Motor ability upward composition

Abstract

The present invention addresses the problem of providing a novel composition which can make a contribution to athletic ability enhancement. The present invention provides an athletic ability enhancing composition including α-cyclodextrin as an active ingredient. The athletic ability enhancement includes at least one effect selected from among physical strength improvement, anti-fatigue, and fatigue feeling mitigation. In addition, the athletic ability enhancement also includes suppressing an increase in heart rate during exercise. Furthermore, provided is a composition which is for proliferating Bacteroides uniformis in the intestinal tract and includes α-cyclodextrin as an active ingredient. In the present invention, α-cyclodextrin is preferably administered in an amount of 0.01 mg / kg body weight to 200 mg / kg body weight per day, and preferably administered for at least seven days.

Description

Technical Field

[0001] The present invention relates to an orally ingestible composition for improving exercise ability and an orally ingestible composition for growing Bacteroides uniformis that can contribute to the improvement of exercise ability.

Background Art

[0002] Normally, when performing activities such as labor and exercise, at least physical strength sufficient to withstand these activities is required. On the other hand, fatigue accumulates in the body due to these activities, and the body's functions decline. It can be said that maintaining / improving physical strength and preventing / recovering from fatigue are essential for performing activities such as labor and exercise on a daily basis. The physical strength for performing activities such as labor and exercise includes physical abilities that form the basis of actions such as muscle strength, endurance, and flexibility.

[0003] So far, compositions for enhancing endurance, preventing or recovering from fatigue, or nourishing and strengthening have been developed. For example, Patent Document 1 describes a composition for enhancing endurance, preventing or recovering from fatigue, or nourishing and strengthening, containing thioctic acids as an active ingredient. Also, Patent Document 2 describes a basal metabolism enhancer containing thioctic acids as an active ingredient, which acts on preventing or early recovering from fatigue and improving activity motivation. It is also described in the compositions of Patent Documents 1 and 2 that cyclodextrin, which is generally used as an encapsulating material, may be included as an encapsulating material for the active ingredient.

[0004] Cyclodextrins, also known as cyclic oligosaccharides, have a structure in which glucose molecules are linked in a ring. Those with six glucose molecules linked together are called α-cyclodextrins, those with seven molecules linked together are called β-cyclodextrins, and those with eight molecules linked together are called γ-cyclodextrins. α-cyclodextrins have the property of incorporating other molecules into their internal cavities (inclusion action), and this property is utilized to commonly use them as stabilizers and emulsifiers in food products. Furthermore, Non-Patent Literature 1 recently reported that administering α-cyclodextrin to obese mice fed a high-fat diet suppressed the decrease in Bacteroides, Bifidobacterium, Lactobacillus, and total bacterial counts in the mice's intestines, thus maintaining the gut microbiota and potentially reducing fat accumulation. However, Non-Patent Literature 1 makes no mention of bacterial species or strains below the genus level in taxonomy. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Japanese Patent Publication No. 2007-131609 [Patent Document 2] Japanese Patent Publication No. 2007-308468 [Non-patent literature]

[0006] [Non-Patent Document 1] BioFactors 2018,Volume44,Issue4,336-347 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] The object of the present invention is to provide a novel composition that can contribute to improving athletic performance. [Means for solving the problem]

[0008] The inventors have found that the ingestion of Bacteroides uniformis has a sustained effect of improving physical strength and / or anti-fatigue (see International Publication No. 2019 / 069735 (PCT / JP2018 / 035295) (an international publication that was not published at the time of filing the basic application (Japanese Patent Application No. 2019-067,505) of this international application)). Based on this finding, the inventors considered that Bacteroides uniformis, known as one of the bacteria that make up the gut flora, might be one of the factors that brings about the effect of improving physical strength and / or anti-fatigue. As a result of diligent research, it was unexpectedly confirmed that the number of Bacteroides uniformis in the intestinal tract increased in a human test group that ingested α-cyclodextrin, and that athletic performance also improved. Based on the results of this research, the present invention was completed.

[0009] In other words, the present invention is configured as follows: [1] to [8]. [1] A composition for improving athletic performance, comprising α-cyclodextrin as an active ingredient. [2] The composition according to [1], wherein the improvement of athletic performance includes at least one action selected from improving physical fitness, anti-fatigue, and reducing the feeling of fatigue. [3] The composition according to [1] above, wherein the improvement of athletic performance includes suppression of the increase in heart rate during exercise. [4] A composition for the proliferation of Bacteroides uniformis in the intestinal tract, comprising α-cyclodextrin as an active ingredient. [5] A composition according to any one of the above items [1] to [4], for oral intake. [6] A composition according to any one of the above items [1] to [4], which is an additive for food and beverages, a pharmaceutical composition, a feed composition, or a feed additive. [7] The composition according to any one of the above items [1] to [6], wherein an amount of α-cyclodextrin ranging from 0.01 mg / kg body weight to 200 mg / kg body weight is administered per day. [8] The composition according to any one of [1] to [7] above, administered for at least 7 days. [Effects of the Invention]

[0010] The present invention can provide a novel composition that contributes to improving athletic performance. [Brief explanation of the drawing]

