Composition for alleviating stress
A composition using young barley leaves addresses the need for naturally derived stress-relieving products by effectively reducing psychological stress and fatigue, validated through animal and human trials.
Patent Information
- Application Number
- JP2024096547
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-06-14
- Publication Date
- 2025-12-25
AI Technical Summary
Existing stress-relieving foods and beverages often rely on synthesized compounds, raising consumer safety concerns, and animal stress tests fail to accurately evaluate psychological stress, making it difficult to develop effective, naturally derived products for alleviating psychological stress.
A composition containing young barley leaves, particularly their dietary fiber, is formulated to alleviate psychological stress through daily intake, leveraging the natural properties of barley leaves to reduce stress and fatigue.
The composition effectively reduces psychological stress and fatigue by incorporating young barley leaves, demonstrated through both animal behavior tests and human clinical trials, showcasing its efficacy in alleviating stress reactions.
Smart Images

Figure 2025187601000001 
Figure 2025187601000002 
Figure 2025187601000003
Abstract
Description
[Technical Field]
[0001] The present invention relates to a composition for relieving stress, which comprises young barley leaves. [Background technology]
[0002] We live in a stressful society, and we are exposed to various stressors every day. There is no shortage of causes of stress (stressors), including stress from social media and other information-based technologies, stress from interpersonal relationships in organizations such as work and school, and stress resulting from anxiety about health and the future. Stressors can be broadly divided into four categories: (1) physical stressors such as heat, cold, and noise; (2) chemical stressors such as nutrient deficiency and oxygen deficiency; (3) physical stressors caused by pain, fever, injury, etc.; and (4) psychological (synonymous with mental) stressors such as anxiety, fear, anger, and tension arising from interpersonal relationships. Of these, psychological stressors are the most common in daily life. If excessive stress is left untreated, it can lead to physical ailments and mental illnesses such as depression, making dealing with psychological stress a key issue in modern society.
[0003] Hobbies, exercise, travel, and other forms of entertainment are ways to prevent or relieve stress, but all of these require a considerable amount of time and expense. Therefore, foods and beverages containing functional ingredients have been developed as a convenient way to relieve stress. Known functional ingredients used in foods and beverages that relieve stress include, for example, 5-aminolevulinic acid phosphate (5-ALA). However, from a safety perspective, some consumers feel uneasy about ingesting unfamiliar compounds. Therefore, there is a demand for the development of foods and beverages that use naturally derived food ingredients as functional ingredients, rather than specific compounds that have been synthesized or concentrated, and that have stress-relieving effects.
[0004] Barley leaves are a naturally occurring food material rich in vitamins, minerals, dietary fiber, and the like, and are known to have various functionalities, such as improving bowel movements and inhibiting the rise in neutral fat levels. However, barley leaves have traditionally been thought to have no stress-relieving effect. For example, Non-Patent Document 2 describes an evaluation of the effect of barley leaf powder on gastric ulcers (an indicator of stress) using a restrained water immersion test in rats, and finds that administration of barley leaf powder alone did not demonstrate any gastric ulcer inhibitory effect. Since animal tests generally serve as indicators for predicting efficacy when used in humans, the results of this test suggest that barley leaves do not exhibit stress-relieving effects in humans.
