Oral composition for improving mild discomfort

Abstract

To provide an oral composition that effectively alleviates mild discomfort symptoms when ingested.SOLUTION: Provided is an oral composition for improving mild discomfort symptoms, comprising piperine as an active ingredient.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an oral composition having an effect of improving mild symptoms of ailments. [Background technology]

[0002] In recent years, sleep debt, excessive stress, and other minor mental and physical disorders that individuals subjectively experience (hereinafter referred to as "minor disorders") have been viewed as problems that lead to reduced labor productivity during work (presenteeism) and economic losses. On the other hand, it has become clear that workers who are free of mental and physical disorders and have a high level of happiness are highly productive and creative. In order to increase individual productivity and reduce economic losses, it has become an urgent task to improve mental and physical disorders and create a vibrant, healthy, and long-lived society.

[0003] Recently, a method for calculating a mild illness score (Patent Document 1) has been developed to enable easy evaluation of mild illness states, and efforts are being made to link the mild illness score to actions (such as exercise or intake of health foods) that are suitable for improving mild illnesses by individual use.

[0004] Long pepper is a plant of the Piperaceae family found in Southeast Asia. Extracts of Long pepper contain piperine, which is known to have various effects. For example, Patent Document 2 shows that piperine suppresses angiotensin-induced blood pressure rise. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2022-157474 A [Patent Document 2] Patent No. 6862688 Summary of the Invention [Problem to be solved by the invention]

[0006] An objective of the present invention is to provide an oral composition that, when ingested, has the effect of improving mild symptoms of illness. [Means for solving the problem]

[0007] The present inventors conducted extensive research into materials that have the effect of improving mild disorders, and as a result, discovered that piperine has the effect of improving mild disorders, thereby completing the present invention.

[0008] That is, the present invention relates to the following (1) to (8). (1) An oral composition for improving mild symptoms, comprising piperine as an active ingredient. (2) The oral composition according to (1), wherein the mild discomfort symptom is impaired sleep quality. (3) The oral composition according to (1), wherein the mild discomfort symptom is stress. (4) The oral composition according to (1), wherein the mild symptom is eye fatigue. (5) The oral composition according to (1), wherein the mild discomfort symptom is constipation. (6) The oral composition according to (1), wherein the mild discomfort symptom is stiffness in the shoulders and / or lower back. (7) The oral composition according to (1), wherein the daily intake amount of piperine is 30 to 270 μg. (8) The oral composition according to (1), wherein piperine is derived from a plant of the family Piperaceae. (9) The oral composition according to any one of (1) to (8), which is a food or drink composition. Effect of the Invention

[0009] By ingesting the composition of the present invention, it is possible to improve mild symptoms of discomfort such as poor quality of sleep, stress, stiff shoulders and lower back, constipation, and eye fatigue. [Brief description of the drawings]

[0010] [Figure 1]This figure shows the VAS questionnaire scores regarding eye fatigue and stiffness in the shoulders and lower back when taking the test food containing piperine. The higher the score, the better the health condition. (++: There is a significant difference from the start (0W) (p < 0.05), Paired t-test) [Diagram 2] This graph shows the change in time from the start (0W) until falling asleep when taking the test food containing piperine and the placebo. The lower the score, the faster the person fell asleep. (**: Significant difference compared to placebo (p < 0.05), *: Significant trend compared to placebo (p < 0.1), Welch's t-test) [Diagram 3] This graph shows the change in frequency of feeling angry from the start (0W) when taking the test food containing piperine and the placebo. The higher the score, the more frequently the person feels angry. (**: Significant difference compared to placebo (p < 0.05), *: Significant trend compared to placebo (p < 0.1), Welch's t-test) [Figure 4] This graph shows the change in frequency of irritability from the start (0W) when taking the test food containing piperine and the placebo product. The higher the score, the more frequently the irritability increases. (**: Significant difference compared to placebo (p < 0.05), *: Significant trend compared to placebo (p < 0.1), Welch's t-test) [Diagram 5] This graph shows the change in bowel movement frequency from the start (0W) when taking the test food containing piperine and the placebo product. The higher the score, the better the bowel movement. (*: Significant trend against placebo (p < 0.1), Welch's t-test) DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] In the present invention, piperine is used as an active ingredient.

[0012] Piperine is a compound represented by the following structural formula.

[0013] [ka]

[0014] Piperine may be a plant raw material or one extracted or purified from a plant raw material, or may be artificially synthesized, but from the viewpoint of safety, it is preferable to use a plant raw material or one extracted or purified from a plant raw material. Since piperine is contained in large amounts in plants of the Piperaceae family, a plant of the Piperaceae family can be used as the plant raw material, but pepper or long pepper is preferable, and long pepper is particularly preferable. As the active ingredient used in the present invention, an extract of a plant of the Piperaceae family, such as pepper or long pepper, containing piperine can also be used.