[0011] [Figure 1] This figure shows the change in the number of Bacteroides uniformis in the intestinal tract of subjects before and 8 weeks after ingestion of the test food in Example 1. [Figure 2] In Example 2, subjects performed exercise loads using an exercise bike (registered trademark) before ingesting the test food, 4 weeks after ingestion, and 8 weeks after ingestion. A Visual Analogue Scale (VAS) questionnaire regarding fatigue was administered immediately after the load, 30 minutes after the load, and 60 minutes after the load. The figure summarizes the changes in general fatigue over time. A student's t-test was used to determine the significant difference between the placebo group and the α-cyclodextrin (αCD) intake group in terms of general fatigue. [Figure 3] In Example 3, subjects were measured for their time cycling 10km on a spin cycle before, 4 weeks after, and 8 weeks after intake of the test food, after exercise in a fatigue reduction test, and after a 60-minute rest. The figure summarizes the changes in exercise performance due to α-cyclodextrin (αCD) intake. Significant differences between the placebo group and the α-cyclodextrin (αCD) intake group were tested using student's t-test. In addition, significant differences were examined using paired t-tests to compare the period before α-cyclodextrin (αCD) intake with the periods 4 weeks and 8 weeks after intake. [Figure 4]In Example 4, subjects underwent exercise stress tests using an exercise bike (manufactured by Konami Sports & Life Co., Ltd., model number AEROBIKE-75XLIII) before ingestion of the test food, 4 weeks after ingestion, and 8 weeks after ingestion (intensity: 50 minutes at 55% of each subject's maximum exercise stress intensity). The figure summarizes the changes in average heart rate during the 10 minutes immediately preceding the end of exercise, comparing the baseline value before ingestion with the values ​​at 4 weeks and 8 weeks after ingestion. A statistical significance test was performed between the placebo group and the α-cyclodextrin (αCD) ingestion group using analysis of covariance (ANCOVA) with the baseline value before ingestion as a covariate (*: p<0.05). [Figure 5] In Example 5, subjects performed exercise loads using an exercise bike (registered trademark) before ingesting the test food and 8 weeks after ingestion. A Visual Analogue Scale (VAS) questionnaire regarding fatigue was administered immediately after the load, 30 minutes after the load, and 60 minutes after the load. The figure summarizes the changes in general fatigue over time. A student's t-test was used to determine the significant difference between the placebo group and the α-cyclodextrin (αCD) intake group in terms of general fatigue. [Figure 6] In Example 6, subjects were measured for their time cycling 10km using a spin cycle before ingesting the test food, 8 weeks after ingestion, after the fatigue reduction test in Example 5, and after a 60-minute rest. The figure summarizes the changes in exercise performance due to α-cyclodextrin (αCD) intake. A statistical significance test was performed between the placebo group and the α-cyclodextrin (αCD) intake group using analysis of covariance (ANCOVA) with pre-ingestion values ​​as a covariate. [Modes for carrying out the invention]

[0012] <Composition for improving athletic performance> The present invention relates to a composition containing α-cyclodextrin (αCD) and having an effect of improving exercise ability. In the present invention, the "effect of improving exercise ability" refers to at least one effect selected from "effect of improving physical strength", "reduction of fatigue feeling", "anti-fatigue", "effect of improving fatigue tolerance", and "suppression of increase in heart rate during exercise". α-Cyclodextrin is a non-reducing oligosaccharide with a cyclic structure and is used as a compound having an inclusion function of taking in various substances, such as functional components in foods, into its cavity. Specifically, for the purpose of increasing the solubility of hydrophobic molecules in water by utilizing the inclusion function of α-cyclodextrin, or for the purpose of stabilizing substances that are likely to react with volatile components, ultraviolet rays, heat, oxygen, etc. by inclusion, it is usually used. In the present invention, a composition using α-cyclodextrin alone as an active ingredient can significantly improve the effect of improving exercise ability. Note that the effects that α-cyclodextrin alone can bring have not been very clear so far. The α-cyclodextrin in the present invention is not particularly limited. For example, it can be obtained by allowing cyclodextrin glucanotransferase to act on starch. Also, commercially available products can be appropriately used.

[0013] In the present invention, "physical strength" relates to the physical ability that is the basis for actions that enable activities such as labor and exercise. In particular, it means the physical strength that enables one to endure activities such as labor and exercise and to continuously perform them. More preferably, "physical strength" means one or more of whole-body endurance and endurance during aerobic exercise that enables continuous performance of aerobic exercise. "Whole-body endurance" refers to the ability to move the body for a long time, which is generally also called stamina.

[0014] In the present invention, "physical strength improvement" means one or more of promoting the improvement and recovery of physical strength. In particular, it means one or more of improving the physical strength that enables the body to withstand and continuously perform activities such as labor and exercise, and promoting the recovery of such physical strength. More preferably, it means one or more selected from the group consisting of improving one or more of overall endurance and endurance during aerobic exercise, and promoting the recovery of one or more of overall endurance and endurance during aerobic exercise. As indicators of overall endurance and endurance during aerobic exercise, although not limited, for example, maximum oxygen uptake and the results of time trials using a fitness bike can be used.

[0015] In the present invention, "fatigue" means that the body function deteriorates as a result of continuous performance of activities such as labor and exercise. In the present invention, "sense of fatigue" is a feeling of being aware of the existence of fatigue, and in many cases, discomfort and a decrease in activity desire are recognized. The general malaise, sluggishness, and weakness observed in various diseases are used almost synonymously with "sense of fatigue".

[0016] In the present invention, "anti-fatigue" and "improve fatigue tolerance" are synonymous, and mean one or more of reducing fatigue, promoting the recovery of fatigue, and preventing fatigue. Preferably, it means reducing the deterioration of body function that occurs as a result of continuous performance of activities such as labor and exercise, promoting the recovery of such deterioration of body function, or preventing such deterioration of body function to make the state in which such deterioration of body function is unlikely to occur. Although not limited, "anti-fatigue" and "fatigue tolerance improvement effect" can be evaluated by, for example, VAS questionnaire, time trial using a fitness bike, maximum oxygen uptake, etc. In this invention, "reducing fatigue" means reducing the sensation of being aware of the presence of fatigue, reducing discomfort and / or a decrease in motivation resulting from continuous activities such as work or exercise, promoting recovery from such discomfort and / or a decrease in motivation, and preventing such discomfort and / or a decrease in motivation. Although not limited to these, the "fatigue-reducing effect" can be evaluated, for example, by a VAS questionnaire.

