Composition for improving bowel movements

Abstract

The present invention aims to provide a composition for improving bowel movements that contains gallic acid as an active ingredient. Furthermore, the present invention aims to provide a food or beverage containing gallic acid as an active ingredient that is labeled as having the function of improving bowel movements. [Solution] A composition for improving bowel movements, characterized by containing gallic acid as an active ingredient. Food and beverages containing gallic acid as an active ingredient, and labeled as having the function of improving bowel movements.

Description

Technical Field

[0001] The present invention relates to a composition for improving defecation characterized by containing gallic acid as an active ingredient, and a food or drink containing gallic acid as an active ingredient and displaying that it has a function of improving defecation.

Background Art

[0002] In recent years, various lifestyle-related diseases have spread due to changes in eating habits, imbalances in diet, stress, etc. One of them is intestinal disorders such as constipation and diarrhea. Constipation is caused by the long retention of feces in the intestine. Moreover, severe constipation can cause an increase in harmful bacteria in the intestine and an increase in the absorption of harmful substances, and may induce colorectal cancer. Therefore, the development of compositions for improving defecation has been promoted. As a substance having an effect of improving defecation, for example, sodium picosulfate hydrate is known. However, since this substance is a pharmaceutical product, it is not something that people with mild constipation symptoms can easily ingest. Therefore, there is a demand for the development of a new composition for improving constipation that can be easily ingested in daily life as a food or drink.

Prior Art Documents

Non-Patent Documents

[0003]

Non-Patent Document 1

Summary of the Invention

[0004] The present inventors diligently studied novel compositions for improving bowel movements and, to their surprise, discovered that compositions containing gallic acid as an active ingredient have excellent bowel movement-improving effects, leading to the completion of the present invention.

[0005] In other words, the present invention relates to a composition for improving bowel movements containing gallic acid as an active ingredient. Furthermore, the present invention relates to a food or beverage containing gallic acid as an active ingredient, which is labeled as having the function of improving bowel movements, preferably a functional food or a food for specified health uses.

[0006] The outline of this invention is as follows: [1] A composition for improving bowel movements, characterized by containing gallic acid as an active ingredient. [2] Food and beverages containing gallic acid as an active ingredient, and labeled as having the function of improving bowel movements. [3] The food or beverage described in [2], wherein the food or beverage is a food with functional claims or a food for specified health uses. [4] A composition for improving bowel movements containing gallic acid as an active ingredient, and further containing ellagic acid. [5] The laxative composition according to [4], characterized in that the mass ratio of gallic acid to ellagic acid is gallic acid:ellagic acid = 1:0.01 to 1. [6] Food and beverages containing gallic acid as an active ingredient, Furthermore, food and beverages that contain ellagic acid and are labeled as having the function of improving bowel movements. [7] The food and beverage according to [6], characterized in that the mass ratio of gallic acid to ellagic acid is gallic acid:ellagic acid = 1:0.01 to 1. [8] The food or beverage described in [6] or [7], wherein the food or beverage is a food with functional claims or a food for specified health uses. [Effects of the Invention]

[0007] According to the present invention, by using gallic acid as an active ingredient, it is possible to provide a composition for improving bowel movements that has an excellent bowel movement-improving effect. Furthermore, according to the present invention, by incorporating gallic acid, which has an excellent bowel movement-improving effect, as an active ingredient in food and beverages, it is possible to provide food and beverages that are labeled as having a function of improving bowel movements. [Modes for carrying out the invention]

[0008] The following describes preferred embodiments of the composition and food / beverage of the present invention. The composition and food / beverage according to the present invention contain gallic acid as an active ingredient for the function of improving bowel movements.

