Stress Relief Composition

Abstract

Providing new ways to reduce stress. [Solution] A composition for reducing stress, comprising a diamine and / or a polyamine.

Description

[Technical field]

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

[0002] In daily life, there are many types of stress, including physical stress, psychological stress, physical stress, and social stress, which cause various 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 a healthy lifespan.

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

[0004] On the other hand, diamines are linear fatty acid hydrocarbon compounds having two amines. Polyamines are linear fatty acid hydrocarbon compounds having three or more amines. It is known that diamines and / or polyamines are widely involved in the synthesis of nucleic acids and proteins and the regulation of enzyme activity (Non-Patent Document 1). In addition, Non-Patent Document 2 shows that an antidepressant effect was observed by administering putrescine, a type of polyamine, to mice. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2013-79209 A [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 of administration 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, canavarimine, aminopentylnorspermidine, N,N-bis(aminopropyl)cadaverine, homospermine, caldopentamine, homocaldopentamine, caldohexamine, and homocaldohexamine spermidine; The composition according to any one of items 1 to 3. Section 5. 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 a diamine and / or a polyamine to a subject in need of stress reduction. Effect of the Invention

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

[0010] 1. Stress-reducing compositions "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 level of a stress response. The type of stress response targeted by the composition for stress reduction is not particularly limited, but in one embodiment, it is preferably a mental stress response. The cause of the stress response targeted by the composition for stress reduction is not particularly limited, but in one embodiment, it is preferably a social or mental stimulus (stressor). In one embodiment, it is preferable that the stress response is a stress response measured by a VAS (visual analog scale) questionnaire, the Japanese version of the Self-Perceived Stress Questionnaire (JPSS), and / or the Brief Occupational Stress Questionnaire (BJSQ). In one embodiment, it is preferable that the stress response is a mental stress response caused by self-management ability (e.g., time management ability, work management ability).

[0013] The presence or absence and the degree of stress-reducing action of the stress-reducing composition can be measured by a VAS (visual analog scale) questionnaire, the Japanese version of the Self-Perceived Stress Questionnaire (JPSS), and / or the Brief Occupational Stress Questionnaire (BJSQ). In the 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 scores to calculate a total score, and the stress level is determined based on the result. In the BJSQ, a total score is calculated based on the answers to the questions, and the stress level is determined based on the result.

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

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

[0016] The person who takes the composition for reducing stress is not particularly limited. In one embodiment, the person who takes the composition for reducing stress is preferably a person of a certain age or more, for example, 20 years old or more, 30 years old or more, 40 years old or more, 50 years old or more, 60 years old or more, 70 years old or more, or 80 years old or more. There is no upper age limit, but it can be, for example, 120 years old or less, 110 years old or less, or 100 years old or less.

[0017] In one embodiment, the consumer is preferably a person who is aware of forgetfulness. In one embodiment, the consumer 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 is determined to have brain function decline. In one embodiment, the consumer preferably has an MMSE score of 24 or more.

[0018] The stress-reducing composition preferably contains a diamine and / or a polyamine. A diamine is a straight-chain fatty acid hydrocarbon compound having two amines. A polyamine is a straight-chain fatty acid hydrocarbon compound having three or more amines. Examples of the diamine include putrescine, cadaverine, 1,3-diaminopropane, and the like, and mixtures thereof. Examples of the polyamine include spermidine, spermine, caldine, homospermidine, aminopropylcadaverine, thermine, thermospermine, canavalmine, aminopentylnorspermidine, N,N-bis(aminopropyl)cadaverine, homospermine, caldopentamine, homocaldopentamine, caldohexamine, homocaldohexamine spermidine, and the like, 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, and preferably contains these in a ratio of 1 (putrescine):10-40 (spermidine):3-15 (spermine) in dry weight conversion.

[0019] The diamine and / or polyamine may be included in the composition as a synthesized compound. The diamine and / or polyamine may also be included 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 "diamine and / or polyamine composition") may contain components other than the diamine and / or polyamine, such as saccharides such as 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 diamine and / or polyamine in the form of a plant extract. The diamine and / or polyamine from a plant, or an extract or purified product containing the same, can be obtained by any method. For example, it can be obtained by the method described in Patent Document 1.

