Oral composition

Abstract

To provide an oral composition that exhibits excellent anti-obesity and muscle-building effects. [Solution] An oral composition containing 3-hydroxy-3-methylbutyric acid or a salt thereof, and at least one other material selected from kudzu flower, Japanese knotweed, thorny grass, mussel grass, and chili pepper.

Description

Technical Field

[0001] The present invention relates to an oral composition comprising 3-hydroxy-3-methylbutyric acid or a salt thereof. Background Art

[0002] 3-hydroxy-3-methylbutyric acid (HMB) is a metabolite of leucine, an essential amino acid, and is known to be involved in promoting muscle synthesis and inhibiting muscle breakdown. However, since the amount of HMB produced in the body is very small, attempts have been made to ingest HMB as dietary supplements and the like.

[0003] Regarding such dietary supplements, a tablet containing calcium 3-hydroxy-3-methylbutyrate (HMBCa) and crystalline cellulose has been proposed (see Patent Document 1). In this Patent Document 1, tableting properties are improved by using crystalline cellulose, and a tablet with an uneven surface is obtained. Prior Art Literature Patent Literature

[0004] Patent Document 1 Japanese Unexamined Patent Publication No. 2015-218158 Summary of the Invention Problem to be Solved by the Invention

[0005] As described above, although studies on HMB have been conducted, studies on the effects of HMB in combination with other ingredients have not been sufficiently conducted.

[0006] An object of the present invention is to provide an oral composition exhibiting an excellent anti-obesity effect. Another object of the present invention is to provide an oral composition with an improved muscle-building effect of HMB. Means for Solving the Problem

[0007] The inventors of this invention diligently studied to solve the above problems and found that by using HMB or its salt together with specific other materials, an excellent anti-obesity effect is achieved, leading to the completion of this invention. Furthermore, they found that by using HMB or its salt together with specific other materials, the muscle-building effect of HMB or its salt can be enhanced, leading to the completion of this invention.

[0008] In other words, the present invention is as follows: [1] An oral composition characterized by containing 3-hydroxy-3-methylbutyric acid or a salt thereof, and at least one other material selected from ceramide, kudzu flower, Japanese knotweed, thorny grass, muscarpa, and chili pepper. [2] The oral composition according to [1], characterized in that it is an anti-obesity composition. [3] The oral composition according to [1], characterized in that it is a muscle-enhancing composition. [4] The oral composition according to [3], wherein the other material is at least one selected from ceramide and kudzu flower. [Effects of the Invention]

[0009] According to the present invention, it is possible to provide an oral composition that exhibits excellent anti-obesity effects. Furthermore, it is possible to provide an oral composition that enhances the muscle-building effects of HMB or its salts. In particular, according to the present invention, it is possible to provide an oral composition that exhibits even better anti-obesity and muscle-building effects when used in combination with exercise. [Brief explanation of the drawing]

[0010] [Figure 1] This figure shows the evaluation results (amount of lipid droplets per cell) of the inhibitory effect on adipocyte differentiation when the composition of the present invention (HMBCa + ceramide) is applied. [Figure 2] This figure shows the evaluation results (amount of lipid droplets per cell) of the inhibitory effect on adipocyte differentiation when the composition of the present invention (HMBCa + kudzu flower) is applied. [Figure 3]This figure shows the evaluation results (amount of lipid droplets per cell) of the inhibitory effect on adipocyte differentiation when the composition of the present invention (HMBCa + Japanese knotweed) is applied. [Figure 4] This figure shows the evaluation results (amount of lipid droplets per cell) of the inhibitory effect on adipocyte differentiation when the composition of the present invention (HMBCa + kotsusaifo) is applied. [Figure 5] This figure shows the evaluation results (amount of lipid droplets per cell) of the inhibitory effect on adipocyte differentiation when the composition of the present invention (HMBCa + Ajuga decumbens) is applied. [Figure 6] This figure shows the evaluation results (amount of lipid droplets per cell) of the inhibitory effect on adipocyte differentiation when the composition of the present invention (HMBCa + chili pepper) is applied. [Figure 7] This figure shows the measurement results of the mRNA expression level of the Myogenin gene (myog) when the composition of the present invention (HMBCa + ceramide) is applied. [Figure 8] This figure shows the measurement results of the mRNA expression level of the Myogenin gene (myog) when the composition of the present invention (HMBCa + kudzu flower) is applied. [Modes for carrying out the invention]

[0011] The oral composition of the present invention is characterized by containing 3-hydroxy-3-methylbutyrate (HMB) or a salt thereof, and at least one other material selected from ceramide, kudzu flower, Japanese knotweed, thorny grass, mussel grass, and chili pepper.

