Hard capsule and method for producing the same

Abstract

To provide a hard capsule for easy intake that effectively prevents weight regain after exercise and dietary therapy and a method for producing the same.SOLUTION: A hard capsule is filled with an agent for preventing weight regain after exercise and dietary therapy, the agent containing tea extract, viable cells of Lactobacillus plantarum 22A-3 strain, water-soluble vitamin, and iron compounds.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a hard capsule that exhibits an excellent effect of inhibiting regaining body weight after exercise and dietary therapy and that allows the contents to be easily ingested, and a method for producing the same. [Background technology]

[0002] Generally, obesity refers to a state in which one weighs more than normal or has an excessive accumulation of body fat. Recently, it has become possible to quantitatively grasp obesity using the body mass index (BMI) as an indicator. There are various causes of obesity, but it is often caused by lifestyle habits such as high-calorie diets, drinking alcohol, smoking, lack of exercise, and stress. Obesity is known as a risk factor for arteriosclerosis, which is believed to be the cause of adult diseases such as myocardial infarction and cerebral infarction, and has become a serious social problem.

[0003] However, there is currently no established fundamental treatment for obesity symptoms other than improving eating habits and moderate exercise. As a method for improving obesity symptoms, a method for reducing body weight or body fat is generally used by combining dieting methods such as a method for reducing energy intake and a method for increasing energy consumption. In addition, as shown in the following literature, it has been reported that certain components have the effect of reducing body fat and body weight.

[0004] Non-Patent Document 1 discloses the effect of reducing body fat and body weight when the total catechin intake is 450 mg / day. Non-Patent Document 2 discloses the effect of reducing body fat and body weight when the total catechin intake is 600 mg / day. Non-Patent Document 3 discloses the effect of reducing body fat when the epigallocatechin gallate (EGCg) intake is 150 to 250 mg / day. Furthermore, Patent Document 1 and Non-Patent Document 4 disclose live bacteria (Smart Lactic Acid Bacteria: Maruzen Pharmaceutical Co., Ltd.) of Lactobacillus plantarum 22A-3 strain (FERM P-21411) having tannase activity that converts EGCg, which is effective in reducing visceral fat but has a low absorption rate in the body, into epigallocatechin (EGC), which is easily absorbed, in the intestine.

[0005] However, dieting, such as restricting energy intake, activates the homeostatic function in the body, resulting in a reduction in energy consumption, enhanced absorption of nutrients, and increased fat accumulation. This causes a stagnation in weight or body fat reduction. In particular, it is known that if a diet method is temporarily stopped, the weight or body fat that was once lost will increase back to the original state or above, resulting in a so-called rebound. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Patent No. 5162212 [Non-patent literature]

[0007] [Non-Patent Document 1] Journal of Health Science (2005), 51(2) pp. 161-171 [Non-Patent Document 2] Progress in Medicine (2002), 22, pp. 2189-2203 [Non-Patent Document 3] Food Funct.,(2016), 7(1), pp. 498-507 [Non-Patent Document 4] More possibilities for "Smart Lactic Acid Bacteria"!, Last updated on July 26, 2022, PR TIMES website [searched on March 22, 2023], Internet<https: / / prtimes.jp / main / html / rd / p / 000000020.000070472.html> Summary of the Invention [Problem to be solved by the invention]

[0008] The ester-type catechins such as EGCg and EGC described in the above literature are effective for dieting, but have a problem of being strongly bitter when ingested. Therefore, when ingesting a high content of catechins, it is necessary to select a dosage form that does not taste.

[0009] In light of the above, the present invention provides a hard capsule that exhibits an excellent effect of inhibiting weight regain after exercise and diet therapy, and also provides a method for producing the same that makes it easy to ingest the contents. [Means for solving the problem]

[0010] As a result of research aimed at solving the above problems, the present inventors have newly discovered that a hard capsule containing tea extract, live Lactobacillus plantarum 22A-3 strain bacteria, water-soluble vitamins, and an iron compound as its ingredients exhibits an excellent effect of inhibiting weight regain after exercise and diet therapy.

[0011] Various aspects for solving the above problems will be described below. The hard capsule of the first aspect is characterized in that it is filled with an agent for inhibiting weight regain after exercise and diet therapy, which contains tea extract, live Lactobacillus plantarum (Lactiplantibacillus plantarum) 22A-3 strain bacteria, water-soluble vitamins, and an iron compound.

[0012] Aspect 2 is a hard capsule according to aspect 1, wherein the agent for suppressing weight regain after exercise and diet therapy is used as an appetite suppressant or reducer, or an agent for suppressing or reducing hunger after exercise and diet therapy.

