Stress-relief composition

Abstract

To provide new means for relieving stress.SOLUTION: A stress-relief composition containing a diamine and / or a polyamine.SELECTED DRAWING: None

Description

[Technical Field]

[0001] Disclosed herein is a technique for reducing stress by utilizing diamines and / or polyamines. [Background technology]

[0002] In everyday life, we are exposed to a wide range of stress, including physical and psychological stress, as well as social stress, which can cause a variety of symptoms. In today's world, where medical advances are leading to an increase in average life expectancy, prevention and countermeasures against stress are considered important for extending healthy life expectancy.

[0003] In particular, psychological stress that occurs during work has become a problem in recent years, and in order to help workers relieve and reduce stress, the implementation of stress checks was made mandatory for businesses with 50 or more employees under the revised Industrial Safety and Health Act in December 2015. In addition to this initiative, stress reduction and prevention measures have also become increasingly important in recent years.

[0004] On the other hand, diamines are straight-chain fatty acid hydrocarbon compounds having two amines. Polyamines are straight-chain fatty acid hydrocarbon compounds having three or more amines. Diamines and / or polyamines are known to be widely involved in the synthesis of nucleic acids and proteins and the regulation of enzyme activity (Non-Patent Document 1). Furthermore, Non-Patent Document 2 shows that administration of putrescine, a type of polyamine, to mice showed an antidepressant effect. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2013-79209 [Non-patent literature]

[0006] [Non-Patent Document 1] Shunsuke Sakai et al., Journal of Urology (1986), 32(3): 343-350 [Non-patent document 2] Zomkowski AD et al, Prog Neuropsychopharmacol Biol Psychiatry. 2006 Dec 30;30(8):1419-25 Summary of the Invention [Problem to be solved by the invention]

[0007] One challenge is to provide new means to reduce stress. [Means for solving the problem]

[0008] The following representative inventions are provided: Section 1. A composition for reducing stress, comprising a diamine and / or a polyamine. Section 2. The composition according to claim 1, wherein the stress is mental stress. Section 3. Item 3. The composition according to Item 1 or 2, wherein the subject is 40 years of age or older. Section 4. the diamine is at least one selected from the group consisting of putrescine, cadaverine, and 1,3-diaminopropane; The polyamine is at least one selected from the group consisting of spermidine, spermine, caldine, homospermidine, aminopropylcadaverine, thermine, thermospermine, canavalmine, aminopentylnorspermidine, N,N-bis(aminopropyl)cadaverine, homospermine, caldopentamine, homocaldopentamine, caldohexamine, and homocaldohexamine spermidine; Item 4. The composition according to any one of items 1 to 3. Section 5. Item 5. The composition according to any one of Items 1 to 4, which is a food composition or a pharmaceutical composition. Section 6. Use of diamines and / or polyamines to reduce stress. Section 7. A method for reducing stress, comprising administering diamines and / or polyamines to a subject in need of stress reduction. [Effects of the Invention]

[0009] It is possible to reduce stress responses. DETAILED DESCRIPTION OF THE INVENTION

[0010] 1. Stress-reducing composition "Stress" generally refers to a state in which a mental or physical reaction (stress response) occurs due to a stimulus (also called a stressor). Such stimuli include physical stimuli such as cold, noise, radiation, and weather changes; chemical stimuli such as drugs, metals, and oxygen deficiency; biological stimuli such as bacterial infection and inflammation; physical stimuli caused by illness or disability such as pain and fever; and social and mental stimuli such as tension, anxiety, and fear arising from human relationships in society and at home.

[0011] Stress reactions include mental stress reactions (e.g., irritability, anxiety, decreased concentration, agitation, anger, decreased satisfaction, etc.) and physical stress reactions (e.g., joint pain, headache, stiff shoulders, back pain, eye fatigue, palpitations, shortness of breath, stomach pain, loss of appetite, constipation, diarrhea, insomnia, sweating, etc.).