[0012] Other materials used with HMB or its salt may be used individually or in combination of two or more. When two or more other materials are used in combination, it is preferable to combine materials that have a high synergistic effect with HMB or its salt. In the present invention, when used as a muscle-enhancing composition, a combination of HMB or its salt, ceramide, and kudzu flower is preferred, and when used as an anti-obesity composition, a combination of HMB or its salt and two or more selected from Japanese knotweed, Osmunda japonica, Ajuga decumbens, and chili pepper is preferred.

[0013] The use of HMB or a salt thereof in combination with another material can inhibit the differentiation of adipocytes, thereby suppressing obesity. That is, the oral composition of the present invention can be used for anti-obesity, body fat reduction, dieting, and the like.

[0014] Furthermore, by using at least one selected from ceramides and puerariae flos together with HMB or a salt thereof, the effects of HMB or the salt thereof can be enhanced. That is, the oral composition of the present invention can enhance the muscle strengthening effect and muscle fatigue recovery (muscle fatigue amelioration) effect of HMB or a salt thereof, and can be used for body shaping, muscle strengthening for athletes, muscle strength recovery after illness, prevention of bedriddenness in the elderly, suppression of muscle damage during exercise, muscle fatigue recovery after exercise, improvement of basal metabolism, and the like.

[0015] [3-hydroxy-3-methylbutyric acid or a salt thereof] 3-hydroxy-3-methylbutyric acid (HMB) is a metabolite of the essential amino acid leucine and is synthesized in the human body. In the present invention, HMB or a salt thereof can be used. The salt of HMB is not particularly limited, and examples thereof include calcium salts, sodium salts, potassium salts, and magnesium salts; from the viewpoint of the muscle strengthening effect and anti-obesity effect, the calcium salt (HMBCa) is preferred. As HMB or a salt thereof in the oral composition of the present invention, those synthesized by known methods or commercially available products can be used. Commercially available products are not limited as long as they are applicable to food.

[0016] The content of 3-hydroxy-3-methylbutyric acid or a salt thereof is not particularly limited as long as a muscle strengthening effect and / or an anti-obesity effect is achieved, and for example, it is 0.1 to 99% relative to the total amount of the composition, preferably 1 to 98%, more preferably 5 to 97%.

[0017] [Other materials] In the oral composition of the present invention, it is preferable to use at least one other material selected from ceramide, kudzu flower, Japanese knotweed, thorny bush, mussel bush, and chili pepper together with HMB or a salt thereof.

[0018] (Ceramide) In the oral composition of the present invention, the ceramide can be human-type ceramides such as ceramide 1, ceramide 2, and ceramide 3, as well as animal-derived ceramides extracted from the brains and spinal cords of animals such as cattle, horses, and pigs, and plant-derived ceramides extracted from wheat, rice, soybeans, spinach, corn, konjac, pineapple, etc. Furthermore, the ceramide in the oral composition of the present invention may also be a glycoceramide, specifically, examples of which include those with monosaccharides such as galactosylceramide and glucosylceramide, or those with oligosaccharides. In the oral composition of the present invention, it is preferable to use plant-derived ceramides, and it is even more preferable to use glucosylceramides derived from grasses such as wheat, corn, and rice. Among these, it is particularly preferable to use glucosylceramide extracted from rice or seeds collected from rice, from the viewpoint of muscle-enhancing effect and / or anti-obesity effect. Examples of solvents used for extraction include water; lower alcohols such as ethanol, methanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. The temperature of the extraction solvent can be appropriately set between room temperature and below the boiling point, depending on the solvent used. In this invention, ethanol or aqueous ethanol is preferred as the extraction solvent because it can efficiently extract the active ingredients.

[0019] The ceramide content is not particularly limited as long as it is an amount that shows muscle-building and / or anti-obesity effects, but for example, it is 0.000001 to 30% of the total amount of the composition, preferably 0.00001 to 20%, and more preferably 0.0001 to 10%.

[0020] (Kudzu flower) Kudzu is a climbing perennial plant belonging to the genus Pueraria in the family Fabaceae. In the oral composition of the present invention, kudzu flowers may be collected at any stage from bud to fully bloomed flower, or a mixture of flowers collected at each stage may be used. There are no particular restrictions on the type of kudzu, but examples include Pueraria thomsonii, Pueraria lobata, Pueraria thunbergiana, etc. Pueraria thomsonii is preferred from the viewpoint of muscle-building effect and / or anti-obesity effect.

[0021] Examples of processed products of kudzu flowers in the oral composition of the present invention include pulverized products, juices, and extracts. Examples of pulverized products include powders and granules, and for example, products that have been washed, dried, and then pulverized can be used. Juices and extracts may be in liquid form, but can also be used as pastes or dried powders. Extracts can be obtained by extraction using a suitable solvent, and examples of solvents include water; lower alcohols such as ethanol, methanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. The temperature of the extraction solvent can be appropriately set between room temperature and below the boiling point depending on the solvent used. In the present invention, kudzu flowers are preferably pulverized products or extracts, extracts are more preferably, and hot water extracts are even more preferably from the viewpoint of muscle-building effects and / or anti-obesity effects.