[0013] Aspect 3 is the hard capsule according to aspect 1 or 2, wherein the water-soluble vitamin comprises at least one selected from vitamin B1, vitamin B2, vitamin B6, and vitamin C.

[0014] Aspect 4 is the hard capsule according to any one of Aspects 1 to 3, in which the content of the content in the hard capsule is 300 mg or more and 360 mg or less. Aspect 5 is the hard capsule according to any one of Aspects 1 to 4, in which the content of the tea extract is 50% by mass or more and 70% by mass or less with respect to the content of the contents in the hard capsule.

[0015] Aspect 6 is a hard capsule according to any one of Aspects 1 to 5, wherein the total catechin content contained as the tea extract is 37.5% by mass or more and 52.5% by mass or less with respect to the content of the contents in the hard capsule.

[0016] Aspect 7 is a hard capsule according to any one of Aspects 1 to 6, in which the content of epigallocatechin gallate contained as the tea extract is 20% by mass or more and 28% by mass or less with respect to the content of the contents in the hard capsule.

[0017] In an eighth aspect of the hard capsule according to any one of the first to seventh aspects, the hard capsule is ingested at a total catechin intake of 450 mg / day or more. A ninth aspect is the hard capsule according to any one of the first to eighth aspects, wherein the hard capsule is ingested at an intake amount of 150 mg / day or more of epigallocatechin gallate.

[0018] Aspect 10 is the hard capsule according to any one of Aspects 1 to 9, wherein the hard capsule further contains starch as an ingredient. In an eleventh aspect, the hard capsule according to the tenth aspect, wherein the starch has a water activity of less than 0.2.

[0019] A twelfth aspect is the hard capsule according to any one of the first to eleventh aspects, wherein the hard capsule further contains silicon dioxide as an ingredient. A thirteenth aspect of the present invention is the hard capsule according to any one of the first to twelfth aspects, wherein the hard capsule further contains a metal stearate as an ingredient.

[0020] A method for producing a hard capsule according to a fourteenth aspect is the method for producing a hard capsule according to the thirteenth aspect, which comprises the following steps (A) to (C): Step (A): A step of dry granulating a mixture obtained by mixing a tea extract and a metal stearate to obtain a dry granulated product.

[0021] Step (B): A step of mixing at least live Lactobacillus plantarum (Lactiplantibacillus plantarum) 22A-3 strain, water-soluble vitamins, an iron compound, and a metal stearate with the dry granulated product of step (A) to obtain a mixture.

[0022] Step (C): Filling the mixture from step (B) into a hard capsule. Effect of the Invention

[0023] The present invention can exert an excellent effect of inhibiting weight regain after exercise and diet therapy, and also makes the contents easier to ingest. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] An embodiment of the hard capsule according to the present invention will be described. The hard capsule of this embodiment is filled with a weight regain inhibitor after exercise and diet therapy (hereinafter referred to as "weight regain inhibitor") containing tea extract, live bacteria of Lactobacillus plantarum 22A-3 strain, water-soluble vitamins, and an iron compound. Note that the genus name of Lactobacillus plantarum has been changed to Lactiplantibacillus plantarum due to reclassification in 2020.

[0025] (tea extract) The tea leaves used as the raw material for the tea extract are not particularly limited, and include non-fermented green tea, semi-fermented tea, fermented tea, etc., but any of them may be used. These may be used alone or in combination of two or more. Among these, green tea is preferred from the viewpoint of exhibiting a more excellent effect of suppressing weight regain after exercise and diet therapy.

[0026] Examples of green tea include sencha, gyokuro, tencha, bancha, etc. Examples of semi-fermented tea include oolong tea, etc. Examples of fermented tea include black tea, etc. The tea extraction method can be appropriately adopted from known methods. For example, known extraction methods such as stirring extraction, kneader extraction, drip extraction, column extraction, etc. can be adopted. Examples of the extraction solvent include water such as hard water, soft water, ion-exchanged water, distilled water, etc., organic solvents such as ethanol, and mixtures of the above water and organic solvents such as ethanol. Extraction aids can be added to the extraction solvent as necessary. Examples of the extraction aids include pH adjusters such as ascorbic acid, potassium carbonate, and sodium bicarbonate.

[0027] The extraction temperature is appropriately set, but is preferably 70 to 100° C., and more preferably 80 to 95° C. The amount of extraction solvent used is appropriately set, but is preferably 5 to 60 times, and more preferably 10 to 50 times, the mass ratio of the tea leaves. The extraction time is appropriately set, but is preferably 1 to 20 minutes, and more preferably 2 to 10 minutes.