[0012] Stress reduction means reducing or alleviating the severity of a stress response. The type of stress response targeted by the stress-reducing composition is not particularly limited, but in one embodiment, a psychological stress response is preferred. The cause of the stress response targeted by the stress-reducing composition is not particularly limited, but in one embodiment, social and psychological stimuli (stressors) are preferred. In one embodiment, the stress response is preferably a stress response measured by a VAS (visual analog scale) questionnaire, the Japanese Self-Perceived Stress Questionnaire (JPSS), and / or the Brief Occupational Stress Questionnaire (BJSQ). In one embodiment, the stress response is preferably a psychological stress response caused by self-management ability (e.g., time management ability, work management ability).

[0013] The presence or absence and degree of stress-reducing effects of a stress-reducing composition can be measured using a VAS (visual analog scale) questionnaire, the Japanese Self-Perceived Stress Questionnaire (JPSS), and / or the Brief Occupational Stress Questionnaire (BJSQ). In a VAS questionnaire, questions about stress are assessed using the VAS method. In the JPSS, responses to questions are obtained on a 5-point scale, which are converted into a score to calculate a total score, and stress levels are determined based on the result. In the BJSQ, a total score is calculated based on the answers to questions, and stress levels are determined based on the result.

[0014] The BJSQ's questions are divided into three groups: "physical and mental stress reactions," "work-related stress factors," and "support from those around you." The evaluation criteria are set so that "those with a high total score for the "physical and mental stress reactions" items" and "those with a total score above a certain level for the "physical and mental stress reactions" items and significantly high total scores for the "work-related stress factors" and "support from those around you" items are considered to be highly stressed."

[0015] In one embodiment, the stress response alleviated by the stress-reducing composition includes irritability, fatigue, anxiety, and / or somatic complaints, etc. These scales can be assessed using questions in the "physical and mental stress response" group of the BJSQ.

[0016] There are no particular limitations on the person who takes the composition for stress reduction. In one embodiment, the person who takes the composition for stress reduction is preferably a person of a certain age or older, for example, 20 years or older, 30 years or older, 40 years or older, 50 years or older, 60 years or older, 70 years or older, or 80 years or older. There is no upper age limit, but the age can be, for example, 120 years or younger, 110 years or younger, or 100 years or younger.

[0017] In one embodiment, the user is preferably a person who is aware of memory loss. In one embodiment, the user may include a person who is not suspected of brain function decline, a person who is suspected of brain function decline, and / or a person who has been determined to have brain function decline. In one embodiment, the user preferably has an MMSE score of 24 or more.

[0018] The stress-reducing composition preferably contains a diamine and / or a polyamine. Diamines are linear fatty acid hydrocarbon compounds having two amines. Polyamines are linear fatty acid hydrocarbon compounds having three or more amines. Examples of diamines include putrescine, cadaverine, 1,3-diaminopropane, and mixtures thereof. Examples of polyamines include spermidine, spermine, caldine, homospermidine, aminopropylcadaverine, thermine, thermospermine, canavalmine, aminopentylnorspermidine, N,N-bis(aminopropyl)cadaverine, homospermine, caldopentamine, homocaldopentamine, caldohexamine, homocaldohexamine spermidine, and mixtures thereof. In one embodiment, the stress-reducing composition preferably contains putrescine, spermidine, and / or spermine, and particularly preferably contains spermidine. In one embodiment, the composition for reducing stress contains putrescine, spermidine, and spermine, preferably in a dry weight ratio of 1 (putrescine): 10-40 (spermidine): 3-15 (spermine).

[0019] The diamines and / or polyamines may be contained in the composition as synthesized compounds. Alternatively, the diamines and / or polyamines may be contained in the composition as an extract, crude product, or purified product from an extract derived from a plant or microorganism containing these compounds. The extract, crude product, or purified product from an extract derived from a plant or microorganism (hereinafter also referred to as a "diamine and / or polyamine composition") may contain components other than the diamines and / or polyamines, such as saccharides (e.g., monosaccharides, oligosaccharides, and polysaccharides), peptides, and proteins. The diamine and / or polyamine composition may be in the form of either an aqueous solution or a powder. In one embodiment, the stress-reducing composition preferably contains the diamines and / or polyamines in the form of a plant extract. Diamines and / or polyamines from plants, or extracts or purified products containing them, can be obtained by any method, such as the method described in Patent Document 1.