[0022] The amount of kudzu flower content is not particularly limited as long as it is an amount that shows muscle-building and / or anti-obesity effects, but for example, it is 0.01 to 50% of the total amount of the composition, preferably 0.03 to 40%, and more preferably 0.05 to 30%.

[0023] (Japanese knotweed) Japanese knotweed (Polygonum sachalinense) is a perennial herb belonging to the genus Polygonum in the family Polygonaceae, and its scientific name is Polygonum sachalinense. Parts used include leaves, stems, buds, roots, and rhizomes, with buds being particularly preferred. Buds are also called young shoots or new shoots. Examples of processed Japanese knotweed used in the oral composition of the present invention include pulverized material, juice, and extracts. Pulverized material can be in the form of powder or granules; for example, it can be used after washing and drying. Juice and extracts may be liquid, but can also be used as a paste or dried powder. Extracts can be obtained by extraction using a suitable solvent. Examples of solvents include water; lower alcohols such as ethanol, methanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. The temperature of the extraction solvent can be appropriately set between room temperature and below the boiling point, depending on the solvent used. In the present invention, Japanese knotweed is preferably in the form of a pulverized product or extract, an extract containing a particularly high amount of active ingredients is even more preferred, and a hot water extract is even more preferred from the viewpoint of muscle-building effect and / or anti-obesity effect.

[0024] The amount of Japanese knotweed contained is not particularly limited as long as it is in an amount that shows muscle-building and / or anti-obesity effects, but for example, it is 0.0001 to 30% of the total amount of the composition, preferably 0.001 to 20%, and more preferably 0.01 to 10%.

[0025] (Bone crushing / reconstruction) Kotsusaiho is derived from the rhizome of Drynaria fortunei, a fern belonging to the Polypodiaceae family. In China, it is used as a traditional Chinese medicine to alleviate bone and joint pain. Examples of Kotsusaiho in the oral composition of the present invention include processed products such as pulverized material, juice, and extract. Examples of pulverized material include powder and granules, and for example, material that has been washed, dried, and then pulverized can be used. The juice and extract may be in liquid form, but can also be used as a paste or dried powder. The extract can be obtained by extraction using a suitable solvent, and examples of solvents include water; lower alcohols such as ethanol, methanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. The temperature of the extraction solvent can be appropriately set from room temperature to below the boiling point depending on the solvent used. In the present invention, the cylindrica root is preferably in the form of a pulverized product or extract, more preferably an extract containing a particularly large amount of the active ingredient, and even more preferably ethanol or aqueous ethanol extract from the viewpoint of muscle-building effect and / or anti-obesity effect.

[0026] The amount of kotsusaiho present is not particularly limited as long as it is an amount that shows muscle-building and / or anti-obesity effects, but for example, it is 0.0001 to 30% of the total amount of the composition, preferably 0.001 to 20%, and more preferably 0.01 to 10%.

[0027] (muscle grass) Ajuga decumbens is a perennial herbaceous plant belonging to the genus Ajuga in the Lamiaceae family, and specific examples include Ajuga decumbens, Ajuga ciliata, and Ajuga lupulina. Examples of processed products of Ajuga decumbens in the oral composition of the present invention include pulverized material, juice, and extract. Examples of pulverized material include powder and granules, and for example, it can be used after washing and drying. The juice and extract may be in liquid form, but can also be used as a paste or dried powder. The extract can be obtained by extraction using a suitable solvent, and examples of solvents include water; lower alcohols such as ethanol, methanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. The temperature of the extraction solvent can be appropriately set from room temperature to below the boiling point depending on the solvent used. In the present invention, Ajuga decumbens is preferably in the form of pulverized material or extract, and extracts containing particularly high amounts of active ingredients are even more preferred. From the viewpoint of muscle-building effect and / or anti-obesity effect, ethanol and aqueous ethanol extracts are even more preferred.

[0028] The amount of Ajuga decumbens contained is not particularly limited as long as it is an amount that shows muscle-building and / or anti-obesity effects, but for example, it is 0.0001 to 30% of the total amount of the composition, preferably 0.001 to 20%, and more preferably 0.01 to 10%.

[0029] (Chili pepper) The chili peppers used in the oral composition of the present invention are not particularly limited as long as they contain capsaicin or capsaicinoid-like substances. The variety and origin of the chili peppers are not particularly limited. Specifically, chili pepper varieties such as CH-19 Ama, Fushimi Amanaga, Shishito, Yamashina, Manganji, Takanotsume, Kagawa Hontaka, Aomori Takanotsume, Sapporo Daicho, California Wonder, Cherry Bomb, etc., can be used. Among these, Fushimi Amanaga is preferred because it contains both capsaicin and capsaicinoid-like substances and has a mild spiciness. The various chili peppers may be used individually or in combination of two or more.

