Composition for improving sleep quality

Abstract

To provide a composition that can improve the quality of sleep. [Solution] A composition for improving sleep quality containing globin protein hydrolysate.

Description

Technical Field

[0001] The present invention relates to a composition for improving the quality of sleep.

Background Art

[0002] It is said that humans spend about one-third of their lives sleeping, and sleep is considered the most important activity for humans. However, in modern society, many people complain of symptoms such as sleep deprivation and insomnia. According to the 2015 National Health and Nutrition Survey Report (Ministry of Health, Labour and Welfare, 2017), about one in five Japanese people are dissatisfied with the quality of their overall sleep. In addition, it has been reported that the average sleep time of Japanese people is getting shorter year by year.

[0003] Furthermore, the quality of sleep declines with aging. Considering the accelerating decline in the birthrate and aging in Japan, it is expected that in the future, as the number of elderly people increases, the number of middle-aged and elderly people with a decline in the quality of sleep will also increase.

[0004] When the quality of sleep deteriorates, not only is physical fatigue likely to remain, but it also causes obesity due to deterioration of blood circulation, metabolism, etc., increasing the risk of developing lifestyle-related diseases.

[0005] Globin proteolysate has been used in specific health foods, foods with functional claims, etc., because it suppresses the increase in postprandial blood triglycerides. Regarding globin proteolysate, Patent Document 1 discloses that globin proteolysate has a liver injury improving effect on a mouse alcoholic liver injury model and a mouse acute liver injury model. However, the relationship between globin proteolysate and the quality of sleep is not known.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0007] The present invention aims to provide a composition that can improve the quality of sleep. [Means for solving the problem]

[0008] The inventors have found that globin protein hydrolysates can improve sleep quality.

[0009] This disclosure provides, for example, the inventions described in [1] to

[10] below. [1] A composition for improving sleep quality, containing a globin protein hydrolysate. [2] A composition for improving morning drowsiness, containing a globin protein hydrolysate. [3] A composition for improving sleep, containing globin protein hydrolysate. [4] A composition for improving sleep duration, containing a globin protein hydrolysate. [5] A composition according to any one of [1] to [4], for use in healthy humans. [6] A method for improving sleep quality, morning drowsiness, dreaming, or sleep duration, comprising administering or ingesting a globin protein hydrolysate. [7] Globin protein hydrolysates for use in improving the quality of sleep, morning drowsiness, dreaming, or sleep duration of the subject. [8] Use of globin protein hydrolysates to improve the quality of sleep, morning drowsiness, dreaming, or sleep duration of the subject. [9] Use of globin protein hydrolysates for the manufacture of compositions for improving the quality of sleep, morning drowsiness, dreaming, or sleep duration of the target.

[10] The above subject is a healthy human being, the method described in any of [6] to [9], a globin protein hydrolysate, or use. [Effects of the Invention]

[0010] According to the present invention, a composition that can improve the quality of sleep can be provided. [Modes for carrying out the invention]

[0011] The embodiments of this disclosure will be described in detail below.

[0012] The sleep quality improvement composition, the morning drowsiness improvement composition, the dream improvement composition, and the sleep duration improvement composition according to this embodiment (hereinafter, these four compositions may be collectively referred to as "the compositions according to this embodiment") contain globin protein hydrolysates.

[0013] The compositions according to this embodiment can improve sleep quality. In this disclosure, sleep quality is a concept that includes the state of sleep and the duration of sleep. Improving sleep quality means, for example, improving the state of sleep such as dreaming, or improving the duration of sleep. By improving sleep quality, morning drowsiness can be improved.

[0014] The composition according to this embodiment can improve and enhance the duration, quality, and feeling of deep sleep, as well as the sleep rhythm. It helps to deepen the depth of sleep, provide a refreshing awakening, provide satisfaction with sleep upon waking, and prevent waking during sleep. It is also suitably used for those who want to sleep soundly, those who seek a refreshing morning, those who want to wake up feeling refreshed, those who want to change their sleep patterns, and those who want to change their awakening patterns.