[0020] Various plants can be used, and are not particularly limited, including Cucurbitaceae, Solanaceae, Gramineae, Cruciferae, Leguminosae, Malvaceae, Asteraceae, Chenopodiaceae, Leguminosae, and Theaceae. Plants may be plant tissues, plant extracts, processed plant products, etc. Specific examples include sweet potato, tomato, cucumber, pumpkin, melon, watermelon, tobacco, Arabidopsis, bell pepper, eggplant, bean, taro, spinach, carrot, strawberry, potato, rice, corn, alfalfa, wheat, barley, soybean, rapeseed, sorghum, eucalyptus, poplar, kenaf, eucommia, sugarcane, sugar beet, cassava, sago palm, chenopodium, lily, orchid, and carne. Examples of suitable microorganisms include chrysanthemums, roses, chrysanthemums, petunias, torenia, snapdragons, cyclamen, baby's breath, geraniums, sunflowers, lawn grass, cotton, enoki mushrooms, shimeji mushrooms, matsutake mushrooms, shiitake mushrooms, other mushrooms, ginseng, agaricus, turmeric, ginseng, citrus fruits, bananas, kiwi, rice, milo, tea, fruit juices, germ extracts, germ extracts, green tea, black tea, oolong tea, natto, soy milk, and okara. Gramineae or legumes are preferred. Microorganisms include yeast, lactic acid bacteria, bifidobacteria, natto bacteria, acetic acid bacteria, koji mold, and mildew. In one embodiment, the "diamine and / or polyamine composition" is preferably derived from rice, wheat, soybean, or yeast.

[0021] The plant body or plant tissue used for producing the diamine and / or polyamine composition is not particularly limited, but is preferably a plant body or tissue in the form of a seed or in the process of growth. Examples of plant body or tissue in the form of a seed or in the process of growth include the whole plant, flower, bud, ovary, fruit, leaf, cotyledon, stem, bud, root, seed, dried seed, embryo, germ, and root. Fruit, leaf, stem, bud, seed, dried seed, germ, and germ are preferred, and seeds, dried seed, germ, and germ are particularly preferred. Microorganisms can also be used for producing the diamine and / or polyamine composition. In particular, yeast contains high concentrations of polyamines, and polyamine-containing fractions can be separated and purified by extracting yeast cells or culture broth with an acid solution (Japanese Patent Laid-Open Publication No. 10-52291). The polyamine contents of yeasts reported in JP-A-10-52291 are about 13 mg per 100 g of dried cells for Saccharomyces cerevisiae, about 23 mg for Saccharomyces diastaticas, and about 103 mg for Candida ulitis.

[0022] In one embodiment, rice seeds, rice germs, wheat seeds, wheat germs, wheat embryos, soybean seeds, soybean germs, soybean embryos, soy milk and okara as processed plant products, or combinations thereof can be suitably used, and more preferably wheat seeds, wheat germs, wheat embryos, soybean seeds, soybean germs, or soybean embryos can be used.

[0023] The diamine and / or polyamine composition is provided in the form of an aqueous solution or powder. The powder of the diamine and / or polyamine composition can be obtained by treating a plant and / or a processed plant product with water under acidic conditions, recovering the liquid fraction by centrifugation or filtration, and then treating the recovered liquid fraction by spray drying or vacuum freeze drying.

[0024] The composition may be prepared by combining a carrier or an additive in addition to the diamine and / or polyamine. The composition is preferably a food composition or an orally administered pharmaceutical composition. When the composition is a food composition, its form is not particularly limited, and it may be in the form of a health food such as a tablet (including a coated tablet), capsule, powder, granule, or drink. It may also be in the form of a soft drink, tea drink, dairy product such as yogurt or lactic acid bacteria drink, seasoning, processed food, dessert, confectionery (for example, gum, candy, jelly), etc.

