MCT formulations for improving cognitive function, and methods for manufacturing and using such formulations.

Abstract

The present disclosure provides a composition containing medium-chain triglycerides (MCTs) and a food matrix in which at least a portion of the MCTs is incorporated. The composition includes a specific gum that provides stability and a pleasant mouthfeel. The composition can improve cognitive function, support memory and / or regeneration, provide energy and / or ketones to the brain, and / or prevent and / or treat mild cognitive impairment (MCI).

Description

[Background Art]

[0001]

[0001] The present disclosure generally relates to a composition comprising medium-chain triglycerides (MCT), and further comprising a food matrix in which at least a portion of said MCT is incorporated. The composition comprises a specific gum that provides stability and good mouthfeel. The composition can improve cognitive function, support memory and / or regeneration, provide energy and / or ketones to the brain, and / or prevent and / or treat mild cognitive impairment (MCI).

[0002]

[0002] The two main ketones, β-hydroxybutyric acid (BHB) and acetoacetic acid (AcA), are important alternative energy sources for extrahepatic tissues such as the brain, heart, or skeletal muscle. Furthermore, there is growing evidence suggesting that ketones may also play a direct or indirect role in signal transduction. Products aimed at increasing blood ketones may have therapeutic effects in a number of conditions including, but not limited to, epilepsy, neurological and neurodegenerative diseases, heart failure, inborn errors of metabolism, obesity, type 2 diabetes, cancer, exercise performance, and non-alcoholic fatty liver disease (NAFLD) such as non-alcoholic steatohepatitis (NASH).

[0003]

[0003] BHB and AcA are actively transported into the brain by monocarboxylic acid transporter 1 (MCT1), and as a result, brain concentration is directly proportional to blood concentration. Therefore, products that result in more sustained plasma ketone concentrations would be expected to have a longer duration of effect (longer plasma ketone half-life T k 1 / 2 ) compared to products with a shorter duration of increased blood ketones (shorter half-life).

[0004]

[0004] Medium-chain triglycerides (MCTs) are efficient ketone precursors when administered orally as a bolus. MCTs are rapidly digested, and the free medium-chain fatty acids (MCFAs) produced by digestion are efficiently absorbed by the portal vein without going through the normal digestion and absorption process of long-chain fatty acids, and are transported to the liver where most of them are metabolized into ketones. These specific formulations may affect the efficiency of ketone body production and gastrointestinal tolerability.

[0005]

[0005] Brain energy rescue is a promising strategy for reducing cognitive decline in mild cognitive impairment (MCI) and Alzheimer's disease (AD). Impairment in certain cognitive functions, such as episodic memory and language skills, is a precursor to MCI and AD. In individuals at high risk of early-onset or late-onset AD, brain glucose uptake is already reduced before the onset of mild cognitive deficits associated with MCI. Thus, there is a deficit of approximately 10% in pre-onset brain energy (glucose), which is sufficient to contribute to cognitive decline in MCI.

[0006]

[0006] MCTs have been included for various purposes in food compositions for animals or humans. MCTs have been added to "wet" foods such as canned foods and other prepared foods, and have also been used to some extent in dry foods as a coating in or on dry foods. Practical considerations seem to limit the amount of MCTs that can be used, especially in dry foods. For example, a considerable amount of MCTs can be incorporated into wet food compositions, but this can lead to separation, flavor problems, and other issues in the wet food composition. In dry foods such as extruded and baked products, compositions are subject to strict limitations, in many products, that prevent the amount of MCTs from exceeding a certain threshold. Therefore, MCTs have been used as coatings or surface coatings for such foods. Surface coatings such as coatings present practical problems during packaging and reduce consumer appeal. For example, if a coating or mixing is required at the time of consumption, or if the dry food has an oily appearance or feel, consuming or administering such food compositions becomes more cumbersome. In addition, the presence of large amounts of MCTs that are not integrated into the food matrix can lead to problems with the palatability and acceptability of such food compositions.

[0007]

[0007] Chemically, MCTs consist of a triglyceride group having three esterified medium-chain (approximately 6-12 carbon) fatty acid molecules in a glycerol molecule. Such a composition differs physically and chemically from most fats typically used in food technology for formulating food products. MCTs are relatively short and tend to exhibit different functional properties during processing compared to their longer-chain counterparts. For example, unlike many other functional fats used by food technologists, MCTs are typically liquid at room temperature.

[0008]

[0008] In addition to having various properties that must be considered when formulating food compositions, MCTs also present another challenge for formulaters. When attempting to formulate a food with a specific macronutrient content, the addition of MCTs may necessitate the exclusion of other fat sources. Many food compositions are formulated so that fat provides a noticeable feeling of fullness, flavor, mouthfeel, texture, and other desirable functional qualities that consumers seek in a particular food product. Thus, since formulating food products involves complex interactions between various raw materials or components, simply replacing one fat with another is not a practical solution. In fact, MCT-based formulas on the market may have sedimentation and a poor mouthfeel, which is undesirable for consumers. [Overview of the Initiative]

[0009]

[0009] Surprisingly and unexpectedly, the inventors have discovered that gum, in particular certain gums, can provide stability to MCT-based formulas and a good mouthfeel by reducing sedimentation.

[0010]

[0010] Accordingly, in non-limiting embodiments, the present disclosure provides compositions comprising: medium-chain triglycerides (MCTs); and at least one gum selected from the group consisting of xanthan gum, gellan gum, carrageenan (iota), carboxymethylcellulose (CMC), and microcrystalline cellulose (MCC).

[0011] At least one of the gums may contain gellan gum and carrageenan iota; or at least one of carboxymethylcellulose (CMC) or microcrystalline cellulose (MCC).

[0012]

[0011] MCT may contain 51% to 90% by weight of octanoic acid. MCT may contain 51% to 70% by weight of octanoic acid. MCT may contain 71% to 90% by weight of octanoic acid. MCT may contain 60% by weight of octanoic acid. MCT may further contain decanoic acid. In one embodiment, the weight ratio of octanoic acid to decanoic acid is about 60:40.

[0013]

[0012] The composition may further contain at least 1% by weight of milk protein concentrate (MPC), for example, about 5% by weight or about 7.5% by weight of MPC. The composition may further contain at least 4g of protein per 100g of composition. The composition may further contain protein at a weight ratio of at least 0.1g of protein per 1.0g of MCT. The composition may further contain protein at a weight ratio of at least 0.4g of protein per 1.0g of MCT.

[0014]

[0013] The composition may optionally further contain (i) carbohydrates in a weight ratio of at least 0.1 g per 1.0 g of MCT, and / or (ii) lipids other than MCT in a weight ratio of at least 0.1 g per 1.0 g of MCT.

[0015]

[0014] The composition may have a pH of about 6.6 to about 7.5.

[0016]

[0015] The composition may be in a form selected from the group consisting of beverages, mayonnaise, salad dressings, margarine, low-fat spreads, dairy products, cheese spreads, processed cheese, dairy desserts, flavored milk, cream, fermented dairy products, cheese, butter, condensed milk products, ice cream mixes, soy products, pasteurized liquid eggs, bakery products, confectionery products, candy bars, chocolate bars, high-fat bars, liquid emulsions, spray-dried powders, freeze-dried powders, UHT puddings, pasteurized puddings, gels, jellies, yogurts, foods having fat-based or water-containing fillings, and combinations thereof.

[0017]

[0016] The composition may be an oral nutritional composition, a nutritional supplement, an oral nutritional supplement, a medical food, a supplement, a food product, or a food for special medical purposes (FSMP).

