compositions delivered to the individual in such cases include a composition as described above, in particular to facilitate raising or lowering specific metabolite levels in the individual. One can measure specific metabolite levels through plasma or fecal samples, for example, in methods well known in the art.

[0056] The method may comprise identifying the individual as having a medical condition or physical state or genetic condition that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels, and / or the method may compriseidentifying the individual as at risk of a medical condition or physical state that would benefit from increased metabolite levels.

[0057] In specific embodiments, an individual is provided effective amounts of compositions as described herein for the explicit purpose of raising intracellular levels of propionate, valerate, N,N-Dimethylglycine, because it is determined that the individual is afflicted with a condition for which such levels are directly or indirectly related. Additionally, an individual is provided effective amounts of compositions as described herein for the explicit purpose of decreasing levels of cadaverine because it is determined that the individual is afflicted with a condition for which such levels are directly or indirectly related.

[0058] Composition for use

[0059] In some embodiments, the composition comprises 20-40% by dry weight of milk protein. Milk protein includes any protein or combination of proteins derived from milk. The milk proteins may have been derived from milk in any suitable way. In a preferred embodiment, the composition comprises 25-40%, more preferably 30-40% by dry weight of milk protein.

[0060] In some embodiments, the food ingredient further comprises 35-55%, more preferably 32-55%, by dry weight of a mixture of lactose, glucose, galactose and GOS, the mixture comprising: 0.1-30% by weight of lactose, 8-40% by weight of glucose, 0.1-20% by weight of galactose and 40-90% by weight of GOS. In a preferred embodiment, the food ingredient comprises 45-55% by dry weight of the mixture of lactose, glucose, galactose and GOS; in a more preferred embodiment, the food ingredient comprises 50-55% by dry weight of the mixture of lactose, glucose, galactose and GOS. In another preferred embodiment of the invention, the mixture of lactose, glucose, galactose and GOS comprises 60-90% by weight of GOS, more preferred 70-90% by weight of GOS. In yet another preferred embodiment, the mixture of lactose, glucose, galactose and GOS contains: 1-20% by weight of lactose, 15-35% by weight of glucose, 1-10% by weight of galactose and 50-85% by weight of GOS. In a more preferred embodiment of the invention, the mixture of lactose, glucose, galactose and GOS contains: 1-14% by weight of lactose, 15-29% by weight of glucose, 1-8% by weight of galactose and 70-90% by weight of GOS.

[0061] In some embodiments, the mixture of lactose, glucose, galactose and GOS comprises 0.1-30%, such as 0.1-5%, 5-10%, 10-15%, 15-20%, 20-25%, or 25-30% by weight of lactose. In some embodiments, the mixture of lactose, glucose, galactose and GOS comprises 8-40%, such as 8-16%, 16-24%, 24-32%, or 32-40%, by weight of glucose. In someembodiments, the mixture of lactose, glucose, galactose and GOS comprises 0.1-20%, such as 0.1-5%, 5-10%, 10-15%, or 15-20%, by weight of galactose. In some embodiments, the mixture of lactose, glucose, galactose and GOS comprises 40-90%, such as 40-50%, 50-60%, 60-70%, or 70-80% by weight of GOS.

[0062] The composition may further comprise 0.5-30% by dry weight of milk fat and / or minerals derived from milk, preferably 2-20%, more preferably 6-10% by dry weight of milk fat and / or minerals derived from milk. Milk fat includes fat derived from milk in any suitable way. Milk derived minerals include minerals derived from milk in any suitable way, e.g. calcium, sodium, potassium, phosphorus and / or magnesium salts. Milk fat and / or milk derived minerals may originate from liquid milk, such as skim milk, partially skimmed milk and / or whole milk, or from milk powder, such as e.g. skim milk powder and / or whole milk powder.

[0063] The composition may further comprise 0.5-30% by dry weight of at least one of milk fat or mineral derived from milk, preferably a combination thereof. The composition may further comprise 5-20% by dry weight of vegetable oil.

[0064] In a preferred embodiment, the composition further comprises 5-20% by dry weight of vegetable oil, more preferably 8-15% by dry weight of vegetable oil. The vegetable oil may be any suitable vegetable oil, preferably palm oil. In one embodiment, the composition relates to a cocoa, coffee, fruit based and / or malt beverage powder comprising: 10-35% by weight of non-fat milk solids; 0-65% by weight of malt extract solids; 0-15% by weight of cocoa solids; 6-15% by weight of vegetable oil and / or milk fat; 0-25% by weight of sucrose; 1-6% by weight of glucose; 0.1-5% by weight of lactose; and 3-10% by weight of GOS.