[0030] In the oral composition of the present invention, any part of the chili pepper containing capsaicin or capsaicinoid-like substances may be used, however, since capsaicin or capsaicinoid-like substances are abundant in the placenta, it is preferable to use the placenta or the fruit containing the placenta. The chili pepper may be used raw or dried. For example, it can be used as a processed product such as a pulverized product, juice, or extract. Examples of pulverized products include powders and granules. The juice and extract may be in liquid form, but can also be used as a paste or dried powder. The extract can be obtained by extraction using a suitable solvent, and examples of solvents include water; lower alcohols such as ethanol, methanol, isopropanol, and butanol; lower esters such as ethyl acetate and methyl acetate; acetone; and mixed solvents of these with water. The temperature of the extraction solvent can be appropriately set from room temperature to below the boiling point depending on the solvent used.

[0031] Furthermore, the chili pepper in the oral composition of the present invention may be fermented. Fermentation is performed, for example, to decompose capsaicinoid-like substances contained in the chili pepper. Fermentation is carried out by contacting the chili pepper with microorganisms that can produce organic acids and can utilize fatty acids produced by the decomposition of capsaicinoid-like substances. The capsaicinoid-like substances are decomposed by changes in pH caused by organic acids produced by the microorganisms.

[0032] Fermentation methods include lactic acid fermentation, citric acid fermentation, alcoholic fermentation, acetic acid fermentation, and combinations thereof. Depending on the type of fermentation, lactic acid bacteria, yeast, acetic acid bacteria, etc., are brought into contact with the chili peppers. These bacteria may be used individually for fermentation, multiple bacteria may be added simultaneously, or different bacteria may be added in stages. Among these, lactic acid fermentation is preferred.

[0033] Examples of lactic acid bacteria include Leuconostoc mecentroides, Lactobacillus plantarum, Lactobacillus brevis, Lactobacillus acidophilus, Lactobacillus casei, Streptococcus thermophilus, Streptococcus faecalis, and Bifidobacterium longum, which are used individually or in combination. For example, when used individually, Lactobacillus plantarum is preferred in terms of its acid resistance, growth temperature, and growth rate.

[0034] The amount of chili peppers is not particularly limited as long as it is in an amount that shows muscle-building and / or anti-obesity effects, but for example, it is 0.0001 to 30% of the total amount of the composition, preferably 0.001 to 20%, and more preferably 0.01 to 10%.

[0035] The oral composition of the present invention can be used, for example, as a pharmaceutical product (including quasi-drugs), a functional food such as a food for specified health uses, a food with nutritional function claims, or a food with functional claims whose efficacy has been approved by a designated institution, as well as a general food, food additive, animal feed, etc.

[0036] The oral composition of the present invention can be used as an anti-obesity composition for anti-obesity purposes. Such an anti-obesity composition is not particularly limited as long as it contains HMB or its salt and other materials and can be distinguished from other products in that it is used for anti-obesity (obesity suppression). For example, any product in which the body, packaging, instructions, or promotional materials of the present invention indicate that it has an anti-obesity function (including diet, body fat reduction, improvement of metabolic syndrome, weight loss, etc.) is included within the scope of the present invention. It should be noted that the anti-obesity composition of the present invention is not limited to those in which the combination of components of the present invention (HMB or its salt and other materials) is indicated as an active anti-obesity ingredient on the product packaging, etc. For example, the active ingredient may not be specified, or only HMB or its salt may be indicated as the active ingredient, or only other materials may be indicated as the active ingredient.

[0037] Specifically, examples of the anti-obesity composition of the present invention include pharmaceuticals (including quasi-drugs) and so-called health foods. Examples of so-called health foods include those labeled with phrases such as "For those concerned about body fat," "For those who are overweight," "For those concerned about their weight (BMI)," "Reduce weight and abdominal fat (visceral fat and subcutaneous fat)," and "Reduce waist circumference."

[0038] Furthermore, the oral composition of the present invention, which contains HMB or a salt thereof along with other materials, can be used as a muscle-building composition for muscle enhancement. In particular, it is preferable to include HMB or a salt thereof along with at least one selected from ceramide and kudzu flower. Such muscle-enhancing compositions are not particularly limited as long as they contain HMB or its salts and other materials and can be distinguished from other products in that they are used for muscle enhancement and muscle fatigue recovery. For example, any product, packaging, instruction manual, or promotional material of the present invention that displays a statement indicating that it has the functions of muscle enhancement, increased muscle synthesis, suppression of muscle breakdown, suppression, maintenance, and increase of muscle mass (muscle weight, muscle cross-sectional area, muscle density), suppression, maintenance, and improvement of muscle quality, suppression, maintenance, and increase of muscle strength (power, endurance), suppression, maintenance, and improvement of athletic performance, suppression, maintenance, and improvement of metabolism (basal metabolism, resting and exercise metabolism), suppression, maintenance, and increase of lean body mass, prevention and improvement of muscle fatigue, metabolic improvement effect through muscle enhancement, prevention and improvement effect of locomotive syndrome, and prevention and improvement effect of sarcopenia is included within the scope of the present invention. For example, the active ingredient may not be specified, or it may only list HMB or its salt as the active ingredient, or it may only list other ingredients as the active ingredient.

