Composition for improving quality of sleep

Abstract

To provide a composition capable of improving the quality of sleep.SOLUTION: A composition contains oenothein B.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a composition for improving sleep quality, which comprises oenothein B. [Background technology]

[0002] A large number of people suffer from sleep disorders and insomnia due to social environments and daily stress. It is known that poor quality sleep increases the risk of developing lifestyle-related diseases and worsens their symptoms, so there is a demand for ways to improve sleep disorders and insomnia.

[0003] In order to improve sleep, the use of hypnotic drugs or herbal medicines, or improvements to bedding and the sleeping environment have been proposed, but since sleep conditions are also greatly influenced by diet, it is considered important to prevent sleep problems with foods that can be safely ingested for a long period of time, and efforts are being made to develop foods that improve sleep quality. For example, it is known that sesamin-based compounds improve sleep quality (Patent Document 1) and lactoferrin improve sleep quality (Patent Document 2). However, the compositions developed so far have not necessarily been effective enough, so there is a demand for the development of new compositions that are excellent in improving sleep quality. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2016-188234 A [Patent Document 2] JP 2018-043964 A Summary of the Invention [Problem to be solved by the invention]

[0005] An object of the present invention is to provide a composition capable of improving the quality of sleep.

[0006] As a result of intensive research to solve the above problems, the present inventors have surprisingly found that a composition having excellent sleep quality improving effect can be obtained by containing onotein B. The present invention has been completed based on such findings.

[0007] The outline of the present invention is as follows. [1] A composition for improving sleep quality, comprising oenothein B. [2] A composition for improving sleep quality, comprising oenothein B, wherein the improvement in sleep quality is achieved by suppressing awakening during sleep. [3] A composition for improving sleep quality, characterized in that oenothein B is an extract from willow herb. Effect of the Invention

[0008] The composition of the present invention has an effect of suppressing awakening during the night, and therefore has an excellent effect of improving the quality of sleep. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The present invention will be described in detail below. Note that the present invention is not limited to the following embodiments.

[0010] The composition of the present invention is characterized by containing oenothein B. Oenothein B is a type of hydrolyzable tannin, and is a compound represented by the following formula (1). Oenothein B is also called oenothein B or oenothein B.

[0011] [ka]

[0012] The oenothein B used in the present invention is not particularly limited as long as it is commonly used in the field of food and beverages, and examples thereof include synthetic products synthesized by methods commonly known to those skilled in the art, plants containing oenothein B, and processed products of said plants. From the viewpoint of safety in oral ingestion, it is preferable to use plants containing oenothein B and processed products of said plants.

[0013] Examples of plants containing othene B used in the present invention include willow herb, eucalyptus, pomegranate, etc. It is preferable to use willow herb or eucalyptus because they are rich in othene B, and it is particularly preferable to use willow herb from the viewpoint of improving the quality of sleep.

[0014] Examples of processed products of plants containing oenothein B include crushed products, squeezed juice, and extracts, but extracts are preferred because they are rich in oenothein B. The solvent used for extraction may be either a polar solvent or a non-polar solvent, and water, methanol, ethanol, acetone, ethyl acetate, diethyl ether, n-hexane, etc., or a mixture thereof may be used, but from the viewpoint of efficient extraction of oenothein B, it is preferable to use water, hydrous ethanol, or ethanol. The extraction method is not particularly limited as long as it is a method that is usually acceptable for extracting plant components, and examples include solid-liquid extraction methods such as heated extraction and supercritical fluid extraction. The squeezed juice or extract may be in liquid form, but can also be used as a paste or dry powder. When making it into a paste or dry powder, it may be produced using only the product itself, or it may be processed together with an excipient. In addition, the processed product obtained may be further subjected to chemical treatment, enzyme treatment, and purification treatment.

[0015] The content of oenothein B in the composition of the present invention can be measured, for example, by HPLC. For example, it can be measured by an HPLC analyzer equipped with an ultraviolet absorption detector, and the analytical column is CAPCELLPAK C18 UG120 5 μm (4.6×250 mm) manufactured by Osaka Soda Co., Ltd., and the mobile phase is a 0.05% aqueous phosphoric acid solution (mobile phase A) and an acetonitrile solution (mobile phase B). The column temperature can be 40° C., and the flow rate can be 1.0 mL / min. The gradient conditions can be as follows:

[0016] [Table A]

[0017] In addition to oenothein B, other components may be added to the composition of the present invention as necessary. Examples of other components include excipients, lubricants, dietary fibers such as soluble dietary fibers and insoluble dietary fibers, proteins, various vitamins and minerals, microorganisms such as algae and yeasts, etc. Furthermore, as necessary, sweeteners, acidulants, nutritional supplements, stabilizers, binders, gloss agents, thickeners, colorants, diluents, emulsifiers, food additives, seasonings, etc. that are commonly used in the food industry may be mentioned. The content of these other components may be appropriately selected depending on the form of the composition of the present invention.