[0017] In this invention, "exercise heart rate" refers to the average number of heartbeats per minute (bpm) during a certain period of time while performing an activity such as labor or exercise of a certain intensity. "Exercise heart rate" is also used to calculate the exercise intensity of a person. For example, it is common practice to set the "exercise heart rate" to 50-80% of the maximum heart rate (the fastest heart rate for each individual) as a barometer for building a healthy body, and exercise heart rate is linked to the exercise load that each subject experiences during exercise. Therefore, as the exercise heart rate of a subject increases, it means that the exercise load that the subject experiences increases, and the discomfort the subject feels during exercise also increases. In this invention, "suppression of heart rate increase during exercise" means, for example, that the heart rate of a subject subjected to a certain intensity of exercise does not rise higher than the heart rate of the same subject subjected to the same intensity of exercise in the past, that is, that it is kept low. When the increase in heart rate during exercise is suppressed in a subject, it means that the subject's physical fitness has improved, and the same exercise intensity for that subject has substantially decreased compared to before, and consequently, the discomfort felt during exercise is also reduced. Therefore, for example, when the increase in heart rate during a subject's exercise at a certain intensity is suppressed, the subject can perform the same intensity of exercise more easily and refreshingly, and can also easily continue activities such as work and exercise. This makes it easier for the subject to make exercise a habit and improves the enjoyment of exercise. The indicator for "suppression of heart rate during exercise" is not limited, but for example, a record of heart rate during an exercise stress test of a certain intensity can be used.

[0018] The amount of α-cyclodextrin contained in the composition of the present invention may vary depending on the dosage form and shape of the composition, but is usually an amount selected from 1 to 100% by mass, preferably 7 to 47% by mass, and more preferably 17 to 37% by mass relative to the composition. For example, when the composition of the present invention is molded into a tablet with a total amount of 250 mg, the amount of α-cyclodextrin contained in one tablet can be an amount selected from 2.5 to 250 mg, preferably 17.5 to 117.5 mg, and more preferably 42.5 to 92.5 mg.

[0019] The subjects (test subjects) to whom the composition of the present invention is administered or ingested include mammals (e.g., humans, primates (monkeys, chimpanzees, etc.), livestock (cattle, horses, pigs, sheep, etc.), pets (dogs, cats, etc.), laboratory animals (mice, rats, etc.)), birds, reptiles, etc., that require one or more of the effects of improving physical strength, reducing fatigue, and anti-fatigue, but mammals are preferred, and humans are particularly preferred. Furthermore, the present invention can improve athletic performance not only in subjects without exercise habits (e.g., humans), but also in humans with a certain level of exercise habits. For example, a subject could be a human who exercises at an intensity of 5 METs or higher for 30 minutes or more at least once a week. Even subjects with such moderate exercise habits can have their athletic performance improved. In addition, it can improve fatigue tolerance during and / or after moderate to high-intensity exercises such as walking, jogging, running, marathon, swimming, cycling, aerobics, tennis, soccer, skiing, and skating, and / or reduce the feeling of fatigue, thus suppressing fatigue accumulation. METs (metabolic equivalent of task) is an index of exercise intensity, where 1 MET is equal to an oxygen consumption of 3.5 ml / kg body weight / min, and is the amount of oxygen required for the body to function at rest.

[0020] The dosage or intake of the composition of the present invention may vary depending on factors such as the age and weight of the subject, the route of administration, the number of administrations / intakes, and the degree of one or more of physical strength or fatigue, and any dosage or intake may be adopted. For example, when administered or ingested orally, the intake of α-cyclodextrin is 0.01 mg / kg body weight or more per day, preferably 0.1 mg / kg body weight or more, more preferably 1 mg / kg body weight or more, and an amount of 200 mg / kg body weight or less, preferably 50 mg / kg body weight or less, more preferably 20 mg / kg body weight or less, or 10 mg / kg body weight or less can be administered or ingested in one or more doses (for example, 2 to 5 times, preferably 2 to 3 times).

[0021] The compositions of the present invention can produce effects in small amounts and over a short period of time, but tend to produce greater effects when administered or ingested over a long period of time. The compositions of the present invention can be shown to improve athletic performance when administered or ingested for at least 7 days, but it is more preferable to administer or ingest the compositions of the present invention continuously for a period of 14 days or more, 1 month or more, 2 months or more, 6 months or more, 1 year or more, or longer, according to the above-mentioned dosage and administration instructions.