[0009] 1. Gallic acid The gallic acid used in this invention is a compound represented by C7H6O5 and is also called 3,4,5-trihydroxybenzoic acid. The gallic acid used in this invention is not particularly limited as long as it can be used as a food product, and plant-derived gallic acid or synthetically obtained gallic acid can be used. When plant-derived gallic acid is used in the composition of this invention, plant extracts or pulverized powders may be used as the source of gallic acid, or purified products thereof may be used. Pulverized powder refers to powder obtained by drying and pulverizing plants. When plant-derived gallic acid is used, examples of the plants from which it may be derived include green tea, date palm, and persimmon. Furthermore, the gallic acid used in this invention may be an anhydrous form or a hydrate such as a monohydrate. Gallic acid may also be in the form of a salt. When a salt of gallic acid is used in this invention, alkali metal salts are examples of salts of gallic acid. In this invention, when gallic acid is in the form of a hydrate, the amount of gallic acid referred to herein is on an anhydrous basis. In this invention, when a salt is used as gallic acid, the amount of gallic acid refers to the amount in terms of gallic acid equivalent.

[0010] From the perspective of further enhancing the function of gallic acid in improving bowel movements and the taste when taken orally, the proportion of gallic acid in the composition of the present invention is preferably 0.001% by mass or more and 96% by mass or less, more preferably 0.001% by mass or more and 90% by mass or less, still more preferably 0.005% by mass or more and 87% by mass or less, and particularly preferably 0.01% by mass or more and 84% by mass or less in the solid content of the composition. In this specification, when the composition is in a solid state, the solid content refers to the content in the composition, and when the composition is in a liquid or fluid state, it refers to the total amount of all components excluding water in the composition.

[0011] The amount of gallic acid in the composition of the present invention can be measured by the HPLC method. For example, using Unison UK-C18 (HT 3μm φ3×100mm) manufactured by Imtakt Corporation, as the liquid medium of the mobile phase, 1% formic acid aqueous solution is used for mobile phase A and 1% formic acid acetonitrile solution is used for mobile phase B, the column temperature can be 45°C, and the flow rate can be 0.7 ml / min. The gradient conditions can be as follows. When measuring, appropriate treatments such as removing impurities in the sample may be carried out as necessary to conform to the separation ability of the device.

[0012]

Table A

[0013] Column: Unison UK-C18 HT 3μm φ3×100mm Column temperature: 45°C Injection volume: 2 μL Flow rate: 0.7 mL / min Measurement wavelength: 276 nm Mobile phase A: 1% formic acid aqueous solution Mobile phase B: 1% formic acid acetonitrile solution

[0014] 2. Ellagic acid From the perspective of further enhancing the function of gallic acid to improve bowel movements, the composition of the present invention preferably further contains ellagic acid. Ellagic acid is a kind of natural phenolic compound and is represented by C 14 H6O8. The ellagic acid used in the present invention is not particularly limited as long as it can be used as a food, and plant-derived ellagic acid or those obtained by synthesis can be used. When using plant-derived ellagic acid in the composition of the present invention, as the ellagic acid source, plant extracts or pulverized powders may be used, or purified products thereof may be used. When using plant-derived ellagic acid, examples of the plant from which it is derived include strawberries, raspberries, pomegranates, etc. Further, the ellagic acid used in the present invention may be an anhydride or a hydrate such as a monohydrate. Also, ellagic acid may be in the form of a salt. When using a salt of ellagic acid in the present invention, an alkali metal salt of ellagic acid can be mentioned. In the present invention, when ellagic acid is a hydrate, the amount of ellagic acid referred to in this specification is in terms of anhydride conversion. In the present invention, when using a salt as ellagic acid, the amount of ellagic acid is the amount in terms of ellagic acid conversion.

[0015] In the present invention, the inventor believes that ellagic acid is an auxiliary component that enhances the effect of gallic acid. In the present invention, from the perspective of further enhancing the function of gallic acid to improve bowel movements, the mass ratio of gallic acid to ellagic acid in the composition is preferably gallic acid:ellagic acid = 1:0.01 to 1, more preferably 1:0.05 to 0.5, still more preferably gallic acid:ellagic acid = 1:0.05 to 0.4, particularly preferably gallic acid:ellagic acid = 1:0.05 to 0.3, and especially preferably gallic acid:ellagic acid = 1:0.1 to 0.3.