[0018]

[0017] The composition may be in the form of a solid powder, powder stick, capsule, or solution.

[0019]

[0018] In another non-limiting embodiment, the Disclosure also provides a method for improving the sedimentation and / or mouthfeel properties of a composition comprising a medium-chain triglyceride (MCT), the step of providing the composition with at least one gum selected from the group consisting of xanthan gum, gellan gum, carrageenan (iota), carboxymethylcellulose (CMC), and microcrystalline cellulose (MCC).

[0020]

[0019] In other embodiments, the composition may be used in a method to support memory and / or recall in an individual; a method to provide energy and / or ketones to the brain of an individual; or a method to prevent and / or treat mild cognitive impairment (MCI) in an individual.

[0021]

[0020] The individual may have mild cognitive impairment (MCI). The individual may have at least one of the following: memory impairment, cognitive impairment including lack of sound decision-making ability and impaired judgment, depression, or anxiety disorder. The individual may have or be afflicted with a brain energy deficiency state or disease, neurological condition, and / or cognitive impairment.

[0022]

[0021] In some embodiments, the composition may be administered to individuals having a condition selected from the group consisting of epilepsy, neurological disorders, neurodegenerative diseases, heart failure, congenital metabolic disorders, obesity, type 2 diabetes, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), cancer, cerebral energy deficiency, migraine, memory impairment, age-related memory impairment, brain injury, stroke, amyloid lateral sclerosis, multiple sclerosis, cognitive impairment, mild cognitive impairment (MCI), post-intensive care cognitive impairment, age-related cognitive impairment, Alzheimer's disease, Parkinson's disease, Huntington's disease, congenital metabolic disorders, bipolar disorder, schizophrenia, and combinations thereof.

[0023]

[0022] Further features and advantages will be described in the following embodiments for carrying out the invention and will become apparent therefrom. [Modes for carrying out the invention]

[0024]

[0023] Definition

[0024] The following are some definitions. However, definitions may also be found in the "Embodiments" section below, and the above heading "Definitions" does not mean that such disclosures in the "Embodiments" section are not definitions.

[0025]

[0025] All percentages are given by weight relative to the total weight of the composition unless otherwise specified. Similarly, all ratios are given by weight unless otherwise specified. As used herein, “about,” “approximately,” and “substantially” are understood to mean a number within a range, for example, within the range of -10% to +10% of the reference figure, preferably within the range of -5% to +5% of the reference figure, more preferably within the range of -1% to +1% of the reference figure, and most preferably within the range of -0.1% to +0.1% of the reference figure.

[0026]

[0026] Furthermore, it should be understood that all numerical ranges in the present specification include all integers, whole numbers or fractions within said ranges. Furthermore, it should be construed that these numerical ranges support claims directed to any number or subset of numbers within said ranges. For example, a disclosure of 1 to 10 should be construed to support ranges such as 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, and the like.

[0027]

[0027] As used in the present specification and the appended claims, singular nouns include the plural unless the context clearly dictates otherwise. Therefore, references to "a", "an" and "the" generally encompass the plural of each respective term. For example, reference to "an ingredient" or "a method" includes a plurality of such "ingredients" or "methods". The term "and / or" when used in the context "X and / or Y" should be interpreted as "X" or "Y" or "X and Y". Similarly, "at least one of X or Y" should be interpreted as "X" or "Y" or both "X and Y".

[0028]

[0028] Similarly, the words "comprise", "comprises", and "comprising" should be construed as non-exclusive and capable of including other elements. Likewise, the terms "include", "including" and "or" should all be construed as capable of including other elements, unless such an interpretation is clearly precluded by context. However, embodiments provided by the present disclosure may optionally exclude any element not specifically disclosed herein. Accordingly, a disclosure of an embodiment defined using the term "comprising" is also a disclosure of embodiments "consisting essentially of" and "consisting of" the disclosed components.

[0029]

[0029] When used herein, the term “example,” especially when followed by a list of terms, is merely illustrative and descriptive, and should not be considered exclusive or comprehensive. All embodiments disclosed herein can be combined with any other embodiments disclosed herein unless otherwise expressly indicated.

[0030]

[0030] The term "animal" includes, but is not limited to, mammals such as rodents, aquatic mammals, domestic animals such as dogs and cats, livestock such as sheep, pigs, cattle and horses, and humans. Wherever the terms "animal," "mammal," or their plural forms are used, these terms also apply to any animal that can obtain the effects indicated or intended to be indicated in that context, for example, an animal that benefits from ketones. The term "individual" is often used herein to refer to a human, but this disclosure is not limited to humans. Therefore, the term "individual" refers to any animal, mammal, or human that can benefit from the methods and compositions disclosed herein.

[0031]

[0031] Relative terms such as “improved,” “increased,” and “enhanced” describe the characteristics or effects of a composition containing MCT in a food matrix (disclosed herein) relative to a composition having the same formulation except for a lower amount of protein and / or carbohydrates. The terms “maintained” and “sustained” mean that an individual’s characteristics, such as neurological health, cognitive function, or motor ability, are approximately the same as the average level of the previous week, the average level of the previous month, or the average level of the previous year.

[0032]

[0032] As used herein, the terms “to treat” and “to treat” mean administering a composition disclosed herein to an object having a condition for the purpose of attenuating, reducing or improving at least one symptom associated with that condition, and / or delaying, reducing or preventing the progression of that condition. The terms “to prevent” and “prevent” mean administering a composition disclosed herein to an object not exhibiting any symptoms of that condition in order to suppress or prevent the onset of at least one symptom associated with that condition.

[0033]

[0033] As used herein, “cognitive function” means any mental process that involves symbolic operations, such as perception, memory (free recall), executive function, processing speed, attention, comprehension of conversation, speech production, language, reading comprehension, image creation, learning, and reasoning, preferably at least memory.

[0034]

[0034] The terms “food,” “food product,” and “food composition” mean a composition intended for consumption by an individual, such as a human, and which provides the individual with at least one nutrient. The term “food matrix” means the physical structure of a food composition, which may be liquid, solid, or semi-solid in various embodiments. “Food” and related terms include any food, feed, snack, supplement, treat, meal substitute, or alternative diet, whether intended for humans or animals. Animal food includes food or feed intended for any domesticated or wild species. In a preferred embodiment, animal food refers to a nutritionally complete food or meal composition, such as pelletized food, extruded food, or dried food. Examples of such animal food include extruded pet food, such as food for dogs and cats.

[0035]

[0035] The term “Foods for Special Medical Use (FSMPs)” refers to formula foods that are specially processed and prepared to meet the special nutritional or dietary needs of people with dietary restrictions, digestive or absorptive disorders, metabolic disorders, or certain diseases. Such foods are used alone or in combination with other foods under the guidance of a physician or clinical dietitian. FSMPs are foods for special purposes and not medicines, and are not typically consumed by healthy individuals. FSMPs are specially developed by clinicians and dietitians based on scientific facts from extensive medical research.

[0036]

[0036] The term "oral nutritional supplements (ONS)" refers to sterile liquids, semi-solids, or powders that provide macronutrients and micronutrients. ONS are widely used in emergency and social health settings for individuals who cannot meet their nutritional requirements with oral diets alone.

[0037]

[0037] Triglycerides (also known as triacylglycerols or triacylglycerides) are esters derived from glycerol and three fatty acids. The fatty acids may be unsaturated or saturated. Fatty acids that are not bound to other molecules are called free fatty acids (FFAs).