[0065] Non-fat milk solids may be derived from any suitable milk source, such as e.g. liquid milk, e.g. skim milk and / or whole milk, and / or milk powder, e.g. skim milk powder and / or whole milk powder. If liquid milk is used, it may be concentrated, e.g. by evaporation or filtration. Malt extract solids may be in any suitable form, e.g. in the form of a powdered or liquid extract of malted barley and / or wheat. Cocoa solids may be from any suitable cocoa source, e.g. in the form of cocoa powder, cocoa mass and / or cocoa butter. Vegetable oil may be any suitable vegetable oil, preferably palm oil. Milk fat may be derived from any suitable milk source, such as e.g. liquid milk or cream, e.g. skim milk, cream, and / or whole milk, and / or milk powder, e.g. skim milk powder, cream powder, and / or whole milk powder, and / or may be in the form of butter, butter oil and / or anhydrous milk fat. If liquid milk or cream is used, it may be concentrated, e.g. by evaporation or filtration.

[0066] Glucose, lactose and GOS are preferably derived from the composition of the present invention. A cocoa and / or malt beverage powder of the invention preferably comprises 10-30% by dry weight of the composition of the invention, more preferably 15-25% by dry weight of the composition of the invention. In a preferred embodiment of the invention, the cocoa and / or malt beverage powder comprises 2-4% by weight of glucose; 0.1-2% by weight of lactose; and 5-10% by weight of GOS.

[0067] A cocoa and / or malt beverage powder of the invention may comprise sucrose. Due to the amounts of lactose, glucose and GOS present in the product, the amount of sucrose may be reduced as compared to a conventional cocoa and / or malt beverage powder while retaining an acceptable taste, sweetness and texture. In a preferred embodiment, a cocoa and / or malt beverage product of the invention does not comprise sucrose. In another preferred embodiment, a cocoa and / or malt beverage powder of the invention comprises 1-25% by weight of sucrose, more preferably 5-20% by weight of sucrose.

[0068] A cocoa and / or malt beverage powder of the invention may comprise any other suitable ingredients known in the art, such as e.g. vitamins, minerals, buffer salts, emulsifiers and stabilizers.

[0069] A cocoa and / or malt beverage powder of the invention may be produced by any suitable method known in the art. The ingredients may e.g. be in powder form and mixed in the dry state, some or all ingredients may be mixed in aqueous solution / suspension and subsequently dried to a powder, or some or all powdered ingredients may e.g. be coagglomerated to produce a powder with improved solubility.

[0070] In a preferred embodiment, the invention relates to a cocoa and malt beverage powder comprising 15-35% by weight of non-fat milk solids; 20-50% by weight of malt extract solids; 5-15% by weight of cocoa solids; 6-15% by weight of vegetable oil and / or milk fat; 0-25% by weight of sucrose; 1-6% by weight of glucose; 0.1-5% by weight of lactose; and 3-10% by weight of galactooligosaccharide.

[0071] In one embodiment, the composition relates to a liquid cocoa and / or malt beverage product comprising: 3-10% by weight of non-fat milk solids; 1-6% by weight of malt extract solids; 0-5% by weight of cocoa solids; 0.3-5% by weight of vegetable oil and / or milk fat; 0-5% by weight of sucrose; 0.4-1.5% by weight of glucose; 0.01-1% by weight of lactose; and 0.5-5% by weight of GOS.

[0072] A liquid cocoa and / or malt beverage product is a cocoa and / or malt beverage product in liquid form which is suitable to be consumed without addition of liquid. It may e.g. be packed in a container from which it can be consumed directly upon opening.

[0073] Non-fat milk solids may be derived from any suitable milk source, such as e.g. liquid milk, e.g. skim milk and / or whole milk, and / or milk powder, e.g. skim milk powder and / or whole milk powder. If liquid milk is used, it may be concentrated, e.g. by evaporation or filtration. Malt extract solids may be in any suitable form, e.g. in the form of a powdered or liquid extract of malted barley and / or wheat. Cocoa solids may be from any suitable cocoa source, e.g. in the form of cocoa powder, cocoa mass and / or cocoa butter. Vegetable oil may be any suitable vegetable oil, preferably palm oil. Milk fat may be derived from any suitable milk source, such as e.g. liquid milk or cream, e.g. skim milk, cream, and / or whole milk, and / or milk powder, e.g. skim milk powder, cream powder, and / or whole milk powder, and / or may be in the form of butter, butter oil and / or anhydrous milk fat. If liquid milk or cream is used, it may be concentrated, e.g. by evaporation or filtration.

