JP2021042142A - Composition for maintaining muscle mass and/or muscle strength or suppressing decrease in muscle mass and/or muscle strength, and pharmaceutical composition and food and drink composition including the composition - Google Patents

Abstract

To provide a new composition for maintaining muscle mass and/or muscle strength or suppressing decrease in muscle mass and/or muscle strength, and a pharmaceutical composition and a food and drink composition including the composition.SOLUTION: The present disclosure provides a composition for maintaining muscle mass and/or muscle strength or suppressing decrease in muscle mass and/or muscle strength, containing Lactobacillus paracasei as an active ingredient. The Lactobacillus paracasei may be Lactobacillus paracasei MCC1849(NITE BP-01633). The composition can be used as a pharmaceutical composition or a food and drink composition.SELECTED DRAWING: None

Description

The present technology relates to a composition for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength, and a pharmaceutical composition and a food and drink composition using the composition.

Traditionally, it has been widely recognized that regular exercise is important for maintaining good health. However, the proportion of the sports population who regularly exercises remains at a low level compared to the national population, and in adults who tend to lack exercise, combined with the effects of aging, muscles. There is a marked decrease in volume and muscle strength. Attenuation of muscle mass and strength reduces the amount of energy metabolism in daily life and can cause not only lifestyle-related diseases but also unexpected injuries in daily life.

In addition, when long-term rest is required after surgery or medical treatment for illness, rapid muscle atrophy and loss of muscle mass may occur, which hinders early return to daily life after healing. Furthermore, elderly people generally have low muscle mass and strength, and in order to live safely, it is desired to maintain or suppress the decrease in muscle mass and strength.

As a muscle-building agent, a steroid agent, a growth hormone, and a growth hormone secretagogue are generally known (for example, Patent Document 1). Further, Patent Document 2 discloses a muscle decomposition inhibitor containing a specific type of lactic acid bacterium.

International Publication No. 98/058948 Pamphlet Japanese Unexamined Patent Publication No. 2016-216408

As described above, although various proposals have been made for methods for maintaining or suppressing the decrease in muscle mass and muscle strength, side effects are a concern in the method using a synthetic compound or the like as in Patent Document 1. Further, as in Patent Document 2, several methods by ingesting probiotic cells or fermented products have already been reported, but it is known that probiotics exhibit different physiological actions depending on the strain. It has been, and the results are not consistent.

Therefore, the present technology provides a composition for maintaining new muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength, and a pharmaceutical composition and a food and drink composition using the composition. The main purpose is that.

That is, in the present technology, first, a composition for maintaining muscle mass and / or muscle strength or suppressing a decrease in muscle mass and / or muscle strength, which contains Lactobacillus paracasei as an active ingredient, is provided.
In the present technology, the Lactobacillus paracasei may be Lactobacillus paracasei MCC1849 (NITE BP-01633).
Further, in the present technology, the composition can be used as a pharmaceutical composition or a food or drink composition.

According to the present technology, it is possible to provide a composition for maintaining new muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength, and a pharmaceutical composition and a food and drink composition using the composition. ..
The effects described here are not necessarily limited, and may be any of the effects described in the present specification.

Hereinafter, suitable embodiments for carrying out the present technology will be described.
It should be noted that the embodiments described below show an example of typical embodiments of the present technology, and the scope of the present technology is not narrowly interpreted by this.

1. 1. Composition for maintaining muscle mass and / or muscle strength, or suppressing decrease in muscle mass and / or muscle strength Composition for maintaining muscle mass and / or muscle strength, or suppressing decrease in muscle mass and / or muscle strength (hereinafter referred to as (Simply also referred to as "composition of the present technology") is characterized by containing lactobacillus paracasei as an active ingredient.

Lactobacillus paracasei is one of the bacterial species belonging to the genus Lactobacillus.
Since the active ingredient of the composition of this technology is Lactobacillus paracasei, which has been widely used as a lactic acid bacterium in the field of foods and drinks, it is excellent in safety and can be continuously administered for a long period of time. It is very useful because there is less need to worry about side effects. Furthermore, its safety is not impaired even when used in combination with other drugs.

Examples of bacteria belonging to Lactobacillus paracasei include Lactobacillus paracasei KW3110 (FERM BP-08634), Lactobacillus paracasei WON0604 (FERM BP-11468), Lactobacillus paracasei MCC1849 (NITE BP-0133), and the like. However, in the present technology, it is particularly preferable to use Lactobacillus paracasei MCC1849 (NITE BP-01633). In the present technology, these types may be used alone, or two or more types may be used in any combination.

Lactobacillus paracasei MCC1849 (NITE BP-01633) was announced on June 6, 2013 by the National Institute of Technology and Evaluation Biotechnology Center Patent Microorganisms Depositary Center (NPMD) (Kazusakamatari, Kisarazu City, Chiba Prefecture 292-0818). Deposited in Room 2-5-8 122), deposited with the deposit number of NITE BP-01633, transferred to the international deposit based on the Budapest Treaty on January 31, 2014, and given the deposit number of NITE BP-01633. Has been done.

The strain specified by the above-exemplified strain name is not limited to the strain itself (hereinafter, also referred to as “deposited strain”) that has been deposited or registered with a predetermined institution under the strain name, and is substantially the same. Strains equivalent to (hereinafter, also referred to as “derivative strain” or “derivative strain”) are also included. That is, for example, "Lactobacillus paracasei MCC1849 (NITE BP-01633)" is not limited to the stock itself deposited at the above depository with the deposit number of MCC1849 (NITE BP-01633), and is substantially equivalent thereto. Strains are also included. Regarding the strain, "a strain substantially equivalent to the above-mentioned deposit strain" belongs to the same species as the above-mentioned deposit strain, and maintains muscle mass and / or muscle strength, which is an effect of the present technology, or muscle mass and / or muscle strength. It means a strain that can obtain the effect of suppressing the decrease of. The strain substantially equivalent to the deposited stock may be, for example, a derivative stock having the deposited stock as a parent stock. Derivative strains include strains bred from deposit stocks and strains naturally generated from deposit stocks.