[0038]

[0038] Medium-chain triglycerides (MCTs) are triglycerides in which all three fatty acid portions of the molecule are medium-chain fatty acids. As defined herein, medium-chain fatty acids (MCFAs) are fatty acids having 6 to 14 carbon atoms, preferably 6 to 12 carbon atoms. Medium-chain fatty acids having 8 carbon atoms may be referred to herein as "C8 fatty acids" or "C8". Medium-chain fatty acids having 10 carbon atoms may be referred to herein as "C10 fatty acids" or "C10".

[0039]

[0039] The term "fatty acid portion" refers to the MCT portion derived from fatty acids in the esterification reaction with glycerol. In an unspecified example, the esterification reaction between glycerol and octanoic acid alone produces MCT containing an octanoic acid portion. In another unspecified example, the esterification reaction between glycerol and decanoic acid alone produces MCT containing a decanoic acid portion.

[0040]

[0040] Octanoic acid (also known as caprylic acid) is a saturated fatty acid with the formula CH3(CH2)6COOH.

[0041]

[0041] Decanoic acid (also known as capric acid) is a saturated fatty acid with the formula CH3(CH2)8COOH.

[0042]

[0042] Embodiment

[0043] One aspect of the present disclosure is a composition comprising medium-chain triglycerides (MCTs) with improved sedimentation and mouthfeel characteristics. The composition may be an oral nutritional composition, a dietary supplement, an oral nutritional supplement, a medical food, a supplement, a food product, or a food for special medical purposes (FSMP). The composition may be in the form of a solid powder, a powder stick, a capsule, or a solution.

[0043]

[0044] The composition preferably comprises a food matrix containing at least a portion of MCT, and a particularly preferred non-limiting embodiment of the composition is a liquid such as a beverage. The composition may also be in the form of a powder that can be easily dissolved in a liquid such as water before ingestion.

[0044]

[0045] MCT contains three fatty acid moieties, each independently having 6-12, 6-11, 6-10, 7-12, 7-11, 7-10, 8-12, 8-11, or 8-10 carbon atoms. In one embodiment, at least a portion of the MCT contains one or more octanoic acid moieties. In one embodiment, at least a portion of the MCT contains one or more decanoic acid moieties. In one embodiment, at least a portion of the MCT contains one or more octanoic acid moieties and one or more decanoic acid moieties.

[0045]

[0046] In one embodiment, MCT contains 51% to 90% by weight of octanoic acid. In one embodiment, MCT contains 51% to 70% by weight of octanoic acid. In one embodiment, MCT contains 71% to 90% by weight of octanoic acid. In one embodiment, MCT contains 60% by weight of octanoic acid. In one embodiment, the weight ratio of octanoic acid to decanoic acid is 60:40.

[0046]

[0047] The composition may further contain at least one MCT-retaining component, which may be, for example, starch, fiber, gluten meal, protein, emulsifier, stabilizer, gum, and / or gelling agent. The MCT-retaining component may include one or more components that can alter the structure of water in the composition, components that can bind to fat in the food composition, and / or components that can emulsify or stabilize fat in the food composition. Such components may include components that can bind to water in the food matrix, bind to fat, emulsify fat, stabilize a water-fat emulsion, or similarly maintain MCT associated with the food matrix. Including one or more such components can increase, for example, the actual retention of MCT in the food matrix, and in some embodiments, can result in improvements to other functional properties, such as maintaining desirable density, volume, texture, hardness, or crispness in foods such as extruded food compositions.

[0047]

[0048] Such components may originate from any source, whether natural or synthetic. Natural sources include all such sources, whether natural animals, plants, or microorganisms. Starch, or starch-like molecules, and gums may also originate from various photosynthetic sources in the plant kingdom or microbial kingdom.

[0048]

[0049] For example, the composition may optionally further contain gum and / or an emulsifier. By including gum and / or an emulsifier, a composition with improved sedimentation and mouthfeel properties can be provided. The gum may include xanthan gum, gellan gum, carrageenan iota, and / or cellulose gel / gum. Preferably, the composition includes a blend of gellan gum and iotacarrageenan; and / or cellulose gel / gum, such as carboxymethylcellulose (CMC) and / or microcrystalline cellulose (MCC). In one embodiment, the composition may include a blend of about 85% by weight of MCC and about 15% by weight of CMC, as in some Avicel® products. The emulsifier may include, for example, soy lecithin, sunflower lecithin, or one or more monoglycerides and diglycerides.

[0049]

[0050] Gum and / or emulsifiers can stabilize MCT oil by reducing or avoiding sedimentation and excessive creaming of the composition when dissolved in liquid form or, in the case of dry form, in a fluid (e.g., water). For example, the composition may contain a protein that can emulsify at least a portion of the MCT oil, and the added gum may have the effect of keeping the protein suspended, thereby preventing sedimentation. The gum can create a smooth mouthfeel and avoid chalkiness in the oral cavity, which can be negatively perceived in terms of sensory content. Furthermore in this regard, since the protein can function as an emulsifier for the MCT oil, any additional emulsifiers can be optionally omitted, and the gum can stabilize the protein and prevent its sedimentation.

[0050]

[0051] In one embodiment, the composition is administered to an individual in such a way that it provides at least about 5 g of MCT per serving, for example, at least about 10 g of MCT, for example, about 15 g of MCT. In one embodiment, the composition is administered to an individual in a daily dose containing about 15 g to about 45 g of MCT; preferably, in a daily dose containing about 30 g of MCT. In one embodiment, at least two servings of the composition are administered daily, each serving containing about 15 g of MCT, preferably two servings of the composition are administered daily, although some embodiments may contain more than two servings of the composition.

[0051]

[0052] The composition may further contain protein, which may be milk protein concentrate (MPC). The composition may contain at least about 1% by weight of MPC, for example, at least about 2% by weight of MPC, about 2% to about 20% by weight, about 2% to about 15% by weight, about 2% to about 10% by weight, about 2% to about 6% by weight, about 2% to about 5% by weight, about 5% to about 8% by weight, about 5% to about 7.5% by weight, about 5% by weight, or about 7.5% by weight of MPC.

[0052]

[0053] The weight ratio of protein to MCT may be at least about 0.1g of protein per 1.0g of MCT, preferably at least about 0.4g of protein per 1.0g of MCT, more preferably at least about 0.8g of protein per 1.0g of MCT, more preferably at least about 1.0g of protein per 1.0g of MCT, even more preferably at least about 1.5g of protein per 1.0g of MCT, and most preferably at least about 1.7g of protein per 1.0g of MCT.

[0053]

[0054] Optionally, in embodiments of compositions having a high protein content, for example, more than 7.5% MPC, the composition may further contain a stabilizer (which may be a stabilizing mineral such as potassium citrate). Non-limiting examples of suitable stabilizers include one or more citrates and / or one or more phosphates that can bind to free magnesium and free calcium to stabilize the protein. Additionally or alternatively, preheating can denature the protein (e.g., whey) before UHT.

[0054] Optionally, the composition may further contain carbohydrates and / or other lipids in addition to MCT.

[0055]

[0055] When carbohydrates are present, the weight ratio of carbohydrates to MCT is preferably at least about 0.3g of carbohydrates per 1.0g of MCT, preferably at least about 1.0g of carbohydrates per 1.0g of MCT, more preferably at least about 2.0g of carbohydrates per 1.0g of MCT, even more preferably at least about 3.0g of carbohydrates per 1.0g of MCT, even more preferably at least about 4.0g of carbohydrates per 1.0g of MCT, and most preferably at least about 4.7g of carbohydrates per 1.0g of MCT.