[0039] Specifically, examples of the muscle-building compositions of the present invention include pharmaceuticals (including quasi-drugs) and so-called health foods. In the case of so-called health foods, examples include those that display claims such as "support the ability to build muscle," "suppress muscle breakdown," "enhance muscle strength," "suppress, maintain, improve, and enhance the decline in walking ability," "improve metabolism through muscle strengthening," "suppress metabolic decline," "prevent and recover from muscle fatigue," "suppress and maintain the decline in balance ability," "shape up," "muscular," "lean and muscular," "beautiful body," "prevention of being bedridden," "prevention of being bedridden," "prevention of falls," "improve metabolism through muscle strengthening," and "maintain muscle mass and strength." The target audience for ingesting the oral compositions of the present invention is not particularly limited to people who need to strengthen their muscles, but preferred examples include people who aim to shape up, athletes, and elderly people with weakened legs and hips.

[0040] The anti-obesity and muscle-building effects of the oral composition of the present invention can be obtained by ingesting the composition in daily life, but even better effects can be obtained by combining it with exercise. The exercise referred to here is one or more types of aerobic exercise or resistance exercise (strength training, weight training). In particular, when obtaining the muscle-building effect of the oral composition of the present invention, there are no particular restrictions on the type of exercise used in combination with the oral composition of the present invention, but it is preferable to perform one or more types of aerobic exercise or resistance exercise, and it is especially preferable to perform resistance exercise. Furthermore, the amount of exercise performed is 10 minutes or more per day, preferably 20 minutes or more, and more preferably 30 minutes or more.

[0041] Examples of the composition of the present invention include tablets, capsules, powders, granules, liquids, granules, rods, plates, blocks, solids, pills, pastes, creams, caplets, gels, chewable tablets, and sticks. Among these, tablets, capsules, powders, granules, pills, and chewable tablets are preferred, and tablets, capsules, pills, and chewable tablets are more preferred.

[0042] When the composition of the present invention is made into tablets, pills, or chewable tablets, it is preferable to add one or more of the following: excipients, lubricants, and fluidizers, in order to improve moldability and enhance the storage stability of the resulting tablets, pills, or chewable tablets. In particular, storage stability can be further enhanced by using excipients and lubricants. Excipients are added to improve the handling or molding of the composition and to make it easier to take. There are no particular limitations on the excipients that can be used in the present invention, and examples include starch or its derivatives such as starch, pregelatinized starch, partially pregelatinized starch, and starch hydrolysates, crystalline cellulose, powdered cellulose, sugar alcohols, lactose, brewer's yeast, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, refined sucrose, light anhydrous silicic acid, calcium silicate, titanium dioxide, precipitated calcium carbonate, reduced maltose, maltose, etc. These may be used individually or in combination of two or more. In the present invention, from the viewpoint of moldability and storage stability, hydroxypropyl cellulose, powdered cellulose, pregelatinized starch, pregelatinized starch, sugar alcohols, reduced maltose, and maltose are preferably used as excipients. A lubricant is used to reduce friction between the tablet press die and the tablet when compressing powder for tablets, and to prevent tableting defects such as sticking. There are no particular restrictions on the lubricant that can be used in the present invention as long as it is a component that can achieve the above purpose. Examples include stearic acid, calcium stearate, magnesium stearate, stearic acid or its salts, sodium stearyl fumarate, sucrose fatty acid esters, talc, polyethylene glycol, vegetable oils and fats, and hydrogenated oils. These may be used individually or in combination of two or more. In the present invention, calcium stearate and sucrose fatty acid esters are preferably used as lubricants from the viewpoint of moldability and storage stability. A fluidizing agent is used to improve the fluidity of mixed powders and granules. There are no particular limitations on the fluidizing agents that can be used in the present invention, and examples include silicon dioxide, aluminum silicate, magnesium aluminosilicate, calcium phosphate, magnesium carbonate, and magnesium oxide. These may be used individually or in combination of two or more.In the present invention, silicon dioxide and magnesium carbonate are preferably used as the fluidizing agent from the viewpoint of moldability and storage stability. In the present invention, commercially available products can be used for the excipient, lubricant, and fluidizing agent.

[0043] The content of HMB or its salt and other materials (components of the present invention) in the composition of the present invention may be appropriately included within a range that achieves the desired effect.