[0028] The obtained extract is concentrated by evaporating water, or dried and powdered. For concentrating and drying the treated liquid, known methods such as reduced pressure concentration, membrane concentration, freeze concentration, vacuum drying, spray drying, or freeze drying are used.

[0029] The tea extract contains tea catechin as a main component of polyphenol. Tea catechin is a compound having a flavanol skeleton, such as epicatechin, epigallocatechin, epicatechin gallate, epigallocatechin gallate, flavanol (catechin), gallocatechin, catechin gallate, gallocatechin gallate, etc. The tea extract may contain these tea catechins alone or in combination of two or more kinds. Among these, epigallocatechin gallate is preferably contained in the tea extract from the viewpoint of exhibiting an excellent effect of suppressing weight regain after exercise and dietary therapy.

[0030] In addition, it is preferable to use the tea extract obtained by the above-mentioned extraction, from which tea catechins are further extracted, roughly refined, and refined. With this configuration, tea catechins can be blended in the re-increase inhibitor at a high concentration. Tea catechins are obtained by subjecting the tea extract obtained as above to a step of separation using one or more chromatographies. As the chromatography, known chromatography such as gas chromatography, liquid chromatography, supercritical fluid chromatography, thin layer chromatography, etc. can be used. As the liquid chromatography, for example, column chromatography can be used, and more specifically, high performance liquid chromatography (HPLC) and open column chromatography can be used. Specific examples of the chromatography carrier include ion exchange chromatography, partition chromatography (normal phase / reverse phase chromatography), adsorption chromatography, molecular exclusion chromatography, etc.

[0031] The content of tea extract in the hard capsule contents (dry matter of the weight regain inhibitor (hereinafter the same)) is appropriately set, but is preferably 50% by mass or more and 70% by mass or less, and more preferably 55% by mass or more and 65% by mass or less. By specifying the content of tea extract within this range, the effect of inhibiting weight regain after exercise and diet therapy can be efficiently exerted.

[0032] The total catechin content contained as tea extract in the hard capsule contents is appropriately set, but is preferably 37.5% by mass or more and 52.5% by mass or less. By defining the total catechin content within this range, the capsule can efficiently exert the effect of suppressing weight gain after exercise and diet therapy.

[0033] The content of epigallocatechin gallate contained as tea extract in the hard capsule contents is appropriately set, but is preferably 20% by mass or more and 28% by mass or less. By specifying the content of epigallocatechin gallate within this range, the capsule can efficiently exert the effect of suppressing weight regain after exercise and diet therapy.

[0034] In order to efficiently inhibit weight regain after exercise and dietary therapy, the intake amount of total catechins is appropriately set, but is preferably 450 mg / day or more, more preferably 500 mg / day or more, even more preferably 550 mg / day or more, and particularly preferably 600 mg / day or more.

[0035] In order to efficiently inhibit weight regain after exercise and dietary therapy, the intake amount of epigallocatechin gallate (EGCg) is appropriately set, but is preferably 150 mg / day or more, more preferably 200 mg / day or more, and even more preferably 250 mg / day or more.

[0036] (Lactobacillus plantarum strain 22A-3) Lactobacillus plantarum strain 22A-3 is a species of Lactobacillus plantarum that has tannase activity but does not have gallic acid decarboxylase activity and has the ability to utilize inulin.

[0037] Lactobacillus plantarum 22A-3 strain may be isolated from pickles or may be obtained from a commercial product, such as Smart Lactic Acid Bacteria (registered trademark) manufactured by Maruzen Pharmaceutical Co., Ltd., which is described in Patent Document 1 and Non-Patent Document 4.

[0038] The content of Lactobacillus plantarum 22A-3 strain in the contents of one hard capsule is appropriately set, but is preferably 100 million to 1.1 billion in terms of viable cell count, more preferably 200 million to 1 billion in terms of viable cell count. By being specified within such range, the effect of suppressing weight gain after exercise and diet therapy can be efficiently exerted.

[0039] In order to efficiently inhibit weight regain after exercise and dietary therapy, the intake amount of Lactobacillus plantarum 22A-3 strain is appropriately set, with a viable cell count of between 400 million and 4.4 billion per day being preferred, and a viable cell count of between 800 million and 4.0 billion per day being more preferred.

[0040] (Water-soluble vitamins) Other than the above, water-soluble vitamins can be used as compounding ingredients. Water-soluble vitamins are effective in improving the body's condition with a small intake amount in hard capsules where the content volume is limited. Examples of water-soluble vitamins include vitamin C and B vitamins. Specific examples of B vitamins include vitamin B1, vitamin B2, vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6, vitamin B7 (biotin), vitamin B9 (folic acid), vitamin B12, etc. These may be used alone or in combination of two or more types.