Examples of substantially the same strains and derivative strains include the following strains.
(1) Strains determined to be the same strain by the RAPD method (Randomly Amplified Polymorphic DNA) and PFGE method (Pulsed-field gel electrophoresis) (described in Probiotics in food / Health and nutritional properties and guidelines for evaluation 85 Page 43).
(2) A strain that possesses only the gene derived from the deposited strain, does not have a gene derived from a foreign country, and has a DNA identity of 95% or more. (3) A strain bred from the strain (genetical engineering modification, mutation). , Including spontaneous mutations.), Strains with the same trait

In the present technique, muscles can extend to the whole body from the head to the lower limbs (specifically, the head, neck, chest, abdomen, back, upper limbs, lower limbs). Further, the muscular strength includes, for example, grip strength, extension muscular strength, back muscular strength, instantaneous force, muscular endurance and the like.
Further, in the present technique, the measurement of muscle mass or muscle strength can be performed based on a conventionally known method.

In the present technology, "maintenance" means preventing a difference from a certain value for an arbitrary parameter. Further, "decrease suppression" means to prevent a difference from occurring in comparison with a certain value for an arbitrary parameter.

As shown in Examples described later, the composition of the present technology has an effect of maintaining muscle mass and / or muscle strength, or an effect of suppressing a decrease in muscle mass and / or muscle strength.

The subject of the composition of the present technology is not particularly limited, and can be applied to animals including humans. In addition, the target gender, target age, etc. are not particularly limited. In addition, because of its high safety, the composition of this technology is used for infants and children, pregnant, perinatal, and lactating women, and elderly and sick people who are at high risk of muscle mass and / or muscle weakness. Can also be used for.

The composition of the present technology may contain a culture containing Lactobacillus paracasei as its active ingredient, Lactobacillus paracasei.

The medium for culturing Lactobacillus paracasei used in the present technology is not particularly limited, and a medium usually used for culturing bacteria belonging to the genus Lactobacillus can be used.

As the carbon source, for example, sugars such as glucose, galactose, lactose, arabinose, mannose, sucrose, starch, starch hydrolyzate, and waste sugar honey can be used depending on the assimilation property. As the nitrogen source, for example, ammonium salts such as ammonia, ammonium sulfate, ammonium chloride and ammonium nitrate, nitrates and the like can be used. As the inorganic salts, for example, sodium chloride, potassium chloride, potassium phosphate, magnesium sulfate, calcium chloride, calcium nitrate, manganese chloride, ferrous sulfate and the like can be used. Further, organic components such as peptone, soybean flour, defatted soybean meal, meat extract, yeast extract and the like may be used. In the present technology, these types may be used alone, or two or more types may be used in any combination.

The culturing conditions are not particularly limited as long as the effects of the present technique are not impaired. For example, the culturing temperature is usually 25 to 50 ° C., preferably 35 to 42 ° C. Further, the culture is preferably carried out under anaerobic conditions, and for example, the culture can be carried out while aerating an anaerobic gas such as carbon dioxide. Further, the cells may be cultured under microaerobic conditions such as liquid static culture.

As the Lactobacillus paracasei used in the present technology, the culture obtained after culturing may be used as it is, diluted or concentrated, or cells recovered from the culture may be used. The term "culture" in the present specification is a concept including a culture supernatant.

As the present cells, the obtained culture after culturing may be used as it is, diluted or concentrated, or the cells recovered from the culture may be used. In addition, various additional operations such as heating and freeze-drying can be performed after culturing as long as the effects of the present technology are not impaired. In addition, this bacterial cell may be a live bacterium or a dead bacterium. In the case of viable bacteria, it is preferable to treat them by a bacterial solution freezing method, a spray-drying method, a freeze-drying method, or an oil drop method. Examples of the killed bacteria include killed bacteria that have been sterilized by heating, freeze-drying, or the like. Other methods for preparing dead cells include spray drying method (spray drying method), retort sterilization method, freeze sterilization method, UHT sterilization method, pressure sterilization method, high pressure steam sterilization method, dry heat sterilization method, and distribution steam sterilization method. , Electromagnetic sterilization method, electron beam sterilization method, high frequency sterilization method, radiation sterilization method, ultraviolet sterilization method, ethylene oxide gas sterilization method, hydrogen peroxide gas plasma sterilization method, chemical sterilization method (alcohol sterilization method, formalin fixation method, electrolysis) Water treatment method, etc.) and the like. In addition, this bacterial cell may be a crushed product. The crushed product may be one in which live bacteria are crushed, one in which dead bacteria are crushed, or one in which heating, freeze-drying, or the like is performed after crushing. Further, for crushing, crushing by a method and equipment known in the present technology, for example, physical crushing, enzyme dissolution treatment, chemical treatment, autolysis treatment and the like can be selected.

The physical crushing may be carried out by either a treatment in the state of a cell suspension or a treatment in the state of a cell powder. Examples of physical crushing include crushing by stirring using an ultrasonic homogenizer, homogenizer, ball mill, bead mill, dyno mill, planetary mill, etc., crushing by pressure using a jet mill, French press, cell crusher, etc., filter filtration treatment. It is possible to select crushing or the like by damaging the bacterial cells. As the enzyme lysis treatment, for example, an enzyme such as lysozyme can be used to destroy the cell structure of the cells. As the chemical treatment, for example, a surfactant such as soybean phospholipid or glycerin fatty acid ester can be used to destroy the cell structure of the cells. As the autolysis treatment, for example, the cells can be dissolved by the enzyme of some lactic acid bacteria themselves. In this technique, physical crushing is preferable because it is not necessary to add other chemicals or compounds.

The composition of the present technology may be composed of only the active ingredient, or may be a composition in which the active ingredient and an arbitrary ingredient other than the active ingredient are blended. The optional component is not particularly limited as long as the effect of the present technology is not impaired, and an additive (such as a formulation carrier described later) conventionally blended in a pharmaceutical product can be blended.

