Food ingredient and beverage products

Abstract

The present invention relates to a food ingredient comprising galactooligosaccharides and nutrients, a way of producing it and beverage products comprising the ingredient. The food ingredient is produced by adding a beta-galactosidase to a composition comprising non-fat milk solids including lactose. The food ingredient may be used e.g. in beverage products to reduce fat and / or sugar without detrimentally impacting sweetness, taste and / or texture. The invention further relates to methods and compositions for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort in a pregnant or lactating individual in need thereof, the composition comprising a low sugar, low lactose, milk-based composition comprising galactooligosaccharide (GOS).

Description

[0001] FOOD INGREDIENT AND BEVERAGE PRODUCTS

[0002] Field of the invention

[0003] The present invention relates to a food ingredient comprising galactooligosaccharides, a way of producing it and beverage products comprising the ingredient. The food ingredient is particularly designed to benefit pregnant or lactating individuals. The present disclosure further relates to compositions and methods for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort in a preganant or lactating individual.

[0004] Background

[0005] Many food products traditionally comprise high amounts of sugar, which is important to achieve the sweet taste and texture the consumers expect of the product. For health reasons there is a desire to reduce the amount of sugar in many food products and to replace it with healthier ingredients like e.g. fibers, but to ensure the consumer liking of the product, it is desired to achieve this without sacrificing taste and texture. One solution is to use artificial sweeteners that provide sweetness without the energy contribution of sugar, but these do not contribute to the texture like sugar and furthermore, many consumers want to avoid artificial ingredients such as sweeteners. Food products such as e.g. cocoa and / or malt beverages traditionally comprise milk, which includes lactose, and sucrose to achieve the desired taste and texture. For the reasons given above, there is a desire to reduce the amount of sugar, preferably replacing it with healthier ingredients, keeping the taste and texture of the original product.

[0006] 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 galacto-oligosaccharides (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.

[0007] Moreover, individuals with lactose intolerance, which has a high prevalence rate in East-Asian countries (such as about 85% in China), are unable to fully digest lactose, a sugar found in milk and dairy products. It is important for lactose intolerant individuals to manage their condition by adjusting their diet to limit or avoid lactose-containing foods and beverages. This is particularly true for pregnant or lactating individuals who have higher diary intake recommendations than other individuals in order to, for example, meet the needs of fetal skeletal calcification during pregnancy.

[0008] It is known that lactose can be polymerized by beta-galactosidase to produce galactooligosaccharide (GOS). GOS acts as prebiotics and is used as an ingredient primarily in infant formulae and baby food. The yield of GOS from polymerization of lactose is normally below 50%, often in the range of 10-30%.

[0009] WO 2021 / 018569 Al relates to a food ingredient and a method of producing the food ingredient. The food ingredient comprises a specific combination of milk protein, sugars and GOS and can be used in food products, to replace skim milk powder or other milk ingredients as well as part of the sucrose normally added, to achieve similar taste and texture with reduced total sugar content and at the same time contribute prebiotic GOS to the product. In particular, WO 2021 / 018569 Al relates to a food ingredient comprising 20-40 % by dry weight of milk protein; and 35-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide, said mixture containing: 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 galactooligosaccharide.

[0010] There remains a need for a composition for easy and convenient administration to pregnant or lactating individuals specifically, resulting in an increase in beneficial microbial metabolites and in meeting their specific dietary intake recommendations of nutrients.

[0011] Summary of the invention

[0012] The invention relates to a food ingredient comprising 20-40% by dry weight of milk protein; niacin; folic acid; optionally iron; and 32-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide, said mixture containing: 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 galactooligosaccharide.

[0013] In further aspects, the invention relates to a method of producing a food ingredient, a beverage powder, for example a modified milk powder, and a liquid beverage product, for example a milk-based beverage, such as modified milk or a cocoa and / or malt beverage.

[0014] In further aspects, the invention relates to methods for improving gastrointestinal health and / or digestive comfort. In particular embodiments, a method for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort includes administering to a pregnant or lactating individual in need thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharides. In some embodiments, the composition comprises milk protein, preferably at 20-40 % by dry weight of the composition; niacin; folic acid; optionally iron; 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.

[0015] Additional features and advantages are described herein and will be apparent from the following Figures and Detailed Description.

[0016] Brief description of the drawings

[0017] 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.

[0018] 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. 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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).

[0023] 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.

[0024] Detailed description of the invention

[0025] Definitions

[0026] All percentages expressed herein are based on the total weight of the food ingredient and / or 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] The terms “food”, “food ingredient”, “food supplement”, “food product” and “food composition” mean a product or composition that is intended for ingestion by an individual such as a pregnant or lactating individual, specifically a pregnant or lactating human, and provides at least one nutrient to the individual. The compositions and food ingredients 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.

[0032] The term “modified milk” disclosed herein refers to a liquid product produced using not less than 80% raw milk, for example cow milk and / or goat milk, or reconstituted milk as main raw materials, with addition of other ingredient derived from food, or / and food additives, or / and nutrition fortification substances, and through appropriate pasteurization or sterilization and other processes.

[0033] The term “modified milk powder” disclosed herein refers to a powdered product produced using raw milk of a single variety and / or its processed products from milk such as whole milk, skimmed or partly skimmed milk, as the main raw material, with the addition of one or more of other ingredients derived from food (excluding other variety of milk product), food additives and food nutrient fortification substances. The milk solid content from the main raw materials shall not be less than 70%.

[0034] “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 non- limiting examples, a treatment can be performed by a patient, a caregiver, a doctor, a nurse, or another healthcare professional.

[0035] 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, the enzyme 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.

[0036] As used herein, the term “low lactose” shall refer to a composition or food ingredient with less than or equal to 30% of lactose.

[0037] As used herein, the term “low sugar” shall refer to a composition or food ingredient with less than or equal to 55% of the composition or food ingredient.

[0038] 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.

[0039] The term “composition” may mean a food, food ingredient, beverage, dietary supplement, complete nutrition or oral nutritional supplement (ONS) or medical food composition, or mixture thereof.

[0040] The composition can be the food ingredient and 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.) 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.

[0041] By “beta-galactosidase” is understood one or more enzymes with enzymatic activity of enzyme class EC 3.2.1.23, also called beta-D-galactoside galactohydrolase, exo-(l- >4)-beta-D-galactanase or lactase, which catalyses the hydrolysis of terminal nonreducing beta-D-galactose residues in beta-D-galactosides, as well as transgalactosylation by transferring a galactose moiety of a beta-D-galactoside to another sugar molecule.