[0005] While the test in Non-Patent Document 2 involves physical stress on animals, it has been pointed out in recent years that stress tests that involve physical stress on animals do not accurately evaluate "psychological" stress. Specifically, it has been pointed out that tests such as the restraint water immersion test and the forced swimming test impose physical stress on animals, and that the test results reflect this effect, so they cannot be considered tests that accurately evaluate psychological stress alone. For example, Non-Patent Document 3 compares mice subjected to physical stress through a restraint water immersion test with mice subjected to psychological stress alone without any physical stimulation, and shows that the mechanisms of stress-induced ulcer development and the effects of drugs on each ulcer are completely different between the two. This document describes that famotidine, which was effective against physical stress ulcers, was ineffective against psychological stress ulcers, and that sulpiride, which was effective against psychological stress ulcers, was ineffective against physical stress ulcers. Similarly, Non-Patent Document 4 states that animal tests that impose physical stress, such as forced swimming tests, or that induce fear through electric shock stimulation cannot accurately evaluate psychological stress because of the influence of pain stimuli associated with the physical stress or electric shock stimulation. Furthermore, this document states that if psychological stress is to be evaluated using animal tests, the evaluation should be based on stress-related behavior induced only by psychological stress loading. [Prior art documents] [Non-patent literature]
[0006] [Non-Patent Document 1] PR TIMES, "The popular 5-ALA tackles depressed moods! Functional food "ALA Plus Mental Care" to be released on July 6th", URL: https: / / prtimes.jp / main / html / rd / p / 000000069.000008331.html, July 6, 2021, accessed April 23, 2024 [Non-patent document 2] Akira Nishimura et al., "Preventive effect of barley grass powder on stress ulcers," Journal of the Japan Mibyo System Association, Vol. 8, No. 2, pp. 207-209, 2002 [Non-patent document 3] Kazuhiko Nomura, "Pharmacological study on the mechanism of gastric mucosal damage induced by psychological stress," Dissertation Abstract, University of Tokyo, Ph.D. (Veterinary Medicine), April 15, 1996, URL; http: / / gakui.dl.itc.u-tokyo.ac.jp / cgi-bin / gazo.cgi?no=212829, accessed April 23, 2024 [Non-patent document 4] Shigeo Miyata et al., "Elevated Platform Test: A Simple Behavioral Analysis Method Suitable for Evaluating Stress Resistance," Journal of the Japanese Pharmacological Society, Vol. 132, pp. 213-216, 2008, URL: https: / / www.jstage.jst.go.jp / article / fpj / 132 / 4 / 132_4_213 / _pdf, accessed April 23, 2024 Summary of the Invention [Problem to be solved by the invention]
[0007] The present invention has been made in view of the above problems, and an object of the present invention is to provide a composition using young barley leaves and having new functions. [Means for solving the problem]
[0008] In the course of researching the functions of young barley leaves, the inventors discovered that young barley leaves have the effect of alleviating psychological stress and reducing fatigue felt in daily life, etc., and thus completed the present invention.
[0009] That is, the present invention is as follows. [1] A composition for relieving psychological stress, characterized by containing young barley leaves as an active ingredient. [2] A composition for relieving psychological stress according to [1], characterized in that dietary fiber derived from young barley leaves is an active ingredient. [3] A composition for relieving psychological stress according to [1] or [2], characterized in that the daily intake of young barley leaves is 0.25 g or more. [4] The composition for relieving psychological stress according to any one of [1] to [3], characterized in that the daily intake of dietary fiber derived from young barley leaves is 0.125 g or more. [5] The composition for relieving psychological stress according to any one of [1] to [4], wherein the psychological stress is one or more selected from stress caused by office work, stress in daily life, temporary stress, relief of temporary depression, relief of tension, relief of irritation, relief of loss of vitality and energy, relief of confusion, fatigue caused by office work, fatigue felt in daily life, and temporary fatigue. [6] The composition for relieving psychological stress according to any one of [1] to [5], characterized in that it is a functional food or a food for specified health uses. [7] A composition for reducing fatigue, characterized by containing young barley leaves as an active ingredient. [8] A food or drink containing barley young leaf powder, The active ingredient is dietary fiber derived from young barley leaves. Food and beverage products that display one or more of the following functionalities: reduction of psychological stress, reduction of stress caused by office work, reduction of stress in daily life, reduction of temporary stress, reduction of fatigue caused by office work, reduction of fatigue felt in daily life, and reduction of temporary fatigue. [9] The composition for relieving psychological stress according to [7], characterized in that the daily intake of dietary fiber derived from young barley leaves is 0.125 g or more.
[10] A composition for relieving stress according to [1] or [2], characterized in that it is a functional food or a food for specified health uses.
