Muscle differentiation promoter and muscle differentiation promoter composition

Abstract

This muscle differentiation promoter is a combination of (A) black ginger extract and (B) an amino acid or a salt thereof. The (B) amino acid or a salt thereof contains one or more selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof and valine or a salt thereof.

Description

Muscle differentiation promoter and composition for promoting muscle differentiation 【0001】 The present invention relates to a muscle differentiation promoter and a composition for promoting muscle differentiation. 【0002】 When performing exercise, the movement is carried out by muscles, and it is necessary to enhance muscle function in order to improve exercise ability. This is not limited to sports players, and muscles are also very important for the general public to lead a healthy daily life such as daily light exercise and maintaining posture. In addition, muscles not only have the function of moving the body, but also play various roles such as controlling blood sugar levels by using glucose, regulating body temperature by generating heat, and regulating fat mass by using lipids, which indicates that they are important for maintaining health. 【0003】 Muscles are formed by the differentiation of muscle cells. In the differentiation of muscle cells, mononuclear myoblasts fuse with each other to form long and multinuclear myotubes. Thereafter, the myotubes aggregate and align to form muscle fibers, generating a large force as muscles. Thus, muscle formation is a complex process consisting of myoblast proliferation and differentiation, recognition and adhesion between muscle cells, and fusion. 【0004】 Black ginger has been used in Thailand, a major producing country, since ancient times as a folk medicine for nourishing and strengthening, such as enhancing energy, improving sexual ability, and alleviating gastrointestinal diseases and pain. In some regions of South Asia, it is highly safe, such as boiling sliced black ginger for tea or steeping it in alcohol to make medicinal liquor for drinking for health purposes. 【0005】 In addition, it has also been reported that black ginger extract has an effect of improving muscle endurance (for example, see Patent Document 1) and an effect of increasing muscle mass (for example, see Patent Document 2). 【0006】 On the other hand, among amino acids, valine, leucine, and isoleucine, which are branched-chain amino acids (hereinafter sometimes referred to as "BCAAs"), are known to play important roles in maintaining and increasing muscle mass. 【0007】As mentioned above, materials that have beneficial effects on muscles are known. However, consumer demand remains strong, and there is a need for the development of technologies that produce even better effects. 【0008】 Japanese Patent Publication No. 2016-008180, International Publication No. 2013 / 172681 【0009】 The present invention aims to solve the aforementioned problems of the conventional approach and achieve the following objectives. Specifically, the present invention aims to provide a muscle differentiation promoting agent and a muscle differentiation promoting composition that have excellent muscle differentiation promoting effects and high safety. 【0010】 In order to solve the aforementioned problems, the present inventors conducted extensive research and found that combining (A) black ginger extract with (B) an amino acid or its salt, which includes one or more selected from the group consisting of leucine or its salt, isoleucine or its salt, and valine or its salt, produces a remarkably excellent muscle differentiation promoting effect, thus completing the present invention. 【0011】The present invention is based on the inventors' knowledge, and the means for solving the above problems are as follows: <1> A muscle differentiation promoter comprising (A) black ginger extract and (B) an amino acid or a salt thereof, wherein the (B) amino acid or salt thereof comprises one or more selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof. <2> The muscle differentiation promoter according to <1>, wherein the (B) amino acid or salt thereof comprises leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof. <3> The muscle differentiation promoter according to <1> or <2>, wherein the total mass of one or more selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof is 50% by mass or more of the total mass of the (B) amino acid or salt thereof. <4> The muscle differentiation promoter according to any one of <1> to <3>, wherein the (B) amino acid or salt thereof further comprises methionine or a salt thereof, tryptophan or a salt thereof, histidine or a salt thereof, lysine or a salt thereof, phenylalanine or a salt thereof, and threonine or a salt thereof. <5> The muscle differentiation promoter according to any one of <1> to <4>, wherein the ratio ((B) / (A)) of the mass of the (A) black ginger extract to the total mass of the (B) amino acid or salt thereof is 1 to 500. <6> The muscle differentiation promoter according to <5>, wherein the total mass of the (B) amino acid or salt thereof is the total mass of the essential amino acid or salt thereof. <7> A muscle differentiation promoting composition characterized by containing the muscle differentiation promoter according to any one of <1> to <6>. 【0012】 According to the present invention, it is possible to solve the aforementioned problems in the conventional era, achieve the aforementioned objectives, and provide a muscle differentiation promoting agent and a muscle differentiation promoting composition that have excellent muscle differentiation promoting effects and are highly safe. 