[0056]

[0056] If lipids other than MCT are present, the weight ratio of lipids other than MCT to MCT is preferably at least about 0.1g of lipids per 1.0g of MCT, at least about 0.2g of lipids per 1.0g of MCT, preferably at least about 0.3g of lipids per 1.0g of MCT, at least about 0.4g of lipids per 1.0g of MCT, at least about 0.6g of lipids per 1.0g of MCT, at least about 0.8g of lipids per 1.0g of MCT, or at least 1.0g of lipids per 1.0g of MCT. In one embodiment, if lipids other than MCT are present, the lipids other than MCT may be present with a ratio of lipids other than MCT to MCT of 0.1:2.0 to 2.0:1.0, preferably 0.1:1.0 to 1.0:2.0.

[0057]

[0057] MCT is preferably 1 to 50% by weight of the composition, for example, 1 to 30% by weight, 1 to 10% by weight, 2 to 10% by weight, 3 to 10% by weight, 4 to 10% by weight, 5 to 10% by weight, 6 to 10% by weight, 7 to 10% by weight, or 8 to 10% by weight of the composition. In embodiments in which the composition is a liquid, the composition may contain at least about 40 g of MCT per liter of liquid, preferably at least about 50 g of MCT per liter of liquid, more preferably at least about 75 g of MCT per liter of liquid, even more preferably at least about 100 g of MCT per liter of liquid, and most preferably at least about 120 g of MCT per liter of liquid. MCT may be present in the liquid at a level of up to about 250 g per liter of liquid, preferably up to about 200 g of MCT per liter of liquid, more preferably up to about 175 g of MCT per liter of liquid, and most preferably up to about 150 g of MCT per liter of liquid.

[0058]

[0058] In one embodiment, the composition may contain at least about 4.0 g of protein per 100 g of composition, for example, about 4.2 g of protein per 100 g of composition, about 6.0 g of protein per 100 g of composition, at least about 6.0 g of protein per 100 g of composition, about 6.3 g of protein per 100 g of composition, about 6.5 g of protein per 100 g of composition, at least about 6.5 g of protein per 100 g of composition, or at least about 6.8 g of protein per 100 g of composition.

[0059]

[0059] In embodiments in which the composition is a liquid, the composition may contain at least about 40 g of protein per liter of liquid, for example, about 42 g of protein per liter of liquid, about 60 g of protein per liter of liquid, at least about 60 g of protein per liter of liquid, about 63 g of protein per liter of liquid, about 65 g of protein per liter of liquid, at least about 65 g of protein per liter of liquid, or at least about 68 g of protein per liter of liquid.

[0060]

[0060] In embodiments where the composition is a liquid, the composition may contain at least about 36 g of carbohydrates per liter of liquid, preferably at least about 50 g of carbohydrates per liter of liquid, more preferably at least about 75 g of carbohydrates per liter of liquid, even more preferably at least about 100 g of carbohydrates per liter of liquid, even more preferably at least about 150 g of carbohydrates per liter of liquid, and most preferably at least about 188 g of carbohydrates per liter of liquid.

[0061]

[0061] Preferably, the composition contains one or more natural sources that provide at least a portion of the MCT. Non-limiting examples of suitable natural sources of MCT include coconut, coconut oil, palm kernel, and palm kernel oil. For example, decanoic acid and octanoic acid account for about 5-8% and 4-10% of the fatty acid composition of coconut oil, respectively.

[0062]

[0062] Additionally or alternatively, at least a portion of the MCT can be synthesized by esterification of glycerol with one or more medium-chain fatty acids (MCFAs) having a tail consisting of 6 to 12 carbon atoms. For example, a homotriglyceride containing three fatty acid moieties, each having 8 carbon atoms, can be synthesized by esterification of glycerol with a C8 fatty acid (e.g., octanoic acid), and a homotriglyceride containing three fatty acid moieties, each having 10 carbon atoms, can be synthesized by esterification of glycerol with a C10 fatty acid (e.g., decanoic acid).

[0063]

[0063] In one embodiment, the composition comprises MCT having at least one octanoic acid moiety or decanoic acid moiety, and the composition is free from or substantially free from any other triglycerides. As used herein, the term "free from any other triglycerides" means that the composition is free from any triglycerides that do not contain at least one octanoic acid moiety or decanoic acid moiety. As used herein, the term "substantially free from any other triglycerides" means that the composition may contain trace amounts of other triglycerides, i.e., less than 5 mol%, preferably less than 3 mol%, more preferably less than 2 mol%, even more preferably less than 1 mol%, or most preferably less than 0.5 mol% of other triglycerides.

[0064]

[0064] After oral absorption, MCTs are metabolized to free fatty acids and then to ketones. Free fatty acids are first metabolized to β-hydroxybutyrate (BHB) and then to acetoacetate (AcA). Depending on the MCTs utilized, MCFAs and ketones may be produced in body fluids in varying amounts, and these molecules can be used as an alternative energy source to glucose or to supplement energy derived from glucose.

[0065]

[0065] Ketones can be transported to the brain, for example, by monocarboxylic acid transporter 1 (MCT1), where they are mainly metabolized by neurons. Free fatty acids, such as C8 free fatty acids and C10 free fatty acids, can reach the brain by diffusion, where they are mainly metabolized by astrocytes.

[0066]

[0066] Oral administration of the composition to a subject brings one or more of ketones, C8 fatty acids, or C10 fatty acids into the subject's body fluids. The subject's exposure to ketones and / or specific fatty acids (e.g., C8 or C10 fatty acids) can be quantified by measuring the levels of ketones and / or specific fatty acids in the subject's plasma, for example, over 8 hours after oral administration. The subject's exposure to ketones and / or specific fatty acids can be calculated by determining the area under the curve (AUC) on a plot of ketone and / or fatty acid concentrations in body fluids (e.g., plasma) against time (e.g., more than 8 hours or more than 24 hours). Before analysis, the body fluids can be treated with an organic solvent to precipitate proteins and reconstituted with a solvent suitable for mass spectrometry (MS). Ketone body and medium-chain fatty acid levels can be evaluated using liquid chromatography-LC-MS coupled with high-resolution mass spectrometry. In particular, the concentrations of β-hydroxybutyrate (BHB), acetoacetic acid (AcA), and certain fatty acids can be quantitatively measured using external calibration methodology.

[0067]

[0067] In one embodiment, the protein is selected from the group consisting of milk protein, plant protein, animal protein, artificial protein, or a combination thereof.

[0068]

[0068] Examples of milk proteins include casein, casein hydrolysates, casein salts (e.g., all forms including sodium caseinate, calcium caseinate, potassium caseinate), whey hydrolysates, whey (e.g., all forms including concentrates, isolates, and desalted products), milk protein concentrates, and milk protein isolates. Examples of plant proteins include soy protein (e.g., all forms including concentrates and isolates), pea protein (e.g., all forms including concentrates and isolates), and canola protein (e.g., all forms including concentrates and isolates). Other commercially available plant proteins include wheat and fractionated wheat protein, corn and its fractions including zein, rice, oats, potatoes, peanuts, and any protein derived from kidney-shaped beans, buckwheat, lentils, and legumes. Examples of animal proteins include beef, poultry, fish, lamb, seafood, pork, eggs, or combinations thereof.

[0069]

[0069] In one embodiment, the protein source is a milk protein. In one embodiment, the milk protein is selected from the group consisting of casein, casein salts, casein hydrolysates, whey, whey hydrolysates, milk protein concentrates, milk protein isolates, or combinations thereof.