[12] Use of young barley leaves for the manufacture of a composition for relieving psychological stress.
[13] A method for alleviating psychological stress in the body of an individual, comprising the step of orally ingesting young barley leaves by the individual. [Effects of the Invention]
[0010] The composition of the present invention can alleviate psychological stress. DETAILED DESCRIPTION OF THE INVENTION
[0011] The composition of the present invention is characterized by containing young barley leaves. The composition of the present invention reduces mental and physical strain caused by psychological stressors such as tension arising from interpersonal relationships, thereby alleviating psychological stress. Here, the term "alleviating psychological stress" as used herein refers to the concept of alleviating, reducing (synonymous with "alleviating"), or preventing psychological stress.
[0012] 1. Barley grass The present invention is characterized by containing young barley leaves. Barley (Hordeum vulgare L.) is an annual or biennial herb belonging to the Poaceae family, believed to be native to Central Asia, and is broadly classified into two-row barley, six-row barley, etc. depending on the panicle shape. Barley grains (seeds) are often used as grains, but young leaves are used in the present invention. Comparing the two, barley grains are primarily composed of starch (carbohydrates), while young barley leaves are primarily composed of dietary fiber and protein, and have completely different component compositions. The barley variety used for the young barley leaves of the present invention is not particularly limited as long as it is commonly available, and any variety of young barley leaves, such as two-row barley or six-row barley, may be used. Note that young barley leaves refer to barley leaves before the start of heading, and in the present invention, they may include stems along with the young leaves.
[0013] Examples of barley leaf that can be used include pulverized material, squeezed juice, extract, and extraction residue. Examples of pulverized material include dried powder (barley leaf powder), shredded material, and dried products thereof (dried shredded material). The juice and extract may be in liquid form, but squeezed juice powder is preferred. Examples of barley leaf juice powder that can be used include those obtained by concentrating squeezed barley leaf juice at low temperature to concentrate the solid content and then freeze-drying or spray-drying the concentrate. Examples of extracts that can be used include water (warm water or hot water), ethanol, and aqueous ethanol. Examples of extraction residues that can be used include precipitates obtained by suspending barley leaf powder in water, stirring and shaking, and then centrifuging the suspension. The extraction residue is a fraction that is removed during the process of squeezing juice or obtaining an extract, but because it is rich in dietary fiber derived from barley leaves, it can enjoy the effects of the present invention.
[0014] When barley leaf powder (ground barley leaf powder) is used as the barley leaves of the present invention, it has the advantage of being inexpensive to produce. For example, barley leaf juice powder is produced by extracting soluble components such as water-soluble vitamins by juice extraction, removing insoluble components, and then evaporating the water to dry. However, since insoluble dietary fiber, the main component of barley leaves, is removed, the amount of barley leaf juice powder obtained is small relative to the amount of raw barley leaves (fresh leaves). The same is true for barley leaf extract. On the other hand, barley leaf powder (ground barley leaf powder) is produced by drying and grinding barley leaves (fresh leaves) without removing insoluble components. Therefore, when produced using the same amount of raw barley leaves (fresh leaves), it can be produced in larger quantities than barley leaf juice powder, resulting in lower production costs per unit weight. Furthermore, as shown in the examples below, barley leaf powder (ground barley leaf powder) exhibits the effects of the present invention more effectively than barley leaf juice powder. Therefore, the barley leaves used in the present invention are preferably pulverized, as they can be produced inexpensively by not removing insoluble components, and the effects of the present invention can be more effectively achieved by including dietary fiber derived from barley leaves.Of pulverized products, dried powder (barley leaf powder) is particularly preferred.
[0015] When barley leaf powder is used, for example, barley leaves that have been dried so that the moisture content of the barley leaves is 10% by mass or less, preferably 8% by mass or less, can be used.