[0074] Glucose, lactose and GOS are preferably derived from the composition of the present invention. A liquid cocoa and / or malt beverage product of the invention preferably comprises 10-30% by dry weight of the composition of the invention, more preferably 15-25% by dry weight. In a preferred embodiment, the liquid cocoa and / or malt beverage product comprises 0.5-1% by weight of glucose; 0.01-0.5% by weight of lactose; and 1-4% by weight of GOS.

[0075] A liquid cocoa and / or malt beverage product of the invention may comprise sucrose. Due to the amounts of lactose, glucose and GOS present in the product, the amount of sucrose may be reduced as compared to a conventional cocoa and / or malt beverage powder while retaining an acceptable taste, sweetness and texture. In a preferred embodiment, a cocoa and / or malt beverage product of the invention does not comprise sucrose. In another preferred embodiment, a cocoa and / or malt beverage powder of the invention comprises 0.1-5% by weight of sucrose, more preferably 1-3% by weight of sucrose.

[0076] A liquid cocoa and / or malt beverage product of the invention may comprise any other suitable ingredients known in the art, such as e.g. vitamins, minerals, buffer salts, emulsifiers and stabilizers.

[0077] A liquid cocoa and / or malt beverage product of the invention may be produced in any suitable way known in the art. The ingredients may be in liquid and / or powdered form and may be mixed into an aqueous solution / suspension, e.g. with the addition of water to achieve the desired concentration of ingredients. A food ingredient of the invention is preferably added in liquid form, but may also be added in powdered form.

[0078] In a preferred embodiment, the composition relates to a liquid cocoa and / or malt beverage product comprising: 3-10% by weight of non-fat milk solids; 1-6% by weight ofmalt extract solids; 1-5% by weight of cocoa solids; 0.3-5% by weight of vegetable oil and / or milk fat; 0-5% by weight of sucrose; 0.4-1.5% by weight of glucose; 0.01-1% by weight of lactose; and 0.5-5% by weight of GOS.

[0079] The composition can be in any oral nutritional form, e.g., as a health drink, as a ready-made drink, optionally as a soft drink, including juices, coffee, tea, milk-shake, yogurt drink, smoothie or soy -based drink; in a food bar; a powder, such as in sachet form; or dispersed in foods of any sort, such as baked products, cereal bars, dairy bars, snack-foods, soups, breakfast cereals, muesli, candies, tabs, cookies, biscuits, crackers (such as rice crackers), and dairy and plant-based products.

[0080] In some embodiments, the composition relates to a ready to drink beverage. The % weight are based on dry matter of the composition before reconstitution. In an embodiment, the ready to drink beverage comprises 32%-55% of a mixture of Lactose, Glucose, Galactose, and GOS. In an embodiment, the composition comprises 40-45% by dry weight of the mixture of lactose, glucose, galactose and GOS. In an embodiment, the composition comprises 45-50% by dry weight of the mixture of lactose, glucose, galactose and GOS. In an embodiment, the food ingredient comprises 32-37% by dry weight of the mixture of lactose, glucose, galactose and GOS.

[0081] In some embodiments, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 1-25% by weight of lactose, such as 1-5%, 5-10%, 10-15%, 15- 20%, or 20-25% by weight of lactose. In some embodiments, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 15-35% by weight of glucose, such as 15-20%, 20-25%, 25-30%, or 30-35% by weight of glucose. In some embodiments, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 1-10% by weight of galactose, such as 1-2%, 2-4%, 4-6%, 6-8%, or 8-10% by weight of galactose. In some embodiments, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 50-85% by weight of GOS, such as 50-60%, 60-70%, 70-80%, or 80-85% by weight of GOS.

[0082] In a preferred embodiment, the composition comprises 40-45% of a mixture of Lactose, Glucose, Galactose and GOS. In a preferred embodiment, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 10-20% by weight of lactose. In a preferred embodiment, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 15-25% by weight of glucose. In a preferred embodiment, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 0.1-5% by weight of galactose. In a preferred embodiment, the mixture of Lactose, Glucose, Galactose and GOS in the composition contains 57-70% by weight of GOS.