[0044] Specifically, when the oral composition of the present invention is a supplement or pharmaceutical in the form of tablets, pills, or capsules, it is preferable that the components of the present invention make up 5 to 99% by mass of the total on a dry weight basis, more preferably 8 to 98% by mass, and particularly preferably 10 to 97% by mass. Furthermore, when the oral composition of the present invention is a supplement or pharmaceutical in the form of chewable tablets, it is preferable that the components of the present invention make up 0.1 to 70% by mass of the total on a dry weight basis, more preferably 0.5 to 60% by mass, and particularly preferably 1 to 50% by mass. In the case of powdered or granular supplements or pharmaceuticals, it is preferable that the components of the present invention make up 0.1 to 90% by mass of the total on a dry weight basis, more preferably 0.5 to 80% by mass, and particularly preferably 1 to 70% by mass. In the case of liquid supplements or pharmaceuticals, it is preferable that the components of the present invention make up 5 to 99% by mass of the total on a dry weight basis, more preferably 8 to 98% by mass, and particularly preferably 10 to 97% by mass.

[0045] There are no particular restrictions on the amount of oral composition of the present invention to be taken per day. However, from the viewpoint of more significantly exhibiting the effects of the present invention, it is preferable for adults to take HMB at a rate of 100 mg / day or more per day, more preferably 200 mg / day or more, and even more preferably 300 mg / day or more. The upper limit is, for example, 10,000 mg / day, preferably 8,000 mg / day, and more preferably 5,000 mg / day. In addition, it is preferable for adults to take ceramide, kudzu flower, Japanese knotweed, thorny vine, muscarpus, and chili pepper at a rate of 0.1 mg / day or more per day, more preferably 0.3 mg / day or more, and even more preferably 0.5 mg / day or more. The upper limit is, for example, 1,000 mg / day, preferably 500 mg / day, and more preferably 300 mg / day. The oral composition of the present invention may be appropriately designed so that the daily intake amount is the aforementioned intake amount, and may be taken in one dose or in multiple doses. For example, in the case of tablets, capsules, pills, or chewable tablets, it is sufficient to take them 1 to 4 times per day, so that the total amount taken is the aforementioned intake amount. The oral composition of the present invention can be contained in one container, or divided into, for example, two or three containers, to represent one day's supply, so that the daily intake amount is the aforementioned intake amount.

[0046] The blending mass ratio of HMB or its salt and other materials is preferably in the range of 0.5:1 to 100,000:1 on a dry weight basis, more preferably in the range of 0.75:1 to 50,000:1, even more preferably in the range of 1:1 to 30,000:1, and particularly preferably in the range of 1:1 to 10,000:1 from the viewpoint of muscle-building effect and / or anti-obesity effect.

[0047] The compositions of the present invention can be manufactured by known methods, with the addition of other components besides the components of the present invention as needed. Examples of other components besides the components of the present invention include water-soluble vitamins (vitamins B1, B2, B3, B5, B6, B12, B13, B15, B17, biotin, choline, folic acid, inositol, PABA, vitamin C, vitamin P), oil-soluble vitamins (vitamins A, D, E, K), etc.; minerals such as calcium, magnesium, phosphorus, and iron; sulfur-containing compounds found in taurine, garlic, etc.; flavanoids such as hesperidin and quercetin; proteins such as collagen; peptides; amino acids; animal fats and oils; vegetable fats and oils; and crushed or extracted animal and plant materials. [Examples]

[0048] The present invention will be described below based on examples. [Example 1] Test 1: Evaluation of the inhibitory effect on adipocyte differentiation using fibroblasts.

[0049] (1) Cell culture (method for inducing differentiation into adipocytes) 75cm in a 37℃, 5% CO2 incubator. 2 Mouse fibroblast cell line (3T3-L1) was cultured in a flask using DMEM containing 10% (V / V) FBS. Cells suspended by trypsin were then cultured at 75 cm³. 2 2 × 10⁶ of each well in a collagen-coated 96-well plate from a flask. 4 Cells were seeded at a cell density of cells / well. They were cultured in a 37°C, 5% CO2 incubator until confluence was reached. Three days after confluence, a sample containing the test substance, prepared in differentiation induction medium, was added and cultured for 7 days. During this time, the sample containing the test substance was replaced every 2-3 days with a sample containing the test substance, prepared in differentiation maintenance medium. Cells that did not undergo differentiation induction were cultured in 10% (V / V) FBS-containing DMEM with the same concentration of dimethyl sulfoxide as the sample containing the test substance.

[0050] The differentiation induction medium was prepared by adding 0.5 mM 3-isobutyl-1-methylxanthine, 0.5 μM dexamethasone, and 10 μg / mL insulin to 10% (V / V) FBS-containing DMEM. The differentiation maintenance medium was prepared by adding 10 μg / mL human insulin solution to 10% (V / V) FBS-containing DMEM.