[0016] The barley leaf powder used in the present invention preferably has a median diameter of 5 μm to 50 μm, more preferably 8 μm to 30 μm. The median diameter refers to the particle size at which the cumulative 50% of the particle size distribution of the powder is reached, and specifically, it is the particle size at which the cumulative 50% (×50) of the particle size distribution is reached, as measured using a laser diffraction / scattering light particle size distribution analyzer, LMS-300 or LMS-350, manufactured by Seishin Enterprise Co., Ltd.
[0017] Furthermore, in order to obtain the effects of the present invention more effectively, the barley leaves used in the present invention preferably contain dietary fiber in an amount of 10% by mass or more, more preferably 20% by mass or more, and even more preferably 30% by mass or more. The upper limit may be, for example, 80% by mass. The dietary fiber referred to here is the total amount of insoluble dietary fiber and soluble dietary fiber. The amount of dietary fiber is measured by the Prosky method.
[0018] Furthermore, in order to obtain the effects of the present invention more effectively, the young barley leaves used in the present invention preferably contain 5% by mass or more of insoluble dietary fiber, more preferably 10% by mass or more, and even more preferably 20% by mass or more. The upper limit may be, for example, 70% by mass. The amount of insoluble dietary fiber is measured by the modified Prosky method.
[0019] In order to ensure that the dietary fiber content and insoluble dietary fiber content fall within the above ranges, the barley leaf powder may be prepared by crushing the barley leaves without performing juicing or extraction in the method for producing the barley leaves.
[0020] 2. Psychological stress In this application, "stress" refers to the strain that occurs in the mind and body when a living organism is exposed to a stimulus that causes stress (also referred to as a stressor). Stressors can be broadly divided into four categories: (1) physical stressors such as heat, cold, and noise; (2) chemical stressors such as nutrient deficiency and oxygen deficiency; (3) physical stressors caused by pain, fever, injury, and the like; and (4) psychological (mental) stressors such as anxiety, fear, anger, and tension arising from interpersonal relationships. In this application, "psychological stress" refers to the strain that occurs in the mind and body when a living organism is exposed to stress caused by category (4), i.e., psychological (mental) stressors such as anxiety, fear, anger, and tension arising from interpersonal relationships.
[0021] Reactions caused by psychological stress can be divided into three categories: psychological, physical, and behavioral. Psychological stress reactions include symptoms such as anger, hostility, confusion, embarrassment, depression (low mood, loss of interest), fatigue, lethargy, tension, anxiety, irritability, and loss of vitality. Physical stress reactions include symptoms such as headache, stiff shoulders, joint pain, and loss of appetite. Behavioral stress reactions include increased mistakes at work, increased alcohol consumption, and increased smoking. The composition of the present invention can alleviate these stress reactions.
[0022] 3. Composition of the Present Invention <Composition for relieving psychological stress>
[0023] The psychological stress-relieving composition of the present invention is not particularly limited as long as it contains young barley leaves and can be distinguished from other products in that it is used to relieve psychological stress. For example, the scope of the present invention includes a product in which the function of relieving psychological stress is indicated on the main body, packaging, instructions, or promotional materials (advertising media) of the product according to the present invention. The psychological stress-relieving composition of the present invention may be one in which young barley leaves or a component derived from young barley leaves (such as young barley leaf-derived dietary fiber) is indicated as the active ingredient, but is not limited to one in which young barley leaves or a component derived from young barley leaves (such as young barley leaf-derived dietary fiber) is indicated as the active ingredient on the product packaging, etc. For example, the active ingredient may not be specified. Note that a psychological stress-relieving composition containing young barley leaf-derived dietary fiber as an active ingredient may contain young barley leaf-derived dietary fiber, and does not necessarily need to use fractionated young barley leaf-derived dietary fiber. For example, by blending barley leaves containing dietary fiber derived from young barley leaves, such as barley leaf powder (ground powder), a composition for relieving psychological stress can be obtained that contains dietary fiber derived from young barley leaves as an active ingredient. Furthermore, even general foods that are manufactured and sold with suggested uses are within the scope of the present invention. For example, foods sold with personal testimonials mentioning psychological stress relief from ingestors, as personal impressions, posted on websites, etc., are also within the scope of the present invention. Furthermore, functional foods that use papers demonstrating the psychological stress relief of young barley leaves as the scientific basis for their functionality and contain young barley leaves or components derived from young barley leaves as functional ingredients are also within the scope of the present invention.