[0083] In some embodiments, the ready to drink beverage includes milk. In some embodiments, the milk includes full milk, skim milk, and other types of milk. In some embodiments, the ready to drink beverage is optionally fortified with one or more vitamins and minerals. In a preferred embodiment, the one or more vitamins include vitamins for providing a benefit, such as improving immunity and / or mobility.

[0084] The composition can be administered to the individual at least two days per week, at least three days per week, all seven days of the week respecting serving size; for at least one week, at least one month, at least two months, at least three months, at least six months, or even longer. In some embodiments, the composition is administered to the individual consecutively for a number of days. In an embodiment, the composition can be administered to the individual daily for at least 30, 60 or 90 consecutive days.

[0085] In some embodiments, the serving size of the composition is an amount effective to increase certain metabolites or certain bacteria such as Bifidobacteria, for example, about 100 ml, about 200 ml, or about 300 ml of the composition. In some embodiments, the composition is administered in a unit dosage form that comprises an amount of the composition effective for increasing or decreasing certain metabolites and improving metabolic health.

[0086] In view of the disclosures herein, an embodiment is a method for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort, the method comprising administering to an individual in need thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharide. In some embodiments, the composition is as described above.

[0087] The preventing and / or treating of the gastrointestinal health and / or improving digestive comfort can comprise at least one result selected from the group consisting of: (a) preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartbum, acid reflux and / or gastric ulcers (b) preventing and / or attenuating abdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness; (c) reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / or constipation; (d) reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease and / or gastritis (e) prevent gastrointestinal motility related disorder and / or transit related disorder and combinations thereof.

[0088] In an embodiment, the gastrointestinal motility related disorder and / or transit related disorder is selected from severe constipation, vomititng or regurgitation, bloating,diarrhea, nausea, weight loss, pain or swallowing problems, heartburn or GERD and / or urgent need to have bowel movement.

[0089] In an embodiment the composition is administered in an amount effective for reducing the levels of cadaverine. Research has shown that decreasing cadaverine levels has been linked to the listed benefits (see Galie etal., Mol. Nut. Food Res., 2021). Moreover, high cadaverine concentrations were reported to be cytotoxic (del Rio etal., Scient. Reports., 2019) and detrimental for gut homeostasis by inhibiting epithelial growth and adherence, which might relate to Crohn’s disease pathogenesis (Diederen et al. Scient Report, 2020). This is further supported by the notion that cadaverine might compromise histamine degradation (Sanchez- Perez et al., Frontier Nut, 2022; Khalid Omer et al., Journal of Food Protection, 2021) and thereby could support these adverse effects.

[0090] Another aspect of the present disclosure is a method for preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartbum, acid reflux and / or gastric ulcers, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein. The composition may be administered in an amount effective for reducing gastric distension, gastric volume and / or for increasing levels of NN dimethylglycine. The Research has shown that increasing NN dimethylglycine levels has been linked to the listed benefits (See Hariganesh K, Prathiba J. Effect of dimethylglycine on gastric ulcers in rats. J Pharm Pharmacol. 2000; 52.

[0091] The composition may be administered to the individual in a unit dosage form, wherein the unit dosage form.

[0092] Yet another aspect of the present disclosure is a method for preventing and / or attenuating abdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein. The composition may be administered in an amount effective for decreasing small bowel transit and / or decrease small bowel water content. The composition may be administered to the individual in a unit dosage form.

[0093] Yet another aspect of the present disclosure is a method for reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / or constipation, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein. The composition may be administered in an amount effective to improve colonic fermentation in order e.g. to reduce colonic gas, colonic water content, colonic distention and / or small bowel water content. The composition may be administered to the individual in a unit dosage form.

[0094] Yet another aspect of the present disclosure is a method for reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein. The composition may be administered in an amount effective for increasing levels of valerate in the subject. Research has shown that increasing NN dimethylglycine levels has been linked to the listed benefits (See Zhu L, Li G, Liang Z, Qi T, Deng K, Yu J, Peng Y, Zheng J, Song Y, Chang X. Microbiota-assisted iron uptake promotes immune tolerance in the intestine. Nat Commun. 2023 May 15; 14(l):2790. The composition may be administered to the individual in a unit dosage form.