【0013】(Muscle Differentiation Promoter) The muscle differentiation promoter of the present invention comprises a combination of (A) black ginger extract (hereinafter sometimes referred to as "component (A)") and (B) an amino acid or a salt thereof (hereinafter sometimes referred to as "component (B)"), and optionally includes other components. Component (B) includes at least one selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof. 【0014】 Although the details of how the combination of component (A) and component (B) exhibits a dramatically improved muscle differentiation-promoting effect are unclear, the fact that the combination of component (A) and component (B) has such excellent effects and is extremely useful as a muscle differentiation-promoting agent was completely unknown to the public and represents a new finding by the present inventors. 【0015】 In this specification, promotion of muscle differentiation means promoting the differentiation of myoblasts, and includes promoting the differentiation of myoblasts into myotubes and promoting the maturation of myotubes into muscle fibers. 【0016】 There are no particular restrictions on the method for confirming whether or not muscle differentiation has been promoted, and it can be appropriately selected depending on the purpose. For example, it can be confirmed by checking whether or not the expression of muscle differentiation-related genes included in a group of genes called muscle cell-specific genes (MRFs) has been promoted compared to a case where a muscle differentiation-promoting agent is not administered. Examples of muscle differentiation-related genes included in the muscle cell-specific genes include Myod1, Myog, Myf5, and MRF4. 【0017】 The muscle differentiation promoter may be configured such that the active ingredients, component (A) and component (B), are contained in the same composition, or the components (A) and (B) may be contained in separate compositions and used in combination. Furthermore, the component (B) may be configured such that all of the component (B) used is contained in the same composition, or the component (B) used may be divided and contained in two or more compositions and used in combination. 【0018】<(A) Ingredients> The aforementioned black ginger (scientific name: Kaempferia parviflora) is a plant belonging to the genus Kaempferia in the family Zingiberaceae. 【0019】 The aforementioned black ginger extract may be prepared from the part of the plant used as the raw material for extraction, or a commercially available product may be used. 【0020】 -Extraction Part- There are no particular restrictions on the extraction part of the black ginger, and it can be appropriately selected according to the purpose. Examples include above-ground parts such as flowers, buds, seeds, seed coats, stems, leaves, branches, and branch leaves; and underground parts such as roots and rhizomes. These may be used individually or in combination of two or more. Among these, underground parts such as roots and rhizomes are preferred. There are no particular restrictions on the shape, structure, and size of the black ginger extract material, and it can be appropriately selected according to the purpose. 【0021】 -Method for preparing the extracted portion- There are no particular restrictions on the method for preparing the extracted portion of black ginger, and it can be appropriately selected according to the purpose. For example, the extracted portion can be dried and then used as is or ground using a coarse grinder. The dried portion, or ground portion, can be used as is or ground before solvent extraction. The drying may be done in the sun or using a commonly used drying machine. 【0022】 -Extraction- The black ginger extract can be easily obtained by methods commonly used for plant extraction. There are no particular limitations on the form of the black ginger extract, and can be appropriately selected depending on the purpose. Examples include the extract itself, a diluted extract, a concentrated extract, dried products thereof, crude products, and purified products. 【0023】There are no particular restrictions on the extraction method, and it can be appropriately selected depending on the purpose. For example, extraction can be performed at room temperature or under reflux heating using any extraction apparatus. More specifically, an extract can be obtained by placing the extraction portion of the black ginger, which is the raw material for extraction, into a processing tank filled with an extraction solvent, and allowing it to stand for, for example, 30 minutes to 4 hours while stirring as needed to elute the soluble components, and then filtering to remove the extraction residue. The extract may be further dried after removing the extraction solvent. Alternatively, it may be used as an extraction raw material after being pretreated, such as degreasing with a non-polar solvent such as hexane. Pretreatment such as degreasing allows for efficient extraction using a polar solvent. 【0024】 There are no particular restrictions on the conditions (extraction time and extraction temperature), extraction solvent, and amount of extraction solvent used in the extraction of black ginger, and they can be appropriately selected according to the purpose. 【0025】 The extraction solvent is not particularly limited and can be appropriately selected depending on the purpose. Examples include water, a hydrophilic solvent, or a mixed solvent of water and a hydrophilic solvent. 