2. Specific forms of the composition of the present technology The composition of the present technology can be used in various forms such as foods and drinks, pharmaceuticals, quasi-drugs, and feeds.

The use of this embodiment may be for therapeutic purposes or for non-therapeutic purposes. "Non-therapeutic purpose" is a concept that does not include medical practice, that is, treatment of the human body by treatment, and examples thereof include health promotion and cosmetology.

<Food and drink composition>
A food or drink composition using the composition of the present technology (hereinafter, also simply referred to as “food and drink composition of the present technology”) can be prepared by adding to a conventionally known food or drink composition, or can be eaten or eaten. It can also be mixed with the raw material of the product composition to produce a new food and drink composition.

The food and drink composition of the present technology may be in the form of liquid, paste, solid, powder, etc., in addition to confectionery, liquid food, etc., for example, flour products, instant foods, processed agricultural products, processed marine products, livestock products. Examples include processed products, milk / dairy products, oils and fats, basic seasonings, complex seasonings / foods, frozen foods, confectionery, beverages, and other commercial products.

Examples of wheat flour products include bread crumbs, macaroni, spaghetti, noodles, cake mixes, fried chicken flour, bread crumbs and the like.
Examples of instant foods include instant noodles, cup noodles, retort / cooked foods, canned foods, microwave foods, instant soups / stews, instant miso soups / soups, canned soups, freeze-dried foods, and other instant foods. Be done.
Examples of processed agricultural products include canned agricultural products, canned fruits, jams and marmalades, pickles, boiled beans, dried agricultural products, cereals (processed grain products), and the like.
Examples of processed marine products include canned marine products, fish hams and sausages, fish paste products, marine delicacies, and boiled fish.
Examples of processed livestock products include canned livestock and pastes, livestock ham and sausage.
Examples of milk and dairy products include fermented milk such as yogurts, processed milk, milk drinks, lactic acid bacteria drinks, cheese, ice creams, formula milk powders, creams, infant formulas, infant nutritional supplements, and pregnant women.・ Milk for mothers of lactating women, other dairy products, etc. can be mentioned.
Examples of fats and oils include butter, margarines, vegetable oils and the like.
Examples of basic seasonings include soy sauce, miso, sauces, processed tomato seasonings, mirins, vinegars, etc., and examples of the complex seasonings / foods include cooking mixes, curry ingredients, sauces, and the like. Examples include dressings, mentsuyu, spices, and other complex seasonings.
Examples of frozen foods include raw material frozen foods, semi-cooked frozen foods, and cooked frozen foods.
Examples of confectionery include caramel, candy, gummies, chewing gum, chocolate, cookies, biscuits, cakes, pies, snacks, crackers, Japanese confectionery, rice confectionery, bean confectionery, dessert confectionery, and other confectionery.
Beverages include, for example, carbonated beverages, natural fruit juices, fruit juice beverages, soft beverages containing fruit juice, fruit meat beverages, fruit beverages containing fruit grains, vegetable beverages, soymilk, soymilk beverages, coffee beverages, tea beverages, powdered beverages, concentrated beverages, etc. Examples include sports beverages, nutritional beverages, alcoholic beverages, and other favorite beverages.
Examples of commercially available foods other than these include baby food, sprinkle, ochazuke seaweed and the like.

The food and drink composition of the present technology can be produced by adding the cells to the raw materials of ordinary foods and drinks, and is produced in the same manner as ordinary foods and drinks except that the cells are added. Can be done. The addition of the cells may be carried out at any stage of the manufacturing process of the food or drink composition. In addition, a food or drink composition may be produced through a fermentation step using the added bacterial cells. Examples of such food and drink compositions include lactic acid bacteria beverages and fermented milk.

As a raw material for the food and drink composition of the present technology, a raw material used for ordinary food and drink can be used. The produced food and drink composition can be ingested orally.

Further, for example, it is also possible to adopt a method in which the cells are added to milked breast milk and ingested orally, or a method in which a newborn baby or an infant is ingested by a nasal gastric feeding tube or the like.

Further, in the food and drink composition of the present technology, as long as the effect of the present technology is not impaired, a component having a known or future probiotic effect or a component supporting the probiotic effect shall be used. Can be done.
Here, generally, probiotics refer to bacteria that have a beneficial function in the intestine.

Specific examples thereof include bifidobacteria, lactic acid bacteria and the like.
Bifidobacterium spp. (Also referred to as "Bifidobacterium") include, for example, Bifidobacterium longum subspecies longum, bifidobacteria bifidam, bifidobacteria breve, bifidobacteria. Umm Longum Subspecies Infantis, Bifidobacterium Addressentis, Bifidobacterium Catenuratam, Bifidobacterium Pseudocatenuratam, Bifidobacterium Animalis Subspecies Animalis, Bifido Bacteria, animals, subspecies, lactis, etc. can be mentioned. In the present technology, these types may be used alone, or two or more types may be used in any combination.
Examples of lactic acid bacteria include Lactobacillus plantarum, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus delbilicky subspecies bulgarix, Lactobacillus gasseri, Lactobacillus amirobolas, Lactobacillus reuteri, and Lactobacillus. Examples thereof include Bacillus ramnosus, Lactobacillus fermentum, Lactobacillus salivalius, and Lactobacillus lactis. In the present technology, these types may be used alone, or two or more types may be used in any combination.

, In the food and drink composition of the present technology, use a component having a prebiotic effect known in the past or found in the future, or a component assisting the prebiotic effect, as long as the effect of the present technology is not impaired. Can be done.
Here, prebiotics generally refer to substances that serve as a selective nutrient source for bacteria that perform beneficial functions in the intestine and promote their growth.