[0015] The composition according to this embodiment can improve morning drowsiness. In this disclosure, improving morning drowsiness means reducing morning drowsiness. Morning drowsiness is evaluated by the score for "morning drowsiness" in a questionnaire such as the OSA Sleep Questionnaire MA version.

[0016] The composition according to this embodiment can improve dreaming. In this disclosure, "dreaming" means having many nightmares or dreaming frequently. In this disclosure, improving dreaming means reducing the frequency of nightmares and dreams. Dreaming is evaluated by the score for "dreaming" in a questionnaire such as the OSA Sleep Questionnaire MA version.

[0017] The composition according to this embodiment can improve sleep duration. In this disclosure, improving sleep duration means increasing sleep duration, particularly the amount of sleep that is perceived as insufficient. Sleep duration is evaluated by the score for "sleep duration" in a questionnaire such as the OSA Sleep Questionnaire MA version.

[0018] Whether the composition according to this embodiment can improve sleep quality can be determined by whether it can improve morning drowsiness, dreaming, and sleep duration, that is, whether it can improve the scores for morning drowsiness (Factor 1), dreaming (Factor 3), and sleep duration (Factor 5) as evaluated by the OSA Sleep Questionnaire MA version. For example, if administering the above composition to 35 to 40 people (subjects) in an appropriate dosage and manner improves the scores for morning drowsiness (Factor 1), dreaming (Factor 3), and sleep duration (Factor 5) of those people, then it can be determined that the above composition can improve sleep quality. For example, if the percentage change in the scores for morning sleepiness (Factor 1), dreaming (Factor 3), and sleep duration (Factor 5) after ingestion of the above composition (the average value of the percentage change in the above scores due to ingestion of the above composition, calculated for each subject, relative to the scores before ingestion) is 0.1% or more, 1% or more, 2% or more, 2.5% or more, 3% or more, or 6% or more, then it can be determined that the above composition can improve sleep quality.

[0019] In this disclosure, the OSA Sleep Questionnaire MA version refers to the one developed in: Yukari Yamamoto, Hideki Tanaka, Miki Takase, Katsuo Yamazaki, Kazuo Azumi, Shuichiro Shirakawa: Development and standardization of the OSA Sleep Questionnaire (MA version) for middle-aged and elderly people. Brain and Psychiatry vol.10: pp.401-409, 1999.

[0020] The OSA Sleep Questionnaire MA version is a psychological scale for evaluating sleep introspection upon waking up. The OSA Sleep Questionnaire MA version consists of 16 questions. Among them, the questions categorized as morning sleepiness (Factor 1) are "2. Concentrated - Not Concentrated", "4. Feeling of liberation - Feeling stressed", "8. Clear-headed - Dull-headed", and "14. Can answer the survey quickly - Answering is a hassle". The questions categorized as dreaming (Factor 3) are "9. Had many bad dreams - Had no bad dreams" and "12. Dreamed often - Didn't dream at all". The questions categorized as sleep duration (Factor 5) are "6. Having an appetite - Having no appetite" and "15. Had a long sleep duration - Had a short sleep duration".

[0021] The composition according to this embodiment may be used for a subject (e.g., human; non-human animals such as cows, pigs, horses, sheep, goats, dogs, rabbits, mice, rats, guinea pigs, shrews, hamsters, ferrets, etc.) that requires improvement in sleep quality, morning sleepiness, dreaming, or sleep duration. The above human may be a healthy human.

[0022] In the present disclosure, a "healthy human" may be, for example, a human without a history of suffering from severe liver diseases (such as viral hepatitis, drug-induced liver injury, cirrhosis, etc.), a human not suffering from the above severe liver diseases, a human not suffering from mental diseases, sleep disorders, heart and kidney diseases, diabetes, and other severe diseases, or a human satisfying all of these.

[0023] The above human may be, for example, a human 18 years old or older, a human 20 years old or older, or a human 20 years old or older and less than 65 years old. The above human may be female or male. Also, the above human may be Asian or Japanese. Since the quality of sleep tends to decline particularly due to aging in the age group of middle-aged and older people, the above human may be a middle-aged person, for example, a human 40 years old or older, or an elderly person, for example, a human 60 years old or older.