[0024] Specifically, in the case of so-called health foods, claims include "relieve (relieve / reduce) psychological (mental) stress," "relieve (relieve / reduce) temporary psychological (mental) stress," "relieve (relieve / reduce) temporary psychological (mental) stress associated with clerical work," "relieve (relieve / reduce) psychological (mental) stress associated with temporary work," "relieve (relieve / reduce) temporary psychological (mental) stress caused by work or study," "relieve (relieve / reduce) temporary depression," "relieve (relieve / reduce) temporary stress," "relieve (relieve / reduce) stress caused by clerical work," "relieve (relieve / reduce) temporary stress associated with work," "relieve (relieve / reduce) stress caused by work or study," "relieve (relieve / reduce) depression," and "relieve (relieve / reduce) work stress caused by desk work." Examples of products that display the following statements include: "relieves / alleviates" (relieves / reduces) temporary stress (irritation, tension) associated with work or study, "relieves (relieves / alleviates) fatigue at work after desk work, "relieves (relieves / alleviates) fatigue caused by work, study, etc., "relieves (relieves / alleviates) fatigue in people who experience fatigue in their daily lives," "relieves (relieves / alleviates) temporary mental fatigue," "reported to relieve (relieve / alleviate) psychological (mental) stress," "reported to have the function of relieving (relieves / alleviates) psychological (mental) stress," "reported to relieve (relieves / alleviate) temporary stress," "reported to have the function of reducing (relieves / alleviates) temporary stress," "reduces tension," "reduces irritation," "reduces loss of vitality and energy," "reduces confusion," etc.
[0025] The composition for relieving psychological stress of the present invention can be used for the purpose of relieving stress and fatigue such as stress caused by office work, stress in daily life, temporary stress, fatigue caused by office work, fatigue felt in daily life, and temporary fatigue.
[0026] <Composition dosage form, etc.> The composition of the present invention can be used as an oral composition. The form of the oral composition is not particularly limited, and examples thereof include foods and beverages, quasi-drugs, pharmaceuticals, etc., but from the viewpoint of daily intake of young barley leaves to supplement daily nutrition, it is preferably used as a food and beverage. The form of the food and beverage composition is not particularly limited, and examples thereof include functional food, specified health food, health food, general food and beverage, etc., but from the viewpoint of making it easy for consumers to understand the effects of the present invention, functional food and specified health food are preferred, and functional food is most preferred.
[0027] The composition of the present invention may be in the form of, for example, powder, granules, liquid, tablet, capsule, etc. It may also be in the form of a clear food such as jelly, cookies, candy, gum, etc. The young barley leaves of the present invention have a good taste and are therefore suitable for ingestion in a form that allows the taste to be felt. Therefore, powder, granules, liquid, and tablet forms are preferred, with powder, granules, and liquid being particularly preferred.
[0028] The content of young barley leaves in the composition of the present invention may be appropriately determined within a range that achieves the desired effect. For example, the composition of the present invention may contain young barley leaves in an amount of 0.01 to 100% by mass, preferably 0.1 to 100% by mass, and more preferably 1 to 100% by mass, calculated on a dry mass basis.
[0029] The content of dietary fiber derived from young barley leaves in the composition of the present invention may be appropriately determined within a range that provides the desired effect. For example, the composition of the present invention may contain dietary fiber derived from young barley leaves in an amount of 0.01 to 80% by mass, preferably 0.1 to 75% by mass, and more preferably 1 to 70% by mass, calculated on a dry mass basis.