[0042] EC (Enzyme Committee) numbers refer to the definition of enzymatic activity and nomenclature given by the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology as in force on 3rdJuly 2019.

[0043] “Galactooligosaccharides” (GOS) are oligosaccharides composed of different galactosyl residues (usually from 2 to 9 units) and a terminal glucose linked by P- glycosidic bonds, such as P-(l- 2), P-(l- 3), P-(l- 4), and P-(l- 6). GOS are normally produced through the enzymatic conversion of lactose.

[0044] Food ingredient

[0045] In one aspect, the present invention relates to a food ingredient comprising 20-40% by dry weight of milk protein. By milk protein is meant 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 food ingredient comprises 25-40%. More preferably 30-40% by dry weight of milk protein.

[0046] The food ingredient further comprises 32-55% by dry weight of a mixture of Lactose, Glucose, Galactose and GOS, said mixture containing: 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 said mixture of Lactose, Glucose, Galactose and GOS; in a more preferred embodiment, the food ingredient comprises 50-55% by dry weight of said mixture of Lactose, Glucose, Galactose and GOS. In another preferred embodiment of the invention, said 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 of the invention, said 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, said 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.

[0047] The food ingredient comprises niacin. Niacin is needed for many functions in the body, including energy production and development of the nervous system, digestive system, and skin. Research has shown that a low level of niacin is associated with an increased risk of birth defects such as spina bifida and serious heart defect (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 12mg and 16mg of niacin per day, respectively. Niacin may be included in the food ingredient in an amount greater than 0.001% by dry weight of niacin, preferably comprising greater than 0.003% by dry weight of niacin, more preferably comprising greater than 0.005% by dry weight of niacin, even more preferably comprising about 0.0073% by dry weight of niacin.

[0048] The food ingredient comprises folic acid. Research has shown that folic acid deficiency is related to the appearance of anemia, complications during pregnancy, and serious health problems in the fetus such as intrauterine growth restriction, premature birth, low birth weight, neural tube defects, and other fetal malformations (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022 and Jouanne et al., Nutrients, 2021). The Chinese Dietary Reference Intakes recommend a daily intake of 600pg of folic acid during pregnancy. Enhancing the content of folic acid in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Folic acid may be included in the food ingredient in an amount greater than 0.0002% by dry weight of folic acid, preferably greater than 0.0003% by dry weight of folic acid, more preferably about 0.0004% by dry weight of folic acid.

[0049] The food ingredient may further comprise iron. Iron helps to prevent maternal anemia (see Jouanne el al., Nutrients, 2021). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 29mg and 24mg of iron per day, respectively. Enhancing the content of folic acid in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Iron may be included in the food ingredient in an amount greater 0.01% by dry weight of iron, preferably greater than 0.015% by dry weight of iron, more preferably about 0.02% by dry weight of iron.

[0050] The food ingredient may further comprise manganese. Manganese contributes to normal energy-yielding metabolism, formation of connective tissue, maintenance of normal bones, protection of cells from oxidative stress. The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 4mg and 4.2mg of Manganese per day, respectively. Manganese may be included in the food ingredient in an amount greater than 0.001% by dry weight of manganese, preferably greater than 0.0014% by dry weight of manganese, more preferably about 0.0018% by dry weight of manganese.

[0051] The food ingredient 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. By milk fat is meant fat derived from milk in any suitable way. By milk derived minerals are meant 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 e.g. origin 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.

[0052] In a preferred embodiment, the food ingredient comprises 3-20% by dry weight of vegetable oil, more preferably 3-10% by dry weight of vegetable oil. The vegetable oil may be any suitable vegetable oil, preferably soybean oil, rapeseed oil, and / or sunflower oil. In a preferred embodiment, the food ingredient is fortified with one or more further vitamins and minerals. The food ingredient may comprise at least one of: Vitamin C, Vitamin D, Vitamin E, Vitamin Bl, Vitamin B2, Vitamin B6, Vitamin B12, Pantothenic acid, Choline, zinc, calcium, selenium or a combination thereof.

[0053] In a preferred embodiment, the food ingredient is fortified with further vitamins and minerals. The food ingredient may comprise all of: Vitamin C, Vitamin D, Vitamin E, Vitamin Bl, Vitamin B2, Vitamin B6, Vitamin B12, Pantothenic acid, Choline, zinc, calcium, and selenium.

[0054] The food ingredient may further comprise Vitamin C. During pregnancy, vitamin C is important for the growth and repair of collagen and helps maintain strong bones and teeth (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 115mg and 150mg of vitamin C per day, respectively. Enhancing the content of vitamin C in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Vitamin C may be included in the food ingredient in an amount of about 0.08% by dry weight of Vitamin C.

[0055] The food ingredient may further comprise Vitamin D. Research shows that Vitamin D deficiency during pregnancy is associated with a higher risk for miscarriage, preterm birth, and C- section, and a higher risk of the child developing asthma, language difficulties, and autism (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). Vitamin D may be included in the food ingredient in an amount of about 0.000007% by dry weight of Vitamin D.

[0056] The food ingredient may further comprise Vitamin E. Research has shown that in pregnancy, low vitamin E intake is associated with hyperglycemia, preterm births, preterm placental rupture of membranes (PROM), and placental abruption (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). Vitamin E may be included in the food ingredient in an amount of about 0.009% by dry weight of Vitamin E. The food ingredient may further comprise Vitamin Bl. Vitamin Bl is important during pregnancy to reduce the risk of maternal gestational diabetes and low-birth weight and anencephaly in infants (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 1.5mg of vitamin Bl per day. Vitamin Bl may be included in the food ingredient in an amount of greater than 0.0001% by dry weight of Vitamin Bl, preferably greater than 0.0005% by dry weight of Vitamin Bl, and more preferably about 0.0008% by dry weight of Vitamin Bl.

[0057] The food ingredient may further comprise Vitamin B2. In pregnant women, research has shown that vitamin B2 supplementation alone may prevent severe preeclampsia and hypertension (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 1400pg and 1700pg of vitamin B2 per day, respectively. Enhancing the content of vitamin B2 in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Vitamin B2 may be included in the food ingredient in an amount of about 0.0012% by dry weight of Vitamin B2.