【0026】 There are no particular restrictions on the water mentioned above, and it can be appropriately selected depending on the purpose. For example, it includes pure water, tap water, well water, mineral water, mineral water, hot spring water, spring water, fresh water, and water that has undergone various treatments. Treatments applied to the water include, for example, purification, heating, sterilization, filtration, ion exchange, osmotic pressure adjustment, and buffering. The water that can be used as the extraction solvent also includes purified water, hot water, ion-exchanged water, physiological saline, phosphate buffer, and phosphate-buffered physiological saline. The water may be used alone or in combination of two or more types. 【0027】The hydrophilic solvent is not particularly limited and can be appropriately selected depending on the purpose. Examples include lower alcohols having 1 to 5 carbon atoms such as methanol, ethanol, propyl alcohol, and isopropyl alcohol; lower aliphatic ketones such as acetone and methyl ethyl ketone; and polyhydric alcohols having 2 to 5 carbon atoms such as 1,3-butylene glycol, propylene glycol, and glycerin. These may be used individually or in combination of two or more. 【0028】 There are no particular restrictions on the amount of the hydrophilic solvent used relative to the water in the mixed solvent, and it can be appropriately selected according to the purpose. However, when using a lower alcohol, it is preferable to add 1 to 90 parts by volume per 10 parts by volume of water; when using a lower aliphatic ketone, it is preferable to add 1 to 40 parts by volume per 10 parts by volume of water; and when using a polyhydric alcohol, it is preferable to add 1 to 90 parts by volume per 10 parts by volume of water. 【0029】 There are no particular restrictions on the temperature of the extraction solvent, and it can be appropriately selected depending on the purpose, but it is preferable to use a temperature at room temperature or below the boiling point of the solvent. 【0030】 The obtained black ginger extract may be subjected to dilution, concentration, drying, purification, and other treatments according to conventional methods in order to obtain diluted products, concentrated products, dried products, crude products, purified products, etc. 【0031】 There are no particular restrictions on the purification method of the black ginger extract, and it can be appropriately selected depending on the purpose. Examples of purification methods include activated carbon treatment, adsorption resin treatment, and ion exchange resin treatment. By purifying the extract using these methods, the concentration of active ingredients can be increased, or unwanted substances can be removed. 【0032】 The obtained black ginger extract can be used as is as an active ingredient in the muscle differentiation promoter, but the concentrated liquid and the dried product are preferred for ease of use. When obtaining the dried product, a carrier such as dextrin or cyclodextrin may be added to improve its hygroscopic properties. 【0033】There are no particular restrictions on the amount of black ginger extract contained in the muscle differentiation promoter, and it can be appropriately selected depending on the purpose. 【0034】 <Component (B)> Component (B) is an amino acid or a salt thereof, and includes at least one selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof. Leucine, isoleucine, and valine are amino acids that cannot be synthesized in the body and are classified as essential amino acids. Leucine, isoleucine, and valine are known to play an important role in maintaining and increasing muscle mass. Hereinafter, one or more selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof may be referred to as "BCAA or a salt thereof" or "Component (B1)". 【0035】 The component (B) is not particularly limited as long as it contains the component (B1), and may also contain other amino acids or salts thereof. The other amino acids or salts thereof are not particularly limited and can be appropriately selected depending on the purpose, and examples include essential amino acids or salts thereof other than the component (B1), non-essential amino acids or salts thereof, and amino acids or salts thereof other than essential and non-essential amino acids. 【0036】 Other essential amino acids or their salts besides the aforementioned (B1) component are not particularly limited and can be appropriately selected depending on the purpose. Examples include methionine or its salt, tryptophan or its salt, histidine or its salt, lysine (sometimes referred to as "lysine") or its salt, phenylalanine or its salt, threonine or its salt. These may be used individually or in combination of two or more. Hereinafter, essential amino acids or their salts other than the aforementioned (B1) component may be referred to as "(B2) component". 【0037】The aforementioned non-essential amino acids are amino acids that can be synthesized in the body. There are no particular restrictions on the non-essential amino acids or their salts, and they can be appropriately selected depending on the purpose. Examples include tyrosine or its salts, cysteine ​​or its salts, aspartic acid or its salts, asparagine or its salts, serine or its salts, glutamic acid or its salts, glutamine or its salts, proline or its salts, glycine or its salts, alanine or its salts, and arginine or its salts. These may be used individually or in combination of two or more. Hereinafter, the aforementioned non-essential amino acids or their salts may be referred to as "(B3) component". 