[0024] The healthy individuals described above may also be those with an ALT level between 20 U / L and 50 U / L. In this disclosure, the ALT level refers to the concentration (U / L) of ALT in the blood as measured by the following blood biochemistry test. In the above blood biochemistry test, the blood ALT level is measured using the JSCC standardized method.

[0025] The "Standard Health Checkup and Health Guidance Program (FY2024 Edition)" (Ministry of Health, Labour and Welfare) designates a blood ALT level of 31 U / L as the threshold for health guidance and a blood ALT level of 51 U / L as the threshold for recommending a medical consultation (https: / / www.mhlw.go.jp / content / 12401000 / 000967510.pdf, accessed July 19, 2024). Furthermore, according to the Japan Society for Human Dock and Preventive Medicine (https: / / www.ningen-dock.jp / public_method / , accessed August 6, 2024), a blood ALT level of 30 U / L or less is considered the normal range, and a blood ALT level between 31 U / L and 50 U / L is considered the range requiring attention. Based on these, in this disclosure, the normal range of human blood ALT levels (healthy range of human blood ALT levels) is defined as 50 U / L or less.

[0026] Globin protein hydrolysates are the breakdown products of globin proteins such as hemoglobin and myoglobin. These hydrolysates may also be enzymatic hydrolysates. Globin protein hydrolysates typically contain multiple oligopeptides derived from globin proteins.

[0027] Globin proteins are not particularly limited, but may be derived from the blood or meat (livestock meat, fish meat) of animals such as mammals (cattle, pigs, sheep, humans, horses, etc.) and fish. Blood typically contains a large amount of hemoglobin, while meat typically contains a large amount of myoglobin.

[0028] The method for producing globin protein hydrolysates is not particularly limited, but for example, it may be a method in which a globin protein-containing substance such as blood or meat is added to water to form a dispersion, and a hydrolytic enzyme is added to the dispersion to allow the hydrolysis reaction of the globin protein to proceed.

[0029] The amount of the globin protein-containing substance in the above dispersion may be, for example, 5% by mass or more and 30% by mass or less, calculated on a solid content basis (components other than water) of the globin protein-containing substance.

[0030] As the hydrolytic enzymes mentioned above, acidic proteases, neutral proteases, alkaline proteases, or combinations thereof may be used.

[0031] The above hydrolysis reaction may be carried out at the optimal pH of the hydrolytic enzyme used. The above hydrolysis reaction may be carried out at the optimal temperature of the hydrolytic enzyme used (for example, 20°C to 70°C). The above hydrolysis reaction may be carried out for, for example, 3 hours to 48 hours. There are no particular restrictions on the method of adding the hydrolytic enzyme to the above dispersion, but the hydrolytic enzyme may be added all at once or sequentially.

[0032] The above hydrolysis reaction yields a globin protein hydrolysate dispersed in water. This globin protein hydrolysate may be used as is, dried, or dried and solidified with an appropriate amount of a bulking agent such as carboxymethylcellulose or dextrin. Furthermore, the globin protein hydrolysate may be purified as needed.

[0033] Furthermore, globin protein hydrolysates may be produced by the method described in International Publication No. 89 / 06970.

[0034] The composition according to this embodiment may be used for oral ingestion or administration. That is, the composition may be an oral preparation.

[0035] The globin protein hydrolysate content in the composition according to this embodiment may be, for example, 1% by mass or more and 99% by mass or less, or 10% by mass or more and 90% by mass or less.

[0036] If the composition according to this embodiment is a tablet, the content of the globin protein hydrolysate in the tablet may be, for example, 1 w / w% or more, 2 w / w% or more, 5 w / w% or more, 10 w / w% or more, 20 w / w% or more, or 50 w / w% or more, or 99 w / w% or less, 96 w / w% or less, 91 w / w% or less, or 89 w / w% or less.