[0058] The food ingredient may further comprise Vitamin B6. Vitamin B6 supplementation in pregnancy may help decrease the severity of nausea, reduce the risk of cardiovascular malformation, reduce the risk of preeclampsia, and improve birth weight (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022 and Jouanne et al., Nutrients, 2021). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 2.2mg and 1.7mg of vitamin B6 per day, respectively. Vitamin B6 may be included in the food ingredient in an amount of greater than 0.0002% by dry weight of Vitamin B6, preferably greater than 0.0003% by dry weight of Vitamin B6, and more preferably about 0.0004% by dry weight of Vitamin B6.

[0059] The food ingredient may further comprise Vitamin B12. Vitamin B12 is important for reducing risk of infertility, miscarriage, gestational diabetes, preeclampsia, and preterm birth for the mother (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). For the infant, research shows that vitamin B12 deficiency is associated with low birth weight, neural tube defects, serious heart defect, and childhood diabetes (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 2.9pg and 3.9pg of vitamin B12 per day, respectively. Enhancing the content of vitamin B12 in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Vitamin B12 may be included in the food ingredient in an amount of about 0.000003% by dry weight of Vitamin B 12.

[0060] The food ingredient may further comprise Pantothenic acid. Pantothenic acid is needed to produce Coenzyme A, which has many functions in the body, including energy production from fats, carbohydrates, and protein. Research has shown that a deficiency of pantothenic acid during pregnancy is associated with low birth weight in offspring (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 6mg and 7mg of pantothenic acid per day, respectively. Pantothenic acid may be included in the food ingredient in an amount of greater than 0.003% by dry weight of Pantothenic acid, preferably greater than 0.005% by dry weight of Pantothenic acid, and more preferably about 0.007% by dry weight of Pantothenic acid.

[0061] The food ingredient may further comprise Choline. Choline is important for optimal fetal brain development as well as possibly reducing the risk of neural tube defects, autism, and Down syndrome in the infant (see Adams et al., Maternal Health, Neonatology and Perinatology, 2022). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 460mg and 500mg of choline per day, respectively. Enhancing the content of choline in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Choline may be included in the food ingredient in an amount of about 0.23% by dry weight of Choline.

[0062] The food ingredient may further comprise zinc. Zinc is essential for many biological processes including, for example, cell division, protein synthesis and growth, and nucleic acid metabolism. During pregnancy, zinc deficiencies may lead to congenital malformations, low birth weight, intrauterine growth retardation, and preterm delivery (see Jouanne et al., Nutrients, 2021). The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 10.5mg and 13mg of zinc per day, respectively. Enhancing the content of folic acid in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines. Zinc may be included in the food ingredient in an amount of about 0.012% by dry weight of zinc.

[0063] The food ingredient may further comprise calcium. Calcium participates in the mineralisation of the fetal skeleton, especially during the third trimester of pregnancy (see Jouanne et al., Nutrients, 2021). Calcium may be included in the food ingredient in an amount of about 1.5% by dry weight of calcium.

[0064] The food ingredient may further comprise selenium. Selenium may be included in the food ingredient in an amount of about 0.00002% by dry weight of selenium.

[0065] The food ingredient may comprise further minerals such as phosphorous, magnesium, sodium or potassium. Lactating women lose potassium through milk secretion, therefore they need an additional 400mg / d supplement based on healthy adults. The Chinese Dietary Reference Intakes recommend that pregnant and lactating individuals should consume 2000mg and 2400mg of potassium per day, respectively. Enhancing the content of potassium in the food ingredient, in conjunction with a regular diet, can help reach the recommended levels set by the guidelines.

[0066] In a preferred embodiment, the food ingredient comprises 20-40 % by dry weight of the composition of milk protein; about 0.0073% by dry weight of niacin; about 0.0004% by dry weight of folic acid; about 0.02% by dry weight of iron; about 0.0018% by dry weight of manganese; and a mixture of lactose, glucose, galactose and galactooligosaccharide, the mixture preferably at 32-55% by dry weight of the composition; 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. The food ingredient further comprises at least one of: about 0.08% by dry weight of Vitamin C, about 0.000007% by dry weight of Vitamin D, about 0.009% by dry weight of Vitamin E, about 0.0008% by dry weight of Vitamin Bl, about 0.0012% by dry weight of Vitamin B2, about 0.0004% by dry weight of Vitamin B6, about 0.000003% by dry weight of Vitamin B12, about 0.007% by dry weight of Pantothenic acid, about 0.23% by dry weight of Choline, about 0.012% by dry weight of zinc, about 1.5% by dry weight of calcium, about 0.00002% by dry weight of selenium, or a combination thereof.

[0067] In some embodiments, the food ingredient disclosed herein is a modified milk powder.

[0068] In the present disclosure, a composition for use in any of the methods described herein comprises or consists of the food ingredient of the invention. The compositions comprising or consisting of the food ingredient of the invention may be administered to a pregnant or lactating individual.

[0069] The composition may be in any form that is suitable to administer all the ingredients. Suitably, the composition for use according to the present invention may be in the form of a powdered nutritional composition that can be reconstituted in milk, water or any liquid, of a food product, of a drink, of a nutritional supplement or of a nutraceutical.

[0070] Liquid beverage product

[0071] A liquid beverage product comprising the food ingredient 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.

[0072] The food ingredient 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. In some embodiments, the food ingredient relates to a ready to drink beverage. In some further 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 health benefit as disclosed herein.

[0073] The food ingredient can be administered to the pregnant or lactating 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 food ingredient is administered to the pregnant or lactating individual consecutively for a number of days. In an embodiment, the food ingredient can be administered to the pregnant or lactating individual daily for at least 30, 60 or 90 consecutive days.

[0074] In some embodiments, the serving size of the food ingredient 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 food ingredient. In some embodiments, the food ingredient is administered in a unit dosage form that comprises an amount of the food ingredient effective for increasing or decreasing certain metabolites and improving health benefits as disclosed herein.

[0075] In some embodiments, the food ingredient disclosed herein is a modified milk.

[0076] Metabolic health

[0077] In certain embodiments of the invention, there are methods and compositions for improving metabolic health, the improvement of metabolic health caused directly or indirectly by increasing or decreasing levels of certain metabolites or certain bacteria such as Bifidobacteria in the pregnant or lactating individual. 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 that are treated or prevented directly or indirectly with increased or decreased metabolite levels, or has a medical condition or physical state that are treated or prevented directly or indirectly with increased metabolite levels. The compositions delivered to the pregnant or lactating individual in such cases include at least a mixture of lactose, glucose, galactose and galactooligosaccharide, 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 galactooligosaccharide, 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.