[0025] Examples of carriers and additives used in preparing the composition include various types of carriers and additives commonly used in conventional pharmaceuticals, depending on the dosage form of the composition, such as excipients, binders, disintegrants, lubricants, colorants, flavoring agents, odorants, surfactants, etc.

[0026] When the composition is prepared as an oral solid preparation such as a tablet, powder, granule, pill, or capsule, carriers may be used, for example, excipients such as lactose, sucrose, sodium chloride, glucose, urea, starch, calcium carbonate, kaolin, crystalline cellulose, silicic acid, methylcellulose, glycerin, sodium alginate, or gum arabic; or binders such as simple syrup, glucose solution, starch solution, gelatin solution, polyvinyl alcohol, polyvinyl ether, polyvinylpyrrolidone, carboxymethylcellulose, shellac, methylcellulose, ethylcellulose, water, ethanol, or potassium phosphate. Disintegrants such as mixtures, dry starch, sodium alginate, agar powder, laminaran powder, sodium bicarbonate, calcium carbonate, polyoxyethylene sorbitan fatty acid esters, sodium lauryl sulfate, stearic acid monoglyceride, starch, and lactose; disintegration inhibitors such as sucrose, stearic acid, cocoa butter, and hydrogenated oil; absorption promoters such as sodium lauryl sulfate; humectants such as glycerin and starch; adsorbents such as starch, lactose, kaolin, bentonite, and colloidal silicic acid; and lubricants such as purified talc, stearates, boric acid powder, and polyethylene glycol.

[0027] Here, tablets include oral tablets (plain tablets, sugar-coated tablets, gelatin-coated tablets, enteric-coated tablets, film-coated tablets, double-layered tablets, multi-layered tablets, etc.), chewable tablets (including those that are taken by chewing in the oral cavity), lozenges (including those that are taken after dissolving in the oral cavity, such as lozenges), sublingual tablets, and buccal tablets.

[0028] When the compounding agent or preparation is a solid oral preparation in the form of a pill, excipients such as glucose, lactose, starch, cacao butter, hardened vegetable oil, kaolin, talc, etc.; binders such as powdered gum arabic, powdered tragacanth, gelatin, etc.; disintegrants such as laminaran, agar, etc. can be used as carriers in the preparation.

[0029] When the compounding agent or formulation is an oral solid preparation in the form of a capsule, the capsule is prepared by mixing the active ingredient with the various carriers exemplified above and filling the mixture into a hard capsule, a soft capsule, or the like.

[0030] When the compounded agent or preparation is a liquid, it need only be in a liquid form, and may be an aqueous or oily suspension, solution, syrup, elixir, or drink. The liquid is prepared using conventional additives in a conventional manner. The container into which the liquid is filled is not limited as long as it can be sealed, and may be a glass container, an aluminum container, or a plastic container.

[0031] The content of diamine and / or polyamine contained in the stress-reducing composition is not limited, but may be, for example, 0.01% by mass to 10% by mass, preferably 0.05% by mass to 7% by mass, and more preferably 0.05% by mass to 4% by mass, calculated on a dry weight basis.

[0032] The amount of intake of the composition is not particularly limited, but can be, for example, 0.1 mg / day to 10 mg / day, preferably 0.3 mg / day to 5 mg / day, and more preferably 0.5 mg / day to 3 mg / day, calculated as the amount of diamine and / or polyamine per adult. In one embodiment, the composition is preferably taken in two or three divided doses per day. The composition can be taken, for example, every day, every two days, every three days, every four days, every five days, every week, every two weeks, every three weeks, or every four weeks. In one embodiment, the composition is preferably taken daily.

[0033] The intake amount of the composition can be 0.08 mg / day to 8 mg / day, preferably 0.24 mg / day to 4 mg / day, and more preferably 0.4 mg / day to 2.4 mg / day, calculated as the amount of spermidine per adult. The composition is preferably taken two to three times a day. The composition can be taken, for example, every day, every two days, every three days, every four days, every five days, every week, every two weeks, every three weeks, or every four weeks. In one embodiment, the composition is preferably taken daily.