[0041] Among these, from the viewpoint of exhibiting a more excellent effect of inhibiting weight regain after exercise and dietary therapy, at least one selected from vitamin B1, vitamin B2, vitamin B6, and vitamin C is preferable. Moreover, it is more preferable that the weight regain inhibitor contains vitamin B1, vitamin B2, vitamin B6, and vitamin C. Note that vitamin C exhibits the effect of promoting the absorption of iron compounds, which will be described later.

[0042] The lower limit of the total water-soluble vitamin content in the hard capsule content is appropriately set, but is preferably 1% by mass or more, more preferably 2% by mass or more. The upper limit of the total water-soluble vitamin content is appropriately set, but is preferably 6% by mass or less, more preferably 5% by mass or less. Any combination of the above upper and lower limits is also possible.

[0043] The individual water-soluble vitamin contents in the hard capsules are as follows: The lower limit of the content of vitamin B1 in the hard capsule is appropriately set, but is preferably 0.04% by mass or more, more preferably 0.07% by mass or more. The upper limit of the content of vitamin B1 is appropriately set, but is preferably 0.18% by mass or less, more preferably 0.15% by mass or less. Any combination of the above upper and lower limits is also possible.

[0044] The lower limit of the content of vitamin B2 in the hard capsule is appropriately set, but is preferably 0.05% by mass or more, more preferably 0.08% by mass or more. The upper limit of the content of vitamin B2 is appropriately set, but is preferably 0.19% by mass or less, more preferably 0.16% by mass or less. Any combination of the above upper and lower limits is also possible.

[0045] The lower limit of the vitamin B6 content in the hard capsule content is appropriately set, but is preferably 0.07% by mass or more, more preferably 0.10% by mass or more. The upper limit of the vitamin B6 content is appropriately set, but is preferably 0.21% by mass or less, more preferably 0.18% by mass or less. Any combination of the above upper and lower limits is also possible.

[0046] The lower limit of the vitamin C content in the hard capsule is set appropriately, but is preferably 0.5% by mass or more, more preferably 1.5% by mass or more. The upper limit of the vitamin C content is set appropriately, but is preferably 5.5% by mass or less, more preferably 4.5% by mass or less. Any combination of the above upper and lower limits is also possible.

[0047] By defining the content of water-soluble vitamins within such range, the effect of inhibiting regain of body weight after exercise and diet therapy can be efficiently exerted. (Iron Compounds) Other than the above, iron compounds can be used as compounding ingredients. In hard capsules with limited content, iron compounds are effective in improving the body's condition with a small intake. The type of iron compound applied to the re-increase inhibitor is not particularly limited, and may be divalent iron or trivalent iron. Specific examples of trivalent iron include ammonium ferrous citrate, ferric pyrophosphate, ferric phosphate, ferric hydroxide, ferric oxide, etc. Among these, ferric pyrophosphate is preferably applied. Specific examples of divalent iron include sodium ferrous citrate, ferrous pyrophosphate, ferrous phosphate, ferrous hydroxide, ferrous oxide, etc. These may be used alone or in combination of two or more types.

[0048] The lower limit of the content of the iron compound in the hard capsule content is set appropriately, but is preferably 0.1% by mass or more, more preferably 0.2% by mass or more in terms of the amount of iron. The upper limit of the content of the iron compound is set appropriately, but is preferably 0.6% by mass or less, more preferably 0.5% by mass or less in terms of the amount of iron. Any combination of the above upper and lower limits is also envisioned. By specifying the content of the iron compound within this range, the effect of suppressing weight gain after exercise and diet therapy can be efficiently exerted.

[0049] (Additives) The re-growth inhibitor is filled into a hard capsule together with a metal stearate as an additive and other additives added as necessary, such as plant extracts other than those mentioned above, excipients, anti-caking agents, auxiliaries, sugars, flavors, sweeteners, oils and fats, etc.

[0050] When the content is in powder form, the metal stearate is blended to improve the fluidity of the particles. As described later, by dry granulating the mixture of tea extract and stearate, the water content can be reduced, and the amount of tea extract that can be filled into a hard capsule can be increased while suppressing the death of live lactic acid bacteria due to water.

[0051] Metal salts constituting metal stearates include, for example, alkali metal salts and alkaline earth metal salts. Specific examples of alkali metal salts include, for example, sodium, potassium, and lithium. Specific examples of alkaline earth metal salts include metals belonging to Group 2 elements, such as calcium, magnesium, beryllium, strontium, and barium.