【0038】 There are no particular restrictions on the amino acids or salts other than the essential and non-essential amino acids mentioned above, and they can be appropriately selected depending on the purpose. Examples include citrulline or its salts, ornithine or its salts. These may be used individually or in combination of two or more. Hereinafter, the amino acids or salts other than the essential and non-essential amino acids mentioned above may be referred to as "(B4) components." 【0039】 There are no particular restrictions on the salt of the amino acid, and it can be appropriately selected depending on the purpose. Examples include salts with inorganic or organic acids such as hydrochloride, sulfate, and acetate salts; and salts with bases such as sodium and potassium salts. 【0040】 The aforementioned component (B) preferably contains leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof, and more preferably contains methionine or a salt thereof, tryptophan or a salt thereof, histidine or a salt thereof, lysine or a salt thereof, phenylalanine or a salt thereof, and threonine or a salt thereof. 【0041】 There are no particular restrictions on the amount of component (B) in the muscle differentiation promoter, and it can be appropriately selected depending on the purpose. Similarly, there are no particular restrictions on the ratio of each amino acid used as component (B), and it can be appropriately selected depending on the purpose. 【0042】The total mass of one or more selected from the group consisting of leucine or its salt, isoleucine or its salt, and valine or its salt ((B1) component total mass) relative to the total mass of the (B) component is not particularly limited and can be appropriately selected according to the purpose, but 50% by mass or more is preferable, 50 to 70% by mass is more preferable, and 50 to 60% by mass is particularly preferable. 【0043】 The mass ratio of leucine or its salt, isoleucine or its salt, and valine or its salt (leucine or its salt: isoleucine or its salt: valine or its salt) is not particularly limited and can be appropriately selected according to the purpose, but 2 to 3:1:1 to 2 is preferable. 【0044】 The total mass of essential amino acids or their salts ((B1) component and (B2) component total mass) relative to the total mass of the (B) component is not particularly limited and can be appropriately selected according to the purpose, but 80% by mass or more is preferable, 90% by mass or more is more preferable, and 95% by mass or more is particularly preferable. The (B) component may consist only of essential amino acids or their salts. 【0045】 The ratio ((B) / (A)) of the mass of the (A) component to the total mass of the (B) component in the muscle differentiation promoter is not particularly limited and can be appropriately selected according to the purpose, but it is preferably 1 to 500, more preferably 1 to 250, further preferably 1 to 100, even more preferably 1 to 50, and particularly preferably 1 to 20. The mass ratio of the (A) component to the (B) component is a value in terms of solid content. 【0046】 The "total mass of the (B) component" in the ratio (B) / (A) is not particularly limited and can be appropriately selected according to the purpose, but the total mass of essential amino acids or their salts ((B1) component and (B2) component total mass) is preferable. 【0047】Since components (A) and (B) have excellent muscle differentiation-promoting effects, they can be used as active ingredients in muscle differentiation promoters. These muscle differentiation promoters can be used in a wide range of applications, including pharmaceuticals, quasi-drugs, oral compositions, cosmetics, and research reagents. 【0048】 The muscle differentiation promoter may consist only of component (A) and component (B), or it may be a mixture of component (A) and component (B), or it may be a formulation of at least one of component (A) and component (B). 【0049】 When formulating, the drug can be manufactured in any dosage form, such as powder, granules, tablets, or liquid, using pharmaceutically acceptable carriers such as dextrin or cyclodextrin, or other optional excipients, in accordance with conventional methods. In this case, excipients such as excipients, binders, disintegrants, lubricants, stabilizers, and flavoring / odorizing agents can be used. The muscle differentiation promoter can be used in combination with other compositions (for example, muscle differentiation promoting compositions described later), or it can be used as tablets, capsules, etc. 【0050】 There are no particular restrictions on the content of at least one of component (A) and component (B) in the formulated muscle differentiation promoter, and they can be appropriately selected depending on the purpose. 【0051】 Furthermore, the muscle differentiation promoter may, if necessary, be used as an active ingredient by combining other components having muscle differentiation-promoting effects with at least one of the components (A) and (B). 【0052】 <Other Components> The other components mentioned above are not particularly limited as long as they do not impair the effects of the present invention, and can be appropriately selected depending on the form in which the muscle differentiation promoter is used. Examples include components that can be used when formulating the above-mentioned formulation. The other components may be used alone or in combination of two or more. 