[0037] If the composition according to this embodiment is a liquid, the content of the globin protein hydrolysate in the liquid may be, for example, 0.01 w / v% or more, 0.02 w / v% or more, 0.1 w / v% or more, 0.2 w / v% or more, 0.3 w / v% or more, or 0.4 w / v% or more, and may also be 25 w / v% or less, 20 w / v% or less, 10 w / v% or less, 8% or less, or 5 w / v% or less.

[0038] If the composition according to this embodiment is in the form of granules, the content of the globin protein hydrolysate in the granules may be, for example, 10 w / w% or more, 15 w / w% or more, 20 w / w% or more, 30 w / w% or more, 40 w / w% or more, or 50 w / w% or more, or 99 w / w% or less, 97 w / w% or less, 91 w / w% or less, 85 w / w% or less, or 80 w / w% or less.

[0039] The composition according to this embodiment may be used in an amount equivalent to globin protein hydrolysate, for example, 0.5 g to 5 g per day, for example, 0.5 g to 4 g per day, for example, 1 g to 3 g per day, for example, 1.5 g to 2.5 g per day, or 2 g per day.

[0040] The composition according to this embodiment may be used for ingestion or administration for 4 weeks or more, or for ingestion or administration for 8 weeks or more. Ingestion or administration of the composition according to this embodiment daily for 8 weeks or more can significantly improve sleep quality. The above-mentioned dosage and duration of ingestion or administration can be combined as desired.

[0041] The composition according to this embodiment may further contain pharmacologically active ingredients or physiologically active ingredients, as long as the effects of the present invention are not impaired. Specific examples of such pharmacologically active ingredients or physiologically active ingredients include, for example, ubiquinone (coenzyme Q10), vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin A, vitamin E, niacin, calcium pantothenate, taurine, carnosine, anserine, balenine, citrulline, gamma-aminobutyric acid, valine, leucine, isoleucine, glycine, glutamic acid, glutamine, creatine, carnitine, luteolin, and quercetin. Examples of pharmacologically active ingredients include genistin, cyanidin, resveratrol, diosgenin, isoflavone aglycone, lipoic acid, zinc, iron, calcium, selenium, astaxanthin, zeaxanthin, beta-carotene, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, arachidonic acid, placenta extract, pycnogenol, isoerucitrin, hyperoside, docosahexaenoic acid, eicosapentaenoic acid, and arctigenin. From the viewpoint of further enhancing the effects according to the present invention, ubiquinone (coenzyme Q10), vitamin B12, vitamin C, vitamin E, astaxanthin, zinc, and carnitine are preferred as pharmacologically active ingredients, and ubiquinone (coenzyme Q10), astaxanthin, and zinc are more preferred. The pharmacologically active ingredients or physiologically active ingredients may be used individually or in combination of two or more.

[0042] The composition according to this embodiment may further contain various additives, as long as they do not impair the effects of the present invention. Specific examples of such additives include, for example, excipients, binders, disintegrants, lubricants, colorants, flavoring agents, odorants, sugars, sugar alcohols / polyhydric alcohols, high-intensity sweeteners, oils and fats, emulsifiers, thickeners, acidulants, fruit juices, etc. Examples of excipients include lactose, sucrose, sodium chloride, glucose, starch, gelatin, calcium carbonate, kaolin, crystalline cellulose, and silicic acid. Examples of binders include water, ethanol, propanol, simple syrup, glucose solution, starch solution, gelatin solution, cellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxypropyl starch, methylcellulose, ethylcellulose, calcium phosphate, and polyvinylpyrrolidone. Examples of disintegrants include dried starch, sodium alginate, agar powder, sodium bicarbonate, calcium carbonate, sodium lauryl sulfate, monoglyceride stearate, and lactose. Examples of lubricants include talc, stearate, borax, and polyethylene glycol. Examples of flavoring agents include sucrose, orange peel, citric acid, and tartaric acid. Examples of sugars include sucrose, isomerized sugar, glucose, fructose, palatinose, trehalose, lactose, and xylose. Examples of sugar alcohols and polyhydric alcohols include sorbitol, xylitol, erythritol, lactitol, maltitol, palatinose, reduced starch syrup, reduced maltose syrup, glycerin, and propylene glycol. Examples of high-intensity sweeteners include aspartame, stevia, acesulfame potassium, and sucralose. Examples of oils and fats include safflower oil, grape seed oil, sunflower oil, olive oil, corn oil, sesame oil, soybean oil, rapeseed oil, perilla oil, and rice oil. Examples of emulsifiers include sucrose fatty acid esters, glycerin fatty acid esters, and lecithin. Examples of thickeners include carrageenan, xanthan gum, guar gum, pectin, and locust bean gum. Examples of acidulants include citric acid, lactic acid, and malic acid. Examples of fruit juices include lemon juice, orange juice, and berry juices.Examples of fragrances include citrus fragrances and black tea fragrances. Additives may be used individually or in combination of two or more.