[0016] From the viewpoint of further enhancing the function of gallic acid in improving bowel movements, the proportion of ellagic acid in the composition of the present invention is preferably 0.00001% by mass or more and 40% by mass or less, more preferably 0.00005% by mass or more and 30% by mass or less, and even more preferably 0.0001% by mass or more and 25% by mass or less, in the solid content of the oral composition, provided that the mass ratio of gallic acid to ellagic acid is within the range described above.

[0017] The amounts of gallic acid and ellagic acid in the composition of the present invention can be measured by HPLC. For example, a Unison UK-C18 (HT 3μm φ3×100mm) manufactured by Imtakt Corporation can be used, with 1% formic acid aqueous solution as mobile phase A and 1% formic acid acetonitrile solution as mobile phase B, with a column temperature of 45°C and a flow rate of 0.7 mL / min. The gradient conditions can be as follows. When measuring, appropriate treatment may be performed as needed, such as removing impurities from the sample to match the separation capacity of the instrument.

[0018] [Table B]

[0019] Column: Unison UK-C18 HT 3μm φ3×100mm, manufactured by Imtakt Corporation. Column temperature: 45°C Injection volume: 2μL Flow rate: 0.7mL / min Measurement wavelength: 276nm Mobile phase A solution: 1% formic acid aqueous solution Mobile phase B: 1% formate acetonitrile solution

[0020] 3. Composition for improving bowel movements The laxative composition of the present invention may contain other components besides gallic acid and ellagic acid, to the extent that they do not inhibit the expression of the laxative function of gallic acid. Examples of such other components include sugars, vitamins, minerals, proteins, dietary fiber such as insoluble dietary fiber, plants or processed plant products, and yeast. Furthermore, it may contain, if necessary, sweeteners, acidulants, colorants, thickeners, glazing agents, lubricants, excipients, anticaking agents, nutritional supplements, binders, lubricants, stabilizers, diluents, bulking agents, emulsifiers, food additives, seasonings, etc., which are commonly used in the food industry.

[0021] Examples of the present invention's laxative composition can be in the form of tablets, capsules, powders, granules, liquids, granular preparations, rods, plates, blocks, solids, pills, pastes, creams, caplets, gels, chewables, sticks, and the like. Among these forms, tablets, capsules, powders, granules, and liquids are preferred from the viewpoint of ease of administration.

[0022] The present invention's composition for improving bowel movements can take the form of pharmaceuticals (including quasi-drugs) and food and beverages. Among these, food and beverages are particularly preferred from the viewpoint of being easily consumed in daily life.

[0023] Examples of foods and beverages of the present invention include general foods, foods with nutritional function claims, foods for specified health uses whose efficacy claims have been approved by designated institutions, and so-called health foods such as foods with functional claims. Foods that display efficacy claims are sometimes collectively referred to as "health functional foods" or "functional foods." From the viewpoint of making it easier to display the effects of the present invention, it is particularly preferable that the product be a food with functional claims or a food for specified health uses.

[0024] The present invention does not particularly limit the food and beverages, but examples include: milk and dairy products; beverages such as soft drinks, fruit juices, milk beverages, alcoholic beverages, sports drinks, and nutritional drinks; seasonings; alcoholic beverages; processed agricultural and forestry products; confectionery and bread; flour and noodles; processed marine products; processed livestock products; oils and fats; frozen prepared foods; retort foods; instant foods; food ingredients; and supplements. Examples of supplement forms include tablets, capsules, powders, granules, and liquids.