[0030] The intake amount of young barley leaves in the present invention is not particularly limited, but in order to enjoy the effects of the present invention more effectively, the intake amount of young barley leaves is preferably 0.25 g or more per day for an adult, more preferably 0.5 g or more, and particularly preferably 1.0 g or more, with the upper limit being, for example, 30 g, preferably 20 g, and more preferably 10 g.
[0031] Furthermore, there is no particular restriction on the amount of intake of dietary fiber derived from young barley leaves in the present invention, but in order to enjoy the effects of the present invention more effectively, the intake amount of dietary fiber derived from young barley leaves per day for an adult is preferably 0.125 g or more, more preferably 0.25 g or more, and particularly preferably 0.5 g or more, with the upper limit being, for example, 15 g, preferably 10 g, and more preferably 5 g.
[0032] The composition of the present invention may be appropriately designed so that the daily intake of young barley leaves or dietary fiber derived from young barley leaves is the above-mentioned intake amount, and may be ingested in one sitting or in multiple sittings. That is, for example, the daily amount may be contained in one container or divided into 2 to 4 containers.
[0033] The composition of the present invention can be produced by a known method, adding other ingredients in addition to young barley leaves, if necessary. [Example]
[0034] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples, and the present invention can take various forms as long as the object of the present invention can be achieved.
[0035] Test 1. Evaluation by elevated platform test As mentioned in the Background Art section, Non-Patent Document 2 concludes that a water immersion restraint test using rats does not demonstrate any gastric ulcer inhibitory effect when administered with young barley leaf powder alone. However, the present inventors believed that the test method described in Non-Patent Document 2 imposes a physical load on the rats, and therefore fails to accurately evaluate the effect of young barley leaf on "psychological" stress. To evaluate the effects of psychological stress in animal tests, it is recommended to evaluate stress-related behavior induced solely by psychological stress without imposing a physical load on the animals (see Non-Patent Documents 3 and 4, if necessary). Therefore, the present inventors chose the "elevated platform test" proposed in Non-Patent Document 4 as a method for analyzing animal behavior under psychological stress without imposing a physical load on the animals, and decided to evaluate the effects of psychological stress induced by young barley leaf. The elevated platform test is a test that evaluates the strength of an animal's stress response using freezing behavior observed during high-altitude stress as an indicator, and serves as an indicator of stress resistance.
[0036] <Test substance> (Barley grass powder) The raw material used was the above-ground parts (leaves and stems) of barley harvested at a height of approximately 30 cm. The barley was washed with water to remove any adhering mud, cut into pieces approximately 5 cm in size, blanched once in hot water at 95°C for approximately 100 seconds, and cooled in cold water. The resulting young barley leaves were dried with hot air in a dryer and coarsely crushed to pieces approximately 1 mm in size. This was then finely crushed using a jet mill to produce young barley leaf powder (median diameter approximately 20 μm, moisture content 5% by mass or less, and dietary fiber derived from young barley leaves 51% by mass).
[0037] (Test substances other than barley leaf powder) The test substances used other than barley leaf powder were as follows: Dietary fiber derived from young barley leaves: Dietary fiber derived from young barley leaves was fractionated from the barley leaf powder obtained by the method described above and used as the test substance. Barley leaf juice powder: Barley leaf juice was mixed with dextrin and dried to form a powder (2% by mass of dietary fiber derived from barley leaves). Barley (grain): Commercially available barley flour was used. Indigestible dextrin: Commercially available indigestible dextrin was used. Cellulose: Commercially available cellulose was used. Fructooligosaccharides: Commercially available fructooligosaccharides were used. Ground coffee powder: Commercially available ground coffee beans were used. Coffee is known to have a stress-relieving effect, so it was used as a positive control.