[0015] As the above-mentioned long pepper extract, for example, a powder obtained by extracting the long pepper head with a solvent, concentrating as necessary, and adding an excipient such as dextrin and drying can be used. As the solvent, organic solvents such as water, lower alcohols such as methanol and ethanol, polyhydric alcohols such as propylene glycol and 1,3-butylene glycol, and ketones such as acetone can be used alone or in combination of two or more kinds, and among these, water and lower alcohols are preferable in terms of the effect of improving mild disorders. The amount of the extraction solvent is not particularly limited, but is usually about 5 to 15 times the mass ratio of the long pepper head as the extraction raw material. The extraction temperature is not particularly limited, but the extraction process may be performed at room temperature or at a temperature below the boiling point of the solvent for about 30 minutes to 4 hours. A paste-like concentrate is obtained by distilling off the solvent from the obtained extract, and dextrin is added to this concentrate as necessary, and further dried to obtain a long pepper extract. The above-mentioned extract can be used as it is, or in a general form such as a dried extract, a liquid extract, or a tincture. In addition, commercially available long pepper extracts can also be used, such as long pepper extract powder (manufactured by Maruzen Pharmaceuticals), long pepper extract (manufactured by Sabinsa Japan Corporation), etc. The content of piperine in the long pepper extract is not particularly limited, but is preferably 0.06 to 10% by mass, and more preferably 0.06 to 1% by mass, in the long pepper extract.

[0016] The dosage form of the oral composition of the present invention is not particularly limited, and it can be taken in the form of tablets, capsules, fine granules, microgranules, liquids, chewable tablets, troches, etc., but preferred are tea-flavored liquids and preparations containing tea, tea extracts, rice, etc. (liquids are added at the time of ingestion) which are dosage forms that are easy to take continuously every day. When the composition of the present invention is used as a pharmaceutical composition, it is preferred to provide it as an oral preparation such as a solid or liquid for oral administration. When the composition of the present invention is used as a food or beverage composition, the food or beverage composition can be, for example, a health food, a functional food, a food for specified health uses, a nutritional supplement, a food for the sick, or a food additive. Specific examples of food and drink compositions include liquid foods such as drinks, soups, milk drinks, soft drinks, tea drinks, alcoholic drinks, jelly-like drinks, and functional drinks; oil-containing products such as edible oils, dressings, mayonnaise, and margarine; carbohydrate-containing foods such as rice, noodles, and bread; processed livestock foods such as ham and sausage; processed seafood foods such as kamaboko, dried fish, and salted fish; processed vegetable foods such as pickles; semi-solid foods such as jelly and yogurt; fermented foods such as miso and fermented drinks; various confectioneries such as Western confectioneries, Japanese confectioneries, candies, gums, gummy candies, frozen desserts, and iced desserts; retort products such as curry, thickened sauce, and Chinese soup; instant foods such as instant soup and instant miso soup, and microwaveable foods. Furthermore, health foods and drinks prepared in the form of powder, granules, tablets, capsules, liquids, pastes, or jellies are also included. The production of the food and drink composition of the present invention can be carried out by a production technique known in the art.

[0017] Furthermore, other known additives such as herbal medicines, natural products, excipients, pH adjusters, cooling agents, suspending agents, thickening agents, solubilizing agents, disintegrants, binders, lubricants, antioxidants, coating agents, colorants, flavoring agents, surfactants, plasticizers, and fragrances can be mixed as necessary within qualitative and quantitative ranges that do not impair the effects of the invention.

[0018] The oral composition of the present invention can be administered or ingested by animals, preferably mammals, more preferably humans. When ingested by humans, the amount of piperine ingested per day can be appropriately increased or decreased in consideration of age, sex, body weight, etc., but is preferably 0.1 μg to 30 mg, more preferably 3 μg to 3 mg, even more preferably 30 μg to 270 μg, and particularly preferably 30 μg to 120 μg. The content of piperine can be measured by high performance liquid chromatography (HPLC), but the measurement method is not limited to HPLC. In addition, when using a long pepper extract, the amount of long pepper extract ingested per day can be appropriately increased or decreased in consideration of age, sex, body weight, etc., but is preferably 1 to 750 mg, more preferably 10 to 300 mg, per day in terms of the crude drug.

[0019] Ingestion of the oral composition of the present invention can improve mild disorders such as poor quality of sleep, stress, eye fatigue, constipation, stiff shoulders and / or lower back, and can provide, for example, an effect of improving quality of sleep by shortening the time it takes to fall asleep from an awake state and improving how well one falls asleep, and an effect of reducing stress by suppressing frustration and anger caused by stress. The oral composition of the present invention and its instruction manual may be labeled with the following: improvement of quality of sleep, improvement of how well one falls asleep, shortening the time it takes to fall asleep, stress reduction, suppression of frustration and anger caused by stress, improvement of eye fatigue, reduction of eye fatigue, improvement of constipation, improvement of bowel movements, improvement of stiff shoulders and lower back, and improvement of mild disorders. Here, "labeled" includes being labeled on the main body, container, packaging, etc. of the product containing the oral composition of the present invention, being labeled on documents such as instructions disclosing product information, package inserts, pamphlets, and other printed matter, and being labeled on various flyers and advertisements used for promotion including the Internet. EXAMPLES