[0052] The lower limit of the content of the metal stearate in the hard capsule content is set appropriately, but is preferably 2% by mass or more, more preferably 4% by mass or more. The upper limit of the content of the metal stearate is set appropriately, but is preferably 12% by mass or less, more preferably 10% by mass or less. Any combination of the above upper and lower limits is also possible. By specifying the content of the metal stearate within this range, the fluidity of the content can be improved, and the manufacturability of the card capsule can be improved.

[0053] As the excipient, a known excipient may be appropriately used, for example, starch, cellulose, sugars, etc. Among these, starch is preferred from the viewpoint that it does not affect each component blended in the re-growth inhibitor and the contents can be easily powder-granulated. Specific examples of starch include corn starch, tapioca starch, potato starch, sweet potato starch, sago starch, and wheat starch. When starch is used as the excipient, the water activity of the starch is preferably less than 0.2, more preferably less than 0.1, and even more preferably less than 0.05. By specifying the water activity within such a range, the water content in the contents can be reduced, and the death of lactic acid bacteria due to water can be suppressed.

[0054] Specific examples of the anti-caking agent include silicon dioxide, calcium phosphate, powdered cellulose, silicate, etc. Among these, silicon dioxide is preferred from the viewpoint of easily granulating the contents into powder without affecting each component blended in the re-growth inhibitor. The silicon dioxide is preferably fine silicon dioxide from the viewpoint of improving the fluidity of the contents.

[0055] (Hard capsule) The hard capsule is filled with the re-increase inhibitor containing each of the above-mentioned components as the contents. The dosage form of the contents is not particularly limited, and may be powder, particulate, granule, etc. Among the contents, the tea extract and the stearate are preferably granulated using a dry granulation method and then filled into the hard capsule. In addition, the filling method of the contents may be, for example, an auger type, a tapping type, a funnel type, etc. The filling method is not particularly limited, but preferably the tapping type or the auger type is applied, and more preferably the auger type is applied.

[0056] The hard capsule can be produced by a known method. The hard capsule of the present embodiment preferably includes the following steps (A) to (C). Through these steps, a content containing a larger amount of tea extract can be efficiently obtained. Furthermore, by carrying out dry granulation in step (A), the moisture content in the content can be reduced, and the death of lactic acid bacteria due to moisture can be suppressed.

[0057] Step (A): A step of dry granulating a mixture obtained by mixing a tea extract and a metal stearate to obtain a dry granulated product. Step (B): A step of mixing the dry granulated product of step (A) with live Lactobacillus plantarum 22A-3 strain bacteria, water-soluble vitamins, an iron compound, and a metal stearate to obtain a mixture.

[0058] Step (C): Filling the mixture from step (B) into a hard capsule. When other components are contained in addition to the above components, they may be blended in either step (A) or step (B).

[0059] The material constituting the hard capsule can be appropriately selected from known materials, such as vegetable polysaccharides such as cellulose and pullulan, cellulose derivatives such as hydroxypropylmethylcellulose, and gelatin. These materials may be used alone or in combination of two or more. The shape of the hard capsule is not particularly limited, and known shapes, such as a shape consisting of a main body and a cap, can be appropriately selected. These capsules may be packaged in a packaging form such as a bottle package, a PTP package, or a pouch. The content of the contents in the hard capsule is preferably 300 mg or more and 360 mg or less per capsule. By specifying the content within this range, the re-increase inhibitor can be efficiently ingested.

[0060] (regrowth inhibitor) The weight regain inhibitor exerts an inhibitory effect on weight regain after exercise and diet therapy by the above-mentioned components. It exerts an inhibitory effect on so-called rebound after dieting. Weight regain refers to the phenomenon in which weight lost by dieting increases. Weight regain refers to weight gain, particularly due to an increase in fat. As an inhibitory effect on weight regain after exercise and diet therapy, specifically, an appetite suppressing or reducing effect after exercise and diet therapy, and an inhibitory or reducing effect on hunger are mentioned. As an appetite suppressing or reducing effect, specifically, an inhibitory or reducing effect on appetite for sweets, and an inhibitory or reducing effect on appetite for snacks are mentioned. Due to these effects, it exerts an inhibitory effect on weight regain after exercise and diet therapy. Therefore, the weight regain inhibitor can also be applied as an appetite suppressing or reducing agent after exercise and diet therapy, an inhibitory or reducing agent on hunger, an inhibitory or reducing agent on appetite for sweets, and an inhibitory or reducing agent on appetite for snacks.