[0078] In specific embodiments, improvement of metabolic health is associated with increased and / or decreased levels of certain metabolites, certain bacteria such as Bifidobacteria, or functional derivatives thereof. In particular embodiments, improving metabolic health comprises one or more of the following: (a) appetite or food intake control or regulation; (b) managing glucose levels; (c) weight management; (d) normalizing blood lipid profiles; (e) skin health; (f) reducing inflammation; (g) preventing and / or attenuating oxidative stress; (h) improved lipid / fat metabolism; (i) improving intestinal barrier; (j) reducing intestinal permeability; (k) modulation of glucose metabolism; (1) protection from fatty liver; (m) promoting growth of Faecalibacterium prausnitzii, (n) protecting kidneys, particularly in chronic kidney disease; (o) promoting growth of Bifidobacterium-, (p) increasing Bifidobacterium shunt pathway; (q) increasing NAD salvage pathwa(r) preservation of P-cell function; (s) preventing diabetes, (t) improving insulin sensitivity; (u) preventing and / or treating obesity; (x) regulating blood pressure; (y) maintain insulin response; and (z) combinations thereof.

[0079] The pregnant or lactating 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 pregnant or lactating individual may be treated with other therapy or therapies in addition to methods of the disclosure.

[0080] In one embodiment of the disclosure, there is a method of producing increased blood levels of certain metabolites, including 3-indole propionate, propionate, indoxyl-3- carboxylate, valerate, tricarballylic acid, imidazole acetate, acetate, N,N,- dimethylglycine, caprylic acid, nicotinamide, beta-alanine, ketone bodies, 3- hydroxybutyrate, 12,13-diHODE, and / or 3-hydroxydecanoic acid. Preferably, the composition is administered in an effective amount to increase one or more Bifidobacterium, including but not limited to B. longum, B. adolescentis, B. bifidum, in a pregnant or lactating individual in need thereof by administering the composition disclosed herein. The pregnant or lactating individual may be known to have a medical condition or physical state 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.

[0081] The method may comprise identifying the pregnant or lactating individual as having a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels, and / or the method may comprise identifying the individual as at risk of a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels. In particular embodiments, the pregnant or lactating individual subjected with methods and / or compositions of the invention is desiring prevention of one or more undesirable physical states (or the effects thereof, such as with aging) or medical conditions.

[0082] In specific embodiments, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of raising intracellular levels of 3-indole propionate, propionate, indoxyl-3-carboxylate, valerate, tricarballylic acid, imidazole acetate, acetate, N,N, -dimethylglycine, caprylic acid, nicotinamide, beta-alanine, ketone bodies, 3-hydroxybutyrate, 12,13-diHODE, and / or 3-hydroxydecanoic acid. Preferably, the composition is administered in an effective amount to increase one or more Bifidobacterium, including but not limited to B. longum, B. adolescentis, B. bifidum, because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related. Additionally, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of decreasing levels of indoxyl sulfate and / or p-cresol sulfate because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related.

[0083] In some embodiments, there is a method of preventing and / or treating pellagra, acne, skin cancer, and / or improving skin health in a pregnant or lactating individual. In some embodiments, there is a method of improving the level of blood lipids in pregnant or lactating individuals. In some embodiments, there is a method of improving cognition. In specific embodiments, administering the compositions contemplated herein increase levels of nicotinamide for which pellagra, skin cancer, acne, blood lipid profile, improved cognition, and / or skin health are directly or indirectly related.

[0084] In some embodiments, there is a method of preventing and / or treating obesity in a pregnant or lactating individual. For example, the method of preventing and / or treating obesity may include improving appetite control, improving food intake control, managing weight, and managing glucose, such as through insulin sensitivity. In some embodiments, there is a method of preventing and / or treating viral respiratory infections, such as respiratory syncytial virus (RSV). In some embodiments, there is a method of treating and / or preventing cognitive decline. In specific embodiments, administering the compositions contemplated herein increase levels of acetate for which obesity, cognitive decline, and viral respiratory infections are directly or indirectly related.

[0085] In some embodiments, there is a method of preventing and / or treating obesity in a pregnant or lactating individual. For example, the method of preventing and / or treating obesity may include improving appetite control, improving food intake control, managing weight, and managing glucose, such as through insulin sensitivity. In some embodiment, there is a method of preventing and / or treating viral respiratory infections, such as respiratory syncytial virus (RSV). In some embodiments, there is a method of protecting a pregnant or lactating individual against pathogens. In specific embodiments, administering the compositions contemplated herein increase levels of Bifidobacterium, such as adolescentis, bifidum, and / or longum, for which obesity, viral respiratory infections, and / or protection from pathogens are directly or indirectly related.

[0086] In some embodiments, there is a method of treating or preventing chronic kidney disease or protecting kidney function. In specific embodiments, administering the compositions contemplated herein increase levels of 3-indole propionate and decrease levels of p-cresol sulfate and indoxyl sulfate for which chronic kidney disease and kidney function are directly or indirectly related. In some embodiments, there is a method of reducing and / or preventing oxidative stress in a pregnant or lactating individual. In a specific embodiment, the methods are useful for treating and / or preventing medical conditions associated with oxidative stress. In particular cases, the present invention provides methods and compositions useful for aging. In specific embodiments, administering the compositions contemplated herein increase levels of 3 -Hydroxybutyrate for which oxidative stress and age-associated diseases are directly or indirectly related.

[0087] In some embodiments, there is a method of improving lipid metabolism in a pregnant or lactating individual. In specific embodiments, administering the compositions contemplated herein increase levels of 12,13-diHODE for which lipid metabolism is directly or indirectly related.

[0088] Evidence of improvement in metabolic health when administering the composition comprising the food ingredient of the invention is disclosed in pending PCT patent application PCT / EP2024 / 061792.