Specifically, for example, various proteins such as whey protein, casein protein, soybean protein or pea protein (pea protein) or mixtures thereof, decomposition products; amino acids such as leucine, valine, isoleucine or glutamine; vitamin B6 or vitamin C. Vitamins such as creatin; citric acid; fish oil; or oligosaccharides such as isomaltooligosaccharides, galactooligosaccharides, xylooligosaccharides, soybean oligosaccharides, fructo-oligosaccharides, lactulose, human milk oligosaccharides (HMO) and other components and books. It can be produced by blending with bacterial cells. In the present technology, these types may be used alone, or two or more types may be used in any combination.

Examples of human milk oligosaccharides include 2'-fucosyl lactose, 3-fucosyl lactose, 2', 3-difucosyl lactose, lacto-N-triose II, lacto-N-tetraose, lacto-N-neotetraose, and the like. Lactose-N-fucopentaose I, lacto-N-neofcopentaose, lacto-N-fucopentaose II, lacto-N-fucopentaose III, lacto-N-fucopentaose V, lacto-N-neofcopentaose V, lacto-N Neutral human milk oligosaccharides such as -difucohexaose I, lacto-N-difucohexaose II, 6'-galactosyl lactose, 3'-galactosyl lactose, lacto-N-hexaose and lacto-N-neohexaose Examples thereof include acidic human milk oligosaccharides such as 3,'-sialyl lactose, 6'-sialyl lactose, 3-fucosyl-3'-sialyl lactose, and disialyl-lacto-N-tetraose. In the present technology, these types may be used alone, or two or more types may be used in any combination.

The content of Lactobacillus paracasei in the food and drink composition of the present technology can be freely set as long as the effect of the present technology is not impaired. In the present technology, the content of Lactobacillus paracasei in the food or drink composition may be contained in 1 × 10 ³ to 1 × 10 ¹² cfu / g or cfu / ml with respect to the final composition of the food or drink composition. More preferred. The daily dose is at least 1 × 10 ³ cfu / day or more, more preferably 1 × 10 ⁶ cfu / day or more, more preferably 1 × 10 ⁸ cfu / day or more, and more preferably 1 × 10 ¹⁰ It is preferable to add cfu / day or more, or more. In this technique, in particular, per serving, Lactobacillus paracasei preferably be made to contain ¹⁰ 6 ^~10 12 cfu. In addition, "cfu" represents a colony forming unit (colony forming unit). When the cells are killed, cfu / g or cfu / ml can be replaced with individual cells / g or individual cells / ml. When this cell is a crushed product, it can be displayed in terms of weight from the number of bacteria (individual cells / g) before crushing.

[Special purpose food]
In addition, the food and drink composition of the present technology can be applied to foods with health claims and foods for special purposes. The health functional food system was established not only for ordinary foods but also for foods in the shape of tablets, capsules, etc., based on internal and external trends and consistency with the conventional food system for specified health use. There are three types of foods: foods for specified health use, foods with functional claims, and foods with nutritional function. Special-purpose foods are foods intended for special purposes for people who cannot eat normal meals, such as sick people, infants, and the elderly, and foods for the sick (permission standard type, individual evaluation). Type), milk powder for pregnant and lactating women, adjusted milk for babies, and foods for people with swallowing difficulties.

Although not limited to the following description, the food and drink composition of the present technology may be applied to, for example, foods for people with decreased muscle mass or strength, individually evaluated foods for the sick, or It can be applied to foods with functional claims for healthy people, normal low values of muscle mass and strength indicators, and people with mild illness.

In addition, as a food and drink composition of the present technology, milk powder prepared for infants can be mentioned. "Infant formula" means infant formula for infants from 0 to 12 months, follow-up milk for infants from 6 to 9 months and younger infants (up to 3 years old), and birth. Formulated milk for low birth weight infants (low birth weight infants) with a weight of less than 2500 g, various therapeutic milks used for the treatment of infants with morbidity such as milk allergy and lactose intolerance. And so on.

Food and beverage compositions of this technology include nutritionally-adjusted foods such as mom's milk for mothers during pregnancy and lactation (prepared milk powder with a well-balanced mixture of nutrients required for pregnancy and lactation), and adult formula. Examples include nutritional supplements, nutritionally functional foods such as liquid foods, and foods for the sick (special purpose foods) such as phosphorus-reduced powdered milk.

The prepared milk powder can be produced, for example, by the following method.
That is, in this technique, a bacterial cell powder containing a bacterium belonging to the genus Lactobacillus is mixed with any one or more selected from the group consisting of probiotics, prebiotics, and milk powder, and muscle mass and / or muscle strength. Provided is a method for producing milk powder for infants, prepared milk powder for adults, and milk for moms, which obtains milk powder for maintaining or suppressing a decrease in muscle mass and / or strength.
Specifically, for example, a method for producing milk powder for enhancing breast milk components, which comprises the following steps (A) to (C), is provided.
(A) A step of culturing a bacterium belonging to the genus Lactobacillus in a medium containing a milk component to obtain a culture;
(B) A step of subjecting the culture to spray drying and / or freeze-drying to obtain bacterial cell powder;
(C) The bacterial cell powder is mixed with any one or more selected from the group consisting of probiotics, prebiotics, and milk powder to maintain muscle mass and / or muscle strength, or decrease muscle mass and / or muscle strength. The process of obtaining milk powder for suppression.

〔supplement〕
In addition, the food and drink composition of the present technology may be a supplement for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength.

A supplement for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength can be produced, for example, by the following method.
That is, the present technology provides, for example, a method for producing a supplement for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength, including the following steps (A) and (B).
(A) A step of mixing probiotics and / or prebiotics, Lactobacillus spp., And excipients to obtain a mixture;
(B) A step of locking the mixture.

[Food and drink with functional indication]
In addition, the food and drink composition of the present technology can be provided and sold as food and drink having a specific use (particularly for health use) and a function.

The "display" act includes all acts for informing the consumer of the use, and if the expression can remind or analogize the use, the purpose of the display, the content of the display, and the display. Regardless of the object, medium, etc., all fall under the "display" act of this technology.