[0022] The composition of the present invention has an effect of improving athletic performance. Specifically, the composition of the present invention can bring about one or more effects in a subject who is administered or ingested, compared to when the composition is not administered or ingested, such as improving and restoring physical strength, particularly improving the physical strength that enables the subject to withstand and continue to perform work and exercise, and promoting the recovery of said physical strength, and more preferably improving one or more of the following: improving general endurance and endurance during aerobic exercise, and promoting the recovery of one or more of the following: general endurance and endurance during aerobic exercise. Furthermore, the composition of the present invention can bring about one or more effects in a subject who is administered or ingested, compared to when the composition is not administered or ingested, such as reducing fatigue, promoting recovery from fatigue, and preventing fatigue, preferably reducing the decline in physical function that results from continuous activities such as work and exercise, promoting the recovery of said decline in physical function, and preventing said decline in physical function to make it less likely for said decline in physical function to occur. Furthermore, the compositions of the present invention can produce one or more effects in subjects who receive them compared to when they do not receive them, such as reducing fatigue and reducing the sense of being aware of fatigue, preferably reducing discomfort and / or decreased motivation resulting from continuous activities such as work or exercise, promoting recovery from such discomfort and / or decreased motivation, and preventing such discomfort and / or decreased motivation. In addition, the compositions of the present invention can produce one or more effects in subjects who receive them compared to when they do not receive them, such as suppressing the increase in heart rate during exercise, performing exercise more easily and refreshingly, making it easier to continue activities such as work or exercise, making it easier for subjects to make exercise a habit, and / or improving the enjoyment of exercise. Based on these effects, the compositions of the present invention have efficacy and effects in nourishing and strengthening the body, in treating weak constitutions, in supplementing nutrition in cases of physical fatigue, etc.

[0023] <Composition for the proliferation of Bacteroides uniformis in the intestinal tract> The present invention also relates to a composition containing α-cyclodextrin for promoting the growth of Bacteroides uniformis in the intestinal tract. Subjects who ingest or are administered α-cyclodextrin show a significant increase in Bacteroides uniformis in the intestinal tract compared to before ingestion. Furthermore, subjects who ingest or are administered α-cyclodextrin show improved athletic ability. Therefore, it is conceivable that the increase in the number of Bacteroides uniformis in the intestinal tract due to the ingestion or administration of the composition of the present invention is one reason why athletic ability can be improved. Here, the intestinal flora is extremely complex and consists of a delicate balance of bacterial composition. Therefore, even if a system is established to grow Bacteroides uniformis alone in vitro, it cannot be simply applied to Bacteroides uniformis in the intestinal flora. The composition according to the present invention has been confirmed to significantly increase the number of Bacteroides uniformis in the intestinal tract of mammals when ingested or administered into the body of a mammal.

[0024] The "Bacteroides uniformis" in this invention is publicly known and can be characterized based on known mycological properties described in Burgess' Manual of Bacteriology Vol. 4 (1989), etc. Bacteroides uniformis is an anaerobic, gram-negative rod-shaped bacterium approximately 0.8 × 1.5 μm in size, which does not form spores and is non-motile. Bacteroides uniformis is a true bacterium that is normally present in the intestines of many mammals, including humans. The "Bacteroides uniformis" that can be propagated in this invention are strains found in mammals (e.g., humans, monkeys, chimpanzees, cattle, horses, pigs, sheep, dogs, cats, mice, rats, etc.), preferably human intestinal strains.

[0025] The composition of the present invention can propagate any strain of bacteria classified as Bacteroides uniformis. The Bacteroides uniformis to be propagated may be a strain of Bacteroides uniformis present in the intestinal tract of the person ingesting the composition of the present invention, or a strain of Bacteroides uniformis ingested from an external source. The Bacteroides uniformis strain to be ingested from an external source is not particularly limited as long as it is a Bacteroides uniformis strain, but examples include strains ATCC8492, CCUG4942, CIP103695, DSM6597, NCTC13054, JCM5828, CP3585, and CP3586. Preferably, strains JCM5828, CP3585, and CP3586 are used. The JCM5828 strain is a reference strain registered and preserved at the Microbial Materials Development Laboratory, BioResource Center, RIKEN (3-1-1 Takanodai, Tsukuba, Ibaraki 305-0074, Japan). The CP3585 and CP3586 strains were internationally deposited on August 25, 2017, at the Patent Microbial Depositary Center, National Institute of Technology and Evaluation (2-5-8122 Kazusa-Kamatari, Kisarazu, Chiba 292-0818, Japan) under accession numbers NITEBP-02536 and NITEBP-02537.

[0026] Intestinal Bacteroides uniformis can be isolated and identified according to known methods (Paola Gauffin, Canoetal, PLoS One, July 2012, Volume 7, Issue 7, e41079). Specifically, mammalian feces, fecal matter, or stool is diluted in a suitable solvent, seeded on plate medium, cultured under anaerobic conditions, and colonies are picked from the medium. While the media described in detail below can be used, it is preferable to use a selective isolation medium that can identify and select Bacteroides for efficiency of isolation (Jap. J. vet. Sci., 36, 93-98 (1974)). After confirming that the obtained bacteria are Gram-negative bacilli by Gram staining and microscopy, Bacteroides uniformis can be identified and cloned from the selected bacteria by analyzing the base sequence of the 16S rRNA gene. The nucleotide sequence of the Bacteroides uniformis 16S rRNA gene is publicly known and disclosed in publicly available databases such as GenBank, and is registered as NR_040866, AB050110, AB510711, and L16486. This sequence information can be used when analyzing the 16S rRNA gene. Analysis and identification of the 16S rRNA gene can be performed using known methods such as quantitative PCR, DGGE / TGGE, FISH, 16S rDNA cloning library, T-RFLP, FISH-FCM, and nucleotide sequencing (Biochemistry, Vol. 80, No. 5, 421-425, 2008; JNutr. 2004 Feb; 134(2):465-72; Appl. Environ. Microbiol. 64, 3336-3345, 1998; Appl. Environ. Microbiol., 65, 4799-4807, 1999; Appl. Environ. Microbiol., 62, 2273-2278, 1996; Appl. Environ. Microbiol., 64, 3854-3859, 1998).