[0070]

[0070] The composition may further contain one or more additional components, such as minerals; vitamins; salts; or functional additives, for example, palatants, colorants, emulsifiers, antimicrobial agents, or other preservatives. Non-limiting examples of minerals suitable for the compositions disclosed herein include calcium, phosphorus, potassium, sodium, iron, chloride, boron, copper, zinc, magnesium, manganese, iodine, selenium, chromium, molybdenum, fluoride, and any combination thereof. Non-limiting examples of vitamins suitable for the compositions disclosed herein include water-soluble vitamins (such as thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin (vitamin B7), myo-inositol (vitamin B8), folic acid (vitamin B9), cobalamin (vitamin B12), and vitamin C) and fat-soluble vitamins (such as vitamins A, D, E, and K), including their salts, esters, or derivatives. Inulin, taurine, carnitine, amino acids, enzymes, coenzymes, and any combination thereof may be included in various embodiments.

[0071]

[0071] In one embodiment, the composition further comprises at least one of pyridoxine (vitamin B6), folic acid (vitamin B9), or cobalamin (vitamin B12). Folic acid (vitamin B9) supplementation is beneficial for memory, better cognitive function, and psychomotor speed. Vitamin B 12 Deficiency is mainly associated with changes in absorption in the elderly. Vitamin B 12 Folic acid deficiency can cause symptoms such as low mood, fatigue, and irritability. Furthermore, folic acid and vitamin B 12 It is required for the synthesis of neurotransmitters.

[0072]

[0072] The composition may further contain one or more active ingredients that promote or maintain the overall health of the nervous system or further improve cognitive function. Examples of such active ingredients include choline, phosphatidylserine, alpha-lipoic acid, CoQ10, acetyl-L-carnitine, omega-3 fatty acids, and herbal extracts (such as ginkgo biloba, Bacopa monniera, Convolvulus pluricaulis, and snowdrop).

[0073]

[0073] In some embodiments, the composition has a pH of about 6.6 to about 7.5, preferably about 6.7 to about 7.0, about 6.75 to about 7.0, more preferably about 6.8 to about 7.0, for example, about 6.8, about 6.85, about 6.9, about 6.95, about 6.99, and about 7.0.

[0074]

[0074] The pH of the composition can be adjusted by adding an acid or alkali. For example, citric acid can be used to lower the pH, and sodium hydroxide and / or potassium hydroxide can be used to raise the pH of the composition.

[0075]

[0075] The composition may be in the form of a medical food. As used herein, the term “medical food” means a food product that is specially formulated for the dietary management of a medical disease or condition. For example, a medical disease or condition may have specific nutritional needs that cannot be met by a normal diet alone. Medical foods may be administered under medical supervision. Medical foods may be administered orally or as enteral nutrition. The term “enteral nutrition” means a product intended to deliver nutrients directly into the gastrointestinal tract of a subject through a feeding tube. Enteral nutrition may be administered, for example, by a feeding tube placed through the subject’s nose (such as a nasogastric tube, nasoduodenal tube, and nasojejunal tube) or by a feeding tube placed directly into the subject’s abdomen (such as a gastrostomy tube, gastrojejunostomy tube, or jejunal tube).

[0076]

[0076] The composition may be in the form of a nutritional composition or a nutritional supplement. The term "nutritional supplement" refers to a product intended to supplement the target person's usual diet.

[0077]

[0077] The composition may be in the form of a complete nutrition product. The term "complete nutrition product" refers to a product that can be the sole source of nutrition for the subject.

[0078]

[0078] In various embodiments, the composition may be in the form of a beverage, mayonnaise, salad dressing, margarine, low-fat spread, dairy products, cheese spread, processed cheese, dairy desserts, flavored milk, cream, fermented dairy products, cheese, butter, condensed milk products, ice cream mix, soy products, pasteurized liquid eggs, bakery products, confectionery products, candy bars, chocolate bars, high-fat bars, liquid emulsions, spray-dried powders, freeze-dried powders, UHT puddings, pasteurized puddings, gels, jellies, yogurts, or foods having fat-based or water-containing fillings.

[0079]

[0079] In one embodiment, the composition may be an infant formula. In yet another embodiment, the composition can be used to coat food, snacks, pet food, or pet treats.

[0080]

[0080] The compositions disclosed herein may be administered to subjects enterally or parenterally. Preferably, the compositions are administered enterally. For example, the compositions may be administered in the form of food products or supplements. Enteral administration may be oral, gastric, and / or rectal. Preferably, the compositions are administered orally.

[0081]

[0081] The subject may be a human, dog, cat, horse, goat, cow, sheep, pig, deer, or mammal such as a primate. Preferably, the subject is a human. In one embodiment, the subject is an infant. The infant may be a human such as a newborn (i.e., an infant less than 28 days old) or a premature infant (i.e., an infant born before the completion of a 37-week gestation period).

[0082]

[0082] In one embodiment, the subject is an aged subject. For example, a subject may be an aged subject if it has reached 40%, 50%, 60%, 66%, 70%, 75%, or 80% of its estimated lifespan. The determination of lifespan may be based on actuarial tables, calculations, or estimates, and may take into account past, present, and future influences, or factors known to have a positive or negative effect on lifespan. When determining lifespan, species, sex, size, genetic factors, environmental and stress factors, current and past health status, past and present nutritional status, and stress factors may be taken into consideration. An aged subject may be, for example, a human subject whose age is over 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 years.

[0083]

[0083] In one embodiment, the subjects are those diagnosed with mild cognitive impairment or those suffering from memory complaints. The subjects may require improvement in cognitive functions, particularly episodic memory, executive function, and language. The subjects may have or suffer from brain energy deficiency or deficiency, neurological conditions, and / or cognitive impairment.

[0084]

[0084] All references herein to treatment include curative, palliative, and prophylactic treatments. Treatment may also include treatment to slow the progression of disease severity. Treatments for both humans and animals are within the scope of this disclosure.

[0085]

[0085] Free fatty acids and ketones produced from MCTs provide an alternative energy source to glucose, replenishing or replacing the energy of cells such as astrocytes, muscle cells, cardiomyocytes, or nerve cells.

[0086]

[0086] Brain tissue consumes a large amount of energy relative to its volume. In an average healthy subject, the brain obtains most of its energy from oxygen-dependent glucose metabolism. Typically, most of the brain's energy is used to assist in signaling in neurons or nerve cells, and the remaining energy is used to maintain the health of the cells. For example, a deficiency of brain energy caused by impaired glucose utilization can lead to neuronal hyperactivity, seizures, and cognitive impairment.

[0087]

[0087] Examples of brain energy deficiency states or diseases include migraines, memory impairment, age-related memory impairment, brain injury, neurorehabilitation, stroke and post-stroke, amyloid lateral sclerosis, multiple sclerosis, cognitive impairment, mild cognitive impairment (MCI), post-intensive care cognitive impairment, age-related cognitive impairment, Alzheimer's disease, Parkinson's disease, Huntington's disease, congenital metabolic disorders (such as glucose transporter 1 deficiency syndrome and pyruvate dehydrogenase complex deficiency), bipolar disorder, schizophrenia, and / or epilepsy.

[0088]

[0088] As used herein, the term “neurological condition” refers to a disorder of the nervous system. A neurological condition may be the result of damage to the brain, spine, or nerves caused by disease or injury. Non-limiting examples of symptoms of a neurological condition include paralysis, weakness, poor coordination, loss of sensation, seizures, confusion, pain, and altered level of consciousness. A nervous system disorder can be determined in a subject by performing an assessment of their response to touch, pressure, vibration, limb position, heat, cold, pain, and reflexes.