[0020] As the plant, various plants can be used, and examples thereof include, but are not limited to, cucurbits, solanaceae, gramineae, cruciferae, legumes, mallows, asteraceae, chenopodiaceae, legumes, and theaceae. The plant may be a plant tissue, a plant extract, a plant extract, or a processed plant. Specifically, the plant may be 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, chenopodiaceae, lily, orchid, carne. Examples of the microorganisms that may be used include chrysanthemum, rose, chrysanthemum, petunia, torenia, snapdragon, cyclamen, gypsophila, geranium, sunflower, turfgrass, cotton, enoki mushroom, honshimeji mushroom, matsutake mushroom, shiitake mushroom, other mushrooms, ginseng, agaricus, turmeric, ginseng, citrus fruits, banana, kiwi, rice, milo, tea, fruit juice, germ extract, germ extract, green tea, black tea, oolong tea, natto, soy milk, and okara. Preferably, a plant of the family Poaceae or a plant of the family Bean is used. Examples of the microorganisms include yeast, lactic acid bacteria, bifidobacteria, natto bacteria, acetic acid bacteria, koji mold, and white mold. 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 the plant body or tissue in the form of a seed or in the process of growth include whole trees, flowers, buds, ovaries, fruits, leaves, cotyledons, stems, shoots, roots, seeds, dry seeds, embryos, germs, and roots. Preferred are fruits, leaves, stems, shoots, seeds, dry seeds, germs, and embryos, and particularly preferred are seeds, dry seeds, germs, and embryos. 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 solution with an acid solution (JP Patent 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, soybean lees 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 a 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, and recovering the liquid fraction by centrifugation or filtration separation, and treating the 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 a pharmaceutical composition for oral administration. When it is a food composition, the form is not particularly limited, and it can be in the form of a health food such as a tablet (including a coated tablet), a capsule, a powder, a granule, or a drink. It can also be in the form of a soft drink, a tea drink, a dairy product such as yogurt or a lactic acid bacteria drink, a seasoning, a processed food, a dessert, a 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, flavorings, odorants, and surfactants.

[0026] When the composition is prepared as an oral solid preparation such as a tablet, powder, granule, pill, or capsule, a carrier 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 liquid, starch liquid, gelatin solution, polyvinyl alcohol, polyvinyl ether, polyvinylpyrrolidone, carboxymethylcellulose, shellac, methylcellulose, ethylcellulose, water, ethanol, or potassium phosphate. Combinations; disintegrants such as dried starch, sodium alginate, powdered agar, powdered laminaran, sodium bicarbonate, calcium carbonate, polyoxyethylene sorbitan fatty acid esters, sodium lauryl sulfate, stearic acid monoglyceride, starch, lactose, etc.; disintegration inhibitors such as sucrose, stearic acid, cocoa butter, hydrogenated oil, etc.; absorption promoters such as sodium lauryl sulfate, etc.; moisturizers such as glycerin, starch, etc.; adsorbents such as starch, lactose, kaolin, bentonite, colloidal silicic acid, etc.; lubricants such as purified talc, stearates, powdered boric acid, polyethylene glycol, etc.

[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 above-mentioned compounding agent or preparation is prepared as a solid oral preparation in the form of a pill, the carrier that can be used in the preparation may include, for example, 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.

[0029] When the compounding agent or preparation is a solid oral 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 compounding agent or preparation is a liquid, it is sufficient that it is liquid, and it may be an aqueous or oily suspension, solution, syrup, elixir, or drink. The liquid is prepared by a conventional method using a conventional additive. The container in 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 may be, for example, 0.1 mg / day to 10 mg / day, preferably 0.3 mg / day to 5 mg / day, 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 portions per day. The composition may 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 every day.

[0033] The amount of intake of the composition can be 0.08 mg / day to 8 mg / day, preferably 0.24 mg / day to 4 mg / day, more preferably 0.4 mg / day to 2.4 mg / day, calculated as the amount of spermidine per adult. The composition is preferably taken in 2 to 3 portions per day. The composition can be taken, for example, every day, every 2 days, every 3 days, every 4 days, every 5 days, every week, every 2 weeks, every 3 weeks, or every 4 weeks. In one embodiment, the composition is preferably taken every day.

[0034] The composition for reducing stress can be applied to either therapeutic (medical) or non-therapeutic (non-medical) uses. Specifically, the composition can be used as a composition that explicitly or implicitly claims to prevent, reduce or ease stress, regardless of whether it is classified as a drug, quasi-drug, cosmetic, food or drink, etc. In addition, the composition for reducing stress can prevent or reduce diseases caused by stress, as well as prevent a decrease in performance caused by stress. Examples of such performance include, but are not limited to, desk work, physical labor, presentations, calculations, etc.

[0035] Diseases caused by stress include, but are not limited to, respiratory diseases such as bronchial asthma and hyperarousal syndrome; circulatory 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 chronic rheumatoid arthritis and lower back pain; urinary and reproductive diseases such as bedwetting and psychogenic impotence; ophthalmological diseases such as eyestrain and essential blepharospasm; otorhinolaryngological 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, the disease caused by stress is not particularly limited, but is preferably anxiety and insomnia.

[0036] The composition for reducing stress may be labeled with a function exhibited by reducing stress. Such a label may be called a functional label, and the labeling content is not particularly limited, but may include, for example, "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 "reduces headaches," or functional labels that can be regarded as equivalent to these. In the present invention, the labeling may be attached to the composition itself, or to the container or packaging of the composition.