[0027] For example, using quantitative PCR, primers specific to Bacteroides uniformis can be created based on the known nucleotide sequence information of the 16S rRNA gene of the bacterium. Using DNA extracted from the selected bacterium as a template, a PCR reaction is performed using these primers, and it is possible to determine whether the bacterium is Bacteroides uniformis based on the presence or absence of a PCR amplification product of the intended size. The design of specific primers and the determination of PCR conditions can be carried out according to standard procedures (Bio-Experiment Illustrated 3: PCR That Really Increases: Cell Engineering Supplementary Notebook Series; by Hiroki Nakayama, Shujunsha Co., Ltd.).

[0028] <Optional additives> The composition of the present invention may include, along with α-cyclodextrin, additives such as excipients, lubricants, binders, and disintegrants that are commonly used in the manufacture of pharmaceuticals and food products, and can be manufactured in a dosage form or shape suitable for the intended route of administration and method of intake.

[0029] Excipients include lactose, sucrose, D-mannitol, D-sorbitol, starch, pregelatinized starch, dextrin, glucose, corn starch, crystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethylcellulose, gum arabic, pullulan, light anhydrous silicic acid, synthetic aluminum silicate, magnesium aluminometasilicate, and the like.

[0030] Examples of lubricants include sugar esters such as sucrose fatty acid esters and glycerin fatty acid esters, hydrogenated oils such as calcium stearate, magnesium stearate, stearic acid, stearyl alcohol, and powdered vegetable oils, waxes such as bleached beeswax, talc, silicic acid, and silicon.

[0031] Examples of binders include pregelatinized starch, sucrose, gelatin, gum arabic, methylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, crystalline cellulose, sucrose, D-mannitol, trehalose, dextrin, pullulan, hydroxypropylcellulose, hydroxypropylmethylcellulose, and polyvinylpyrrolidone.

[0032] As disintegrants, lactose, sucrose, starch, carboxymethylcellulose, filtration, salting out, solvent precipitation, solvent extraction, distillation, immunoprecipitation, polyacrylamide gel electrophoresis, isoelectric focusing, dialysis, recrystallization, etc., can be appropriately selected and combined.

[0033] Furthermore, examples of additives commonly used in the manufacture of pharmaceuticals and food and beverages that can be used in the compositions of the present invention include various oils and fats (e.g., vegetable oils such as soybean oil, corn oil, safflower oil, and olive oil; animal oils such as beef tallow and sardine oil), herbal medicines (e.g., royal jelly, ginseng, etc.), amino acids (e.g., glutamine, cysteine, leucine, arginine, etc.), polyhydric alcohols (e.g., ethylene glycol, polyethylene glycol, propylene glycol, glycerin, sugar alcohols, e.g., sorbitol, erythritol, xylitol, maltitol, mannitol, etc.), and natural polymers (e.g., gum arabic, agar, water-soluble corn fiber, gelatin). Examples of ingredients include: corn, xanthan gum, casein, gluten or gluten hydrolysate, lecithin, starch, dextrin, etc., vitamins (e.g., vitamin C, B vitamins, etc.), minerals (e.g., calcium, magnesium, zinc, iron, etc.), dietary fiber (e.g., mannan, pectin, hemicellulose, etc.), surfactants (e.g., glycerin fatty acid ester, sorbitan fatty acid ester, etc.), purified water, molding aids (e.g., tricalcium phosphate), flow improvers (e.g., tricalcium phosphate), diluents, stabilizers, isotonic agents, pH adjusters, buffers, wetting agents, solubilizers, suspending agents, colorants, flavoring agents, odorants, fragrances, antioxidants, sweeteners, flavor components, acidulants, etc.

[0034] <Any other active ingredients> In addition to the active ingredient α-cyclodextrin, the composition of the present invention may include other components known to have one or more of the following effects: improving physical strength, anti-fatigue effects, and reducing fatigue. Examples of such other components include, but are not limited to, taurine, glutathione, carnitine, creatine, coenzyme Q10, glucuronic acid, glucuronolactone, guarana extract, theanine, gamma-aminobutyric acid (GABA), capsaicin, capsiate, allicin, vitamins (vitamins B1, B2, B6, B12, C, E, etc.), various organic acids (citric acid, etc.), flavonoids, polyphenols, catechins, caffeine, etc.

[0035] Furthermore, although the composition of the present invention is used to propagate Bacteroides uniformis, the composition may also contain Bacteroides uniformis or a processed product thereof as another active ingredient. The Bacteroides uniformis available in the present invention can be cultured and harvested using a normal culture medium and culture conditions capable of culturing the bacterium.

[0036] The culture medium can be any medium capable of culturing Bacteroides uniformis and is not particularly limited, but for example, it can include glucose, fructose, galactose, maltose, lactose, cellobiose, sucrose, rhamnose, amygdalin, esculin, salicin, melibiose, trehalose, L-arabinose, ribose, D-xylose, inulin, raffinose, starch, molasses, etc. as a carbon source, inorganic ammonium salts such as ammonium sulfate and ammonium nitrate, urea, amino acids, meat extract, yeast extract, polypeptone, organic nitrogen-containing substances such as protein hydrolysates, etc., and inorganic salts such as magnesium sulfate, potassium dihydrogen phosphate, potassium tartrate, zinc sulfate, magnesium sulfate, copper sulfate, calcium chloride, iron chloride, manganese chloride, etc. Known culture media suitable for culturing Bacteroides uniformis (e.g., NBGT medium, BL medium, GAM medium, etc.) can be used. A liquid culture medium is preferred, but if necessary, agar or gelatin may be added to create a solid or semi-solid culture medium. Cultivation can be carried out under anaerobic conditions at a temperature of 20°C to 50°C, preferably 25°C to 45°C, and more preferably 35°C to 37°C. "Anaerobic conditions" means an environment with low oxygen levels sufficient for Bacteroides uniformis to grow, and can be achieved, for example, by using an anaerobic chamber, anaerobic box, sealed container or culture vessel containing an oxygen absorber.