[0095] Yet another aspect of the present disclosure is a method for preventing gastrointestinal motility related disorders and / or transit related disorders, the method comprising administering to an individual in need thereof or at risk thereof any of the compositions disclosed herein. The composition may be administered in an amount effective for increasing levels of propionate in the individual. Research has shown that increasing propionate levels has been linked to the listed benefits (SeeYano, J. M. et al. Indigenous bacteria from the gut microbiota regulate host serotonin biosynthesis. Cell 161, 264-276 (2015). The composition may be administered to the individual in a unit dosage form.

[0096] In an embodiment, the composition according to the present invention has been shown to increase production of SCFA by comparison to regular milk in lactose malabsorbers. Moreover, the processus of fermentation was shown to be optimized, with less gas produced for the same amount of SCFA. This phenomenon could improve gut comfort, by minimizing colonic gas production needed for producing SCFA and retaining the benefit associated with bacterial fermentation in the colon. In a particular embodiment, the composition according to the present invention, produces less gas for the same amount of SCFA produced as exemplified below. Additionally, our composition was shown to produce similar amount of gas in lactose malabsorption condition than in regular condition, suggesting that it should not induced gas-associated discomfort in lactose malabsorbers.EXAMPLES

[0097] The following non-limiting example generally illustrates the concepts underlying the embodiments disclosed herein.

[0098] Example 1

[0099] In-vitro batch fermentation experiment was set up to compare the effect of 24h fermentation of GOS or the active composition on the microbial metabolism in healthy adults (H) or in adults with lactose malabsorption (LM). For this, the active composition according to Table 1 was subjected to a simulation of upper gastrointestinal tract digestion according to the INFOGEST 2.0 method (Brodkorb et al) to mimic the human upper gastrointestinal tract digestion before being introduced in the fermenters. This step removed small sugars such as lactose, glucose and galactose. The in vitro digestion process also removed some of the GOS (which is contrary to what is observed in vivo in human where GOS remains undigested in the upper gastrointestinal tract). For these reasons, some GOS was directly added in the fermenters to mimic human digestion; final concentrations of GOS are presented in Table 2. In other experiments, lactose (+ / - GOS) was added to the fermenters to mimic human lactose malabsorption (LM); final concentrations of lactose are presented in Table 2. A negative control was also introduced to evaluate the basal microbial metabolism after 24h without any substrate addition (NSC). Each condition was tested using fecal inoculum of 12 healthy adult donors. Microbial metabolites (including short chain fatty acids) were measured using a combination of targeted and untargeted metabolomics approaches by ultra-high performance liquid chromatography mass spectrometry (UPLC-MS). Significant differences in microbial metabolite production between conditions were calculated using paired-t test (*<pvalue=0.05; * *<p-value=0.01 ; * * *<p-value=0.001 ).

[0100] Additionally, gas production was measured in each fermenter (in mbar) and normalized to the total amount of substrate (GOS and lactose) added to the fermenters (expressed in mbar / g of added substrate). This data was also used to calculate the ratio of gas production to SCFA (expressed in mbar / mM of SCFA produced). A low gas production in relation to the amount of added substrate or the amount of SCFA produced are indicative of an optimized colonic fermentation.

[0101] Table 1 : Active compositionfermentation.

[0103] Results

[0104] FIGS. 1-3 include box plots showing significant increase in production of valerate, propionate and N,N-Dimethylglycine metabolites after 24h fermentation of the composition disclosed herein by comparison to GOS alone or negative control (NSC) using batch fermentation.

[0105] The box plots displayed the median, the 25thand 75thpercentile and the distribution of the metabolite level for each donor (n=12) after 24h fermentation in mM for propionate and valerate or in arbitrary unit (A.U) for NN-dimethylglycine. A significant increase in propionate, valerate and NN-dimethylglycine was found after 24h fermentation of the active composition by comparison to GOS alone or in the NSC highlighting a boost in the production of microbial metabolites with known gut-related benefits. Indeed, Research has shown that increasing valerate levels has been linked to the listed benefits (Zhu L et al. Microbiota-assisted iron uptake promotes immune tolerance in the intestine. Nat Commun. 2023 May 15;14(l):2790. Also, Research has shown that propionate levels have been linked to gut motility (Yano, J.M. et al. Indigenous bacteria from the gut microbiota regulate host serotonin biosynthesis. Cell 161, 264-276 (2015). Additionally, NN dimethyl glycine has been linked to gastric ulcers (Hariganesh K, et al. Effect of dimethyl glycine on gastric ulcers in rats. J Pharm Pharmacol. 2000;52: 1519-1522).