[0038] <Test Method> Four-week-old male ICR mice were acclimated for 5 days and then divided into nine groups (four mice per group) to ensure that their body weights were approximately equal on the day of testing. Each test substance was dissolved or suspended in purified water to the concentrations listed in Table 1 to prepare a 10% (w / v) test substance solution (20% (w / v) for barley leaf juice powder). Each test substance was prepared at 1 g / kg (2 g / kg for barley leaf juice powder) and administered orally (10 mL / kg) to each group of mice. Thirty minutes after administration, mice were subjected to altitude stress and the duration of freezing behavior was measured. Specifically, a clear acrylic cylinder (11.4 cm diameter, 18 cm height) was inverted, and mice were placed on the bottom of the acrylic cylinder as a platform. Video recording was performed for 10 minutes, and the duration of freezing behavior (no visible movement other than breathing) was measured and accumulated using a stopwatch. If the mouse slipped off the platform during the experiment, the mouse was quickly placed back on the platform and the measurement was continued.
[0039] [Table 1]
[0040] <Test Results> The test results are shown in Table 1. In Examples 1 to 3, in which young barley leaves were administered, a reduction in freezing time was observed compared to the control. In particular, in Example 1, in which young barley leaf powder was administered, and Example 2, in which dietary fiber derived from young barley leaves was administered, a greater reduction in freezing time was observed than in the positive control. This demonstrates that administration of young barley leaves alleviates psychological stress. On the other hand, in Comparative Examples 1 to 4, no reduction in freezing time was observed.
[0041] Test 2. Clinical trial evaluation To confirm that the psychological stress-relieving effect is also observed in humans, a clinical trial was conducted to evaluate psychological state using POMS2 (registered trademark). POMS2 (Profile of Mood States 2nd Edition) is a registered trademark of Multi-Health Systems, Inc. and is a globally trusted psychological test. POMS2 evaluates psychological state using the factors "anger-hostility," "confusion-bewilderment," "depression-depression," "fatigue-apathy," "tension-anxiety," "vigor-vitality," "friendliness," and "overall mood state." The specific test method is described below.
[0042] <Test Method> Test food The test food was a powdered drink made by mixing young barley leaf powder (manufactured using the method described in Test 1) with maltose. The control food was a powdered drink made without barley leaf powder, but with maltose and coloring and flavoring to make it indistinguishable in appearance from the test food. The daily intake of both the test food and control food was set at 5.6g, and 2.8g portions were distributed to the subjects in plain aluminum bags to ensure blinding for the subjects and interventionists. The calorie and nutritional values per recommended daily intake (2 bags) of the test food are shown in Table 2. The recommended daily intake (2 bags) of dietary fiber derived from young barley leaf contained in the test food was 0.7g.
[0043] [Table 2]
[0044] 2) Subjects Paid volunteers were publicly recruited as subjects, and 40 healthy Japanese men and women aged 20 to 65 years who did not meet the following exclusion criteria (10 men and 30 women) were selected as subjects. Exclusion criteria: (1) individuals suffering from or undergoing treatment for serious liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, or other metabolic diseases; (2) individuals with chronic diseases and taking medication; (3) individuals with digestive diseases or a history of digestive surgery that affect digestion and absorption; (4) individuals taking medications, health foods, or supplements that may affect sleep or stress; (5) individuals who consume excessive alcohol; (6) individuals who cannot abstain from alcohol the day before the test (the day before the sleep questionnaire was recorded); (7) individuals with or suspected of having sleep apnea syndrome; (8) individuals with a history of treatment for or a current history of a psychiatric disorder related to sleep disorders; (9) individuals who sleep in the same room as family members or others and may be woken up during sleep; (10) individuals planning a business trip (domestic or overseas) or travel (domestic or overseas) during the test period; (11) individuals who are taking lactic acid bacteria or Bifidobacterium lactis during the test period. (11) Those who cannot stop consuming foods containing live bacteria such as Bifidobacterium and Bacillus subtilis natto, foods enriched with oligosaccharides and dietary fiber, health foods believed to be good for improving constipation, and foods containing a large amount of sugar alcohol; (12) Those who have previously been consuming regular foods containing lactic acid bacteria, Bifidobacterium, and oligosaccharides for the purpose of relieving constipation; (13) Those who have declared an allergy to the ingredients of the test foods; (14) Those with a past or current history of drug or alcohol dependence; (15) Those who are pregnant or breastfeeding, or those planning to become pregnant; (16) Those with extremely irregular eating habits, or those with irregular sleep hours and habits due to irregular shift work or late-night shift work; (17) Those who are currently participating in or intend to participate in tests of other foods, drugs, or cosmetics or drugs; (18) Others who the principal investigator deems unsuitable as subjects