[0037] Culture can be carried out in any format, such as static culture, shaking culture, or tank culture, and there are no particular restrictions on the culture time, but it can be, for example, from 3 hours to 7 days.

[0038] After culturing, the resulting culture may be used as is, or Bacteroides uniformis may be purified or crudely purified from the culture before use.

[0039] The purification or crude purification of bacterial cells from the culture can be carried out by any means, such as centrifugation or filtration.

[0040] The Bacteroides uniformis used in this invention may be in the form of moist or dried cells.

[0041] In the present invention, treated products of Bacteroides uniformis can also be used. In the present invention, "treated products" include, for example, cell complexes of Bacteroides uniformis. Cell complexes can be obtained by coating Bacteroides uniformis with a coating agent, and can be obtained by known treatments. Examples of coating agents include polysaccharides such as starch, amylose, cellulose, hemilose, mannan, and chitosan, as well as thickening polysaccharides such as gelatin, gellan gum, locust bean gum, carrageenan, ferceleran, tamarind, and pectin, casein, and proteins such as skim milk powder.

[0042] The Bacteroides uniformis or its processed product used in the present invention can be used in any form, such as dried, frozen, aqueous dispersion, or emulsion. Dried products can be obtained using any drying method, such as spray drying, drum drying, vacuum drying, or freeze-drying, and can be in powder or granular form.

[0043] <Aspects of composition> The dosage form or shape of the composition of the present invention is not particularly limited. For example, the pharmaceutically acceptable dosage forms may include tablets, capsules, granules, powders, syrups, dry syrups, liquids, suspensions, inhalants, suppositories, etc., but oral preparations are preferred. Liquid preparations such as liquids and suspensions may be provided in a state that can be freeze-dried and stored, and may be dissolved in a buffer solution containing water or biosaline before use to adjust to an appropriate concentration. Solid dosage forms such as tablets may be coated as needed (e.g., sugar-coated tablets, gelatin-coated tablets, enteric-coated tablets, etc.), or may be prepared using known techniques to control release, such as sustained-release preparations, delayed-release preparations, or immediate-release preparations.

[0044] Examples of food and beverages include health foods and beverages in the form of tablets, chewable tablets, powders, capsules, granules, and drinks (supplements, nutritional supplements, health foods, nutritional adjustment foods, etc.), soft drinks, tea drinks, jelly drinks, sports drinks, coffee drinks, carbonated drinks, vegetable drinks, fruit juice drinks, fermented vegetable drinks, fermented fruit juice drinks, fermented milk drinks (such as yogurt), lactic acid bacteria drinks, milk drinks, powdered drinks, cocoa drinks, confectionery (for example, biscuits and cookies, chocolate, candy, chewing gum, tablets), and jelly (but are not limited to these).

[0045] Food and beverages can be classified as health functional foods (including foods for specified health uses (including conditionally designated foods for specified health uses), nutrient functional foods, foods with functional claims, health foods, beauty foods, etc.) that contain ingredients that have an effect of improving athletic performance.

[0046] Furthermore, the compositions of the present invention can be used not only as food and beverages for humans, but also as feed or feed additives for livestock, racehorses, pets, etc.

[0047] The following examples are merely illustrative of the subject matter disclosed herein and should not be considered in any way as limiting the scope of the disclosed subject matter. [Examples]

[0048] The subjects, selection criteria, composition of the test food, and the test period and evaluation items for Examples 1 to 3 were as follows. 1. Subjects and Selection Criteria The study included 21 healthy men aged 20-49 who had an exercise habit of performing exercise at an intensity of 5 METs or higher for 30 minutes or more, 1-2 times a week, and who were able to continue their exercise habit during the study period. Of the 21 participants, 10 were assigned to the α-cyclodextrin (αCD) intake group, and the remaining 11 to the placebo group. The participants themselves were not informed which group they belonged to. 2. Test Foods The test food (tablet) used had the composition listed in Table 1 below. Each test food tablet contained approximately 250 mg.

[0049] [Table 1] 3. Examination period and evaluation items The subjects in the α-cyclodextrin intake group and the placebo group were instructed to take three tablets of the above-mentioned test food once a day at a time of their choosing. In other words, subjects in the α-cyclodextrin intake group took approximately 200 mg of α-cyclodextrin per day. The test food intake period was 9 weeks. Changes in gut flora were evaluated before intake, after 4 weeks, and after 8 weeks, and a fatigue questionnaire was administered. Changes in running time were also evaluated. Participants were asked to maintain the same lifestyle as before the test during the test period. Foods and beverages that claim to support sports or training, pharmaceuticals and quasi-drugs whose efficacy includes recovery, prevention, or improvement of "fatigue," "tiredness," "physical strength," and / or "lethargy," and all supplements (including functional foods and foods for specified health uses) were prohibited from being consumed for one week prior to the date of consent to participate in the test and throughout the test period.

