Agent for improving quality of sleep

Abstract

To provide an agent for improving quality of sleep.SOLUTION: There is disclosed an agent for improving quality of sleep that comprises a plant belonging to the genus Trapa or a processed product thereof.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an agent for improving sleep quality. [Background technology]

[0002] Humans spend about one-third of their lives "sleeping," and sleep is considered to be the most important act for humans. However, the quality and quantity of sleep of modern people is declining due to various external environmental factors, and many people complain of symptoms of sleep deprivation and insomnia. Since a decline in sleep quality not only leads to serious illnesses such as myocardial infarction and cerebral infarction, but also affects concentration and work performance, products with better sleep-improving effects are desired.

[0003] On the other hand, it has been reported that extracts of plants belonging to the genus Trachyspermum have excellent Maillard reaction inhibitory effects (Patent Document 1).

[0004] In addition, it has been reported that compounds isolated from a hot water extract of either or both of the pericarp and fruit of a plant belonging to the family Trachycarpa, and having molecular weights in the ranges of 70 to 130 and 290 to 380 as measured by gel filtration chromatography, have a high ability to inhibit the formation of advanced glycation end products (Patent Document 2).

[0005] Furthermore, it has been reported that one or more compounds contained in either or both of the pericarp and fruit of plants belonging to the family Trachycarpa have activity in improving infertility (Patent Document 3).

[0006] In addition, it has been reported that one or more compounds contained in either or both of the pericarp and fruit of plants belonging to the family Trachyaceae have high adiponectin secretion-promoting activity and adipose precursor cell differentiation-promoting activity (Patent Document 4).

[0007] It has been reported that one or more compounds contained in either or both of the pericarp and fruit of plants belonging to the family Trachycarpa have high amyloid beta aggregation inhibitory activity and BACE1 inhibitory activity, and are used as components of anti-Alzheimer's compositions (Patent Document 5). [Prior art documents] [Patent documents]

[0008] [Patent Document 1] JP 2014-94964 A [Patent Document 2] JP 2015-209420 A [Patent Document 3] JP 2016-145182 A [Patent Document 4] JP 2019-52122 A [Patent Document 5] JP 2020-83815 A Summary of the Invention [Problem to be solved by the invention]

[0009] As described above, it is known that extracts of plants belonging to the Trachyspermum genus have various effects, but it is not known that extracts of plants belonging to the Trachyspermum genus have an effect of improving sleep quality, for example.

[0010] An object of the present invention is to provide an agent for improving sleep quality. [Means for solving the problem]

[0011] Means for Solving the Problems The present inventors have conducted intensive research to achieve the above object, and as a result have discovered that a hot water extract of Trapa bisporus peel exhibits a significantly excellent effect of improving sleep quality.

[0012] The present invention has been completed based on these findings and through further investigation, and provides the following sleep quality improving agent.

[0013] Item 1. A sleep quality improving agent containing a plant belonging to the genus Trapa or a processed product thereof. Item 2. The sleep quality improving agent according to Item 1, wherein the plant belonging to the genus Trapa is Trapa. Item 3. The sleep quality improving agent according to Item 1 or 2, wherein the plant belonging to the genus Trachyspermum or a processed product thereof is an extract of a plant belonging to the genus Trachyspermum. Item 4. The sleep quality improving agent according to Item 1 or 2, wherein the plant belonging to the Trachys genus or a processed product thereof is an extract of the pericarp of a plant belonging to the Trachys genus. Item 5. The sleep quality improving agent according to Item 1 or 2, wherein the plant belonging to the genus Trapa or a processed product thereof is an extract of Trapa bisporus pericarp. Effect of the Invention

[0014] A plant belonging to the genus Trapa or a processed product thereof has a significantly excellent effect of improving the quality of sleep, and is therefore useful as an active ingredient of an agent for improving the quality of sleep.

[0015] In addition, plants belonging to the genus Trapa or processed products thereof are highly safe since they are naturally derived ingredients. [Brief description of the drawings]

[0016] [Figure 1] Graph showing the results of the daytime awakening difficulty score of the Pittsburgh Sleep Quality Index of the embodiment. Left: Daytime awakening difficulty score (EMM (Estimated Marginal Mean)), p value is based on ANCOVA, Right: Daytime awakening difficulty score progress (Mean (average value)) DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] Hereinafter, an embodiment of the present invention will be described in detail.

[0018] The sleep quality improving agent of the present invention is characterized by containing a plant belonging to the genus Trapa or a processed product thereof.

[0019] Plants belonging to the genus Trachyspermum or processed products thereof Examples of plants belonging to the Trapa genus include, but are not limited to, Trapa japonica, Trapa natans L. ver. Japonica, Trapa incisa, Trapa bispinosa Roxb., Trapa acornis, Trapa natans, etc. Among these, Trapa bispinosa is preferred.