[0089] Immune health

[0090] In specific embodiments, improvement of immune health is associated with increased and / or decreased levels of certain metabolites, certain bacteria such as Bifidobacteria, or functional derivatives thereof. In particular embodiments, improving immune health comprises one or more of the following: (a) protection from infections, such as viral respiratory infections; (b) protection against pathogens; (c) reducing inflammation; (d) preventing and / or attenuating oxidative stress; (e) improving intestinal barrier; (f) reducing intestinal permeability; (g) promoting growth of Bifidobacterium-, (h) increasing Bifidobacterium shunt pathway; (i) increasing NAD salvage pathway; and (j) preventing and / or treating allergic asthma, (k) promoting immune homeostasis; (1) preventing and / or treating Clostridium difficile infection, (m) cancer immunotherapy, (o) preventing and / or treating autoimmune diseases; combinations thereof. The pregnant or lactating 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 pregnant or lactating individual may be treated with other therapy or therapies in addition to methods of the disclosure. In one embodiment of the disclosure, there is a method of producing increased blood levels of certain metabolites, including 3-indole propionate, acetate, caprylic acid, nicotinamide, beta-alanine, ketone bodies, 3-hydroxybutyrate, 12,13-diHODE, propionate, indole-3 -carboxylate, valerate, N,N-Dimethylglycine, tricarballylic acid, propionate, and / or 3-hydroxydecanoic acid (or functional derivatives thereof) or increased fecal levels of Bifidobacterium, including but not limited to B. adolescentis, bifidum, longum, in a pregnant or lactating individual in need thereof by administering the composition disclosed herein. The individual may be known to have a medical condition or physical state 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.

[0091] The method may comprise identifying the pregnant or lactating individual as having a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels, and / or the method may comprise identifying the pregnant or lactating individual as at risk of a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels. In particular embodiments, the pregnant or lactating individual subjected with methods and / or compositions of the invention is desiring prevention of one or more undesirable physical states (or the effects thereof, such as with aging) or medical conditions.

[0092] In specific embodiments, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of raising intracellular levels of 3-indole propionate, acetate, caprylic acid, nicotinamide, betaalanine, ketone bodies, 3-hydroxybutyrate, 12,13-diHODE, propionate, indole-3- carboxylate, valerate, N,N-Dimethylglycine, tricarballylic acid, propionate, and / or 3- hydroxydecanoic acid or increasing fecal levels of Bifidobacterium, including but not limited to B. adolescentis, bifidum, longum, because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related. Additionally, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of decreasing levels of indoxyl sulfate and / or p-cresol sulfate because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related.

[0093] In some embodiments, there is a method of reducing and / or preventing oxidative stress in a pregnant or lactating individual. In a specific embodiment, the methods are useful for treating and / or preventing medical conditions associated with oxidative stress. In particular cases, the present invention provides methods and compositions useful for aging. In specific embodiments, administering the compositions contemplated herein increase levels of 3 -hydroxybutyrate for which oxidative stress and age-associated diseases are directly or indirectly related.

[0094] Evidence of improvement in immune health when administering the composition comprising the food ingredient of the invention is disclosed in pending PCT patent application PCT / EP2024 / 061789.

[0095] Brain health

[0096] In specific embodiments, improvement of brain health is associated with increased and / or decreased levels of certain metabolites, certain bacteria such as Bifidobacteria, or functional derivatives thereof. In particular embodiments, improving brain health comprises one or more of the following: (a) appetite or food intake control; (b) managing glucose levels; (c) weight management; (d) protection from viral respiratory infections; (e) normalizing blood lipid profiles; (f) skin health; (g) protection against pathogens; (h) improved cognition; (i) reducing inflammation; (j) preventing and / or attenuating oxidative stress; (k) attenuating neuronal damage following stroke; (1) stress management; (m) improved lipid metabolism; (n) improving intestinal barrier; (o) reducing intestinal permeability; (p) modulation of glucose metabolism; (q) protection from fatty liver; (r) protection against neurodegenerative diseases including but not limited to Alzheimer’s; (s) protection against neuronal damage; (t) promoting growth of Faecalibacterium prausnitzii, (u) protecting kidneys, particularly in chronic kidney disease; (v) promoting growth of Bifidobacterium , (w) increasing Bifidobacterium shunt pathway; (x) increasing NAD salvage pathway; and (y) a combination thereof. The pregnant or lactating 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 pregnant or lactating individual may be treated with other therapy or therapies in addition to methods of the disclosure.

[0097] In certain embodiments, the composition is administered in an amount effective for improvement of cognitive function in an individual, particularly in a pregnant or lactating individual that does not have detectable impairment of cognitive function, or for a pregnant or lactating individual that has detectable impairment of cognitive function, including impairment for any reason. In specific embodiments, the methods delay onset of cognitive dysfunction and / or enhance normal cognitive function.

[0098] In one embodiment of the disclosure, there is a method of producing increased blood levels of certain metabolites, including 3-indole propionate, acetate, caprylic acid, nicotinamide, beta-alanine, ketone bodies, 3-hydroxybutyrate, 12,13-diHODE, and / or 3-hydroxydecanoic acid (or functional derivatives thereof) or increased fecal levels of Bifidobacterium, including but not limited to B. adolescentis, bifidum, longum, in a pregnant or lactating individual in need thereof by administering the composition disclosed herein. The pregnant or lactating individual may be known to have a medical condition or physical state that would benefit from increased metabolite levels, or the pregnant or lactating 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.

[0099] The method may comprise identifying the pregnant or lactating individual as having a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels, and / or the method may comprise identifying the pregnant or lactating individual as at risk of a medical condition or physical state that would benefit from increased metabolite levels, or increased beneficial fecal bacteria levels. In particular embodiments, the pregnant or lactating individual subjected with methods and / or compositions of the invention is desiring prevention of one or more undesirable physical states (or the effects thereof, such as with aging) or medical conditions.

[0100] In specific embodiments, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of raising intracellular levels of 3-indole propionate, acetate, caprylic acid, nicotinamide, betaalanine, ketone bodies, 3-hydroxybutyrate, 12,13-diHODE, and / or 3-hydroxydecanoic acid or increasing fecal levels of Bifidobacterium, including but not limited to B. adolescentis, bifidum, longum, because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related. Additionally, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of decreasing levels of indoxyl sulfate and / or p-cresol sulfate because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related.

[0101] In some embodiments, there is a method of improving cognitive function, such as in pregnant or lactating individuals with diabetes induced cognitive impairment, managing stress, preventing oxidative stress, preventing and / or treating type II diabetes, reducing inflammation, improving the intestinal barrier, reducing intestinal permeability, modulating glucose metabolism, protecting against fatty liver, and / or neuroprotection, such as protecting neurons against oxidative damage in a pregnant or lactating individual. In specific embodiments, administering the compositions contemplated herein increase levels of 3-indole propionate for which cognitive function, managing stress, oxidative stress, inflammation, intestinal permeability, glucose metabolism, fatty liver, and / or neuroprotection are directly or indirectly related.