[0089]

[0089] Some neurological conditions are lifelong, and their onset can be experienced at any point in time. Other neurological conditions, such as cerebral palsy, are present from birth. Some neurological conditions, such as Duchenne muscular dystrophy, generally manifest in infancy, while other neurological conditions, such as Alzheimer's disease and Parkinson's disease, primarily affect older adults. Some neurological conditions develop suddenly due to injuries or diseases such as head injury or stroke, or cancer of the brain and spine.

[0090]

[0090] In one embodiment, the neurological condition is the result of traumatic brain injury. Additionally or alternatively, the neurological condition is the result of energy deficiency in the brain or muscles.

[0091]

[0091] Examples of neurological conditions include migraines, memory impairment, age-related memory impairment, brain injury, neurorehabilitation, stroke and post-stroke, amyloid lateral sclerosis, multiple sclerosis, cognitive impairment, mild cognitive impairment (MCI), post-intensive care cognitive impairment, age-related cognitive impairment, Alzheimer's disease, Parkinson's disease, Huntington's disease, congenital metabolic disorders (such as glucose transporter 1 deficiency syndrome and pyruvate dehydrogenase complex deficiency), bipolar disorder, schizophrenia, and / or epilepsy.

[0092]

[0092] Migraine is a severe headache accompanied by other symptoms such as nausea (feeling unwell), visual disturbances, and increased sensitivity to light or sound. Migraines may be preceded by an aura, the main symptoms of which are visual disturbances such as blurred vision (difficulty focusing), scotoma, flashes of light, or zigzag patterns moving from the central field of vision to the edges.

[0093]

[0093] A stroke (also known as a cerebrovascular accident (CVA) or cerebrovascular injury (CVI)) occurs when blood flow to the brain becomes insufficient, resulting in cell death. There are two main types of strokes: ischemic (caused by insufficient blood flow) and hemorrhagic (caused by bleeding). A stroke causes a part of the brain to stop functioning normally. Signs and symptoms of a stroke may include inability to move one side of the body, loss of sensation on one side of the body, difficulty understanding or speaking, a feeling that the world is spinning, or a loss of vision on one side. Signs and symptoms often appear immediately after a stroke.

[0094]

[0094] Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, Charcot's disease, and motor neuron disease, is characterized by the death of neurons that control voluntary muscles. ALS is characterized by progressively worsening weakness due to muscle stiffness, muscle contractions, and muscle wasting; which makes it difficult to speak, swallow, and eventually breathe.

[0095]

[0095] Multiple sclerosis is a disease that affects the nerves of the brain and spinal cord, causing a wide range of symptoms including problems with muscle movement, motor function and balance, numbness and tingling, blurred vision (typically unilateral visual field defects), and fatigue.

[0096]

[0096] Parkinson's disease is a degenerative disease of the central nervous system that primarily affects the motor system. In the early stages of the disease, the most prominent symptoms are motor-related; these include resting tremor, rigidity, bradykinesia, and difficulty walking and gaiting. Later in the course of the disease, problems with thinking and behavior may occur, and dementia generally develops in the advanced stages of the disease. Other symptoms include depression, sensory, sleep, and emotional problems.

[0097]

[0097] Alzheimer's disease is a progressive neurodegenerative disease. Alzheimer's disease is the most common cause of dementia. Symptoms include memory loss and difficulty with thinking, problem-solving, or language. The Mini-Mental State Examination (MMSE) is one example of a test used to diagnose Alzheimer's disease.

[0098]

[0098] Huntington's disease is a genetic condition that causes damage to specific nerve cells in the brain. Huntington's disease affects muscle coordination and leads to mental decline and motor symptoms. In the earliest stages, there are often minor problems related to mood or cognition. Subsequently, there is often a general lack of coordination and unsteady gait. As the disease progresses, uncoordinated, convulsive body movements become more pronounced, along with a decline in cognitive abilities and motor symptoms. Physical abilities gradually deteriorate to the point where coordination becomes difficult. Cognitive abilities generally decline to the point of dementia.

[0099]

[0099] Congenital metabolic disorders are a variety of diseases caused by defective genes. Typically, the defective gene results in a deficiency of an enzyme or transport protein, which inhibits the body's processing of a compound and leads to the accumulation of the compound's toxicity. Congenital metabolic disorders can affect any organ, and usually affect two or more organs. Symptoms tend to be nonspecific in many cases and are usually related to dysfunction or failure of major organs. The onset and severity of metabolic disorders may be aggravated by environmental factors such as diet and co-existing diseases.

[0100]

[0100] Glucose transporter 1 (Glutl) deficiency syndrome is a genetic metabolic disorder involving the GLUT1 protein, which transports glucose across the blood-brain barrier, the boundary separating the microvascular system from brain tissue. The most common symptom is seizures (epilepsy), which usually begin within the first few months of life. Further possible symptoms include varying degrees of cognitive impairment, as well as motor disorders characterized by ataxia, dystonia, and chorea. Glutl deficiency syndrome can be caused by mutations in the SLC2A1 gene, which produces the GLUT1 protein.

[0101]

[0101] Pyruvate dehydrogenase complex deficiency (PDCD) is a neurodegenerative disease associated with mitochondrial metabolic abnormalities and disruption of carbohydrate metabolism. PDCD is characterized by the accumulation of lactate in the body and various neurological disorders. The signs and symptoms of this condition usually first appear shortly after birth, but can vary greatly among affected individuals. The most common feature is a life-threatening accumulation of lactate (lactic acidosis), which can cause nausea, vomiting, severe respiratory distress, and abnormal heartbeat. Other symptoms include neurological problems; delayed development of intellectual abilities and motor skills such as sitting and walking; intellectual disability; seizures; hypotonia (low pressure); poor coordination, and difficulty walking. Some affected individuals have abnormal brain structures, such as underdeveloped corpus callosum (the tissue connecting the left and right hemispheres of the brain), weakening (atrophy) of the outer part of the brain known as the cerebral cortex, or multiple damaged tissue areas (lesions) in parts of the brain.

[0102]

[0102] In PDCD, one of the proteins in the pyruvate dehydrogenase complex (PDC) is deficient. The pyruvate dehydrogenase complex contains three enzymes identified as E1, E2, and E3, with the E1 enzyme containing subunits identified as α and β. The most common form of PDCD is caused by an abnormal gene in the E1α subunit (PDHA1 gene) located on the X chromosome. Some cases of PDCD are caused by genetic mutations in other pyruvate dehydrogenase complex subunits, such as the PDHX gene, PDHB gene, DLAT gene, PDP1 gene, and DLD gene.

[0103]

[0103] Bipolar disorder is a brain disorder characterized by abnormal shifts in mood, energy levels, activity levels, and ability to perform daily tasks. Bipolar disorder is characterized by periods of elevated mood and periods of depression. Bipolar disorder can be diagnosed using the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the International Statistical Classification of Diseases and Related Health Problems guidelines of the World Health Organization.

[0104]

[0104] Schizophrenia is a chronic and serious disorder characterized by abnormal interpretation of reality and resulting brain damage. Schizophrenia can result in several combinations of hallucinations, auditory hallucinations, delusions, and highly confused thoughts and behaviors. Schizophrenia can be diagnosed using the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the World Health Organization's International Statistical Classification of Diseases and Related Health Problems.