[0020] As the plant of the genus Trachysperm, a part or the whole of a plant of the genus Trachysperm may be used. Examples of the part of the plant include flowers, inflorescences, fruit skin, fruit, flesh, stems, leaves, branches, branches and leaves, trunks, bark, rhizomes, root bark, roots, seeds, galls, heartwood, above-ground parts, underground parts, etc., and these parts may be used alone or in combination.

[0021] In the present invention, the term "processed product" is not particularly limited, but may be, for example, a product obtained by subjecting a plant belonging to the genus Trachysus to some kind of processing. Examples of processed products include extracts, ground products, dried powders, crushed products, squeezed juices, crushed products, heat-treated products, chemically treated products, enzyme-treated products, and combinations thereof. The dried powder of a plant belonging to the genus Trachysus can be prepared by drying and further crushing a plant belonging to the genus Trachysus. The drying of a plant belonging to the genus Trachysus can be carried out, for example, by sun drying, hot air drying, freeze drying, spray drying, etc. The crushing and crushing can be carried out, for example, by using a crusher, a crusher, etc., respectively. The processed product of a plant belonging to the genus Trachysus is preferably an extract of a plant belonging to the genus Trachysus.

[0022] For the production of an extract of a plant belonging to the genus Trachysperm, a part or the whole of the plant belonging to the genus Trachysperm may be used. Examples of parts of a plant include flowers, inflorescences, pericarp, fruit, flesh, stems, leaves, branches, foliage, trunks, bark, rhizomes, root bark, roots, seeds, galls, heartwood, above-ground parts, and underground parts, and these parts may be used alone or in combination. The parts of a plant used for the production of an extract are preferably fruits and pericarp, and more preferably pericarp. In addition, any state of the plant, such as raw, dried, cut, or crushed, may be used for the production of an extract. The extract of a plant belonging to the genus Trachysperm is preferably an extract of the pericarp of a plant belonging to the genus Trachysperm, and more preferably a pericarp extract.

[0023] The method for producing an extract of a plant belonging to the genus Trachyspermum is not particularly limited, and can be carried out by a commonly used method. For example, each part of a plant belonging to the genus Trachyspermum is cut into pieces of appropriate size and squeezed or extracted with a solvent. Hot water extraction is particularly preferred as an extraction method. As such an extraction solvent, water, an organic solvent, or a water-containing organic solvent can be used, and examples of the organic solvent include lower alcohols having 1 to 5 carbon atoms such as methanol, ethanol, 1-propanol, 2-propanol, 1-butanol, 2-butanol, 2-methyl-1-propanol, 2-methyl-2-propanol, 1-pentanol, 2-pentanol, and 3-pentanol, ethers such as diethyl ether, esters such as methyl acetate and ethyl acetate, ketones such as acetone, and organic acids such as acetic acid, glacial acetic acid, and propionic acid. The extraction solvent is preferably water, methanol, ethanol, or an aqueous solvent obtained by mixing any two or more of these in any ratio. Particularly preferred extraction solvents are water, and an aqueous solvent obtained by mixing ethanol, an organic solvent approved as a food additive, and water in any ratio.

[0024] The temperature of the extraction solvent can be any temperature above room temperature and below the boiling point of the extraction solvent, and is desirably determined in consideration of the extraction efficiency, heat resistance, volatility, etc. of the extracted substance. If necessary, a heated extraction solvent can be used to improve the extraction efficiency. The extraction time can be within the range of 1 hour to 15 days. When water or an aqueous solvent is used as the extraction solvent, an acid, a base, a salt, etc. can be appropriately contained as necessary to improve the extraction efficiency. The pH of the water used for extraction is not particularly limited, and is preferably near neutral in consideration of use in a living body, more preferably pH 4 to 9, and even more preferably pH 6 to 8.

[0025] Hot water extraction can be carried out by any known method, for example, a method in which a plant belonging to the genus Trapa is mixed in an extraction solvent for a predetermined time and then separated from the solid matter by filtration, centrifugation, decantation, or the like, or a continuous extraction method such as Soxhlet extraction can be used.

[0026] When removing insoluble matters by filtration, adsorbents and filter aids such as activated carbon, bentonite, celite, etc. can be added to remove impurities, if necessary. In particular, when using in the form of an extract, it is preferable to also perform sterilization filtration using a membrane filter, etc.

[0027] The solvent extract of a plant belonging to the genus Trapa can be used as it is, or, if necessary, can be purified by ultrafiltration, molecular sieve chromatography (gel filtration), adsorption chromatography, ion exchange chromatography, affinity chromatography, high performance liquid chromatography (HPLC), dialysis, or a combination of these.

[0028] The solvent extract of a plant belonging to the genus Trapa includes a recovered extract (including one further purified as necessary), a concentrate obtained by concentrating the extract, and a solid obtained by removing the solvent from the extract by freeze-drying, spray-drying, etc. Here, the concentration, freeze-drying, and spray-drying of the extract can be carried out according to a conventional method.