[0045] 3) Test method This study was conducted as a randomized, double-blind, placebo-controlled, parallel-group comparative study (allocation ratio: 1:1) with a 4-week intake period. Participants were allocated using a block randomization method (block size 4) with gender and age as adjusting factors. A controller not directly involved in the study assigned the two groups to the test food group and the control food group. In addition, the controller created and sealed a table (key code) listing the allocation results, and kept it sealed until the key code was disclosed after the analysis subjects were determined, thereby ensuring blinding. During the test period, subjects were instructed to take two packets (5.6 g) of the test food (test food for the test food group and control food for the control food group) dissolved in an appropriate amount of water or hot water per day. During the study period, subjects were instructed to maintain the same lifestyle as before the study began, avoid the use of supplements and health foods, avoid foods containing live bacteria such as lactic acid bacteria, bifidobacteria, and natto bacteria, foods enriched with oligosaccharides and dietary fiber, health foods known to be good for relieving constipation, and foods containing large amounts of sugar alcohols, and avoid consuming large amounts of alcohol (as a rough guide, an amount that would cause mental or physical symptoms to persist until the next day after drinking). Additionally, subjects were instructed to avoid consuming alcohol the day before any test, as a precaution for each test. Subjects were only allowed to use medications with the permission of the study institution, except in emergencies.
[0046] 4) Test items Before and four weeks after the start of intake, various moods and emotional states were assessed using the Japanese version of the POMS2 (short version for adults). POMS2 was administered as an assessment of the past week, including today, and standardized scores, i.e., T-scores, were calculated for seven scales: "anger-hostility," "confusion-bewilderment," "depression-depression," "fatigue-lethargy," "tension-anxiety," "vigor-vitality," and "friendship," as well as the "Total Mood State (TMD) score."
[0047] 5) Subjects of analysis The study enrolled 40 subjects (10 men, 30 women), with no dropouts after randomization, and the study began with 40 subjects. No subjects discontinued or dropped out during the study period, resulting in a total of 40 subjects completing the study. After the study was completed, six subjects (four in the control food group, two in the test food group) were excluded due to issues with the reliability of the data, such as non-compliance with lifestyle precautions, leaving 34 subjects (10 men, 24 women) for analysis (16 in the control food group, 18 in the test food group). The reason for rejection was that issues with the reliability of the data were identified (four in the control food group, two in the test food group).
[0048] <Test Results> The results of the POMS2 analysis are shown in Table 3. Higher scores for two of the evaluation items, "vigor-vitality" and "friendship," and lower scores for six items, "anger-hostility," "confusion-bewilderment," "depression-depression," "fatigue-apathy," "tension-anxiety," and "TMD score," are considered to indicate a more favorable state (a state with less psychological stress). Comparing the rate of change four weeks after intake compared to before intake, the test food group showed higher scores than the control food group for the two items, "vigor-vitality" and "friendship," while the test food group showed lower scores than the control food group for the six items, "anger-hostility," "confusion-bewilderment," "depression-depression," "fatigue-apathy," "tension-anxiety," and "TMD score." These findings confirm that the psychological stress-relieving effect of barley leaf intake is also observed in humans.
[0049] [Table 3] [Industrial Applicability]
[0050] The composition of the present invention contains young barley leaves and is therefore able to exert a psychological stress-relieving effect. Since the composition can be used as a food or beverage intended to relieve psychological stress, it is highly useful industrially.
Claims
[Claim 1] The invention described in the specification.