[0106] FIG. 4 shows the decrease in gas production (-16%) after 24h fermentation of the Active Composition by comparison to regular milk using batch fermentation withsimulated lactose malabsorption (LM). Decrease in gas production is associated with less bloating, less flatulence, potentially leading to an improved gut comfort.

[0107] FIG. 5 shows the slight increase in SCFA production (+8%) after 24h fermentation of the composition disclosed herein by comparison to regular milk using batch fermentation with simulated lactose malabsorption (LM). This indicates that despite producing less gas, the Active Composition leads to more production of SCFA with the associated health benefit as described herein. The processus of fermentation is optimized with the Active Composition leading to more SCFA production for less gas being produced, potentially improving gut comfort while retaining the benefit associated with bacterial fermentation in the colon.

[0108] FIG. 6 shows decrease in the ratio of gas production to total SCFA production of 22% after 24h fermentation of the Active Composition by comparison to regular milk using batch fermentation with simulated lactose malabsorption (LM). The Active Composition produces less gas for a similar quantity of SCFA produced.

[0109] FIG. 7 represents gas production after 24 h fermentation of the Active Composition using batch fermentation with (LM) or without simulated lactose malabsorption. In lactose malabsorber, the Active Composition does not result in more gas production than in individuals that can digest lactose. It should thus not trigger any gas related inconvenience (bloating, less flatulence), similarly as what would be observed in individuals which can digest lactose.

[0110] Example 2

[0111] The inventors examined the effect of administering the composition disclosed herein, versus lactose-free milk, in 26 healthy adults. Table 1 shows the composition administered versus the control.

[0112] Table 3: Active composition versus control composition administered to individuals

[0113] Specifically, the inventors employed targeted metabolomics for fecal samples. The composition disclosed herein was administered once daily for 2 weeks in a 200 ml drink portion.

[0114] 92 plasma and fecal samples were analyzed using liquid chromatography tandem mass spectrometer. Different statistical approaches were tested to study the effect of the administration of the composition. A statistical analysis was performed with linear models (after log transformation of the data) considering the period and the treatment to study the effect of the administration of the composition. Statistical significance was analyzed with a type 2 analysis of covariance and a false discovery rate estimate was performed. p<0.05 was considered as a significant change.

[0115] Polyamines are compounds such as putrescine, spermidine, spermine and cadaverine. Their presence in feces samples is associated to diet composition since there are derived from meal and absorbed in the upper part of the intestine. Fecal analysis of polyamines can be performed using various analytical approaches. Pre-column derivatization with dansylchloride and 9-fluorenylmethylchloroformate with fluorescence detection is one of the most deployed analytical method for the determination of polyamines in feces (Fiori et al., Assessment of gut microbiota fecal metabolites by chromatographic targeted approaches, J. Pharm and Biomedical Analysis., 2020). Different chromatographic conditions can be also used for polyamines analysis such as ion exchange chromatography or with Hydrophilic Interaction Liquid Chromatography coupled to tandem mass spectrometry (HILIC - MS / MS). Briefly, in our study, dried fecal samples were resuspended in milli-Q water, sonicated and centrifuged at 4°C for 15min. An aliquot of the supernatant was then extracted with an organic solvent containing appropriate internal standards, then the mixture was vortexed and centrifuged and transferred into a vial before analysis. A targeted LC-MSMS was then used to determine the absolute concentration of fecal polyamines. The chromatographic separation was conducted in HILIC conditions in positive mode and following specific transitions in MRM mode. External calibration curved were processed in the same conditions and the labeled internal standards were used to establish response factor for each metabolite.

[0116] Results.

[0117] In fecal samples, cadaverine concentrations only increased in the control group but decreased in the intervention group (p=0.018) (Fig. 8).

[0118] The differential effect on cadaverine concentrations is beneficial for improving gut health and reducing digestive symptoms: Indeed, a diet that helps reducing fecal cadaverine levels promotes a healthier gut environment and improved digestion (Galie et al., Mol. Nut. Food Res., 2021). Moreover, high cadaverine concentrations were reported to be cytotoxic (del Rio et al., Scient. Reports., 2019) and detrimental for gut homeostasis by inhibiting epithelial growth and adherence, which might relate to Crohn’s disease pathogenesis (Diederen et al. Scient Report, 2020). This is further supported by the notion that cadaverine might compromise histamine degradation (Sanchez-Perez et al., Frontier Nut, 2022; Khalid Omer etal., Journal of Food Protection, 2021) and thereby could support these adverse effects.