[0025] The laxative composition of the present invention is not particularly limited as long as it contains gallic acid and is used for the purpose of improving laxative function, and can be distinguished from other products as a product. For example, any product in which the function of improving laxative function is displayed on the product itself, packaging, instructions, or promotional materials (advertising media) is included in the scope of the present invention. The laxative composition of the present invention may display gallic acid as the active ingredient, but is not limited to products in which gallic acid is displayed as the active ingredient on the product packaging, etc. For example, it may not specify an active ingredient. Furthermore, even general foods are included in the scope of the present invention if they are manufactured and sold with indications of their use. For example, foods that are sold with statements on websites, etc., mentioning improved laxative function as a personal testimonial from a person who consumed them are also included in the scope of the present invention. Furthermore, functional foods that use papers, etc., demonstrating improved laxative function as the scientific basis for their functionality, and in which gallic acid is the functionally active ingredient, and whose functionality related to improving laxative function is the notified claim, are also included in the scope of the present invention. As mentioned above, in the present invention, ellagic acid is an auxiliary component for enhancing the effect of gallic acid, and therefore is not usually listed as an active ingredient in functional foods or foods for specified health uses that claim to improve bowel movements. However, the bowel movement improving composition of the present invention does not exclude those that list ellagic acid as an active ingredient, and also includes functional foods, etc., that list ellagic acid or the like as an active ingredient.

[0026] It should be noted that the "improvement of bowel movements" in this invention is a distinctly different concept from "improvement of intestinal barrier function." There is no causal relationship between the two, so improvement in one does not necessarily mean improvement in the other. Specifically, for example, a systematic review on intestinal barrier dysfunction in patients with constipation-predominant IBS (irritable bowel syndrome) compared to healthy individuals reported that the prevalence of intestinal barrier dysfunction in patients with constipation-predominant IBS was low, ranging from 4% to 25%, and that there was no difference in intestinal barrier function compared to healthy individuals [Ther Adv Gastroenterol, 2021, Vol.14, p.1-31]. Furthermore, even in the clinical practice guidelines for IBD (inflammatory bowel disease), which is considered to be caused by abnormalities in intestinal barrier function, abdominal pain and diarrhea are listed as the main clinical symptoms of IBD, but constipation is not mentioned ["Inflammatory Bowel Disease (IBD) Clinical Practice Guidelines 2020 (Revised 2nd Edition)", Japanese Society of Gastroenterology, published November 15, 2020]. As is clear from these points, the cause of constipation is not necessarily due to impaired intestinal barrier function, and therefore, improving intestinal barrier function does not necessarily improve constipation. Furthermore, while zinc is known to improve intestinal barrier function (Yasuki Higashimura, et al., "The Importance of Zinc in Intestinal Barrier Function," Vitamin, Vol. 91, No. 7, 2017, pp. 437-440), constipation has been reported as a side effect of zinc (Haruhisa Watanabe, et al., "A Case of Taste Disorder Accompanied by Hypozincemia Requiring a Switching of Zinc Preparations," Journal of the Japanese Society of Oral Medicine, Vol. 26, No. 1, 2020, pp. 42-46). Thus, even components that improve intestinal barrier function can cause constipation, so it is obvious that ingesting components that improve intestinal barrier function does not necessarily improve constipation.

[0027] From the viewpoint of reliably obtaining the function of improving bowel movements, it is preferable that the bowel movement improving composition contains 10 to 100 mg of gallic acid per adult per day, and more preferably 15 to 70 mg. Furthermore, it is preferable that the total intake of gallic acid and ellagic acid be 10 to 120 mg, and more preferably 20 to 100 mg taken orally. 4. Food and beverages that are labeled as having the function of improving bowel movements.

[0028] As described above, the present invention includes food and beverages that are labeled as having the function of improving bowel movements. The method of labeling is preferably in the form of (1) or (2) below.

[0029] (1) A label indicating that a food or beverage is a functional food, which has been registered with the Consumer Affairs Agency by the business operator, based on scientific evidence, that it has a function of improving bowel movements. (2) A statement that the food or beverage is a Food for Specified Health Uses (FOSHU) which is permitted by the Consumer Affairs Agency to display on the product packaging that it has a function of improving bowel movements based on scientific evidence.