[0051] The following substances were used as test materials. A commercially available product containing HMBCa was used as HMB or its salt. As the ceramide, we used a purified (commercially available) rice-derived glucosylceramide with a glycoceramide concentration of 99% or higher. For the kudzu flower, we used a hot water extract powder of kudzu flowers (manufactured by Toyo Shinyaku Co., Ltd.). For the Japanese knotweed (Polygonum cuspidatum), a commercially available hot water extract powder of Japanese knotweed was used. For the saccharomyces kotsusaiho, a commercially available ethanol extract powder of saccharomyces kotsusaiho was used. For the preparation of the Asparagus plant, we used a commercially available ethanol extract powder of Asparagus plant. For the chili pepper used, we used "Green Chili Pepper Fermented Extract" (manufactured by Toyo Shinyaku Co., Ltd.), which is a lactic acid bacteria fermented extract of Fushimi Amagana pepper.

[0052] (2) Staining of intracellular lipid droplets After culturing, 100 μL of sample and an equal volume of 10% formalin solution were added to the cells, and the cells were left undisturbed at room temperature for 10 minutes. The formalin solution was removed, and 100 μL / well of fresh 10% formalin solution was added to the cells, and the cells were fixed by leaving them undisturbed at room temperature for 10 minutes. The formalin solution was removed, and the cells were washed twice with PBS. 50 μL / well of 60% isopropanol-oil red solution was added to the cells and blank wells, and the cells were stained by leaving them undisturbed at room temperature for 30 minutes. The staining solution was removed, and 150 μL / well of 60% isopropanol was added. The 60% isopropanol was removed, and the cells were washed once with PBS. 50 μL / well of 100% isopropanol was added to the cells and blank wells, and the cells were shaken for about 10 minutes to extract the staining solution. The absorbance of the isopropanol solution from which the staining solution was extracted was measured at 520 and 650 nm (turbidity). (3) Method for quantifying protein The isopropanol solution was left at room temperature for one day to completely remove all isopropanol from the plate. After isopropanol removal, 20 μL / well of PBS was added to a 96-well plate and left to stand in a -80°C freezer until completely frozen. The 96-well plate was removed from the -80°C freezer and left to stand at room temperature until completely thawed. 160 μL / well of the reaction solution from the protein assay BCA kit was added. Standards with final BSA concentrations of 0, 25, 125, 250, 500, 750, 1000, and 2000 μg / mL were prepared. After gently shaking in a plate shaker, the plate was incubated at 37°C for 30 minutes. After incubation, 120 μL / well of the supernatant, which had been returned to room temperature, was collected and transferred to another 96-well plate. The absorbance at 562 nm was measured. (4) Data analysis Based on the obtained data, the "% of control" was calculated using the following formula.

[0053] % of control = [Data 520nm - Data 650nm] / [Protein concentration] × 100

[0054] In the formula, the protein concentration was calculated by subtracting the calibration curve (y=Ax+B) from the absorbance of the Standard. Data520nm is the absorbance value at 520nm after oil red staining, Data650nm is the absorbance value at 650nm (turbidity) after oil red staining, and Control is the value of [Data562nm value] - [Standard0].

[0055] Figures 1-6 show the results of evaluating the amount of adipocytes in mouse fibroblasts. Lower values ​​indicate suppressed adipocyte differentiation. Each figure, from left to right, shows the results for "control," "HMBCa alone," "other material alone," and "HMBCa + other material." The concentration units of the added components are μg / mL.

[0056] As shown in Figures 1-6, the compositions of the present invention using HMBCa and other materials of the present invention synergistically suppressed adipocyte differentiation compared to each material alone. Since obesity is caused by the hypertrophy and proliferation of adipocytes, it is thought that obesity can be prevented by suppressing the differentiation of adipocytes. Therefore, the oral compositions of the present invention are useful for preventing obesity.

[0057] Test 2: Evaluation of muscle differentiation-promoting effects using myoblasts (1) 75cm in a 37℃, 5% CO2 incubator 2 Mouse myoblast cell line (C2C12) was cultured in a flask in DMEM containing 10% (V / V) FBS. (2) Cells suspended by trypsin treatment, 75 cm 2 Cells were seeded from the flask into each well of a 96-well plate at a cell density of 5000 cells / well. (3) Pre-cultured for 72 hours in a 37°C, 5% CO2 incubator.

[0058] (4) Specified concentration in DMEM containing 0.5% (V / V) DMSO-10% (V / V) FBS 200 μL of the culture medium containing the test substance, prepared according to the instructions, was added to each sample and incubated for 24 hours. (5) After 24 hours of incubation, RNA was recovered using the RNeasy Mini Kit (QIAGEN), and cDNA was synthesized using ReverTra Ace® qPCR RT Master Mix with gDNA Remover (Toyobo). (6) Using the obtained cDNA as a template, quantitative real-time PCR was performed using a QuantiNova SYBR Green PCR Kit (QIAGEN) with a primer for the Myogenin gene (Myog) to measure the mRNA expression level of the Myogenin gene. As an endogenous control, the mRNA expression level of GAPDH was measured using a GAPDH primer (QIAGEN).