[0043] The composition according to this embodiment can be used, for example, as an ingredient in food and beverages (drinks, food products), pharmaceuticals, quasi-drugs, etc. Furthermore, the composition according to this embodiment can also be used, for example, in foods with functional claims, health supplements, food preparations (e.g., confectionery tablets), foods for specified health uses, nutritional functional foods, foods for special dietary uses, pharmaceutical preparations, quasi-drug preparations, etc.

[0044] Furthermore, when the composition according to this embodiment is used as food or beverage, the food may be a general food or beverage blended with globin protein hydrolysate and, if necessary, other ingredients. Examples of such food or beverages include cookies, biscuits, snack foods, jelly, gummies, chocolate, gum, candy, cheese, noodles such as ramen, seasonings, processed meat products, frozen foods, instant foods, french fries, nutritional drinks, juices, tea beverages, coffee beverages, dairy beverages, and alcoholic beverages.

[0045] Furthermore, the composition according to this embodiment may be in any dosage form depending on the purpose. Examples of such dosage forms include oral preparations such as tablets (including orally disintegrating tablets, chewable tablets, lozenges, etc.), granules, powders, soft capsules, hard capsules, lozenges, jellies, or liquids (including suspensions, emulsions, syrups, etc.); external preparations such as ointments, suppositories, patches, sprays; and injectable preparations.

[0046] Furthermore, the composition according to this embodiment can be ingested or administered to the target person at any time of day, depending on the purpose. For example, it may be ingested or administered after dinner or before going to bed.

[0047] The present invention can also be understood as a method for improving sleep quality, morning drowsiness, dreaming, or sleep duration, comprising administering a composition containing a globin protein hydrolysate to a subject in need. The present invention can also be understood as a globin protein hydrolysate for use in improving the sleep quality, morning drowsiness, dreaming, or sleep duration of a subject. The present invention can also be understood as the use of a globin protein hydrolysate for the manufacture of a composition for healthy humans to improve sleep quality, morning drowsiness, dreaming, or sleep duration. Specific embodiments of the method, globin protein hydrolysate, and use can be applied without limitation to the embodiments described as specific embodiments of the composition according to this embodiment. [Examples]

[0048] The present invention will be described in more detail below with reference to examples.

[0049] This study conducted a randomized, placebo-controlled, double-blind, parallel-group comparative trial to evaluate the effect of consuming a test food containing globin protein hydrolysate on sleep quality.

[0050] This study was approved by the Fukuzumi Internal Medicine Clinic Institutional Review Board on August 7, 2023, and after obtaining written consent from the subjects, it was conducted in accordance with the spirit of the Declaration of Helsinki (revised October 2013), the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects (partially revised March 27, 2023), and the study protocol for this study (Registration Number UMIN000051963).

[0051] [Test foods (test food and control food)] The test foods used were a test food containing excipients and 250 mg of hydrolyzed globin protein (manufactured by MG Pharma Co., Ltd.) per tablet, and a control food consisting of the above excipients but without the hydrolyzed globin protein. Both the test food and the control food were yellow film-coated tablets and packaged in plain aluminum pouches so that neither the subjects nor the researchers could distinguish between the test food and the control food. The hydrolyzed globin protein was obtained by protease hydrolysis of globin protein derived from porcine red blood cells.