[0020] The present invention will be described in more detail below, but the scope of the present invention is not limited thereto. There is none. 1. Test item The long pepper extract used in the test was prepared by extracting dried long pepper with hot water, adding dextrin, and then drying. The prepared long pepper extract (containing 90 μg of piperine), maltodextrin, and calcium stearate were filled into capsules (made of hydroxypropyl methylcellulose) to prepare the test food. On the other hand, only maltodextrin and calcium stearate were filled into capsules (made of hydroxypropyl methylcellulose) to prepare a placebo product. Each test product was packed into an aluminum package so that it could not be distinguished from the outside. The piperine contained in the test products was also measured by HPLC. 2. Subjects The subjects were volunteers registered with Hokkaido Information University, and those who the principal investigator deemed appropriate for participation in the study were selected as subjects. The subjects were Japanese, aged 40 to 65 years, with a BMI of 30 kg / m 2 Based on the inclusion and exclusion criteria, such as being under the age of 18 or older, not receiving treatment or medication for high blood pressure, diabetes, etc., 36 people were selected and divided into a placebo group (group that took a placebo product) and a test food group (group that took the test food), and the study was conducted. 3. Test Method This study was a randomized, double-blind, placebo-controlled, parallel group comparison. The intake period was 8 weeks, and subjects took one capsule of the test product once a day from the start of intake until the visit after 8 weeks. 4. Evaluation Methodology (1) Evaluation using the Visual Analogue Scale (VAS) (Figure 1) "Eye fatigue," "stiff shoulders," and "stiff lower back" were evaluated using a VAS. A 100mm line was prepared for each item, with the left end marked "feel very much" and the right end marked "don't feel at all." Subjects were asked to mark their own state at the time of the questionnaire by drawing an "X" on the line and measuring the length (in mm) from the left end to the "X." (2) Time until falling asleep (Figure 2) In response to the question, "During the past month, how long did it take you to fall asleep after getting into bed?" the time (in minutes) stated was recorded as a score. (3) Frequency of feeling angry (Figure 3) For the state of "feeling angry," participants were asked to choose from three options that best described their state over the past month: "almost never (1 point), sometimes (2 points), often (3 points), almost always (4 points)." This was used as the score. (4) Frequency of feeling irritated (Figure 4) For the state of being "irritated," participants were asked to choose from three options that best described their state over the past month: "almost never (1 point), sometimes (2 points), often (3 points), almost always (4 points)," and the score was calculated based on the answer selected. (5) Frequency of bowel movements (Figure 5) In response to the question, "How often did you have bowel movements in the past month?", participants were scored based on the answer selected from the following options: "Less than twice a week (0 points), 3-4 times a week (1 point), 5-6 times a week (2 points), once a day (3 points), or more than twice a day (4 points)." Evaluations were conducted at the start of intake (0W), after 4 weeks of intake (4W), and after 8 weeks of intake (8W). Only the VAS evaluation was conducted after 2 weeks of intake (2W). The average score for each evaluation was calculated for each group (18 subjects). For item (1) above, the effects of piperine were verified by comparing the scores at each evaluation point relative to the start of intake (0W) for the test food group within the group, and for items (2) to (4) above, the effects of piperine were verified by comparing the change in score from the start of intake (0W) to each evaluation point between the groups. 5. Test Results The scores or changes in scores for each of the above evaluations (1) to (5) are shown over time in Figures 1 to 5. Improvements were observed in shoulder and lower back stiffness and eye fatigue from the start of intake (0 weeks) in the test food group (Figure 1). Compared to the placebo group, improvements were observed in the time it takes to fall asleep, frequency of feeling irritated, frequency of feeling angry, and frequency of bowel movements in the test food group (Figures 2 to 5). These results demonstrate that piperine is effective in improving mild symptoms of ailments.

[0021] On the other hand, no side effects were observed in any group during the study period. [Industrial Applicability]

[0022] The composition of the present invention is an oral composition that is highly safe, can be taken on a daily basis, and can improve mild symptoms of illness. It can be used as a medicine, a quasi-drug, a food for specified health uses, or a food with functional claims, such as a food approved by a regulatory authority for a health purpose or functionality, or as a general food including so-called health foods.

Claims

1. An oral composition for improving mild symptoms, comprising piperine as an active ingredient.

2. The oral composition according to claim 1, wherein the mild disorder symptom is a decrease in quality of sleep.

3. 2. The oral composition according to claim 1, wherein the mild discomfort symptom is stress.

4. 2. The oral composition according to claim 1, wherein the mild discomfort symptom is eye fatigue.

5. 2. The oral composition according to claim 1, wherein the mild discomfort symptom is constipation.

6. 2. The oral composition according to claim 1, wherein the mild discomfort symptom is stiffness in the shoulders and / or lower back.

7. 2. The oral composition according to claim 1, wherein the daily intake of piperine is 30 to 270 μg.

8. 2. The oral composition of claim 1, wherein the piperine is derived from a plant of the family Piperaceae.

9. The oral composition according to any one of claims 1 to 8, which is a food or drink composition.

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