[0061] (Usage form) As a specific formulation form of the hard capsule filled with the regrowth inhibitor of this embodiment, it can be applied as a food, medicine, quasi-drug, etc. for the purpose of obtaining the above-mentioned action effects.

[0062] When the hard capsule filled with the re-growth inhibitor of this embodiment is applied to food, additives other than those mentioned above, such as base materials, food additives, sub-materials, bulking agents, etc., may be appropriately blended as the contents. The uses of the food are not particularly limited, and include so-called (1) general foods, (2) health foods such as nutritional supplements, dietary supplements, nutritionally adjusted foods, and supplements, (3) health functional foods such as foods for specified health uses, foods with nutritional functions, foods with functional claims, and functional foods, and (4) special purpose foods such as foods for sick people. When the uses of food and drink are indicated, this includes indication on packages such as wrapping and containers, as well as indication on advertising media such as pamphlets.

[0063] Examples of uses for suppressing regain include suppressing regain of weight or fat after exercise and diet therapy. Other examples include suppressing or reducing appetite after exercise and diet therapy, suppressing or reducing hunger, suppressing or reducing appetite for sweets, and suppressing or reducing appetite for snacks. Also included are claims that suggest such suppression or reduction. Specifically, claims such as suppressing rebound after dieting are exemplified.

[0064] When used as a pharmaceutical composition or quasi-drug, it is taken (orally) in the form of a hard capsule. When used as a pharmaceutical composition or quasi-drug, pharma- ceutical acceptable additives other than those mentioned above, such as bases, carriers, dispersants, emulsifiers, buffers, stabilizers, binders, disintegrants, lubricants, etc., may be further blended as the contents.

[0065] When the hard capsule of this embodiment is applied as a food or the like, the daily intake amount is not particularly limited. From the viewpoint of the expression of an excellent effect of suppressing weight regain after exercise and diet therapy, the amount of the re-gain inhibitor is preferably 100 mg or more and 3000 mg or less per day, more preferably 150 mg or more and 2000 mg or less per day. In addition, the intake time is not particularly limited, and it can be taken during the diet period and after the end of the diet period. From the viewpoint of the expression of an excellent effect of suppressing weight regain after exercise and diet therapy, it is preferable to take it for several months from the start of the diet to the end of the diet period.

[0066] The effects of the hard capsule of this embodiment will be described. (1) The hard capsule of this embodiment is filled with the above-mentioned tea extract, live bacteria of Lactobacillus plantarum 22A-3 strain, water-soluble vitamins, and a weight regain inhibitor containing an iron compound. Therefore, it exerts an excellent effect of inhibiting weight regain after exercise and diet therapy. Therefore, it is possible to maintain the body shape or weight after dieting. In addition, by selecting a hard capsule as the dosage form, it is easy to take without affecting the bitterness of ester-type catechins even when the tea extract is mixed at a high content.

[0067] (2) In addition, when the tea extract is dry granulated, the amount of tea extract filled into the hard capsule can be increased and the stability of the live bacteria of Lactobacillus plantarum strain 22A-3 can be improved. In addition, water-soluble vitamins and iron compounds are added as functional ingredients to prevent rebound, and Lactobacillus plantarum strain 22A-3 and catechins, which are also useful for preventing rebound, are added. This leads to saving of the content volume. In addition, the number of hard capsules required for intake is minimized, improving ease of intake and cost benefits. Furthermore, the tannase activity of Lactobacillus plantarum strain 22A-3 can increase the body absorption rate of EGCg, thereby further improving rebound prevention.

[0068] (3) In addition, the agent for suppressing weight regain after exercise and dietary therapy exerts an excellent effect of suppressing or reducing appetite or suppressing or reducing hunger after exercise and dietary therapy, and therefore makes it easy to maintain one's body shape or weight after dieting.

[0069] (4) In the hard capsule of the present embodiment, when the contents are formed using a dry granulation method, the moisture content can be reduced to suppress the death of live lactic acid bacteria caused by moisture. Also, a large amount of contents can be filled into the capsule. Furthermore, when tapioca starch with low water activity is used as an excipient, the death of live lactic acid bacteria can also be suppressed.

[0070] The above embodiment may be modified as follows: The above embodiment and the following modifications may be combined with each other to the extent that no technical contradiction occurs. The hard capsule in the above embodiment can be applied not only to humans but also to pets, livestock and other domestic animals. EXAMPLES

[0071] The configuration and effects of the present invention will be specifically described below using examples, but the present invention is not limited to these examples. <Test Example 1: Hard Capsule Ingestion Test> A test was conducted to examine the effect of subjects taking hard capsules filled with the weight regain inhibitor manufactured as described below for a specified period of time on inhibiting weight regain after exercise and diet therapy.