[0052] [subject] In this study, the number of subjects was designed during the planning stage. The number of subjects was determined by referring to the results of a similar study conducted prior to this study that confirmed the effect of improving liver function and preventing liver damage (Kikuchi, Masahiro; Aoki, Yudai; Aizawa, Koichi; Suganuma, Hiroyuki; Nishizaki, Yasuhiro; Verification of the efficacy of a broccoli sprout extract-containing supplement on liver function in healthy adults - A multicenter, randomized, double-blind, placebo-controlled, parallel-group comparative study -, Pharmacology and Therapeutics 2018, 46(1), 81-95). Assuming an effect of 0.7 for the test food, a significance level of 0.05, and a power of 80%, it was determined that 33 subjects per group were needed, resulting in a total of 66 subjects. Assuming a dropout or discontinuation rate of approximately 20% during the study period, 82 subjects (41 in each group) were selected for this study.

[0053] Recruitment was conducted, and prospective participants visited Fukuhara Clinic under the direction of the research collaborators. The principal investigator obtained written consent from the prospective participants to participate in the study, and then conducted screening tests. Subsequently, the principal investigator reviewed the results obtained and considered the eligibility for inclusion in the study based on the following selection criteria (1) to (4) and exclusion criteria (1) to (17). As a result, it was confirmed that a sufficient number of potential subjects had been secured, and subjects to be included in the intervention (ingestion of the test food) were selected. <Selection criteria> (1) Japanese men and women aged 20 to under 65 at the time of obtaining consent to participate in the study, (2) individuals with a blood ALT level of 20 U / L to 50 U / L at the time of screening, (3) individuals who can come to the study site on the scheduled date, and (4) individuals who fully understand the purpose and content of this study and give written consent before the start of the study. <Exclusion criteria> (1) Individuals with chronic diseases who regularly take medications; (2) Individuals with a history of serious liver disease (viral hepatitis, drug-induced liver injury, and cirrhosis), or those suspected of currently having the above liver disease; (3) Individuals with mental illness, sleep disorders, heart or kidney disease, diabetes, or other serious illnesses; (4) Individuals with a history of severe illness who are deemed unsuitable for participation in the study; (5) Individuals who may show allergic symptoms to the components contained in the test food (test food and control food); (6) Shift workers or night shift workers whose work schedule extends beyond 0:00 AM; (7) Individuals with extremely irregular daily lifestyles or eating habits; (8) Individuals with a systolic blood pressure of less than 90 mmHg; (9) Individuals who, in a survey of alcohol consumption for one week starting the day after the screening test, have a habit of drinking 60g or more per day in terms of pure alcohol; (10) Individuals with a history of blood sampling. (1) Individuals who have experienced malaise or deterioration of physical condition due to (11) medications, quasi-drugs, herbal medicines, or health foods (including supplements) that may affect the study; (12) Individuals who cannot comply with requests to subjects during the study period; (13) Individuals who are participating in other clinical trials at the time of screening, or who have participated in other clinical trials within two months prior to the start of the study; (14) Individuals who have undergone apheresis donation or whole blood collection of 200 mL or more within one month prior to screening, or who have either planned during the study period; (15) Individuals who travel or go on business trips for an average of 10 days or more per month; (16) Individuals who wish to become pregnant during the study period, or who are pregnant (including those who may be pregnant) or breastfeeding; (17) Others whom the principal investigator deems unsuitable based on data such as health checkup results.

[0054] [Experimental Design] The study period was 8 weeks, and tests were conducted before the start of intake of the test food, 4 weeks after intake (after 4 weeks of intake), and 8 weeks after intake (after 8 weeks of intake).

[0055] An independent external organization, not involved in this study, acted as the allocation manager, dividing subjects into two groups and randomly assigning them to the test food group and the control food group using random numbers. At this time, it was confirmed that there were no significant differences between the groups in the allocation factors of age, sex, AST, ALT, and γ-GT. The allocation manager sealed the test food allocation sheet and kept it strictly confidential until the end of the study, ensuring the confidentiality of the allocation to all individuals involved in this study, including the study sponsor, principal investigator, co-investigators, consultants, and subjects, thereby guaranteeing the blinding of the test food.