[0018] As described in the Examples below, the composition of the present invention can improve the quality of sleep by suppressing midnight awakening. Since the composition of the present invention has an effect of improving sleep quality, it can be used as a composition for improving sleep quality.

[0019] The composition of the present invention is not particularly limited as long as it can be distinguished from other products as a product in terms of its use for improving sleep quality, and for example, the scope of the present invention includes products that display the function of improving sleep quality on the main body, packaging, instructions, or advertising materials of the product of the present invention. For example, so-called health foods such as pharmaceuticals (including quasi-drugs), functional foods such as specified health foods, nutritional functional foods, and functional foods whose efficacy has been approved by a designated organization, and feeds, etc. can be mentioned. In addition, even if it is a general food, those that are manufactured and sold with the suggestion of the use of improving sleep quality are included in the scope of the composition for improving sleep quality of the present invention.

[0020] Specifically, the composition for improving sleep quality can be advertised or promoted using phrases such as "improving sleep quality", "improving sleep quality (depth of sleep, satisfaction with sleep upon waking)", "improving feeling of deep sleep", "reducing the number of awakenings during sleep", "reducing the time spent waking during sleep", "improving depth of sleep", "improving satisfaction with depth of sleep", "improving sleep rhythm", "improving daytime sleepiness", "improving satisfaction upon waking", "improving feeling of extended sleep time", "supporting good quality sleep at night", "sleep support", "improving sleep", "reducing sleepiness upon waking", "reducing fatigue upon waking", "supporting good quality sleep", "relieving daytime sleepiness", etc., and such advertising and promotion can be considered as implementing the present invention.

[0021] The composition of the present invention is not particularly limited as long as it is in a form suitable for oral use, and examples thereof include tablets, capsules, powders, granules, liquids, granules, rods, plates, blocks, solids, rounds, pastes, creams, caplets, gels, chewables, and sticks. Among these, from the viewpoint of ease of administration, tablets, capsules, powders, granules, and liquids are preferred, and tablets, capsules, and granules are more preferred. Examples of oral compositions used as tablets, capsules, powders, granules, and liquids include supplements, food additives, container-packed beverages filled in PET bottles, cans, bottles, etc., and powdered beverages to be dissolved in water (hot water), milk, fruit juice, etc. and drunk.

[0022] The content of oenothein B in the composition of the present invention may be appropriately contained within the range in which the effect is exerted. From the viewpoint of improving the quality of sleep, the content of oenothein B in the solid content is preferably 0.001% by mass or more, more preferably 0.01% by mass or more, and particularly preferably 0.1% by mass or more. In addition, from the viewpoint of easy continuous oral intake in daily life, the content of oenothein B is preferably 80% by mass or less, more preferably 60% by mass or less, even more preferably 40% by mass or less, and particularly preferably 20% by mass or less.

[0023] The amount of intake of the composition of the present invention is not particularly limited, but from the viewpoint of improving the quality of sleep, the amount of onotein B is preferably 0.01 mg or more per day, more preferably 0.1 mg or more, even more preferably 1 mg or more, and particularly preferably 10 mg or more. Also, from the viewpoint of easy continuous oral intake in daily life, the amount of onotein B is preferably 1000 mg or less per day, more preferably 500 mg or less, and particularly preferably 200 mg or less.

[0024] The composition of the present invention may be appropriately designed so that the daily intake of oenothein B is the above-mentioned amount, and may be in a form in which the above-mentioned amount is taken in one dose or in a form in which the above-mentioned amount is taken in multiple doses. That is, for example, the composition may be stored in one container or in 2 to 4 multiple containers as a daily amount.

[0025] The packaging form of the composition of the present invention is not particularly limited and can be appropriately selected depending on the dosage form, etc., and examples thereof include blister packs such as PTPs; strip packaging; heat seals; aluminum pouches; film packaging using plastics, synthetic resins, etc.; glass containers such as vials; and plastic containers such as ampoules. EXAMPLES

[0026] The present invention will be described in more detail below with reference to examples. However, 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.

[0027] <Test: Evaluation of the effect of suppressing awakening during the night> In order to confirm that the ingestion of the composition of the present invention has the effect of improving sleep quality by suppressing awakenings during sleep, the following test was carried out.

[0028] [1. Test Food] As oenothein B, a hydrous ethanol extract of willow herb was used. In Example 1, a tablet was used in which the willow herb extract was mixed with reduced maltose, cellulose, calcium stearate, and silicon dioxide and compressed. In Example 2, a tablet was used in which half of the willow herb extract in Example 1 was replaced with reduced maltose. In the comparative example, the willow herb extract in Example 1 was replaced with reduced maltose, and further, in order to make it difficult to distinguish from Examples 1 and 2 in appearance, a tablet was used in which caramel coloring was added and the amount of silicon dioxide was adjusted. In all of Examples 1, 2, and the comparative example, the daily recommended intake (250 mg x 2 tablets) was individually packaged in plain aluminum to ensure blinding to the subjects and interventionists. The amount of oenothein B contained in Example 1 per recommended daily intake was 30 mg, and the amount of oenothein B contained in Example 2 per recommended daily intake was 15 mg. The content of oenothein B in Examples 1 and 2 was measured by HPLC.