Further, it is preferable that the "display" is performed by an expression that allows the consumer to directly recognize the above-mentioned use. Specifically, the act of transferring a product related to food and drink or the packaging of the product with the above-mentioned use, displaying it for delivery, transfer or delivery, and importing it, advertising on the product, price list or transaction documents Examples include the act of describing the above-mentioned use and displaying or distributing it, or describing the above-mentioned use in the information containing these and providing it by an electromagnetic (Internet, etc.) method.

On the other hand, as the display content, it is preferable that the display is approved by the government or the like (for example, a display obtained based on various systems established by the government and performed in a manner based on such approval). In addition, it is preferable to attach such display contents to packaging, containers, catalogs, pamphlets, promotional materials such as POPs at sales sites, and other documents.

In addition, "labeled" includes health foods, functional foods, foods for the sick, enteral nutrition foods, special purpose foods, health functional foods, specified health foods, functional foods, nutritional functional foods, and pharmaceutical departments. Labeling as a foreign product can also be mentioned. Among these, in particular, labeling approved by the Consumer Affairs Agency, for example, a food system for specified health use, a food system with functional labeling, a labeling approved by a system similar to these, and the like can be mentioned. More specifically, labeling as a food for specified health use, labeling as a conditional food for specified health use, labeling as a food with functional claims, labeling to the effect that it affects the structure and function of the body, labeling for reducing the risk of illness, etc. Can be mentioned. Among these, as a typical example, labeling as a food for specified health use stipulated in the Health Promotion Law Enforcement Regulations (April 30, 2003, Ministry of Health, Labor and Welfare Ordinance No. 86) (especially labeling for health uses) , Labeling as functional foods stipulated in the Food Labeling Law (Act No. 70 of 2013) and labeling similar to these.

It should be noted that the wording used to perform the above-mentioned display is not only a wording for maintaining muscle mass and / or muscle strength, or a wording for suppressing a decrease in muscle mass and / or muscle strength, but also other words. However, if it is a wording that expresses the effect of prevention, treatment and / or improvement of various diseases and symptoms related to maintenance of muscle mass and / or muscle strength, or suppression of decrease in muscle mass and / or muscle strength, the scope of the present technology. Needless to say, it is included in. Such words include, for example, "for those who are concerned about muscle mass" and "for those who are concerned about muscle strength" for consumers to maintain muscle mass and / or muscle strength, or to maintain muscle mass and / or muscle strength. It is also possible to display based on various uses so as to recognize the effect of suppressing the decrease of.

<Pharmaceutical composition, quasi-drug composition>
A pharmaceutical composition or a quasi-drug composition using the composition of the present technology (hereinafter, also simply referred to as "composition such as a pharmaceutical product of the present technology") is a conventionally known pharmaceutical or quasi-drug (hereinafter, "" It can also be prepared by adding it to a composition (also referred to as "pharmaceutical product or the like"), or it can be mixed with a raw material of the composition such as a pharmaceutical product to produce a new composition such as a pharmaceutical product.

When the composition of the present technology is used for a composition such as a pharmaceutical product, the composition can be appropriately formulated into a desired dosage form according to an administration method such as oral administration or parenteral administration. The dosage form is not particularly limited, and in the case of oral administration, for example, solid preparations such as powders, granules, tablets, troches, capsules; preparations in liquid preparations such as solutions, syrups, suspensions and emulsions. Can be transformed into. In the case of parenteral administration, it can be formulated into, for example, a suppository, a spray, an inhalant, an ointment, a patch, an injection, or the like. In the present technology, it is particularly preferable to formulate the dosage form for oral administration. The formulation can be carried out by a conventionally known method depending on the dosage form.

At the time of formulation, the formulation may be formulated by appropriately blending a formulation carrier or the like. In addition to the compositions of the present technology, components such as excipients, pH adjusters, colorants, and flavoring agents that are usually used for formulation can be used. Further, components having a preventive, ameliorating and / or therapeutic effect on diseases and symptoms known in the past or found in the future can be used in combination as appropriate according to the purpose as long as the effects of the present technology are not impaired. ..

As the preparation carrier, various organic or inorganic carriers can be used depending on the dosage form. Examples of the carrier in the case of a solid preparation include excipients, binders, disintegrants, lubricants, stabilizers, flavoring agents and the like.

Examples of excipients include sugar derivatives such as lactose, sucrose, glucose, mannit, and sorbit; starch derivatives such as corn starch, horse bell starch, α-starch, dextrin, and carboxymethyl starch; crystalline cellulose, hydroxypropyl cellulose, and the like. Cellulous derivatives such as hydroxypropylmethyl cellulose, carboxymethyl cellulose, carboxymethyl cellulose calcium; gum arabic; dextran; purulan; silicate derivatives such as light anhydrous silicic acid, synthetic aluminum silicate, magnesium aluminometasilicate; phosphate derivatives such as calcium phosphate; carbonic acid Carbonate derivatives such as calcium; sulfate derivatives such as calcium sulfate can be mentioned. In the present technology, these types may be used alone, or two or more types may be used in any combination.

Examples of the binder include gelatin; polyvinylpyrrolidone; macrogol and the like in addition to the above-mentioned excipients. In the present technology, these types may be used alone, or two or more types may be used in any combination.
Examples of the disintegrant include, in addition to the above-mentioned excipients, chemically modified starch or cellulose derivatives such as croscarmellose sodium, carboxymethyl starch sodium, and crosslinked polyvinylpyrrolidone. In the present technology, these types may be used alone, or two or more types may be used in any combination.

Examples of the lubricant include talc; stearic acid; metal stearate salts such as calcium stearate and magnesium sulfate; colloidal silica; waxes such as pea gum and gay wax; boric acid; glycol; carboxylic acids such as fumaric acid and adipic acid. Sodium carboxylic acid salts such as sodium benzoate; sulfates such as sodium sulfate; leucine; lauryl sulfates such as sodium lauryl sulfate and magnesium lauryl sulfate; silicic acids such as silicic acid anhydride and silicate hydrate; starch derivatives and the like. Be done. In the present technology, these types may be used alone, or two or more types may be used in any combination.