[0030] For example, examples of the expressions in (1) and (2) above include: "improves bowel movements," "reported to have a function of improving bowel movements," "helps improve bowel movements," "supports bowel movement improvement," "helps improve bowel movements," "suitable for those concerned about bowel movements," "relieves constipation," "helps relieve constipation," "supports constipation relief," "helps relieve constipation," "suitable for those concerned about constipation," "reduces constipation," "alleviates constipation," "suppresses constipation," "suitable for those prone to constipation," "improves bowel movements," "improves bowel movements," "regulates stomach condition," "regulates stomach condition," "helps improve bowel movements," etc. [Examples]

[0031] The present invention will be described below based on examples. However, the present invention is not limited to the following examples. Unless otherwise specified, "%" below refers to "mass%".

[0032] [Test Example 1] Confirmation of the effect on improving bowel movements in mice [Examples 1-1 to 1-6 and Comparative Examples 1-1 to 1-3] The test substances for Examples 1-1 to 1-6 and Comparative Examples 1-1 to 1-3 were prepared using the raw materials listed in Tables 1 and 2. Here, Example 1 (control group) consisted solely of MF powdered feed (Oriental Yeast Co., Ltd.). When multiple raw materials were used, the test substances were prepared by mixing the multiple raw materials. The amounts of raw materials used are shown in Tables 1 and 2.

[0033] Gallic acid Gallic acid reagent (powdered, purity approximately 97% or higher) was used. Ellagic acid Ellagic acid reagent (powdered, purity approximately 98% or higher) was used. • Peucedanum japonicum 50% ethanol extract Dried peony leaves were air-dried and crushed to obtain a peony powder, which was then extracted with 50% ethanol. The solvent was removed from this extract by evaporating and freeze-drying before use. Sodium gluconate A sodium gluconate reagent (powdered, purity of approximately 98% or higher) was used.

[0034] [Table 1]

[0035] [Table 2]

[0036] The following tests were performed on the test substances of Examples 1-1 to 1-6, Comparative Examples 1-1 to 1-3, and Control Example 1.

[0037] As test animals, four-week-old male ICR mice (Nippon SLC Co., Ltd.) were acclimated for five days. For the rearing environment, the lighting time was 12 hours, and the cages used were flat-bottomed polycarbonate cages (W172×D240×H129mm; Nippon Crea Co., Ltd.) with paper chips (Paper Clean; Nippon SLC Co., Ltd.) as bedding. One mouse was housed per cage.

[0038] During the acclimatization period, feeding was generally left to the animals' discretion. MF powdered feed (Oriental Yeast Co., Ltd.) was used, and tap water was provided for drinking.

[0039] After the acclimatization period, healthy test animals were selected to have nearly uniform body weights and used in the experiment. However, care was taken to ensure that there were no differences in the weight of wet feces collected from day 1 to day 0 of the experiment.

[0040] (Test Procedure) After the acclimatization period, the test animals were divided into 10 groups, each containing one of the 10 test substances: Control Example 1, Comparative Examples 1-3, and Examples 1-6. Each group consisted of 3 test animals. The 5-week-old test animals were given free access to each test substance for 28 days starting from the start of the experiment (Day 0). The housing environment consisted of a 12-hour lighting period and a polycarbonate flat-bottom cage (W172 x D240 x H129 mm; Nippon Crea Co., Ltd.) with paper chips (Pepperclean; Nippon SLC Co., Ltd.) as bedding. Each cage contained 1 animal. A Roden Cafe feeder (Oriental Yeast Co., Ltd.) was used to facilitate measurement of food intake.

[0041] Feces were collected on the 29th day after the start of the experiment, and the dry fecal weight was measured. The percentage increase in fecal weight for each example or comparative example compared to the control example was calculated based on the following formula. Increase in fecal weight compared to the control example (%) = (Fecal weight of the example or comparative example - Fecal weight of the control example) ÷ Fecal weight of the control example × 100 Table 3 shows the results of measuring the weight of dry feces.