[0059] The following substances were used as test materials. A commercially available product containing HMBCa was used as HMB or its salt. As the ceramide, we used a purified (commercially available) rice-derived glucoside ceramide with a glycoceramide concentration of 99% or higher. For the kudzu flower, we used a hot water extract powder of kudzu flowers (manufactured by Toyo Shinyaku Co., Ltd.).

[0060] Figures 7 and 8 show the measurement results of myogenin gene mRNA expression levels. Myogenin is a gene that functions during the differentiation of myoblasts into muscle cells, and the amount of myogenin gene mRNA expression serves as an indicator of muscle cell differentiation. Higher values ​​indicate higher myogenin gene mRNA expression levels. Each figure, from left to right, shows the results for "control," "HMBCa alone," "other material alone," and "HMBCa + other material," and the concentration units of the added components are μg / mL.

[0061] As shown in Figures 7 and 8, the compositions of the present invention using HMBCa and specific materials showed a synergistically higher myogenin gene mRNA expression level compared to each material alone. Based on these results, it is considered that the compositions of the present invention can effectively promote the differentiation of myoblasts into muscle cells in skeletal muscle and more effectively enhance skeletal muscle.

[0062] [Example 2] (Manufacturing of tablets) Tablets (250 mg) containing the following ingredients were manufactured. Take 5 of these tablets daily.

[0063] HMBCa 50% Kudzu flower hot water extract 25% Calcium stearate 2% Silicon dioxide 2% Reduced maltose 21%

[0064] [Example 3] (Manufacturing of tablets) Tablets (350 mg) containing the following ingredients were manufactured. Six of these tablets should be taken daily.

[0065] HMBCa 85% Rice-derived glucosylceramide 0.1% Pullulan 1% Reduced maltose 13.9%

[0066] The above tablets, taken once a day or in two or three divided doses with water, provide excellent muscle-building and anti-obesity effects.

[0067] [Example 4] (Manufacturing of capsules) The following mixture was enclosed in hard capsules to produce capsules (300 mg). Five of these hard capsules should be taken daily.

[0068] HMBCa 70% Japanese knotweed aqueous ethanol extract 0.5% Kotsusaiho aqueous ethanol extract 0.5% Muscle grass hot water extract 0.5% Capsicum Ethanol Extract 0.5% Lactic acid bacteria 5% Cellulose 21% Silicon dioxide 2%

[0069] The above capsules, when taken once a day or in 2 to 4 divided doses with water, provide excellent muscle-building and anti-obesity effects.

[0070] [Example 5] (Production of granules) The following ingredients were mixed and a granular preparation (3000 mg) was manufactured by a conventional method. Taking the resulting granular preparation with water yields excellent muscle-building and anti-obesity effects.

[0071] HMBCa 50% Kudzu flower water extract 10% Corn-derived glucosylceramide 2% Aspartame 0.1% Thiamine hydrochloride 0.33% Riboflavin 0.33% Vitamin B6 0.17% Cyanocobalamin 0.17% Fragrance 0.17% Reduced palatinose 6.67% Calcium stearate 3.33% Hydrodoxypropylcellulose Remainder

[0072] [Example 6] (Manufacturing of chewable tablets) We manufactured chewable tablets (1000 mg per tablet) containing the following ingredients. Taking two of these chewable tablets three times a day (a total of six tablets) provides excellent muscle-building and anti-obesity effects.

[0073] HMBCa 20.00% Kudzu flower hot water extract 15.00% Kotsusaiho water extract 0.70% Ajuga decumbens ethanol extract 0.70% Sucralose 0.10% Aspartame 0.05% Vitamin B1 0.01% Vitamin B2 0.01% Vitamin B6 0.01% Fragrance 0.01% Calcium stearate 1.00% Silicon dioxide 2.00% Hydroxypropylcellulose 1.00% Cellulose 30.00% Reduced palatinose (remaining portion)

[0074] [Example 7] (Manufacturing of chewable tablets) We manufactured chewable tablets (700 mg per tablet) containing the following ingredients. Taking two of these chewable tablets per day provides excellent muscle-building and anti-obesity effects.

[0075] HMBCa 40.00% Japanese knotweed aqueous ethanol extract 0.70% Kotsusaifoethanol extract 0.70% Muscle grass hot water extract 0.70% Fragrance 0.01% Sucrose fatty acid ester 3.00% Silicon dioxide 2.00% Hydroxypropylcellulose 5.00% Reduced palatinose (remaining portion) [Industrial applicability]

[0076] The oral composition of the present invention has muscle-building effects, anti-obesity effects, and other such effects, making it highly useful in the industry.

Claims

[Claim 1] An oral composition containing 3-hydroxy-3-methylbutyric acid or a salt thereof and kotsusaifo.

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