[0056] During the study period, participants were instructed to take 8 tablets (equivalent to 2000 mg of hydrolyzed globin protein) of either the test food or the control food daily with water or lukewarm water. The intake period was 8 weeks, from the day before the pre-intake examination to the day before the 8-week post-intake examination. There was no specific time of intake, but it was prohibited to carry over intake to the next day if intake was not possible on the day. On the pre-intake and 4-week post-intake examination days, the test food was to be taken after the examination was completed.

[0057] Participants were required not to significantly change their lifestyle habits (diet, exercise, sleep, smoking, alcohol consumption, etc.) from before the study, and were prohibited from taking any medicines, quasi-drugs, herbal medicines, or health foods (including supplements) that could potentially affect the study. Blood donation was also prohibited during the study period.

[0058] [Inspection items] (Blood ALT level) In the screening test, serum ALT levels were measured. Serum ALT levels were measured using a blood biochemistry test. Specifically, the JSCC standardized method was used.

[0059] (OSA Sleep Questionnaire MA version) Morning sleepiness, dreaming, and sleep duration were measured using the OSA Sleep Questionnaire MA version during pre-intake, 4-week post-intake, and 8-week post-intake examinations. These measurements were taken at the subjects' homes upon waking.

[0060] (Doctor's consultation) The principal investigator conducted interviews and auscultations before the start of intake, 4 weeks after intake, and 8 weeks after intake.

[0061] [Analysis subjects] Of the 82 subjects enrolled in this study (41 in the test food group and 41 in the control food group), one subject lost track of the study during the test food intake period, and the study was terminated at the discretion of the principal investigator. Therefore, 81 subjects completed the study. In addition, one subject was found to have not complied with the restrictions, and another subject was deemed unsuitable for analysis by the principal investigator, thus meeting the exclusion criteria. The remaining 79 subjects, excluding the one subject who lost track of the study and the two subjects who met the exclusion criteria, were included in the PPS (Per Protocol Set) analysis.

[0062] [result] Table 1 shows the mean ± standard deviation of the measured morning sleepiness scores before and 4 weeks after intake for each group included in the PPS analysis, the mean ± standard deviation of the change in morning sleepiness scores for each subject from before intake to 4 weeks after intake, and the mean ± standard deviation of the percentage change (%), which is the ratio of the above change to the morning sleepiness score for each subject relative to the morning sleepiness score before intake.

[0063] [Table 1]

[0064] Table 2 shows the mean ± standard deviation of the measured Yumemi score before intake, 4 weeks after intake, and 8 weeks after intake for each group included in the PPS analysis, the mean ± standard deviation of the change in Yumemi score for each subject from before intake to 4 weeks after intake and 8 weeks after intake, and the mean ± standard deviation of the percentage of the above change relative to the Yumemi score before intake for each subject.

[0065] [Table 2]

[0066] Table 3 shows the mean ± standard deviation of measured sleep duration before and 4 weeks after intake for each group included in the PPS analysis, the mean ± standard deviation of the change in sleep duration for each subject from before intake to 4 weeks after intake, and the mean ± standard deviation of the percentage of the above change relative to sleep duration before intake for each subject.

[0067] [Table 3]

[0068] As shown in Tables 1-3, the average percentage change in morning sleepiness after 4 weeks of intake, the average percentage change in dreaminess after 4 and 8 weeks of intake, and the average percentage change in sleep duration after 4 weeks of intake were all greater than those of the control food group. Therefore, it was shown that intake of globin protein hydrolysate can improve morning sleepiness, dreaminess, and sleep duration. Thus, it was shown that the above-mentioned globin protein hydrolysate can improve sleep quality.

Claims

1. A composition for improving sleep quality, containing globin protein hydrolysate.

2. A composition containing globin protein hydrolysate for improving morning drowsiness.

3. A composition for improving sleep quality, containing globin protein hydrolysate.

4. A composition for improving sleep duration, containing globin protein hydrolysate.

5. A composition according to any one of claims 1 to 4, for use in healthy humans.

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