[0105]

[0105] Epilepsy is a neurological disorder in which the activity of nerve cells in the brain is disrupted, resulting in seizures, or abnormal behavior, sensations, and sometimes periods of loss of consciousness.

[0106]

[0106] The terms "cognitive impairment" and "cognitive disorder" refer to a group of disorders that cause impairment in cognition, particularly those that primarily affect learning, memory, perception, and / or problem-solving.

[0107]

[0107] Cognitive impairment may occur in patients after intensive care. Cognitive impairment can occur as part of aging, for example, as mild cognitive impairment (MCI).

[0108]

[0108] The term “cognition” refers to the entire set of intellectual abilities and processes, including knowledge, attention, memory and working memory, judgment and evaluation, reasoning and “calculation,” problem solving and decision-making, and language comprehension and production. The level and improvement of cognition can be readily assessed by those skilled in the art using any suitable neurological and cognitive tests known in the art, including cognitive tests designed to assess information processing speed, executive function and memory. Suitable test examples include the Mini-Mental State Examination (MMSE), CANTAB (Cambridge Neuropsychological Test Automated Battery), Alzheimer's Disease Assessment Scale Cognitive Test (ADAScog), Wisconsin Card Classification Task, Verbal and Visual Fluency Tests and Trailmaking Test, Wechsler Memory Scale (WMS), Immediate and Delayed Visual Reproduction Test (Trahan et al. Neuropsychology, 1988 19(3) p.173-89), and the Ray Auditory Language Learning Scale (RAVLT) (Ivnik, RJ. et al. Psychological Assessment: A Journal of Consulting and Clinical). Psychology, 1990(2): p.304-312), electroencephalography (EEG), magnetoencephalography (MEG), positron emission tomography (PET), single-photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), functional magnetic resonance imaging (fMRI), computed tomography, and long-term enhancement are among the available techniques.

[0109]

[0109] EEG, the measurement of electrical activity in the brain, is achieved by placing electrodes on the scalp at various landmarks and amplifying and recording brain signals. MEG is similar to EEG in that it measures magnetic fields that are related to electric fields. MEG is used to measure spontaneous brain activity, including synchronization waves in the nervous system.

[0110]

[0110] PET provides indicators of oxygen utilization and / or glucose metabolism. In this technique, a radioactive positron-emitting tracer is administered, and the brain's uptake of the tracer correlates with brain activity. These tracers emit gamma rays, which are detected by sensors surrounding the head, thereby obtaining a 3D map of brain activation. As soon as the tracer is taken up by the brain, radioactivity is detected in accordance with local cerebral blood flow. During activation, an increase in cerebral blood flow and neuronal glucose metabolism can be detected within seconds.

[0111]

[0111] Preferred analysis may also be based on neuropsychological tests, clinical examinations, and complaints of individual cognitive decline (e.g., subjective memory loss). Further preferred tests may be based on assessments of locomotion, memory and attention, seizure susceptibility, and social engagement and / or social cognition.

[0112]

[0112] Memory impairment is the result of nerve damage to brain structures that impairs the storage, retention, and retrieval of memories. Memory impairment may progress with age (e.g., Alzheimer's disease) or may result directly from, for example, head injury. The level and improvement of memory impairment can be readily assessed by those skilled in the art using any suitable test known in the art, such as the Alzheimer's Disease Assessment Scale Cognitive Test (ADAScog), the Mini-Mental State Examination (MMSE), computed tomography (CT) scans, magnetic resonance imaging (MRI), single-photon emission computed tomography (SPECT), positron emission tomography (PET), and electroencephalography (EEG).

[0113] [Examples]

[0113]

[0114] The following non-limiting examples present scientific data that expand upon and support the concept of an MCT-based composition with improved sedimentation and mouthfeel properties, including a specific gum, as provided by this disclosure.

[0114]

[0115] In the examples, the physical stability of the samples was observed and evaluated. As used herein, physical stability refers to the inherent tendency of emulsions and suspensions or mixtures to separate into distinct phases. When instability increases in dairy or nutritional products, multiple distinct phases such as creaming, whey, and precipitate may be observed. This separation may be reversible or irreversible. The physical stability of the sample was evaluated by creaming, whey, and precipitate, each of which was scored on a scale of 0 to 5. 0 represents no evidence, and 5 represents the most severe / highest level.

[0115]

[0116] Creaming is the suspension of fat particles (liquid droplets or solids) onto the surface of a product. Creaming can be cloudy, meaning that slight fat separation appears as very fine streaks on the product surface. Creaming can occur within a single layer; that is, the fat covers the product surface or forms clumps or fragments (i.e., separated fat forms irreversible clumps or fragments on the product surface or lid). Creaming is evaluated based on the amount of fat deposits on the product surface and on the lid of the package. The evaluation of creaming is as follows:

[0116]

[0117] Rating Explanation

[0118] 0 Zero = No creaming observed

[0119] 1. Minor = The lid or product surface is covered by a thin layer of fat deposits on one-quarter of its surface.

[0120] 2. Mild = The lid or product surface is half covered with a thin layer of fat deposits.

[0121] 3. Clearly = The lid or product surface is covered by a thin layer (<1 mm) of fat deposits on three-quarters of its surface.

[0122] 4. Severity = The lid or product surface is completely covered with a layer (1-2 mm) of fat deposits.

[0123] 5. Most severe = The lid or product surface is completely covered with a thick layer (>2mm) of grease deposits.

[0124] Whey can form when liquid dairy and nutritional products exhibit creaming and / or sedimentation. Whey can also appear when the network (proteins and / or hydrophilic colloids) exhibits syneresis. Whey can be clear or cloudy. Whey is evaluated by pouring the liquid product into a glass beaker. The scoring system for evaluating whey is as follows:

[0117]

[0125] Rating Explanation

[0126] 0 = No whey is observed.

[0127] 1. Minor = Streaks can be seen while pouring.

[0128] 2. Mild = approximately 2% of package volume

[0129] 3. Obvious = approximately 5% of package volume

[0130] 4. Severe = Severe = Approximately 10% of package volume

[0131] 5. Most severe = 20% or more of the package volume

[0132] Sedimentation refers to the precipitation of particles at the bottom of the package. The precipitate is evaluated at the bottom of the package after the liquid has been poured into a glass beaker.

[0118]

[0133] Rating Explanation

[0134] 0 = No sediment is observed at the bottom.

[0135] 1. Minor damage = The area near the bottom wall is covered.

[0136] 2. Mild = approximately 1 mm; the central seal is still clearly visible.

[0137] 3. Clear = Approximately 2mm; the central seal is barely visible.

[0138] 4. Severity = approximately 3mm (evaluated with a ruler)

[0139] 5. Most severe = ≥ 4mm (evaluated with a ruler)

[0140] All of the following samples contain 15g of MCT per serving, along with 5% or 7.5% MPC.