[0102] In some embodiments, there is a method of reducing and / or preventing oxidative stress in a pregnant or lactating individual. In a specific embodiment, the methods are useful for treating and / or preventing medical conditions associated with oxidative stress. In particular cases, the present invention provides methods and compositions useful for aging. In specific embodiments, administering the compositions contemplated herein increase levels of 3 -Hydroxybutyrate for which oxidative stress and age-associated diseases are directly or indirectly related.

[0103] In some embodiments, there is a method of treating or preventing cognitive impairment, reducing oxidative stress and / or increasing levels of Faecalibacterium prausnitzii in the gut microbiome in a pregnant or lactating individual. In specific embodiments, administering the compositions contemplated herein decrease levels of p-cresol sulfate for which cognitive impairment, oxidative stress, and / or Faecalibacterium prausnitzii levels are directly or indirectly related.

[0104] Evidence of improvement in brain health when administering the composition comprising the food ingredient of the invention is disclosed in pending PCT patent application PCT / EP2024 / 061788.

[0105] Gastrointestinal disorder and digestive comfort

[0106] 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.

[0107] Then, in an embodiment, the pregnant or lactating individual may be susceptible to particular medical conditions or physical states that would benefit from increased metabolite levels, or the pregnant or lactating 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 pregnant or lactating individual in such cases include a composition as described above, in particular to facilitate raising or lowering specific metabolite levels in the pregnant or lactating individual. One can measure specific metabolite levels through plasma or fecal samples, for example, in methods well known in the art.

[0108] The method may comprise identifying the pregnant or lactating 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 comprise identifying the pregnant or lactating individual as at risk of a medical condition or physical state that would benefit from increased metabolite levels. In specific embodiments, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of raising intracellular levels of propionate, valerate, N,N-Dimethylglycine, because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related. Additionally, a pregnant or lactating individual is provided effective amounts of food ingredients as described herein for the explicit purpose of decreasing levels of cadaverine because it is determined that the pregnant or lactating individual is afflicted with a condition for which such levels are directly or indirectly related.

[0109] In view of the disclosures herein, the invention further relates to a method for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort, the method comprising administering to a pregnant or lactating individual in need thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharide. In some embodiments, the composition comprises or consists of the food ingredient as described above. In a preferred embodiment, the method for treating and / or preventing gastrointestinal disorders and / or improving digestive comfort comprises administering to a pregnant or lactating individual in need thereof a low sugar, low lactose, milkbased composition comprising galactooligosaccharide, niacin, folic acid and optionally iron.

[0110] 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.

[0111] 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, heartbum or GERD and / or urgent need to have bowel movement.

[0112] 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 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 et al., Journal of Food Protection, 2021) and thereby could support these adverse effects.

[0113] In some embodiments, the method is 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 a pregnant or lactating 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).

[0114] In some embodiments, the method 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 a pregnant or lactating 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 pregnant or lactating individual in a unit dosage form.

[0115] In some embodiments, the method 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 a pregnant or lactating 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 pregnant or lactating individual in a unit dosage form.

[0116] In some embodiments, the method is a method for reducing and / or preventing intestinal inflammation such as colitis, ulcerative colitis, inflammatory bowel disease, the method comprising administering to a pregnant or lactating 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 pregnant or lactating individual in a unit dosage form.

[0117] In some embodiments, the method is a method for preventing gastrointestinal motility related disorders and / or transit related disorders, the method comprising administering to a pregnant or lactating 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 pregnant or lactating 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 pregnant or lactating individual in a unit dosage form.

[0118] 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 the composition leading to more SCFA production for less gas being produced than regular milk. This phenomenon could improve gut comfort, by minimizing colonic gaz production (responsible for bloating, flatulence and discomfort) while retaining the benefit associated with bacterial fermentation in the colon (SCFA production). In a particular embodiment, the composition comprising the food ingredient 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.

[0119] Process for producing a food ingredient

[0120] In another aspect the invention relates to a method of producing a food ingredient of the invention. Accordingly, in one embodiment, the invention relates to a process for producing a food ingredient, the process comprising: a) providing an aqueous composition comprising 30-90% by weight of non-fat milk solids including lactose, niacin, folic acid and optionally iron, b) adding a beta-galactosidase to the composition c) allowing the beta-galactosidase to react for 10-240 minutes at 50-65°C; and d) heat treating the composition after step c) at a temperature of 70-150°C for 10-150 seconds

[0121] An aqueous composition comprising 30-90% by weight of non-fat milk solids including lactose may be provided in any suitable way known in the art, e.g. by concentrating milk, such as e.g. skim milk and / or whole milk, to the desired solids concentration, e.g. by evaporation or filtration, or by dissolving milk powder, such as e.g. skim milk powder and / or whole milk powder, in water to arrive at the desired solids concertation. The aqueous composition provided in step a) preferably comprises between 40 and 90% by weight of non-fat milk solids. The aqueous composition provided in step a) preferably comprises 15-45% lactose by weight, more preferably 20-45% lactose by weight. It has been found that this level of solids and / or lactose facilitates the hydrolysis of lactose and formation of GOS. In a preferred embodiment, the composition further comprises 3-20% by weight of vegetable fat, e.g. soybean oil, rapeseed oil and / or sunflower oil.

[0122] The aqueous compostion is fortified with one or more vitamins and minerals, in particular niacin, folic acid and optionally iron. A beta-galactosidase is added to the aqueous composition provided in step a). The beta-galactosidase may be any suitable beta-galactosidase. The amount of betagalactosidase added may depend on the specific enzyme, its level of activity and its formulation. The skilled person will now how to choose the amount according to the desired result. Typically, the amount will be in the order of 0.5-2% by weight of lactose in the aqueous composition. The aqueous composition may be at the desired reaction temperature when the beta-galactosidase is added, or it may be heated to the reaction temperature following the addition of the beta-galactosidase. In step b), the beta-galactosidase is allowed to react with the lactose in the aqueous composition to hydrolyse the lactose and produce GOS. The enzyme is allowed to react for 10-240 minutes at 50-65°C. It has been found that this temperature range facilitates the hydrolysis of lactose and formation of GOS.