[0034] Stress-reducing compositions can be used for both therapeutic (medical) and non-therapeutic (non-medical) purposes. Specific examples include compositions that explicitly or implicitly claim to prevent, reduce, or alleviate stress, regardless of whether they are classified as pharmaceuticals, quasi-drugs, cosmetics, foods, beverages, or the like. Furthermore, stress-reducing compositions can not only prevent or reduce stress-induced illnesses, but also prevent stress-induced declines in performance. Examples of such performance include, but are not limited to, desk work, physical labor, presentations, and calculations.

[0035] Diseases caused by stress include, but are not limited to, respiratory diseases such as bronchial asthma and hyperarousal syndrome; cardiovascular diseases such as essential hypertension and coronary artery disease (angina pectoris, myocardial infarction); digestive diseases such as gastric and duodenal ulcers, irritable bowel syndrome, ulcerative colitis, and psychogenic vomiting; endocrine and metabolic diseases such as simple obesity and diabetes; neurological and muscular diseases such as muscle contraction headache, spasmodic torticollis, and writer's cramp; dermatological diseases such as chronic urticaria, atopic dermatitis, and alopecia areata; orthopedic diseases such as rheumatoid arthritis and lower back pain; urinary and reproductive diseases such as bedwetting and psychogenic impotence; ophthalmological diseases such as eye strain and essential blepharospasm; otolaryngological diseases such as Meniere's disease; and dental and oral surgery diseases such as temporomandibular joint disorder. Other examples include anxiety, insomnia, mental fatigue, autonomic imbalance, menopausal disorder, nervous vomiting, etc. In the present invention, although not particularly limited, anxiety and insomnia are preferred as diseases caused by stress.

[0036] A stress-reducing composition can be labeled with a function that is achieved by reducing stress. Such a label is also called a functional label, and the content of the label is not particularly limited, but examples include "prevents stress," "reduces stress," "alleviates stress," "reduces mental fatigue," "enhances nervous function," "relieves anxiety," "calms the mind," "provides relaxation," "suppresses shortness of breath and palpitations," "relieves insomnia," and "relieves headaches," or functional labels that can be considered equivalent to these. In the present invention, the label may be attached to the composition itself, or to the container or packaging of the composition.

[0037] 2. Evaluation of the effects of taking diamines and / or polyamines An embodiment of the present invention relates to a method for determining the effect of ingestion of a diamine and / or a polyamine in a subject who has ingested the diamine and / or polyamine (hereinafter referred to as the "determination method").

[0038] The assessment method includes obtaining a stress score for a subject at a first time point before or during the ingestion of diamines and / or polyamines, and obtaining a score for the same stress index for the same subject at a second time point after the first time point, during or after the ingestion of diamines and / or polyamines. In the assessment method, if the score at the second time point is less than or equal to the score at the first time point, it suggests that the ingestion of diamines and / or polyamines was effective. Furthermore, if the score at the second time point is equal to or greater than the score at the first time point, it suggests that the ingestion of diamines and / or polyamines was ineffective. However, this is the case when a lower score indicates a lower level of stress response. The stress index score can be obtained by a stress-related questionnaire using the VAS method described in 1 above, the Japanese Subjective Stress Questionnaire (JPSS), or the Brief Occupational Stress Questionnaire (BJSQ). [Example]

[0039] The present invention will be described in more detail below with reference to examples, but the present invention should not be construed as being limited to these examples.

[0040] 1. Subject of consideration In this study, subjects who met all of the following conditions were selected as subjects, and the stress-reducing effect of polyamine-containing capsules (hereinafter referred to as "the test food") was evaluated when they were given the capsules for 12 consecutive weeks. -Those who have received a full explanation of the purpose and content of this study, are able to consent, fully understand the study, and have volunteered voluntarily and agreed to participate in writing. Healthy Japanese people aged 40 years or older at the time of consent ·Those who are aware of forgetfulness MMSE score of 24 or higher at screening