【0053】There are no particular restrictions on the content of the other components in the muscle differentiation promoter, and they can be appropriately selected depending on the purpose. 【0054】 <Applications> There are no particular restrictions on the applications of the muscle differentiation promoter, and it can be appropriately selected according to the purpose. Examples include pharmaceuticals, quasi-drugs, food and beverages, and cosmetics. 【0055】 The muscle differentiation promoter has excellent muscle differentiation promoting effects and is highly safe, so it can be suitably used, for example, as an active ingredient in a muscle differentiation promoting composition described later. In this case, component (A) and component (B) may be combined as they are, or a muscle differentiation promoter formulated from at least one of component (A) and component (B) may be combined. 【0056】 The muscle differentiation promoter can promote muscle differentiation through the actions of the active ingredients, components (A) and (B). This makes it possible to increase muscle mass, suppress muscle mass loss, increase basal metabolic rate, enhance muscle strength, suppress muscle strength decline, improve muscle endurance, improve athletic performance, improve muscle function, promote muscle hypertrophy, suppress muscle atrophy, promote muscle regeneration, increase muscle protein synthesis, and improve muscle metabolism. However, the muscle differentiation promoter of the present invention can be used in all applications where it is meaningful to exhibit a muscle differentiation promoting effect, in addition to these applications. 【0057】 The muscle differentiation-promoting agent of the present invention is suitably applied to humans, but can also be applied to animals other than humans (e.g., mice, rats, hamsters, dogs, cats, cattle, pigs, monkeys, etc.) as long as its effects are achieved. 【0058】 Furthermore, while the muscle differentiation-promoting agent of the present invention can be suitably used for individuals who engage in training such as strength training, it can also be used for individuals who do not regularly engage in training. 【0059】 There are no particular restrictions on the method of use of the muscle differentiation promoter, and it can be appropriately selected according to the purpose. For example, methods of use include oral administration, parenteral administration, and topical administration, but oral administration is preferred. 【0060】There are no particular restrictions on the method of administration, dosage, administration site, duration of administration, or administration interval (sometimes referred to as "method of use, dosage, administration site, duration of use, or administration interval") of the aforementioned muscle differentiation promoter, and these can be appropriately selected according to the purpose. 【0061】 The muscle differentiation promoting agent of the present invention can also be used as a reagent for research on the mechanism of action of muscle differentiation promoting action. 【0062】 (Composition for promoting muscle differentiation) The composition for promoting muscle differentiation of the present invention comprises at least the muscle differentiation promoting agent of the present invention, and optionally comprises other components. 【0063】 <Muscle Differentiation Promoting Agent> The muscle differentiation promoting agent is the muscle differentiation promoting agent of the present invention as described above. The muscle differentiation promoting agent to be incorporated into the muscle differentiation promoting composition may be a mixture of component (A) and component (B) as is, or a formulation of at least one of component (A) and component (B) may be incorporated. 【0064】 There are no particular restrictions on the content of the muscle differentiation promoter in the muscle differentiation promoting composition, and it can be appropriately adjusted depending on the form of the muscle differentiation promoting composition and the physiological activity of the active ingredient in the muscle differentiation promoter. However, the total content (in terms of solid content) of component (A) and component (B) is preferably 0.0001 to 20% by mass, and more preferably 0.0001 to 10% by mass. The muscle differentiation promoting composition may consist only of the muscle differentiation promoter. 【0065】 <Other Components> There are no particular restrictions on the other components in the muscle differentiation promoting composition, and they can be appropriately selected depending on the form in which the muscle differentiation promoting composition is used. For example, they can be the same as the other components listed in the section on muscle differentiation promoting agents above. These may be used individually or in combination of two or more. 【0066】 There are no particular restrictions on the content of the aforementioned other components in the muscle differentiation promoting composition, and they can be appropriately selected depending on the purpose. 【0067】<Appearance> There are no particular limitations on the appearance of the muscle differentiation promoting composition, and it can be appropriately selected according to the purpose. Examples include pharmaceuticals, quasi-drugs, food and beverages, and cosmetics. The muscle differentiation promoting composition of the present invention is highly safe and can be used on a daily basis. Through the action of the active ingredients, component (A) and component (B), it can exert various physiologically active effects, including muscle differentiation promoting effects, very effectively. 