[0050] [Example 1] Test of the effect of α-cyclodextrin on the proliferation of Bacteroides uniformis in the intestinal tract Changes in Bacteroides uniformis within the intestinal tract of the subjects were examined. Fecal samples were collected from each subject before ingestion of the test food and 8 weeks after ingestion for evaluation. DNA was extracted from the collected feces using a standard method, and quantitative PCR (probe method) was performed using a standard method with forward primers, reverse primers, and probes that targeted specific sequences in the 16S rDNA region of Bacteroides uniformis, referencing the description in Anaerobe (2011), 17, 64-68, Jia Tong et al., to evaluate the absolute number of Bacteroides uniformis in the intestinal tract. Forward primer sequence: 5'-TCTTCCGCATGGTAGAACTATTA-3' (SEQ ID NO: 1) Reverse primer sequence: 5'-ACCGTGTCTCAGTTCCAATGTG-3' (SEQ ID NO: 2) Probe sequence: 5'-CGTTCCATTAGGTTGTTGGCGGGG-3' (Sequence ID 3) The results are shown in Figure 1. In the α-cyclodextrin intake group, the number of Bacteroides uniformis bacteria in the intestinal tract increased approximately 2.5 times after 8 weeks of intake (8w) compared to before intake (0w). On the other hand, in the placebo group, no statistically significant change in the number of Bacteroides uniformis bacteria was observed when comparing before intake and after 8 weeks of intake. The statistical analysis of the bacterial count before intake and after 8 weeks of intake was performed using the Wilcoxon signed-rank test (*: p<0.05).

[0051] [Example 2] Fatigue reduction test using α-cyclodextrin The subjects underwent exercise using an AEROBIKE® (registered trademark) (manufactured by Konami Sports & Life Co., Ltd., model number AEROBIKE-75XLIII) before ingesting the test food, 4 weeks after ingestion, and 8 weeks after ingestion (exercise intensity: 50 minutes at 45% of each subject's maximum exercise intensity). In this example, the maximum exercise intensity refers to the pedal resistance (W) just before exhaustion in a pre-tested incremental load test where the load was increased by 15W per minute. Regarding fatigue, a Visual Analogue Scale (VAS) questionnaire was administered immediately after the load, 30 minutes after the load, and 60 minutes after the load, based on the fatigue sensation VAS test method established by the Japanese Society for Fatigue Research, to investigate the changes in fatigue sensation over time. The questionnaire items were "general fatigue," "leg fatigue," "leg stiffness," "general malaise," and "shortness of breath," and the "best state (0mm)" and "worst state (100mm)" for each item were based on the criteria shown in Table 2. In each intake group, the change in measured values ​​after 4 weeks and 8 weeks of intake was evaluated, using pre-intake measurements as the baseline. The α-cyclodextrin intake group showed a significantly lower level of post-exercise general fatigue compared to the placebo group during each intake period. A student's t-test was used to determine the significant difference between the placebo group and the α-cyclodextrin (αCD) intake group regarding general fatigue, and the results are summarized in Figure 2 (*: p<0.05). The results for "leg fatigue," "leg stiffness," "general malaise," and "shortness of breath" are summarized in Table 3. In Table 3, a paired t-test was used to examine significant differences compared to pre-αCD intake, and a student's t-test was used to determine the significant difference between the placebo group and the α-cyclodextrin (αCD) intake group. As can be seen from Table 3, in the α-cyclodextrin intake group, the score was significantly lower (i.e., fatigue was reduced) compared to before intake, especially after 8 weeks of intake. Furthermore, it was suggested that fatigue tolerance also improved in the α-cyclodextrin intake group compared to before intake, especially after 8 weeks of intake.

[0052] [Table 2]

[0053] [Table 3]

[0054] [Example 3] Exercise performance improvement test using α-cyclodextrin (exercise performance test) To evaluate the changes in exercise performance due to α-cyclodextrin (αCD) intake, subjects were measured for their cycling time when pedaling 10km using a spin cycle (Fujimori Co., Ltd., model number FBS-101) after exercise in the fatigue reduction test described in Example 2, and after a 60-minute rest period, before intake of the test food, 4 weeks after intake, and 8 weeks after intake. The load intensity was set to a value that could be set on the spin cycle close to 45% of each subject's maximum exercise load intensity. After 4 weeks of αCD intake, the time was significantly shorter compared to the time before intake in the same group, and further after 8 weeks of αCD intake, it was significantly shorter compared to the time before intake in the same group and the time after 8 weeks of intake in the placebo group. The results are summarized in Figure 3 as a graph. For comparisons with the period before αCD intake, a paired t-test was used to examine statistical significance. For statistical significance testing between the placebo group and the α-cyclodextrin (αCD) intake group, a student's t-test was performed (*: p<0.05, **: p<0.01). The results in Figure 3 show that α-cyclodextrin intake not only reduces fatigue but also contributes to improved physical fitness, particularly overall endurance and endurance during aerobic exercise. Furthermore, the results in Figure 3 indicate that α-cyclodextrin intake also contributes to improved fatigue tolerance. The data from Examples 1-3 supported the finding that α-cyclodextrin intake contributes to improved athletic performance.

[0055] Next, the subjects and selection criteria, the composition of the test food, and the test period and evaluation items for Examples 4 to 6 were as follows. 1. Subjects and Selection Criteria The study included 86 healthy men aged 20-49 who had an exercise habit of performing exercise at an intensity of 5 METs or higher for 30 minutes or more, 1-2 times a week, and who were able to continue their exercise habit during the study period. Of the 86 participants, 43 were placed in the α-cyclodextrin (αCD) intake group, and the remaining 43 in the placebo group. The participants themselves were not informed which group they belonged to. 2. Test Foods The test food (tablet) used had the composition listed in Table 4 below. Each test food tablet contained approximately 600 mg.