[0037] 2. Evaluation of the effect 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 a diamine and / or a polyamine (hereinafter referred to as the "determination method").

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

[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 study In this study, subjects who met all of the following conditions were selected, and the stress-reducing effect of taking polyamine-containing capsules (hereinafter referred to as "the test food") for 12 consecutive weeks was evaluated. -Those who have been fully informed of the purpose and contents of this study, are able to consent, fully understand the study, and have volunteered of their own volition and agreed to participate in the study in writing Healthy Japanese subjects aged 40 years or older at the time of obtaining informed 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 each of the following study groups, 30 subjects each. Group I: Subjects took 9 tablets of test food A per day for 12 weeks, 3 tablets each after breakfast, lunch, and dinner. Group II: Subjects took nine tablets of test food B daily for 12 weeks, three tablets each after breakfast, lunch, and dinner. (2) Overview of the foods used in this study 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 mixed with excipients and placed in a dark-colored capsule so that the contents of the capsule were completely invisible from the outside. b. Ingredients / raw material display Polyamine-containing capsule: 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 further contains asparagine, maleic acid, glycolic acid, gluconic acid, and succinic acid, 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: Stress VAS questionnaire Japanese Self-Perception Stress Questionnaire (JPSS) · Short Job Stress Questionnaire (BJSQ) Urinary polyamines Blood polyamines Subjective findings (daily diary) Objective findings (questionnaire) (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 allocation manager assigned 30 participants to groups I and II, 30 in each group, based on the MMSE scores and median ages 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 consenter, 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 pre-intake test), weight, BMI Urine test: Urinary polyamine content Blood test: Blood polyamine levels Daily diary (including daily test food intake and physical condition during the study period) b. Schedule The above tests were performed according to the following schedule.

[0042] [Table 1]

[0043] Subjects were advised to pay attention to the following points during the study: - Do not make any major changes to your current diet, exercise, or other lifestyle habits. During the study period, subjects were not allowed to take polyamine-containing supplements or natto (1 pack per day) other than the study food. 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, drinking a lot of alcohol, 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 test to a third party. In particular, do not provide any 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 drug treatment, or those with a history of serious illness 2) Those 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 consume one or more packs of natto every day 6) Those 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 who plan to participate in other studies after consenting to this study 8) Those who are judged ineligible by the study director 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 As a general rule, the Shapiro-Wilk test was used to examine the normality of the obtained evaluation results in the case of continuous data, and paired t-test was used if normality was indicated, and Wilcoxon signed-rank test was used if it was not. For unpaired data, variance was tested using F-test if normality was indicated, followed by Student's t-test (with homogeneity of variance) or Aspin-Welch's t-test (without homogeneity of variance), and if normality was not indicated, Mann-Whitney U-test was used. For ordinal data with many stages, Wilcoxon signed-rank test was used for paired data, and Mann-Whitney U-test was used for unpaired data. For ordinal data and nominal data with few stages, McNemar test was used for paired data, and Fisher's exact test or χ2 test was used for unpaired data depending on the number of data. 2 Tests were performed. When multiple comparisons were necessary, the Bonferroni method, Tukey method, Dunnett method, etc. were used depending on the format of the data. 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 judged to be "statistically significant," and between 5% and 10% was judged to be "tendency." Statistical analysis was mainly 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 1 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. Validity evaluation: Japanese version of the Self-Perceived Stress Questionnaire (JPSS) The analysis results of the Japanese Self-Perceived Stress Questionnaire (JPSS) are shown in Table 4. The total score was significantly lower in the polyamine intake group compared to the placebo intake group, indicating a significant reduction in stress. In terms of individual survey items, the numerical response to the question, "To what extent have you been able to control how you spend your time during the past month?" was particularly significantly lower in Group I compared to Group II. In addition, the numerical response to the questions, "To what extent have you felt that you were unable to control important things in your life during the past month?" and "To what extent have you felt that you were able to adapt well to major changes that occurred in your life during the past month?" was also significantly lower in Group I compared to Group II.

[0051] [Table 4]

[0052] The analysis results of the Brief Job Stress Questionnaire (BJSQ) are shown in Table 5. Of the individual question items, three items, "Feeling irritated," "Restrained," and "Feeling sad," were found to have significantly lower values ​​after polyamine intake.

[0053] [Table 5]

[0054] 3-3. Safety evaluation The analysis results of the safety evaluation are shown in Table 6. A significant reduction 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 mental stress, comprising an extract of wheat germ or soybean germ containing spermidine, spermine, and putrescine, the composition being ingested in an amount of 0.4 mg / day to 1.1 mg / day calculated as the amount of spermidine.

2. The composition described in claim 1, comprising an extract of wheat germ containing spermidine, spermine, and putrescine.

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

4. The composition according to claim 1 or 2, which is a food composition or a pharmaceutical composition.

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