【0068】 The muscle differentiation-promoting composition can promote muscle differentiation through the actions of its active ingredients, components (A) and (B). This makes it possible to increase muscle mass, suppress muscle mass loss, increase basal metabolic rate, enhance muscle strength, suppress muscle strength decline, improve muscle endurance, improve athletic performance, improve muscle function, promote muscle hypertrophy, suppress muscle atrophy, promote muscle regeneration, increase muscle protein synthesis, and improve muscle metabolism. However, the muscle differentiation-promoting composition of the present invention can be used in all applications where it is meaningful to exhibit a muscle differentiation-promoting effect, in addition to these applications. 【0069】 The muscle differentiation-promoting composition of the present invention is suitably applied to humans, but can also be applied to animals other than humans (e.g., mice, rats, hamsters, dogs, cats, cattle, pigs, monkeys, etc.) as long as their respective effects are achieved. 【0070】 Furthermore, the muscle differentiation-promoting composition of the present invention can be suitably used by individuals who engage in training such as strength training, but it can also be used by individuals who do not regularly engage in training. 【0071】 There are no particular limitations on the use of the muscle differentiation-promoting composition of the present invention, and the method can be appropriately selected depending on the purpose. For example, methods of use include oral administration, parenteral administration, and topical administration, but oral administration is preferred. 【0072】Examples of the oral composition include oral preparations and food and beverages. Here, "food and beverages" refers to substances that pose little risk to human health and are consumed orally or through the gastrointestinal tract in normal social life, and is not limited to administrative classifications such as food, pharmaceuticals, or quasi-drugs. Therefore, "food and beverages" broadly includes food and beverages that constitute general foods, health foods (functional foods and beverages), health functional foods (foods for specified health uses, nutrient functional foods, foods with functional claims), quasi-drugs, pharmaceuticals, etc., that are ingested orally. Preferably, the food and beverages are foods or beverages that can display the desirable effects of the active ingredient according to the present invention on the food or beverage or its packaging, and are particularly preferably health functional foods (foods for specified health uses, nutrient functional foods, foods with functional claims), quasi-drugs, or pharmaceuticals. 【0073】There are no particular restrictions on the types of oral compositions mentioned above, and they can be appropriately selected according to the purpose. Examples include: beverages such as tea beverages, soft drinks, carbonated drinks, nutritional drinks, fruit drinks, lactic acid drinks, alcoholic beverages, coffee beverages, coffee-flavored soft drinks, and non-alcoholic beer-flavored beverages (including concentrated stocks and powders for adjusting these beverages); frozen desserts such as ice cream, ice sherbet, and shaved ice; noodles such as soba, udon, vermicelli, dumpling wrappers, shumai wrappers, Chinese noodles, and instant noodles; confectionery such as candy, candy, gummy candy, gum, chocolate, tablets, snacks, biscuits, cookies, jelly, pudding, jam, cream, baked goods, and bread; and crab, salmon, clams, tuna, sardines, shrimp, bonito, mackerel, whale, oysters, saury, squid, ark clams, scallops, abalone, sea urchin, salmon roe, and abalone. Processed seafood products such as kamaboko, ham, sausage, and other processed seafood and livestock products; dairy products such as processed milk and fermented milk; oils and processed foods such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, and dressings; seasonings such as sauces and dressings; curry, stew, oyakodon, porridge, rice gruel, chukadon, katsudon, tempuradon, unadon, hayashi rice, oden, mapo tofu, gyudon, meat Examples include retort pouch foods such as soups like tomato sauce and egg soup, omelets, dumplings, shumai, hamburgers, and meatballs; prepared foods such as salads and pickles; health, beauty, and nutritional supplements in various forms; pharmaceuticals and quasi-drugs such as tablets, powders, capsules, granules, extracts, syrups, drinks, lozenges, and mouthwashes; and oral fresheners and toothpastes used in the mouth, such as breath fresheners and bad breath preventatives. 【0074】 There are no particular limitations on the method for producing the muscle differentiation-promoting composition, and it can be appropriately selected depending on the form in which the muscle differentiation-promoting composition is used. 【0075】 There are no particular restrictions on the method of use, amount, duration of use, or interval between uses of the aforementioned muscle differentiation-promoting composition (sometimes referred to as "method of intake, amount of intake, duration of intake, or interval between intake"), and these can be appropriately selected according to the purpose. 【0076】The aforementioned muscle differentiation-promoting composition can also be used as a reagent for research on the mechanism of action of muscle differentiation-promoting effects. 