[0042] [Table 3]

[0043] In Comparative Examples 1-3, the dry stool weight was equal to or less than that of Control Example 1. On the other hand, in Examples 1-1 to 1-6 of the present invention, which contained gallic acid, the dry stool weight increased compared to Control Example 1 and Comparative Examples 1-1 to 1-3, confirming the laxative effect of gallic acid. Furthermore, in Examples 1-2 to 1-6, which contained ellagic acid in addition to gallic acid, the dry stool weight increased even further, confirming that ellagic acid further enhances the laxative function of gallic acid. In particular, when the mass ratio of gallic acid to ellagic acid was in the range of gallic acid:ellagic acid = 1:0.1 to 0.3 (Examples 1-3 and 1-4), the dry stool weight increased the most, confirming an even better laxative effect.

[0044] [Test Example 2] Confirmation of the effect on improving bowel movements in humans 1 1. Test food As the test food (Example 2), gallic acid, reduced maltose, cellulose, calcium stearate, and silicon dioxide were mixed to produce tablets (swallowable tablets) containing 220 mg per tablet (10.4 mg of gallic acid). In addition, a control food (Control Example 2) was prepared using the same method, in which the gallic acid in the test food was replaced with caramel coloring so that it could not be distinguished from the test food by appearance.

[0045] 2. Subjects This study included 46 healthy adults (10 males and 36 females) who met the following selection criteria and did not violate any exclusion criteria.

[0046] The selection criteria were: (i) healthy men and women aged 20 to under 65 at the time of obtaining consent; (ii) those who have bowel movements 3 to 5 times per week; (iii) those who are not heavy drinkers; (iv) those who normally eat three meals a day at regular intervals; and (v) those who have received a full explanation of the purpose and content of the study, have the capacity to give consent, fully understand it, voluntarily volunteer to participate, and give written consent to participate in the study. Exclusion criteria include: (i) individuals who regularly use intestinal regulators or laxatives (including laxatives); (ii) individuals suffering from or currently receiving treatment for serious liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease, or other metabolic disease; (iii) individuals who have been diagnosed with irritable bowel syndrome or inflammatory bowel disease; (iv) individuals with a history of or current illness of drug dependence or alcohol dependence; and (v) individuals who consumed foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and natto bacteria, or foods fortified with oligosaccharides and dietary fiber during the study period. (vi) Individuals who cannot stop consuming health foods (including Foods for Specified Health Uses and Foods with Function Claims) that are said to be good for improving constipation, and foods containing large amounts of sugar alcohols; (vi) Individuals who have been regularly consuming regular foods containing lactic acid bacteria, bifidobacteria, and oligosaccharides for the purpose of relieving constipation; (vii) Individuals who have taken antibiotics within two weeks of the screening test; (viii) Individuals with digestive diseases that affect digestion and absorption, and a history of digestive surgery; (ix) Individuals who have declared that they have a food allergy; (x) Individuals who have consumed approximately 20% pure alcohol equivalent. (xi) individuals who consume excessive amounts of alcohol (more than g / day) or who drink alcohol four or more days a week; (xii) individuals who cannot abstain from alcohol for two days prior to the screening test or each test; (xiii) individuals who report having a significantly irregular menstrual cycle; (xiv) pregnant individuals, individuals who intend to become pregnant during the study period, or breastfeeding individuals; (xv) individuals who have had more than 200 mL of blood drawn or donated more than 400 mL of blood within one month prior to the date of consent, or within three months prior to the date of consent; (xvi) individuals currently participating in studies involving the intake of other foods or the use of pharmaceuticals, or studies involving the application of cosmetics and pharmaceuticals, individuals who have participated in other clinical studies within one month of obtaining consent, or individuals who intend to participate; (xvii) individuals deemed unsuitable as research subjects by the principal investigator based on the tests performed during the screening test; (xviii) other individuals deemed unsuitable as research subjects by the principal investigator.

[0047] Furthermore, during the study period, participants were instructed to (i) avoid consuming foods containing live bacteria such as lactic acid bacteria, foods fortified with oligosaccharides and dietary fiber, foods said to be good for relieving constipation, foods containing large amounts of sugar alcohols, medicines such as intestinal regulators and laxatives, health foods and supplements, (ii) maintain the same lifestyle as before the study, (iii) avoid consuming large amounts of alcohol, (iv) avoid participating in other studies, (v) avoid consuming alcohol starting two days before the screening test, and (vi) avoid eating or drinking anything other than water after 9 PM the day before all tests.