[0072] (1) Manufacturing method of hard capsules The contents used were a regrowth inhibitor consisting of the components shown in Table 1 below. As the hard capsule, a No. 2 capsule having a body and a cap made of HPMC was used. The hard capsule was prepared by the method of steps (A) to (C) shown below.

[0073] [Table 1] In step (A), the mixture of the tea extract and the calcium stearate (4 mg / grain) was dry granulated to obtain a dry granulated product. Next, in step (B), the dry granulated product of step (A) was mixed with the ingredients other than the tea extract and the remaining 18.054 mg / grain of the metal stearate to obtain a mixture. In step (C), the mixture of step (B) was filled into the main body of a hard capsule at a ratio of 330 mg / grain, and a cap was placed to obtain a hard capsule filled with a re-growth inhibitor as the content.

[0074] (2) Exercise, diet and hard capsule intake Fourteen adults aged 25-49 years participated in the study. As shown in Table 2 below, the test period consisted of a diet period involving exercise and dietary therapy, a period in which subjects took in hard capsules filled with the above-mentioned re-growth inhibitor, and a period in which subjects took in a placebo (contents: starch).

[0075] First, the subjects went on a 30-day diet consisting of exercise and diet therapy. In order to ensure that each subject was on a reasonable diet, they were asked to limit their calorie intake to within a few hundred calories per day, or to exercise more than usual, taking into consideration their age, weight, lifestyle, etc.

[0076] The subjects took the above hard capsules for a total of 60 days, including 30 days during the diet period and 30 days after the end of the diet period. Four hard capsules (total of 1320 mg of contents) were taken per day. After the hard capsule intake period ended, the subjects took a placebo for an additional 30 days. The amount of placebo taken was the same as that of the hard capsules.

[0077] [Table 2] (3) Weight measurement For each subject, body weight was measured before starting the diet (day 0 from the start of the study), after the diet period ended (day 30 from the start of the study), after the hard capsule intake period ended (day 60 from the start of the study), and after the placebo intake period ended (day 90 from the start of the study).

[0078] The weight gain or loss (kg) during each period was calculated based on the weight before the diet. The weight change after the end of the diet period, the weight change after the end of the hard capsule intake period, and the weight change after the end of the placebo intake period are shown in the "Weight change after the end of the diet period (kg) (a)" column, the "Weight change after the end of the hard capsule intake period (kg) (b)" column, and the "Weight change after the end of the placebo intake period (kg) (c)" column of Table 3. The weight change (kg) from the end of the diet period to the end of the hard capsule intake period is shown in the "(b)-(a)" column of Table 3. The weight change (kg) from the end of the hard capsule intake period to the end of the placebo intake period is shown in the "(c)-(b)" column of Table 3.

[0079] [Table 3] As shown in Table 3, the weight after the diet period ended did not increase significantly during the hard capsule intake period, and the average weight tended to decrease slightly. On the other hand, the weight after stopping the intake of the hard capsules and taking the placebo tended to increase. This shows that the intake of the hard capsules suppressed the weight gain after the diet period ended.

[0080] (4) Waist measurement For each subject, waist circumference around the navel was measured before starting the diet (day 0 of the study), after the diet period ended (day 30 of the study), after the hard capsule intake period ended (day 60 of the study), and after the placebo intake period ended (day 90 of the study).

[0081] The increase or decrease (cm) in each period was calculated based on the waist circumference around the navel before the diet. The change in waist circumference around the navel after the end of the diet period, the change in waist circumference around the navel after the end of the hard capsule intake period, and the change in waist circumference around the navel after the end of the placebo intake period are shown in the "Change in waist circumference around the navel after the end of the diet period (cm) (a)" column, the "Change in waist circumference around the navel after the end of the hard capsule intake period (cm) (b)" column, and the "Change in waist circumference around the navel after the end of the placebo intake period (cm) (c)" column in Table 4. The change in waist circumference around the navel after the end of the diet period and the end of the hard capsule intake period is shown in the "(b)-(a)" column in Table 4. The change in waist circumference around the navel after the end of the hard capsule intake period and the end of the placebo intake period is shown in the "(c)-(b)" column in Table 4.

[0082] [Table 4] As shown in Table 4, the waist circumference around the navel after the diet period did not increase significantly during the hard capsule intake period, and the average waist size tended to decrease slightly. On the other hand, the waist circumference around the navel tended to increase after the intake of the hard capsules and the intake of the placebo. This shows that the intake of the hard capsules suppressed the increase in the waist circumference around the navel after the diet period.