[0123] After the beta-galactosidase has been allowed to react in step c), the composition is heat treated at 70-150°C for 10-150 seconds, preferably at 72-130°C for 10-120 seconds. The purpose of the heat treatment is to prevent substantial degradation of the GOS by further reaction of the beta-galactosidase, as well as ensuring the microbiological stability of the product, without creating excessive denaturation of protein or formation of Maillard reaction products. The food ingredient may be used directly as it is after the heat treatment, or it may e.g. be packed, stored and / or distributed for subsequent use. If the food ingredient is not spray dried, the heat treatment of step d) is preferably conducted at 140-145°C for 10-30 seconds.

[0124] In a preferred embodiment, the method comprises spray drying the composition after the heat treatment of step d). It has been found that the heat treatment may not in itself necessarily completely inactivate the beta-galactosidase, but in combination with subsequent spray drying, it ensures full inactivation of the beta-galactosidase. In this way, a more severe heat treatment that would completely inactivate the betagalactosidase, but also create unnecessary protein denaturation and formation Maillard products, can be avoided by spray drying the composition after the heat treatment to produce a dry powdered food ingredient. When the heat treatment is followed by spray drying, it is preferably conducted at 80-90°C for 10-30 second. The powdered food ingredient may further be packed and distributed, or used directly in the production of a food product, e.g. a cocoa and / or malt beverage product.

[0125] In some embodiments, the dry powdered food ingredient obtained after spray drying may be further fortified with one or more minerals, such as iron.

[0126] In a specific embodiment, the invention relates to a process for producing a food ingredient, the process comprising: a) concentrating skim milk to a solids concentration of 30-90% by weight, the skim milk comprising niacin, folic acid and optionally iron; b) adding a beta-galactosidase to the concentrated skim milk; c) allowing the beta-galactosidase to react for 10-240 minutes at 50-65°C; d) heat treating the composition after step c) at 80-90°C for 10-30 seconds; and e) spray drying the composition.

[0127] In another specific embodiment, the invention relates to a process for producing a food ingredient, the process comprising: a) providing an aqueous composition comprising 30-90% by weight of non-fat milk solids, niacin, folic acid and optionally iron, b) adding a beta-galactosidase to the composition c) allowing the beta-galactosidase to react for 10-240 minutes at 50-65°C; and d) heat treating the composition after step c) at 140-145°C for 10-30 seconds.

[0128] Cocoa and / or malt beverage powder

[0129] In one embodiment, the invention relates to a cocoa 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.

[0130] 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, such as palm oil, soybean oil, rapeseed oil, and / or sunflower 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.

[0131] Glucose, lactose and GOS are preferably derived from the food ingredient of the present invention. A cocoa and / or malt beverage powder of the invention preferably comprises 10-30% by dry weight of the food ingredient of the invention, more preferably 15-25% by dry weight of the food ingredient 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.

[0132] 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.

[0133] A cocoa and / or malt beverage powder of the invention may comprise niacin, folic acid and optionally iron, as well as any other suitable ingredients known in the art, such as e.g. vitamins, minerals, buffer salts, emulsifiers and stabilizers.

[0134] 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 co-agglomerated to produce a powder with improved solubility. 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; niacin, folic acid and optionally iron; 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 galactooligo saccharide .

[0135] Liquid cocoa and / or malt beverage product

[0136] In one embodiment, the invention 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.

[0137] 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.

[0138] 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, such as palm oil, soybean oil, rapeseed oil, and / or sunflower 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.

[0139] Glucose, lactose and GOS are preferably derived from the food ingredient of the present invention. A liquid cocoa and / or malt beverage product of the invention preferably comprises 10-30% by dry weight of the food ingredient 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.

[0140] 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.

[0141] A liquid cocoa and / or malt beverage product of the invention may comprise niacin, folic acid and optionally iron, as well as any other suitable ingredients known in the art, such as e.g. vitamins, minerals, buffer salts, emulsifiers and stabilizers.

[0142] 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.

[0143] A food ingredient of the invention may form the basis of producing a liquid cocoa and / or malt beverage product of the invention. For example, a food ingredient may be produced by the method of the invention, and after the beta-galactosidase has been allowed to react in step c), the remaining ingredients of the liquid cocoa and / or malt beverage product may be added to the ingredient and the total composition may be heat treated according to step d) of the method of the invention, preferably at 140- 145°C for 10-30 seconds.

[0144] In a preferred embodiment, the invention 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; 1-5% by weight of cocoa solids; niacin, folic acid and optionally iron; 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.

[0145] EXAMPLES

[0146] The following non-limiting examples generally illustrate the concepts underlying the embodiments disclosed herein.

[0147] Example 1: Preparation of a composition comprising milk protein and a mixture of lactose, glucose, galactose and galactooligosaccharide

[0148] Skimmed milk powder (MSK) was mixed with water to form a slurry with 60% total solids content at 60°C. 1% of a beta-galactosidase with transgalactosylase activity was added to the MSK slurry. The reaction was allowed to proceed for duration of 60 min. Pasteurization at 85°C for 18 seconds was applied to pasteurize the milk and partially inactivate enzymes before spray-drying to form dried skimmed milk powder. It was demonstrated that with spray drying, it was possible to completely inactivate the enzymes and no residual enzyme activity was detected in the final spray dried powder. The composition of the skim milk powder and the enzyme treated powder is shown in table 1.

[0149] Table 1. Composition of skim milk powder before and after treatment.

[0150] Example 2: Preparation of cocoa and malt beverage powder with enzyme-treated skimmed milk powder

[0151] The enzyme treated skimmed milk powder produced in example 1 was used in the preparation of a cocoa malt beverage powder comprising 20% skimmed milk powder, the composition is given in table 2. A reference cocoa and malt beverage powder was produced in the same way with the same composition, except that untreated skim milk powder was used instead of enzyme treated skim milk powder. The sugar composition of the product and the reference is given in table 3.

[0152] Table 2. Composition of cocoa and malt beverage powder with enzyme-treated skimmed milk powder of example 2.

[0153] Table 3. Sugar composition of cocoa and malt beverage powder with enzyme-treated skimmed milk powder and reference of example 2.

[0154] The cocoa and malt beverage powder with enzyme-treated skimmed milk powder and the reference cocoa and malt beverage powder were compared by a sensory panel. No significant differences in sweetness and body were found.

[0155] Example 3: Liquid cocoa and malt beverage product The enzyme treated skimmed milk powder produced in example 1 was used in the preparation of a liquid cocoa malt beverage product with the composition given in table 4. A reference liquid cocoa and malt beverage product was produced in the same way with the same composition, except that untreated skim milk powder was used instead of enzyme treated skim milk powder. The sugar composition of the product and the reference is given in table 5.