[0041] 2. Test Method (1) Study design a. Randomization: Randomized comparison b. Blinding: double-blind c. Control: Placebo control d. Allocation: Parallel group comparison In this study, 60 subjects were assigned to the following study groups, 30 subjects each. Group I: 9 tablets of test food A were taken daily for 12 weeks, 3 tablets after breakfast, lunch, and dinner. Group II: 9 tablets of test food B were taken daily for 12 weeks, 3 tablets each after breakfast, lunch, and dinner. (2) Overview of the foods used in this study a. Test food Test food A was a 2700 mg polyamine-containing capsule (containing 1.1 mg spermidine). Test food B was a 2700 mg placebo. Each test food was blended with excipients and placed in a dark-colored capsule so that the contents of the capsule could not be seen from the outside. b. Ingredients / raw materials display Polyamine-containing capsules: wheat germ extract 409 mg, starch hydrolysate 372 mg, sodium citrate 149 mg, dextrin 1734 mg, calcium stearate 36 mg (The wheat germ extract was prepared by the method described in Patent Document 1, and contains at least putrescine and spermine in addition to spermidine. The wheat germ extract also contains asparagine, maleic acid, glycolic acid, gluconic acid, succinic acid, etc., but these substances have not been reported to have a stress-reducing effect.) Placebo: sodium citrate 149 mg, dextrin 2515 mg, calcium stearate 36 mg (3) Evaluation items The evaluation items were as follows: VAS questionnaire on stress Japanese Self-Perceived Stress Questionnaire (JPSS) ·Brief Job Stress Questionnaire (BJSQ) Urinary polyamines Blood polyamines Subjective findings (daily diary) Objective findings (interview) (4) Allocation method This study was conducted using a randomized comparative method to ensure that differences in medical background did not occur between the study groups due to allocation. The person in charge of allocation assigned 30 people to each of Group I and Group II based on the MMSE score and median age at screening. (5) Test flow and schedule, and sample and information acquisition method a. Sample (information) and acquisition method On each test day, information was collected using the following methods. Consent of study subjects: Name of consenting person, date of consent Background of test subjects: age (date of birth), gender, etc. Questionnaire at the time of the test (exercise and meals the day before, physical condition and meals on the day, etc.) Physical examination: height (only at the pre-intake test), weight, BMI Urine test: urinary polyamine levels Blood test: blood polyamine levels Daily diary (including daily test food intake and physical condition during the test period) b. Schedule The above tests were carried out according to the following schedule.

[0042] [Table 1]

[0043] During the study, subjects were advised to pay attention to the following points: Do not make any major changes to your current lifestyle habits such as diet or exercise. During the study period, polyamine-containing supplements and natto (1 pack per day) other than the test foods were not allowed. Avoid consuming more than one pack (about 200 mL) of soy milk per day. The day before the test, avoid strenuous exercise and finish eating by 9 p.m. Also, avoid overeating, excessive drinking, smoking, and staying up late. - On the day of the test, avoid excessive exercise until the test is completed. If you have an acute illness such as fever, diarrhea, or vomiting on the day of the test, the test will be cancelled. Do not disclose any information you learn about this exam to any third party. In particular, do not provide information via social media (Facebook, Twitter, Instagram, LINE, etc.).

[0044] (6) Exclusion criteria Subjects who met any of the following criteria were excluded from the study. 1) Those who have a chronic illness and are receiving medication, or those with a history of serious illness 2) People suffering from cancer, familial adenomatous polyposis, or Helicobacter pylori infection 3) People who have allergies to the test food (especially people who have allergies to wheat, as the test food contains wheat germ extract) 4) People who regularly take large amounts of polyamine-containing supplements 5) People who eat one or more packs of natto every day 6) People who consume more than one pack (approximately 200 mL) of soy milk every day 7) Those who have participated in other studies within one month prior to the start of this study, or those who plan to participate in other studies after consenting to this study 8) Those who are judged ineligible by the study physician and study representative. 9) Those who are breastfeeding, pregnant, or planning or hoping to become pregnant during the study period