Examples of the stabilizer include paraoxybenzoic acid esters such as methylparaben and propylparaben; alcohols such as chlorobutanol, benzyl alcohol and phenylethyl alcohol; benzalconium chloride; acetic anhydride; and sorbic acid. In the present technology, these types may be used alone, or two or more types may be used in any combination.
Examples of the flavoring agent include sweeteners, acidulants, and flavors. In the present technology, these types may be used alone, or two or more types may be used in any combination.
Examples of the carrier used in the case of a liquid preparation for oral administration include a solvent such as water, a flavoring and odorant, and the like. In the present technology, these types may be used alone, or two or more types may be used in any combination.

The content of Lactobacillus paracasei in the pharmaceutical composition of the present technology can be freely set as long as the effect of the present technology is not impaired. In the present technology, the content of Lactobacillus paracasei in a composition such as a pharmaceutical product may be contained in 1 × 10 ³ to 1 × 10 ¹² cfu / g or cfu / ml with respect to the final composition of the composition such as a pharmaceutical product. More preferred. The daily dose is at least 1 × 10 ³ cfu / day or more, more preferably 1 × 10 ⁶ cfu / day or more, more preferably 1 × 10 ⁸ cfu / day or more, and more preferably 1 × 10 ¹⁰ It is preferable to add cfu / day or more, or more. In this technique, in particular, per packaging unit, it is preferable that the Lactobacillus paracasei to contain ¹⁰ 6 ^~10 12 cfu.

<Feed composition>
The feed composition using the composition of the present technology can be prepared by adding it to a conventionally known feed composition, or can be mixed with the raw material of the feed composition to produce a new feed composition. it can.

When the composition of the present technology is used in a feed composition, the raw materials for the feed composition include, for example, cereals such as corn, wheat, barley, and rye; bran such as bran, wheat bran, rice bran, and defatted rice bran; corn gluten. Manufacture of meals, corn jam meals, etc. Cereals; Animal feeds such as defatted milk powder, whey, fish powder, bone meal; Yeasts such as beer yeast; Mineral feeds such as calcium phosphate, calcium carbonate; Oils and fats; Amino acids; Sugars And so on. Examples of the feed form include pet food (pet food, etc.), livestock feed, fish feed, and the like.

The content of Lactobacillus paracasei in the feed composition of the present technology can be freely set according to the body weight and the like as long as the effect of the present technology is not impaired. In the present technique, it is more preferable that the content of Lactobacillus paracasei in the feed composition is 1 × 10 ³ to 1 × 10 ^{12 cfu / g with respect to the final composition of the feed composition.} The daily dose is at least 1 × 10 ³ cfu / day or more, more preferably 1 × 10 ⁶ cfu / day or more, more preferably 1 × 10 ⁸ cfu / day or more, and more preferably 1 × 10 ¹⁰ It is preferable to add cfu / day or more, or more.

<Others>
The composition of the present technology may contain sugars, dietary fiber, nucleic acids, vitamins, minerals and the like which are usually acceptable for the purpose of nutritional supplementation in foods and drinks, pharmaceuticals and the like, or feeds. Examples of the sugar include dextrin, sucrose, glucose, fructose, maltose, lactulose, raffinose and the like. Examples of dietary fiber include cellulose, indigestible dextrin, and arabia gum. Examples of the nucleic acid include nucleotides, nucleosides, DNA, RNA, bases and the like. Examples of vitamins include vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, niacin, pantothenic acid, folic acid, β-carotene and the like, which are commercially available. Vitamin mixture (manufactured by Tanabe Pharmaceutical Co., Ltd., etc.) may be used. Examples of the mineral include phosphorus, calcium, sodium, potassium, chlorine, magnesium, iron, copper, zinc, manganese and the like, but a commercially available mineral mixture (manufactured by Tomita Pharmaceutical Co., Ltd., etc.) may be used. In the present technology, these types may be used alone, or two or more types may be used in any combination.

In this technology, it is also possible to adopt the following configurations.
[1]
A composition containing Lactobacillus paracasei as an active ingredient for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength.
[2]
The composition of [1], wherein the Lactobacillus paracasei is Lactobacillus paracasei MCC1849 (NITE BP-01633).
[3]
The composition according to [1] or [2], which is a pharmaceutical composition.
[4]
The composition according to [1] or [2], which is a food and drink composition.
[5]
The composition according to [3], which comprises ^{10 6} to 10 ¹² cfu of Lactobacillus paracasei per packaging unit.
[6]
The composition of [4], which comprises ^{10 6} to 10 ¹² cfu of Lactobacillus paracasei per serving.
[7]
The composition of [5] or [6], which is fermented milk.
[8]
Maintenance of muscle mass and / or muscle strength, or muscle mass and / or muscle weakness inhibitor, muscle mass and / or muscle strength maintenance, muscle mass and / or muscle strength loss inhibitory drug, or muscle mass and / or muscle strength Use of lactobacillus paracasei in foods and drinks for maintaining or suppressing muscle mass and / or muscle weakness.
[9]
The use of [8], wherein the Lactobacillus paracasei is Lactobacillus paracasei MCC1849 (NITE BP-01633).
[10]
A method for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength, which comprises administering Lactobacillus paracasei to a subject.
[11]
The method of [10], wherein the Lactobacillus paracasei is Lactobacillus paracasei MCC1849 (NITE BP-01633).

Hereinafter, the present technology will be described in more detail based on Examples.
It should be noted that the examples described below show an example of typical examples of the present technology, and the scope of the present technology is not narrowly interpreted by this.