[0029] [2. Subjects] Forty subjects (16 men and 24 women) were selected.

[0030] 3. Study Design This study was conducted as a randomized, double-blind, placebo-controlled, parallel group comparative study (allocation ratio 1:1:1) for a total of 9 weeks consisting of a pre-observation period (1 week) and an intake period (8 weeks). The principal investigator enrolled the subjects according to the inclusion and exclusion criteria, and the randomizer allocated them using a block randomization method with age, sex, and total number of urinations per day as adjustment factors. The three allocated groups were allocated to Example 1 group, Example 2 group, and Comparative Example group by a person responsible for allocation who was not directly involved in the study. In addition, the person responsible for allocation created and sealed a table (key code) containing the allocation results, and kept it sealed until the key code was disclosed after the analysis subjects were determined, thereby ensuring blinding. During the intake period, the subjects were asked to take one bag (2 tablets) of the test food (Example 1 for Example 1 group, Example 2 for Example 2 group, and Comparative Example for Comparative Example group) once a day with water or lukewarm water.

[0031] [4. Evaluation method] To evaluate efficacy, the time spent awake on the spot was measured twice, once before the start of intake (hereafter, before intake) and once after 8 weeks of intake (hereafter, after 8 weeks of intake), using an electroencephalogram (EEG) measuring device. The time spent awake on the spot was measured using a wearable EEG measuring device (InSomnograf K2, manufactured by S'UIMIN Co., Ltd.) for three days, from two days before each test date to the day of the test. The time spent awake after falling asleep was calculated from the EEG, and the average value of the three days' data was used. However, data in which the time that could not be determined due to poor measurement exceeded 5% of the night was rejected, and if the number of days for which the data was rejected exceeded 50% of the number of days for which measurements were taken during the test period, the data was considered missing.

[0032] [5.Statistical analysis] The population to be analyzed was the PPS (Per-Protocol Set), and subjects with missing values ​​in the EEG measurements were excluded from the analysis of only those items. For the duration of awakening during the night, a repeated measures analysis of variance was first performed, and if an interaction between group and time point was observed, a comparison between the actual test values ​​and the change from before intake was performed for each test using the Dunnett test to compare the groups against the comparison example. The significance level was set at 0.05 on both sides. Statistical analysis was performed using IBM SPSS Statistics 28. Statistical data was shown as the mean ± standard error.

[0033] [6. Results] The results are shown in Table 1.

[0034] [Table 1]

[0035] As shown in Table 1, the time spent waking up during the night was reduced by taking Examples 1 and 2 containing onotein B. Therefore, the composition of the present invention exhibits an effect of suppressing waking up during the night, and is therefore expected to have an effect of improving the quality of sleep.

[0036] [Production Example] Based on the results of the Examples, Production Examples of the present invention are given below.

[0037] [Production Example 1-4: Granules] According to the formulation in Table 2, oenothein B and other raw materials were mixed, and then fluidized bed granulation was performed using a granulator to produce the granules described in Production Example 1-4. The granules described in Production Example 1-4 may be taken by dissolving 3 g per day in 100 ml of water or the like, or may be taken as is without dissolving. All of the granules in Production Example 1-4 can suppress midnight awakening and are effective in improving the quality of sleep.

[0038] [Table 2]

[0039] [Production Example 5-8: Tablets] According to the composition in Table 3, oenothein B and other raw materials were mixed, and then tableted using a rotary tablet press to produce tablets (250 mg) of Production Example 5-8. One to two tablets of the tablets described in Production Example 5-8 may be taken per day with water or the like. All tablets of Production Example 5-8 can suppress midnight awakening and are effective in improving the quality of sleep.

[0040] [Table 3]

[0041] [Production Example 9-12: Hard Capsule] According to the composition in Table 4, oenothein B was mixed with other raw materials and encapsulated with a film containing gelatin or hydroxypropyl cellulose to produce hard capsules (contents: 300 mg). One to two capsules per day can be taken with water or the like. All of the hard capsules in Production Examples 9 to 12 can suppress midnight awakening and are effective in improving the quality of sleep.

[0042] [Table 4]

[0043] [Manufacturing example 13-16: PET beverage] According to the formula in Table 5, a liquid formulation containing oenothein B and other ingredients was packed in a PET container to produce a PET beverage (500 ml). One bottle should be consumed per day. All of the PET beverages in Production Examples 13-16 can suppress midnight awakening and are effective in improving the quality of sleep.

[0044] [Table 5] [Industrial Applicability]

[0045] The composition of the present invention is industrially useful since it can improve the quality of sleep and can be used as a health food or the like.

Claims

[Claim 1] A composition for improving sleep quality, comprising oenothein B.

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