【0077】 As described above, the muscle differentiation promoting agent and muscle differentiation promoting composition of the present invention have excellent muscle differentiation promoting effects. Therefore, the present invention also relates to a method for promoting muscle differentiation, characterized by administering at least one selected from the group consisting of the muscle differentiation promoting agent and the muscle differentiation promoting composition to an individual (subject). 【0078】 The present invention also relates to an mRNA expression promoter for muscle differentiation-related genes included in a muscle cell-specific gene group, comprising (A) black ginger extract and (B) an amino acid or a salt thereof, wherein (B) the amino acid or salt thereof comprises one or more selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof. Furthermore, the present invention relates to an mRNA expression promoter for muscle differentiation-related genes included in a muscle cell-specific gene group, characterized by administering the mRNA expression promoter for muscle differentiation-related genes included in a muscle cell-specific gene group to an individual (subject). 【0079】 Furthermore, the present invention also relates to the use of a combination of (A) black ginger extract and (B) an amino acid or a salt thereof for the manufacture of a pharmaceutical composition or food or beverage. Diseases targeted by the said pharmaceutical composition or food include, for example, age-related muscle weakness (sarcopenia), frailty (a frail state in the elderly), growth hormone deficiency, testosterone deficiency, disuse muscle atrophy, postoperative muscle weakness, muscular dystrophy, amyotrophic lateral sclerosis, Parkinson's disease, muscle metabolic disorders, myositis, muscle weakness associated with chronic diseases, muscle injuries such as muscle strains, etc. Therefore, more specifically, the present invention also relates to the use of a combination of (A) black ginger extract and (B) an amino acid or a salt thereof for the manufacture of a pharmaceutical composition or food or beverage for at least one of the diseases targeted by the said pharmaceutical composition or food. 【0080】The present invention also relates to a method for preventing or treating a disease, characterized by administering (A) black ginger extract and (B) an amino acid or a salt thereof to an individual (subject). Diseases targeted by the above method include, for example, age-related muscle weakness (sarcopenia), frailty (a weakened state in the elderly), growth hormone deficiency, testosterone deficiency, disuse muscle atrophy, postoperative muscle weakness, muscular dystrophy, amyotrophic lateral sclerosis, Parkinson's disease, muscle metabolic disorders, myositis, muscle weakness associated with chronic diseases, and muscle injuries such as muscle strains. 【0081】 The following describes test examples and formulation examples of the present invention, but the present invention is not limited in any way to these test examples and formulation examples. 【0082】 (Test Example 1: Muscle Differentiation Promoting Effect Test) The muscle differentiation promoting effect was tested using the following test sample and the following test method. <Test Sample> ・Black ginger extract: Clear Black Ginger (manufactured by Maruzen Pharmaceutical Co., Ltd.) ・Amino acids or their salts: Essential amino acid mixture The composition of the essential amino acid mixture is as follows. • L-Leucine 25.0% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Isoleucine 11.0% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Valine 14.0% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Methionine 9.0% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Tryptophan 2.5% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Histidine Hydrochloride 4.5% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Lysine Hydrochloride 16.0% by mass (manufactured by Nippon Rikagaku Yakuhin Co., Ltd.) • L-Phenylalanine 4.5% by mass (manufactured by Tomo Chemical Co., Ltd.) • L-Threonine 13.5% by mass (manufactured by Tomo Chemical Co., Ltd.) Total 100.0% by mass 【0083】<Test Method> Mouse skeletal muscle-derived myoblasts (C2C12) were used in Dulbecco's modified Eagle medium (DMEM) containing 10% by mass of fetal bovine serum (FBS) and CO2 ２ The cells were cultured at a concentration of 5% and 37°C, then harvested by trypsin treatment. The harvested cells were 2.0 × 10⁶ ４ After diluting to a concentration of cells / mL, 2 mL was seeded per well into a collagen-coated 6-well plate, and CO2 was added. ２ The cultures were incubated at a concentration of 5% and 37°C for 3 days. Afterward, the culture medium was removed, and 2 mL of the test sample, dissolved in 2% by mass horse serum-containing DMEM, was added to each well (see Tables 1 and 2 below for the concentration of the test sample). ２ Myotubular differentiation was induced by culturing cells at a 5% concentration and 37°C for one day. After culturing, the culture medium was discarded, and total RNA was extracted using QuickGene-Mini 480 and RNA culture cell kit S (manufactured by Kurabo Industries Ltd.). The amount of each RNA was measured using a spectrophotometer, and total RNA was prepared to 200 ng / μL. Using this total RNA as a template, the expression levels of myotubular differentiation-related genes (Myod1 and Myog) and the internal standard Gapdh mRNA were measured. Detection