[Experimental example]
<Production of sample>
A dietary supplement beverage (liquid food for energy supplementation) having a content of 125 ml was produced by a conventional method based on the composition and the amount of ingredients shown in Table 1 below. More specifically, a dairy raw material, water as required, other components and the like were mixed, and homogenization treatment and heat sterilization treatment were carried out by a conventional method to produce a sterilized milk preparation liquid. Next, heat-sterilized bacterial powder of Lactobacillus paracasei MCC1849 (NITE BP-01633) strain was added to the heat-sterilized sterilized emulsion, and after cooling, this was used as a test sample.
On the other hand, as a control sample, a fruit juice beverage (100% orange juice: manufactured by Snow Brand Megmilk Co., Ltd.) was used.
The composition and component amount per one (125 ml) of the test sample and the control sample are shown in Table 1 below.

<Subject>
Japanese men and women at home who were 65 years of age or older at the time of obtaining consent and were feeling tired on a daily basis were enrolled in the clinical trial. Furthermore, 62 subjects who did not violate the following exclusion criteria were selected by blood tests and interviews by doctors.
(1) Those who are being treated or have a history of malignant tumors (2) Those who are being treated or have a history of autoimmune diseases (3) Those who are being treated or have a history of inflammatory bowel disease (4) Those who are hospitalized (5) Persons who regularly consume foods for specified health use and foods with functional claims (6) Persons who regularly consume foods / beverages containing natto, yogurt, and lactic acid bacteria (7) Smokers (8) Those who regularly use anti-allergic drugs (9) Those who regularly use foods / beverages such as supplements that are considered to be functional in addition to foods for specified health use and foods with functional claims (10) Allergies (pharmaceuticals / test foods) Those who have (related foods) (11) Those who are pregnant, breastfeeding, or willing to become pregnant during the study period (12) Those who participated in other clinical trials in the three months prior to the date of consent acquisition (13) Others who are judged by the investigator to be inappropriate for this study

Each subject was assigned based on the allocation table prepared by the person in charge of allocation. The allocation in this experimental example was a stratified random allocation using the immunity score (manufactured by Health Life Science Co., Ltd.), age, and gender as allocation adjusting factors, and 31 subjects were randomly assigned to the test sample group and the control sample group.

<Test method>
The prepared test sample or control sample was ingested once a day after breakfast. The intake period was 4 weeks. The number of Lactobacillus paracasei MCC1849 (NITE BP-01633) strains contained in the test sample was 10 billion per day (1). That is, the daily intake was 10 billion as a heat sterilized body of Lactobacillus paracasei MCC1849 (NITE BP-01633) strain.

For each subject, muscle mass and grip strength were measured before sample intake (baseline: 0 week) and 4 weeks after sample intake. A body composition analyzer ZEUS 9.9 (manufactured by Kobe Medicare) was used for muscle mass measurement, and a digital grip strength meter Grip D TKK5401 (manufactured by Takei Kikai Kogyo Co., Ltd.) was used for grip strength measurement.
Drinking and excessive exercise were prohibited from the day before the measurement until the end of the measurement on the day. The health status of the subjects was confirmed by interviews on the day of measurement, and the intake status of the samples was confirmed by a diary recorded daily.

<Statistical analysis>
Those whose intake rate of the test sample or control sample was less than 90% and those who deviated significantly from the protocol were excluded from the analysis, and PPS (Per Protocol set) analysis was performed.

<Analysis target>
No one had an intake rate of less than 90% throughout the sample intake period, but one person in each group was found to be unable to confirm the presence or absence of intervention because the test diary was not submitted and the sample was not returned after the start of this experiment. Therefore, it was excluded from the analysis. Therefore, the analysis target population was 30 test sample groups (10 males, 20 females, average age 69.5 ± 4.4 years) and 30 control sample groups (10 males, 20 females, average age 69). It was .4 ± 4.9 years old).

<Result 1>
Table 2 below shows the measurement results of maximum grip strength before and 4 weeks after ingestion.

平均±標準偏差

Mean ± standard deviation

At 4 weeks after ingestion, the maximum grip strength decreased from the baseline to -0.8 ± 2.6 kg in the control sample group, whereas the maximum grip strength was maintained at 0.1 ± 2.7 kg in the test sample group. Therefore, it was suggested that by ingesting a composition containing Lactobacillus paracasei as an active ingredient, muscle strength was maintained or suppressed.

<Result 2>
The measurement results of muscle mass before and 4 weeks after ingestion are shown in Table 3 below.

平均±標準偏差

Mean ± standard deviation

At 4 weeks after ingestion, muscle mass decreased from baseline to -0.1 ± 1.4 kg in the control sample group, whereas muscle mass was maintained at 0.0 ± 1.5 kg in the test sample group. Therefore, it was suggested that by ingesting a composition containing Lactobacillus paracasei as an active ingredient, muscle mass was maintained or suppressed.

[Manufacturing example]
An example of manufacturing a pharmaceutical composition and a food composition using the composition of the present technology is shown below.

[Manufacturing Example 1]
Lactobacillus paracasei MCC1849 (NITE BP-01633) was added to 3 mL of MRS liquid medium, and after anaerobic culture at 37 ° C. for 16 hours, the culture solution was concentrated, freeze-dried, and lyophilized powder of bacteria (bacterial powder). To get. The bacterial powder, Whey protein concentrate (WPC), and prebiotics (lacturose, raffinose, and galactooligosaccharide) are uniformly mixed to obtain a composition. 20 g of the composition is dissolved in 200 g of water to obtain a composition for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength. Administration of the composition can maintain muscle mass and / or muscle strength, or suppress a decrease in muscle mass and / or muscle strength.

[Manufacturing Example 2]
Lactobacillus paracasei MCC1849 (NITE BP-01633) was added to 3 mL of MRS liquid medium, and after anaerobic culture at 37 ° C. for 16 hours, the culture solution was concentrated, freeze-dried, and lyophilized powder of bacteria (bacterial powder). To get. Uniformity of bacterial powder, dry powder of milk protein concentrate (MPC480, manufactured by Fontera, protein content 80% by mass, casein protein: whey protein = about 8: 2) and prebiotics (lacturose, raffinose and galactooligosaccharide) To obtain the composition. 20 g of the composition is dissolved in 200 g of water to obtain a composition for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength. Administration of the composition can maintain muscle mass and / or muscle strength, or suppress a decrease in muscle mass and / or muscle strength.