[0056] [Table 4]

[0057] 3. Examination period and evaluation items The subjects in the α-cyclodextrin intake group and the placebo group were instructed to take four tablets of the above-mentioned test food once a day at a time of their choosing. In other words, subjects in the α-cyclodextrin intake group took approximately 1000 mg of α-cyclodextrin per day. The test food intake period was 8 weeks. Exercise heart rate was measured before intake, 4 weeks after intake, and 8 weeks after intake, and changes in heart rate were evaluated. In addition, a fatigue questionnaire was administered before intake and 8 weeks after intake, and changes in running time were evaluated. Participants were asked to maintain the same lifestyle as before the study period. Foods and beverages that claim to support sports or training, pharmaceuticals and quasi-drugs whose efficacy includes recovery, prevention, or improvement of "fatigue," "tiredness," "physical strength," and / or "lethargy," and all supplements (including functional foods and foods for specified health uses) were prohibited from consumption for one week prior to the date of consent to participate in the study and throughout the study period.

[0058] [Example 4] Test to suppress the increase in heart rate during exercise using α-cyclodextrin Subjects underwent exercise stress tests using an AEROBIKE® (registered trademark) (manufactured by Konami Sports & Life Co., Ltd., model number AEROBIKE-75XLIII) before ingestion of the test food, 4 weeks after ingestion, and 8 weeks after ingestion (intensity: 50 minutes at 55% of each subject's estimated maximum exercise stress). In this example, the estimated maximum exercise stress refers to the maximum exercise stress (pedal resistance (W)) calculated from the heart rate during exercise using the AEROBIKE's built-in program. The estimated maximum exercise stress was measured in advance for each subject. Heart rate during the exercise stress test was recorded every minute using an ear sensor. The change (Δ value) between 4 weeks and 8 weeks of ingestion, relative to pre-ingestion, was evaluated for the average heart rate in the 10 minutes immediately preceding the end of exercise (i.e., from 40 minutes after the start of exercise to the end of exercise). The α-cyclodextrin (αCD) group showed a significantly lower heart rate after 8 weeks of ingestion compared to the placebo group (Figure 4). Furthermore, at 4 weeks after ingestion, heart rate tended to be significantly lower in the α-cyclodextrin (αCD) group compared to the placebo group (Figure 4). A statistical significance test was performed using analysis of covariance (ANCOVA) with pre-ingestion baseline to determine the significant difference between the placebo group and the α-cyclodextrin (αCD) intake group (*: p<0.05). Exercise heart rate refers to the average heart rate over a certain period of time during exercise and is used to calculate exercise intensity, as it is linked to the exercise load experienced during exercise. The fact that the subjects' exercise heart rate decreased after taking α-cyclodextrin means that the exercise load for the subjects was reduced. In other words, the results of this example suggest that taking α-cyclodextrin improved exercise performance, suppressed the rise in heart rate during exercise, and further reduced the discomfort felt during exercise.

[0059] [Example 5] Fatigue reduction test using α-cyclodextrin Before ingesting the test food and 8 weeks after ingestion, subjects underwent exercise using an AEROBIKE® (registered trademark) (manufactured by Konami Sports & Life Co., Ltd., model number AEROBIKE-75XLIII) (exercise intensity: 55% of each subject's estimated maximum exercise intensity for 50 minutes). In this example, the estimated maximum exercise intensity refers to the maximum exercise intensity (pedal resistance (W)) calculated from the heart rate during exercise using the AEROBIKE's built-in program. The estimated maximum exercise intensity was measured in advance for each subject. Regarding fatigue, a Visual Analogue Scale (VAS) questionnaire was administered immediately after the exercise, 30 minutes after the exercise, and 60 minutes after the exercise, based on the fatigue sensation VAS test method established by the Japanese Society for Fatigue Research, to investigate the change in fatigue sensation over time. The questionnaire consisted of one item, "General Fatigue," and the criteria for "Best State (0mm)" and "Worst State (100mm)" are shown in Table 5. In each intake group, the change in measured values ​​(Δ value) after 8 weeks of intake was evaluated, using the measured values ​​before intake as a baseline. The α-cyclodextrin intake group showed a significantly lower level of general fatigue immediately after exercise compared to the placebo group after 8 weeks of intake (Figure 5). Student's t-test was used to test for the significant difference between the placebo group and the α-cyclodextrin (αCD) intake group regarding general fatigue (*: p<0.05).

[0060] [Table 5]

[0061] [Example 6] Exercise performance improvement test using α-cyclodextrin (exercise performance test) To evaluate the changes in exercise performance due to α-cyclodextrin (αCD) intake, subjects underwent the exercise stress test described in Example 5 before and 8 weeks after intake of the test food. After a 60-minute rest, the time taken to cycle 10km using a spin cycle (Fujimori Co., Ltd., model number FBS-101) was measured. The load intensity was set to a value that could be set on the spin cycle, close to 45% of the estimated maximum exercise load intensity for each subject. When the change in time after 8 weeks of intake (Δ value) was evaluated, using the time before α-cyclodextrin (αCD) intake as the baseline, the time after 8 weeks of intake was significantly lower in the α-cyclodextrin (αCD) intake group compared to the placebo group (Figure 6). A statistical significance test between the placebo group and the α-cyclodextrin (αCD) intake group was performed using analysis of covariance (ANCOVA) with the pre-intake measurement as a covariate (*: p<0.05). The data from Examples 4-6 supported the finding that α-cyclodextrin intake contributes to improved athletic performance.

Claims

[Claim 1] A composition for the proliferation of Bacteroides uniformis in the human intestinal tract, comprising α-cyclodextrin as an active ingredient, A composition administered orally, containing α-cyclodextrin in an amount ranging from 0.01 mg / kg body weight to 200 mg / kg body weight per day, for use as a food additive, and administered for at least 8 weeks.

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