Claims

CLAIMSClaim 1 : A method for preventing and / or treating gastrointestinal disorders and / or improving digestive comfort, the method comprising administering to an individual in need thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharide.Claim 2: The method of claim 1, wherein the composition decreases the ratio of gas production to total SCFA by comparison to regular milk.Claim 3: The method of claim 1 or 2, wherein the composition comprises 35-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide.Claim 4: The method of any of claims 2 to 3, wherein the composition comprises 20- 40 % by dry weight of milk protein; and 32-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide.Claim 5: The method of any of claims 2 to 4, wherein the mixture of lactose, glucose and galactose and galactooligosaccharide comprises 0.1-30% by weight of lactose.Claim 6: The method of any of claims 2 to 5, wherein the mixture of lactose, glucose and galactose and galactooligosaccharide comprises: 8-40% by weight of glucose.Claim 7: The method of any of claims 2 to 6, wherein the mixture of lactose, glucose and galactose and galactooligosaccharide comprises: 0.1-20% by weight of galactose.Claim 8: The method of any of claims 2 to 7, wherein the mixture of lactose, glucose and galactose and galactooligosaccharide comprises 40-90% by weight of galactooligosaccharide.Claim 9: The method of any of preceding claims, wherein the milk-based composition comprises: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition;preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.Claim 10: The method of any preceding claims, wherein the treating and / or preventing gastrointestinal disorders health and / or improving digestive comfort comprises at least one result selected from the group consisting of: (a) preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartburn, acid reflux and / or gastric ulcers (b) preventing and / or attenuating abdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness; (c) reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / or constipation; (d) reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease and / or gastritis (e) prevent gastrointestinal motility related disorder and / or transit related disorder and combinations thereof.Claim 11 : The method according to claim 10, wherein the gastrointestinal motility related disorder and / or transit related disorder is selected from constipation, vomititng or regurgitation, bloating, diarrhea, nausea, weight loss, pain or swallowing problems, heartburn or GERD and / or urgent need to have bowel movement.Claim 12: The method according to any of claims 10 to 11, wherein the composition is administered in an amount effective for reducing the levels of cadaverine.Claim 13: A method for preventing and / or attenuating stomach related disorders such as belching, stomach discomfort, fullness, nausea, heartburn, acid reflux and / or gastric ulcers the method comprising administering to an individual in need thereof or at risk thereof a composition comprising: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.Claim 14: The method of claim 13, wherein the composition is administered in an amount effective for reducing gastric distension, gastric volume and / or for increasing levels of NN dimethylglycine.Claim 15: A method for preventing and / or attenuating abdominal related disorders such as rumbling, abdominal discomfort, cramps and / or fullness, the method comprising administering to an individual in need thereof or at risk thereof a composition comprising: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.Claim 16: The method of claim 15, wherein the composition is administered in an amount effective to decrease small bowel transit and / or decrease small bowel water content.Claim 17: A method for reducing and / or preventing colon related digestive disorders such as bloating, gas / flatulence, diarrhea and / or constipation, the method comprising administering to an individual in need thereof or at risk thereof a composition comprising: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.Claim 18: The method of claim 17, wherein the composition is administered in an amount effective to improve colonic fermentation, reduce colonic fermentation, colonic gas, colonic water content and / or small bowel water content.Claim 19: A method for reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease, the method comprising administering to an individual in need thereof or at risk thereof a composition comprising:milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.Claim 20: the method according to claim 19, wherein the composition is administered in an amount effective for increasing levels of valerate in the subject.Claim 21 : A method for preventing gastrointestinal motility related disorders and / or transit related disorders, the method comprising administering to an individual in need thereof or at risk thereof a composition comprising: milk protein, preferably at 20-40 % by dry weight of the composition; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; preferably, the mixture comprising: 0.1-30% by weight of the lactose, 8-40% by weight of the glucose, 0.1-20% by weight of the galactose and 40-90% by weight of the galactooligosaccharide.Claim 22: The method of claim 21, wherein the composition is administered in an amount effective for increasing levels of propionate in the individual.Claim 23 : The method of any preceding claim, wherein the composition is administered to the individual in a unit dosage form.Claim 24: The method according to any preceding claim, wherein the individual is lactose mal-absorber.

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