[0045] (7) Statistical analysis method Regarding the evaluation results obtained, in principle, the Shapiro-Wilk test was used to examine normality for continuous data. For paired data, if normality was demonstrated, a paired t-test was performed; if not, a Wilcoxon signed-rank test was used. For unpaired data, if normality was demonstrated, an F-test was used to test variance, followed by a Student's t-test (with homogeneity of variance) or an Aspin-Welch's t-test (without homogeneity of variance). If normality was not demonstrated, a Mann-Whitney U-test was used. For ordinal data with many levels, a Wilcoxon signed-rank test was used for paired data, and a Mann-Whitney U-test was used for unpaired data. For ordinal data with few levels or nominal data, a McNemar test was used for paired data, and Fisher's exact test or χ test was used for unpaired data depending on the number of data. 2 Tests were performed. When multiple comparisons were necessary, Bonferroni, Tukey, Dunnett, or other methods were used depending on the data format. Analysis of variance, correlation coefficient tests, and subgroup analyses were also performed as necessary. Regarding safety evaluation items, in principle, only intra-group comparisons of values ​​before and after intake and between-group comparisons of values ​​before and after intake were performed, and between-group comparisons of differences before and after intake were not performed. In two-sided tests, a significance level of less than 5% was considered to be "statistically significant," and a level between 5% and less than 10% was considered to be "tendency." Statistical analysis was primarily performed using R, but IBM SPSS Statistics (ver. 25) was also used when necessary.

[0046] 3. Test Results 3-1.Efficacy evaluation: VAS questionnaire Of the 60 study participants, 11 dropped out for personal reasons and one person was found to have deviated from compliance with the study protocol, and the remaining 48 participants were included in the efficacy analysis. Table 2 shows the background of the subjects in the efficacy analysis.

[0047] [Table 2]

[0048] The analysis results of the VAS questionnaire are shown in Table 3. The questionnaire asked, "How much stress have you felt over the past month?" The polyamine intake group had significantly lower scores than the placebo intake group, indicating a significant reduction in stress.

[0049] [Table 3]

[0050] 3-2.Efficacy evaluation: Japanese Self-Perceived Stress Questionnaire (JPSS) The analysis results of the Japanese Self-Perceived Stress Questionnaire (JPSS) are shown in Table 4. The polyamine intake group had a significantly lower total score than the placebo intake group, demonstrating a significant reduction in stress. Regarding individual survey items, the numerical response to the question, "Over the past month, to what extent have you had control over how you spent your time?" was particularly significant in Group I compared to Group II. Furthermore, the numerical responses to the questions, "Over the past month, how often have you felt that you were unable to control important things in your life?" and "Over the past month, how often have you felt that you were adapting well to major changes in your life?" were also significantly lower in Group I compared to Group II.

[0051] [Table 4]

[0052] The analysis results of the Brief Occupational Stress Questionnaire (BJSQ) are shown in Table 5. Of the individual question items, significant reductions in the scores for three items, "feeling irritated," "feeling restless," and "feeling sad," were observed with polyamine intake.

[0053] [Table 5]

[0054] 3-3. Safety evaluation The analysis results of the safety evaluation are shown in Table 6. A significant decrease in weight and BMI was observed in both the polyamine intake group and the placebo intake group, but no significant differences were observed between the groups.

[0055] [Table 6]

Claims

1. A composition for reducing stress, comprising a diamine and / or a polyamine.

2. The composition according to claim 1, wherein the stress is mental stress.

3. 3. The composition according to claim 1 or 2, for reducing stress in people aged 40 or over.

4. the diamine is at least one selected from the group consisting of putrescine, cadaverine, and 1,3-diaminopropane; the polyamine is at least one selected from the group consisting of spermidine, spermine, caldine, homospermidine, aminopropylcadaverine, thermine, thermospermine, canavalmine, aminopentylnorspermidine, N,N-bis(aminopropyl)cadaverine, homospermine, caldopentamine, homocaldopentamine, caldohexamine, and homocaldohexamine spermidine; The composition according to any one of claims 1 to 3.

5. The composition according to any one of claims 1 to 4, which is a food composition or a pharmaceutical composition.

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