[0048] 3. Exam Schedule This study was conducted as a randomized, double-blind, placebo-controlled crossover trial. The person responsible for assigning the study food prepared and sealed a table (key code) containing the assignment results and kept it sealed until the key code was disclosed after the participants were selected, thereby ensuring blinding to anyone other than the person responsible for assigning the study food. Furthermore, the study food was distributed to the study participants in plain aluminum bags containing two tablets each, ensuring blinding to both the study participants and the intervention implementers. The study was conducted over a total of 12 weeks, consisting of a pre-observation period (2 weeks), intake period I (4 weeks), rest period (2 weeks), and intake period II (4 weeks).

[0049] Both the test food and the control food were designed with a daily intake of 220 mg x 2 tablets (20.8 mg of gallic acid per daily intake). In Phase I, the group that received the test food first received the test food, and the group that received the control food first received the control food. In Phase II, the study foods were reversed, with subjects taking 2 tablets once a day with water or lukewarm water along with a meal.

[0050] 4. Evaluation Items To investigate the effects of gallic acid intake on the intestines, the frequency of bowel movements, the number of days with bowel movements, and the amount of stool were evaluated.

[0051] During the study period, participants were asked to record the number of bowel movements and the amount of stool each time in a daily log. The number of days with bowel movements was calculated as the number of days per week in which a bowel movement occurred. Participants were asked to quantify the amount of stool by eye, using the size of one medium-sized chicken egg as a guideline. If the amount of stool was smaller than one chicken egg, participants were asked to record the amount to one decimal place.

[0052] From two weeks before Phase I until the day before the final examination in Phase II, research participants were given a food diary and a research participant diary, and were instructed to fill in the following survey items daily. Survey items: (i) Intake status of research foods (during intake period only) (ii) Presence or absence of menstruation (women only) (iii) Presence or absence of changes in physical condition (iv) Presence or absence of changes in lifestyle or environment (v) Use of pharmaceuticals (pharmaceuticals, newly designated quasi-drugs, newly defined quasi-drugs) (vi) Dietary content (including supplements, health foods, nutritional drinks, and alcohol)

[0053] (result) 1 Subject This study enrolled 46 participants (10 males and 36 females). There were no dropouts after randomization, and the study began with 46 participants. The intervention was then implemented with 23 participants assigned to each group. There were no dropouts during the study period, and 46 participants completed the study. After the study ended, one participant was found to meet the rejection criteria, so the number of participants was 45 (10 males and 35 females). The reason for rejection was that the principal investigator judged the participant to be unsuitable (1 participant in the control food intake group).

[0054] No significant differences were observed in age, height, or weight between the group that consumed the test food first and the group that consumed the control food first after randomization.

[0055] After ingesting Example 2, which contains gallic acid, an increase in the frequency of bowel movements, the number of days with bowel movements, and the amount of stool was observed 4 weeks after the start of ingestion, compared to when Control Example 2, which does not contain gallic acid, was ingested.

[0056] [Table 4]

[0057] Furthermore, the only adverse events that occurred during the study period were one case of COVID-19 infection and one case of norovirus infection, both of which occurred during the period of consumption of the control food. The principal investigator ruled out any causal relationship between either adverse event or the study food.

[0058] [Test Example 3] Confirmation of the effect on improving bowel movements in humans 2 [Examples 3-1 to 3-13] The raw materials were mixed according to the proportions shown in Table 7, and tablets (for swallowing) with a diameter of 8 mm and a weight of 250 mg per tablet were manufactured using a single-shot tablet press. The compression pressure was set to 3 kN. The resulting tablets showed an effect of improving bowel movements when taken at a dose of two tablets per day.

[0059] [Table 5]

Claims

[Claim 1] A food or beverage for improving bowel movements, characterized by containing gallic acid as an active ingredient.

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