was performed using a real-time PCR instrument, Thermal Cycle Dice® Real Time System III (manufactured by Takara Bio Inc.), and PrimeScript. ＴＭ The analysis was performed using a two-step real-time RT-PCR reaction with RT Master Mix (Perfect Real Time) and TB Green® Fast qPCR Mix (manufactured by Takara Bio Inc.). The mRNA expression levels of each muscle differentiation-related gene were corrected for the mRNA expression level of Gapdh. The calculation method for the mRNA expression enhancement rate of muscle differentiation-related genes is as follows: mRNA expression enhancement rate of muscle differentiation-related genes (%) = A / B × 100 A: Corrected value when test sample is added B: Corrected value when no test sample is added 【0084】 【0085】 【0086】The results in Tables 1 and 2 show that the combined use of black ginger extract with one or more amino acids or salts selected from the group consisting of leucine or its salt, isoleucine or its salt, and valine or its salt significantly promotes mRNA expression of muscle differentiation-related genes, confirming that muscle differentiation is promoted. 【0087】 As examples of compositions for promoting muscle differentiation containing the muscle differentiation promoting agent of the present invention, compositions 1 to 5 were prepared. However, the muscle differentiation promoting compositions of the present invention are not limited to these. 【0088】 (Formulation Example 1) Tablets with the following composition were manufactured by a conventional method: • Black ginger extract 15.0 mg (same as used in Test Example 1) • L-leucine 100.0 mg • Dolomite 83.4 mg (containing 20% ​​calcium and 10% magnesium) • Casein phosphopeptide 16.7 mg • Vitamin C 33.4 mg • Maltitol 36.8 mg • Collagen 12.7 mg • Sucrose fatty acid ester 12.0 mg 【0089】 (Formulation Example 2) An oral liquid formulation having the following composition was manufactured by a conventional method. <Composition in one ampoule (100 mL)> - Black ginger extract 0.1% by mass (same as used in Test Example 1) - L-isoleucine 1.0% by mass - Sorbitol 12.0% by mass - Sodium benzoate 0.1% by mass - Flavoring 1.0% by mass - Calcium sulfate 0.5% by mass - Purified water total residue 100.0% by mass 【0090】(Formulation Example 3) A coffee beverage with the following composition was produced by a conventional method: • Black ginger extract 0.1% by mass (same as used in Test Example 1) • L-valine 1% by mass • Coffee extract 40% by mass (L (brightness) = 20, Brix = 3) • Maltitol 2% by mass • Appropriate amount of flavoring • Total water residue 100% by mass 【0091】 (Formulation Example 4) Capsules having the following composition were manufactured by a conventional method. No. 1 hard gelatin capsules were used. <Composition per capsule> ・Black ginger extract 7.5 mg (same as used in Test Example 1) ・L-leucine 25.0 mg ・L-isoleucine 11.0 mg ・L-valine 14.0 mg ・Corn starch 70.0 mg ・Lactose 80.0 mg ・Calcium lactate 10.0 mg ・Hydroxypropyl cellulose (HPC-L) 10.0 mg 【0092】(Formulation Example 5) A soft drink with the following composition was manufactured by a conventional method: • Black ginger extract 0.02% by mass (same as used in Test Example 1) • L-leucine 0.22% by mass • L-isoleucine 0.5% by mass • L-valine 0.3% by mass • Royal jelly 1.0% by mass • Water-soluble collagen 10.0% by mass • Job's tears extract 1.0% by mass • Korean ginseng extract 1.0% by mass • Oligosaccharide 5.0% by mass • Sucrose 10.0% by mass • Prune juice 2.0% by mass • Pomegranate juice 5.0% by mass • Grapefruit juice 10.0% by mass • Grapefruit flavor 0.7% by mass • Total water residue 100.0% by mass 【0093】 This application claims priority based on Japanese Patent Application No. 2024-216225, filed on 11 December 2024, and the entire contents of Japanese Patent Application No. 2024-216225 are incorporated herein by reference.

Claims

1. A muscle differentiation promoter comprising (A) black ginger extract and (B) an amino acid or a salt thereof, characterized in that the (B) amino acid or salt thereof contains one or more selected from the group consisting of leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof.

2. The muscle differentiation promoter according to claim 1, wherein the (B) amino acid or a salt thereof comprises leucine or a salt thereof, isoleucine or a salt thereof, and valine or a salt thereof.

3. The muscle differentiation promoter according to claim 1, wherein the total mass of one or more amino acids selected from the group consisting of leucine or its salt, isoleucine or its salt, and valine or its salt is 50% by mass or more of the total mass of the (B) amino acids or their salts.

4. The muscle differentiation promoter according to claim 2, wherein the (B) amino acid or a salt thereof further comprises methionine or a salt thereof, tryptophan or a salt thereof, histidine or a salt thereof, lysine or a salt thereof, phenylalanine or a salt thereof, and threonine or a salt thereof.

5. The muscle differentiation promoter according to claim 1, wherein the ratio ((B) / (A)) of the mass of (A) black ginger extract to the total mass of (B) amino acids or their salts is 1 to 500.

6. The muscle differentiation promoter according to claim 5, wherein the total mass of the (B) amino acid or a salt thereof is the total mass of the essential amino acid or a salt thereof.

7. A composition for promoting muscle differentiation, characterized by comprising a muscle differentiation promoting agent according to any one of claims 1 to 6.

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