[0083] (5) Questionnaire 1 After the diet period and hard capsule intake period shown in Table 2 had ended, and after the placebo intake period had ended, the 14 subjects were given a questionnaire about the following items.

[0084] The questionnaire included the question, "After the diet period ended, during the hard capsule intake period, did you feel that you were able to suppress rebound?", which was rated on a 5-point scale: "I feel it," "I feel it a little," "I don't feel it much," "I don't feel it," and "I don't know." In addition, the questionnaire included the question, "During the placebo intake period, did you feel that you were able to suppress rebound?", which was rated on a 5-point scale (I feel it," "I feel it a little," "I don't feel it much," "I don't know). Table 5 shows the number of people who answered the corresponding item.

[0085] [Table 5] As shown in Table 5, it was confirmed that the percentage of subjects who felt that they were able to suppress rebound by taking the hard capsules was high. On the other hand, during the placebo intake period, it was confirmed that the percentage of subjects who answered that they did not feel that they were able to suppress rebound or did not feel that they were able to suppress rebound increased significantly.

[0086] (6) Questionnaire 2 After the end of the diet period using the exercise and dietary therapy shown in Table 2, after the end of the period in which the hard capsules were taken, and after the end of the period in which the placebo was taken, the 14 subjects were given a questionnaire about the following items.

[0087] Regarding appetite, we asked the number of subjects who answered "I ate less," "I don't feel hungry as much," "I don't crave sweets anymore," and "I snack less," and asked them how many of them answered yes. Regarding body shape, we asked the number of subjects who answered "I lost excess fat," and "I noticed a change in my body shape (slimming down)." The results are shown in Table 6.

[0088] [Table 6] As shown in Table 6, it was confirmed that the proportion of people who felt the effect of reducing appetite or hunger was high during the period of taking the hard capsules. It was also confirmed that the proportion of people who felt the effect of reducing fat in terms of body type was high. On the other hand, it was confirmed that the proportion of people who felt the effect of reducing appetite or hunger was significantly reduced after the end of the placebo intake period. It was also confirmed that the proportion of people who felt the effect of reducing fat in terms of body type tended to decrease.

Claims

1. The hard capsule contains as its contents an agent for inhibiting weight regain after exercise and diet therapy, which contains tea extract, live Lactobacillus plantarum (Lactiplantibacillus plantarum) strain 22A-3, water-soluble vitamins, and an iron compound.

2. 2. The hard capsule according to claim 1, wherein the agent for suppressing weight regain after exercise and dietary therapy is used as an appetite suppressant or reducer, or an agent for suppressing or reducing hunger after exercise and dietary therapy.

3. 3. The hard capsule according to claim 1, wherein the water-soluble vitamin comprises at least one selected from the group consisting of vitamin B1, vitamin B2, vitamin B6, and vitamin C.

4. 3. The hard capsule according to claim 1, wherein the content of the content in the hard capsule is 300 mg or more and 360 mg or less.

5. 3. The hard capsule according to claim 1, wherein the content of the tea extract is 50% by mass or more and 70% by mass or less based on the content of the contents in the hard capsule.

6. 3. The hard capsule according to claim 1, wherein the total catechin content contained as the tea extract is 37.5% by mass or more and 52.5% by mass or less relative to the content of the contents in the hard capsule.

7. 3. The hard capsule according to claim 1, wherein the content of epigallocatechin gallate contained as the tea extract is 20% by mass or more and 28% by mass or less relative to the content of the contents in the hard capsule.

8. 3. The hard capsule according to claim 1 or 2, wherein the hard capsule is ingested at a total catechin intake of 450 mg / day or more.

9. 3. The hard capsule according to claim 1, wherein the hard capsule contains 150 mg or more of epigallocatechin gallate per day.

10. 3. The hard capsule according to claim 1, further comprising starch as an ingredient.

11. 11. The hard capsule of claim 10, wherein the starch has a water activity of less than 0.

2.

12. 3. The hard capsule according to claim 1 or 2, further comprising silicon dioxide as an ingredient.

13. 3. The hard capsule according to claim 1, further comprising a metal stearate as an ingredient.

14. The method for producing a hard capsule according to claim 13, comprising the following steps (A) to (C): Step (A): A step of dry granulating a mixture obtained by mixing a tea extract and a metal stearate to obtain a dry granulated product. Step (B): A step of mixing at least live Lactobacillus plantarum (Lactiplantibacillus plantarum) 22A-3 strain, water-soluble vitamins, an iron compound, and a metal stearate with the dry granulated product of step (A) to obtain a mixture. Step (C): Filling the mixture from step (B) into a hard capsule.

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