[0119]

[0141] Example 1: 7.5% MPC (Control 1) [Table 1]

[0120]

[0142] Example 2: Gellan gum (control 2) + 5% MPC [Table 2]

[0121]

[0143] Example 3: Gellan gum + Iotacaragerin + 7.5% MPC [Table 3]

[0122]

[0144] Example 4: Cellulose gel / gum (MCC 85% / 15% CMC) high viscosity + MPC [Table 4]

[0123]

[0145] Example 5: Cellulose gel / gum (MCC 85% / 15% CMC) high viscosity + 5% MPC [Table 5]

[0124]

[0146] Example 6: Gellan gum + Iotacaragelinan + 5% MPC [Table 6]

[0125]

[0147] Example 7: 5% MPC + Gellan Gum + Iotacarrageenan [Table 7]

[0126]

[0148] Example 8: 7.5% MPC + Cellulose Gel / Gum (MCC 85% / 15% CMC) [Table 8]

[0127]

[0149] Example 9: 7.5% MPC + gellan gum + iotacarrageenan [Table 9]

[0128]

[0150] Example 10: 5% MPC + Cellulose Gel / Gum (MCC 85% / 15% CMC) [Table 10]

[0129]

[0151] Example 11: 7.5% MPC + Cellulose Gel / Gum (MCC 85% / 15% CMC) [Table 11]

[0130]

[0152] Example 12: 7.5% MPC + Cellulose Gel / Gum (85% MCC / 15% CMC) + Cappuccino Flavor [Table 12]

[0131]

[0153] Example 13: 7.5% MPC + Cellulose Gel / Gum (MCC 85% / 15% CMC) + Vanilla Chai Flavor [Table 13]

[0132]

[0154] Example 14: 7.5% MPC + cocoa, no flavoring added. [Table 14]

[0133]

[0155] Example 15: 7.5% MPC + Cellulose Gel / Gum (MCC 85% / 15% CMC) + Mocha Flavor [Table 15]

[0134]

[0156] Samples of this composition were collected with no pH adjustment (labels 1-2, pH=6.55) and with pH adjustment using KOH (labels 3-6, pH=6.79 and 6.99). Samples 3-6 were placed in a water bath for different durations, and no fouling, coagulation, or aggregation was observed. However, samples 1-2, with a pH of 6.55, exhibited gelation / fouling. Overall, adjusting the pH to 6.8-7.0 demonstrated further stability during processing. This slight pH change did not significantly affect the final product.

[0135]

[0157] Example 16: 7.5% MPC + Cellulose Gel / Gum (85% MCC / 15% CMC) + Pineapple Mango Flavor [Table 16]

[0136]

[0158] Example 17: 0.5% cellulose gel / gum (MCC 85% / 15% CMC) + 5% MPC [Table 17]

[0137]

[0159] Example 18: Iotacaragerin (control 3) + 7.5% MPC [Table 18]

[0138]

[0160] The following table contains further details of the above embodiment. [Table 19]

[0161]

[0162]

[0139] [Table 20]

[0140]

[0163] Example 19: Cellulose / gel gum (MCC 85% / 15% CMC) + 7.5% MPC and KOH were added to adjust the pH. [Table 21]

[0141] [Table 22]

[0142]

[0164] It should be understood that various changes and modifications to the current preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the spirit and scope of this subject matter and without impairing the intended advantages. Accordingly, such changes and modifications are intended to be covered by the appended claims.

Claims

1. A medium-chain triglyceride (MCT) containing 51% to 90% by weight of an octanoic acid moiety, A blend of gellan gum and carrageenan (iota), The aforementioned MCT contains protein in a weight ratio of at least 0.1 g per 1.0 g, Having a pH of 6.6 to 7.5, composition.

2. The composition according to claim 1, wherein the MCT comprises a decanoic acid portion.

3. The composition according to claim 2, wherein the weight ratio of the octanoic acid portion to the decanoic acid portion is 54 to 66:36 to 44.

4. The composition according to claim 1, wherein the composition comprises at least 1% by weight of milk protein concentrate (MPC).

5. The composition according to claim 1, wherein the composition comprises 4.5 to 5.5% by weight of milk protein concentrate (MPC).

6. The composition according to claim 1, wherein the composition comprises 6.75 to 8.25% by weight of milk protein concentrate (MPC).

7. The composition according to claim 1, wherein the composition comprises at least 4 g of protein per 100 g of the composition.

8. The composition according to claim 1, wherein the composition comprises at least one raw material selected from the group comprising (i) carbohydrates in a weight ratio of at least 0.1 g per 1.0 g of MCT, and / or (ii) lipids other than MCT in a weight ratio of at least 0.1 g per 1.0 g of MCT.

9. The composition according to claim 1, wherein the composition is in a form selected from the group consisting of beverages, mayonnaise, salad dressings, margarine, low-fat spreads, dairy products, cheese spreads, processed cheese, dairy desserts, flavored milk, cream, fermented dairy products, cheese, butter, condensed milk products, ice cream mixes, soy products, pasteurized liquid eggs, bakery products, confectionery products, candy bars, chocolate bars, high-fat bars, liquid emulsions, spray-dried powders, freeze-dried powders, UHT puddings, pasteurized puddings, gels, jellies, yogurts, foods having fat-based or water-containing fillings, and combinations thereof.

10. The composition according to claim 1, wherein the composition is a liquid.

11. The composition according to claim 1, wherein the composition is in powder form.

12. A method for improving the sedimentation and / or mouthfeel characteristics of a composition containing medium-chain triglycerides (MCTs), The composition includes the step of providing a blend of gellan gum and carrageenan (iota), The method further includes the step of adjusting the pH of the composition to a range of 6.6 to 7.

5. A method comprising protein in a weight ratio of at least 0.1 g of protein per 1.0 g of MCT.

13. The method according to claim 12, wherein the MCT contains 51% to 90% by weight of octanoic acid.

14. The method according to claim 13, wherein the MCT comprises a decanoic acid portion.

15. The method according to claim 14, wherein the weight ratio of the octanoic acid portion to the decanoic acid portion is 54 to 66:36 to 44.

16. The method according to claim 12, wherein the composition comprises at least 1% by weight of milk protein concentrate (MPC).

17. The method according to claim 12, wherein the composition comprises at least 4 g of protein per 100 g of the composition.

18. The method according to claim 12, wherein the pH of the composition is adjusted by adding an alkali to the composition.

19. The method according to claim 18, wherein the alkali includes KOH.

20. A composition according to any one of claims 1 to 11 for improving the cognitive function of an individual who requires improvement in cognitive function including at least one of episodic memory, executive function, or language skills.

21. A composition according to any one of claims 1 to 11 for supporting the memory of an individual who requires memory support.

22. A composition according to any one of claims 1 to 11 for providing energy and / or ketones to the brain of an individual that requires the provision of energy and / or ketones to the brain.

23. A composition according to any one of claims 1 to 11 for preventing and / or treating mild cognitive impairment (MCI) in an individual requiring prevention and / or treatment of MCI.

24. The composition according to any one of claims 20 to 23, wherein the individual has mild cognitive impairment (MCI).

25. The composition according to any one of claims 20 to 23, wherein the individual suffers from at least one of the following: memory impairment, cognitive impairment including lack of sound decision-making ability and impaired judgment, depression, or anxiety disorder.

26. The composition according to any one of claims 20 to 23, wherein the individual has or suffers from a state of brain energy deficiency or disease, neurological condition, and / or cognitive impairment.

27. The composition according to any one of claims 20 to 23, wherein the individual has a condition selected from the group consisting of epilepsy, neurological disorders, neurodegenerative diseases, heart failure, congenital metabolic disorders, obesity, type 2 diabetes, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), cancer, cerebral energy deficiency state, migraine, memory impairment, age-related memory impairment, brain injury, stroke, amyloid lateral sclerosis, multiple sclerosis, cognitive impairment, mild cognitive impairment (MCI), post-intensive care cognitive impairment, age-related cognitive impairment, Alzheimer's disease, Parkinson's disease, Huntington's disease, congenital metabolic disorders, bipolar disorder, schizophrenia, and combinations thereof.

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