[0156] Table 4. Composition of liquid cocoa and malt beverage product with enzyme-treated skimmed milk powder of example 3.

[0157] Table 5. Sugar composition of liquid cocoa and malt beverage product with enzyme- treated skimmed milk powder and reference of example 3.

[0158] The cocoa and malt beverage powder with enzyme-treated skimmed milk powder and the reference cocoa and malt beverage powder were compared by a sensory panel. No significant differences in sweetness and body were found. Example 4

[0159] 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 6 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 gastro-intestinal 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 7. In other experiments, lactose (+ / - GOS) was added to the fermenters to mimic human lactose malabsorption (LM); final concentrations of lactose are presented in Table 7. 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).

[0160] 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.

[0161] Table 6: Active composition

[0162] Table 7: Final concentrations of Lactose and GOS before in-vitro batch fermentation. Results

[0163] 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.

[0164] 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 dimethylglycine on gastric ulcers in rats. J Pharm Pharmacol. 2000;52:1519-1522).

[0165] FIG. 4 shows the decrease in gas production (-16%) after 24h fermentation of the Active Composition by comparison to regular milk using batch fermentation with simulated lactose malabsorption (LM). Decrease in gas production is associated with less bloating, less flatulence, potentially leading to an improved gut comfort.

[0166] 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 (EM). 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.

[0167] 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 (EM). The Active Composition produces less gas for a similar quantity of SCFA produced.

[0168] FIG. 7 represents gas production after 24 h fermentation of the Active Composition using batch fermentation with (EM) 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. Example 5

[0169] The inventors examined the effect of administering the composition disclosed herein, versus lactose-free milk, in 26 healthy adults. Table 8 shows the composition administered versus the control.

[0170] Table 8: Active composition versus control composition administered to individuals

[0171] 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.

[0172] 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.

[0173] 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 poly amines can be performed using various analytical approaches. Pre-column derivatization with dansyl-chloride and 9-fhiorenylmethylchloroformate 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 poly amines. 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.

[0174] Results.

[0175] In fecal samples, cadaverine concentrations only increased in the control group but decreased in the intervention group (p=0.018) (Fig. 8).

[0176] 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 et al., Journal of Food Protection, 2021) and thereby could support these adverse effects.

[0177] Example 6: Preparation of the food ingredient of the invention

[0178] A variant of the food ingredient of the invention is prepared as follow. Fresh milk, vegetable oil, whey protein powder, some minerals and vitamins are mixed with water to form a slurry with 60% total solids content at 60°C. About 1% of a betagalactosidase with transgalactosylase activity is added to the slurry. The reaction is allowed to proceed for duration of 60 min. Pasteurization at 85°C for 18 seconds is applied to pasteurize the milk and partially inactivate enzymes before spray-drying. With spray drying, it is possible to completely inactivate the enzymes and no residual enzyme activity was detected in the final spray dried food powder. Some minerals and probiotics are added by dry mixing with spray dried powder to form a food ingredient of the invention.

[0179] The composition of a variant of the food ingredient of the invention in powder form is provided in table 9. The disclosed food ingredient is particularly designed to benefit pregnant or lactating individuals.

[0180] Table 9. Composition of a variant of the food ingredient of the invention.

Claims

Claims1. A food ingredient comprising:20-40 % by dry weight of milk protein; niacin; folic acid; optionally iron; and32-55% by dry weight of a mixture of lactose, glucose, galactose and galactooligosaccharide, said mixture containing: 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 galactooligo saccharide .

2. A food ingredient according to claim 1 further comprising 0.5-30% by dry weight of milk fat and / or mineral derived from milk.

3. A food ingredient according to any one of claims 1 or 2 further comprising 3-20% by dry weight of vegetable oil.

4. A food ingredient according to any one of claims 1 to 3 comprising greater than 0.001000% by dry weight of niacin, preferably comprising greater than 0.003% by dry weight of niacin, more preferably comprising greater than 0.005% by dry weight of niacin, even more preferably comprising about 0.0073% by dry weight of niacin.

5. A food ingredient according to any one of claims 1 to 4 comprising greater than 0.0002% by dry weight of folic acid, preferably greater than 0.0003% by dry weight of folic acid, more preferably about 0.0004% by dry weight of folic acid.

6. A food ingredient according to any one of claims 1 to 5 comprising greater 0.01% by dry weight of iron, preferably greater than 0.015% by dry weight of iron, more preferably about 0.02% by dry weight of iron.

7. A food ingredient according to any one of claims 1 to 6 comprising greater than 0.001% by dry weight of manganese, preferably greater than 0.0014% by dry weight of manganese, more preferably about 0.0018% by dry weight of manganese.

458. A food ingredient according to any one of claims 1 to 7 further comprising at least one of: Vitamin C, Vitamin D, Vitamin E, Vitamin Bl, Vitamin B2, Vitamin B6, Vitamin B12, Pantothenic acid, Choline, zinc, calcium, selenium or a combination thereof.

9. A food ingredient according to any one of claims 1 to 8, wherein the food ingredient is a modified milk or a modified milk powder.

10. A method for preventing and / or treating gastrointestinal disorders and / or improving digestive comfort, the method comprising administering to a pregnant or lactating individual in need thereof a low sugar, low lactose, milk-based composition comprising galactooligosaccharide.

11. The method of claim 10 wherein the low sugar, low lactose, milk-based composition comprises: milk protein, preferably at 20-40 % by dry weight of the composition; niacin; folic acid; optionally iron; 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.

12. A method for producing a food ingredient, the process comprising: a) providing an aqueous composition comprising 30-90% by weight of non-fat milk solids including lactose, niacin, folic acid and optionally iron, b) adding a beta-galactosidase to the composition c) allowing the beta-galactosidase to react for 10-240 minutes at 50-65°C; and d) heat treating the composition after step c) at a temperature of 70-150°C for 10-150 seconds.4613. The method of claim 12 wherein the aqueous composition provided in step a) comprises 15-45% of lactose by weight.

14. The method of any one of claims 12 or 13 further comprising spray drying the composition after step d).

15. The method of any one of claims 12-14 wherein skim milk powder is dissolved in water to provide the composition of step a).

16. The method of any one of claims 12-14 wherein skim milk is concentrated by evaporation and / or filtration to provide the composition of step a).

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