[Manufacturing Example 3]
Lactobacillus paracasei MCC1849 (NITE BP-01633) was added to 3 mL of MRS liquid medium, and after anaerobic culture at 37 ° C. for 16 hours, the culture solution was concentrated, freeze-dried, and lyophilized powder of bacteria (bacterial powder). To get. Next, prebiotics (lacturose, raffinose and galactooligosaccharide) and crystalline cellulose are put into a stirring granulator and mixed. Then, purified water is added to granulate and the granulated product is dried to obtain a granulated product (pharmaceutical composition) containing an extract component of bacteria and prebiotics and containing an excipient. By administering the granulated product, it is possible to maintain muscle mass and / or muscle strength, or suppress a decrease in muscle mass and / or muscle strength.

[Manufacturing Example 4]
The method for producing fermented milk to which Lactobacillus paracasei MCC1849 (NITE BP-01633) is added is shown below.

First, a dairy raw material, water if necessary, other components and the like are mixed, preferably homogenized, and heat sterilized. The homogenization treatment and the heat sterilization treatment can be carried out by a conventional method. After heat sterilization, a lactic acid bacterium starter is added (inoculated) to a sterilized emulsion cooled to a constant temperature and mixed. After filling in a container or the like, it is kept at a predetermined fermentation temperature for fermentation. Fermentation forms curds.
As the lactic acid bacterium starter, for example, lactic acid bacteria usually used for yogurt production such as Lactobacillus bulgaricus, Lactococcus lactis, and Streptococcus thermophilus can be used. In the present technology, these types may be used alone, or two or more types may be used in any combination.
When the pH reaches the target value, the formed curd is crushed by stirring and cooled to 10 ° C. or lower to obtain a fermented product. By cooling to 10 ° C. or lower, the activity of lactic acid bacteria can be reduced and the production of lactic acid can be suppressed.
Next, the fermented product obtained in the fermentation step is heat-treated to the extent that lactic acid bacteria are not killed to obtain a fermented product after heating (fermented product after heat treatment). By appropriately heating the fermented product, it is possible to suppress the production of lactic acid by lactic acid bacteria in the fermented product after heating. In addition, it is possible to suppress a decrease in pH during the subsequent production process and / or during storage of the concentrated fermented milk.

Lactobacillus paracasei MCC1849 (NITE BP-01633) and prebiotics (lacturose, raffinose and galactooligosaccharides) are then added to the post-heated fermented product obtained in the heat treatment step. The amount of Lactobacillus paracasei MCC1849 (NITE BP-01633) added ^{is preferably 1 × 10 7} to 1 × 10 ¹¹ cfu / ml with respect to the fermented product after heating, and 1 × 10 ⁸ to 1 × 10 ¹⁰ cfu / ml. Is more preferable. If Lactobacillus paracasei MCC1849 (NITE BP-01633) is dead, cfu / mL can be replaced with individual cells / mL.
Then, Lactobacillus paracasei MCC1849 (NITE BP-01633) and prebiotics are added to the fermented product after heating to concentrate. The concentration step can be carried out by appropriately using a conventionally known concentration method. For example, a centrifugal separation method, a membrane separation method, or the like can be used. In the centrifugation method, whey in the concentrated product (fermented product after heating to which lactic acid bacteria and prebiotics are added) is removed to obtain concentrated fermented milk containing lactic acid bacteria and prebiotics having an increased solid content concentration. ..
By administering the fermented milk obtained as described above, it is possible to maintain muscle mass and / or muscle strength, or suppress a decrease in muscle mass and / or muscle strength.

The method for producing the prepared milk powder to which Lactobacillus paracasei MCC1849 (NITE BP-01633) is added is shown below.

Desalted milk whey protein powder (manufactured by Mirai) 10 kg, milk casein powder (manufactured by Fontera) 6 kg, lactose (manufactured by Mirai) 48 kg, mineral mixture (manufactured by Tomita Pharmaceutical Co., Ltd.) 920 g, vitamin mixture (manufactured by Tanabe Pharmaceutical Co., Ltd.) 32 g, lactose (manufactured by Morinaga Dairy Co., Ltd.) 500 g, raffinose (manufactured by Nippon Jinna Sugar Co., Ltd.) 500 g, and galactooligosaccharide liquid sugar (manufactured by Yakult Yakuhin Kogyo Co., Ltd.) 900 g are dissolved in 300 kg of warm water, and further heated and dissolved at 90 ° C. for 10 minutes. , 28 kg of prepared fat (manufactured by Taiyo Yushi Co., Ltd.) was added and homogenized. Then, the steps of sterilization and concentration were performed, and the mixture was spray-dried to prepare about 95 kg of prepared milk powder. ^{To this, 100 g of cell powder (1.8 × 10 11} cfu / g, manufactured by Morinaga Milk Industry Co., Ltd.) of Lactobacillus paracasei MCC1849 (NITE BP-01633) dispersed in starch was added to prepare a mixture of lactic acid bacteria and oligosaccharides. Prepare about 95 kg of milk powder. When the obtained prepared milk powder was dissolved in water to prepare a formula having a total solid content concentration of 14% (w / v), which is the standard formula concentration, the number of lactic acid bacteria in the formula was 2.7 × 10 ⁹ cfu. / 100 mL can be obtained.
By administering the prepared milk powder obtained as described above, it is possible to maintain muscle mass and / or muscle strength, or suppress a decrease in muscle mass and / or muscle strength.

Claims (4)

A composition containing Lactobacillus paracasei for maintaining muscle mass and / or muscle strength, or suppressing a decrease in muscle mass and / or muscle strength. The composition according to claim 1, wherein the Lactobacillus paracasei is Lactobacillus paracasei MCC1849 (NITE BP-01633). The composition according to claim 1 or 2, which is a pharmaceutical composition. The composition according to claim 1 or 2, which is a food and drink composition.