[0029] Sleep quality improver The proportion of a plant belonging to the genus Trapa or a processed product thereof contained in the sleep quality improving agent of the present invention is not particularly limited, and may be, for example, 0.001 to 100% by mass of the total amount of the sleep quality improving agent. The upper and lower limits of the range are, for example, 0.01% by mass, 0.1% by mass, 1% by mass, 5% by mass, 10% by mass, 20% by mass, 30% by mass, 40% by mass, 50% by mass, 60% by mass, 70% by mass, 80% by mass, 90% by mass, 95% by mass, 99% by mass, and 99.9% by mass.

[0030] In the present invention, "improving the quality of sleep" means improving the quality of sleep. "Improvement" means improving or maintaining symptoms or conditions, preventing or delaying the worsening of symptoms or conditions, etc.

[0031] An example of a method for evaluating sleep quality is the Pittsburgh Sleep Quality Index (PSQI).

[0032] The sleep quality improving agent of the present invention may contain, as appropriate, known ingredients other than plants belonging to the genus Trapa or processed products thereof, as long as the effects of the present invention are not impaired.

[0033] The sleep quality improving agent of the present invention can be used as food and drink (particularly food and drink intended for health, maintaining or improving health, etc. (e.g., health food, functional food, nutritional supplement, supplement, food for specified health use, nutritional functional food, or food with functional labeling)), medicine (including quasi-drugs), etc. The sleep quality improving agent of the present invention also includes the meaning of an additive that imparts an effect of improving sleep quality.

[0034] In the above-mentioned foods and beverages, extracts of plants belonging to the genus Trapa can be used as they are, but if necessary, vitamins, flavonoids, minerals, quinones, polyphenols, amino acids, nucleic acids, essential fatty acids, cooling agents, binders, sweeteners, colorants, fragrances, stabilizers, preservatives, disintegrants, lubricants, sustained-release regulators, surfactants, solubilizers, wetting agents, etc. can also be blended therein.

[0035] Food and drink includes all foods and drinks that animals (including humans) can consume. The types of food and drink are not particularly limited, and examples thereof include dairy products; fermented foods (yogurt, cheese, etc.); beverages (soft drinks such as coffee, juice, and tea drinks, milk drinks, lactic acid bacteria drinks, drinks containing lactic acid bacteria, yogurt drinks, carbonated drinks, sake, Western liquor, and alcohol such as fruit wine); spreads (custard cream, etc.); pastes (fruit paste, etc.); Western confectionery (chocolate, donuts, pies, cream puffs, gum, candy, jelly, cookies, cakes, puddings, etc.); Japanese confectionery (daifuku, mochi, manju, castella, anmitsu, yokan, etc.); frozen desserts (ice cream, popsicle, sorbet, etc.); foods (curry, beef bowl, porridge, miso soup, soup, meat sauce, pasta, pickles, jam, etc.); and seasonings (dressing, furikake, umami seasoning, soup base, etc.).

[0036] The method for producing the food or drink is not particularly limited, and any known method can be used as appropriate.

[0037] When using foods and beverages as supplements, the dosage unit form is not particularly limited and can be selected appropriately. Examples include tablets, capsules, granules, liquids, powders, and the like.

[0038] The intake amount of food and drink can be appropriately set depending on various conditions such as the weight, age, sex, and symptoms of the person consuming the food and drink.

[0039] For the above-mentioned pharmaceutical products, plants belonging to the genus Trapa or processed products thereof may be used alone, or they may be used in combination with other medicinal ingredients such as vitamins and herbal medicines listed in the Japanese Pharmacopoeia.

[0040] When prepared as a pharmaceutical, the plant belonging to the genus Trapa or a processed product thereof can be used as is, or can be prepared together with pharmaceutical acceptable ingredients into various forms such as tablets (including plain tablets, sugar-coated tablets, film-coated tablets, effervescent tablets, chewable tablets, troches, etc.), capsules, pills, powders (dispersed medicines), fine granules, granules, liquids, suspensions, emulsions, syrups, pastes, and injections (including the case where the plant is mixed with distilled water or infusions such as amino acid infusions or electrolyte infusions at the time of use to prepare a liquid), to form a pharmaceutical preparation.

[0041] In addition to the plant belonging to the genus Trapa or a processed product thereof, pharmaceuticals may contain appropriate pharma- ceutically acceptable ingredients such as excipients, binders, disintegrants, lubricants, suspending agents, thickeners, antioxidants, absorption enhancers, pH regulators, colorants, preservatives, surfactants, stabilizers, sweeteners, flavorings, and fragrances, as necessary.

[0042] The method of administration of the pharmaceutical agent is not particularly limited, and can be, for example, oral administration, intra-arterial administration, intravenous administration, buccal administration, rectal administration, enteral administration, transdermal administration, or the like.

[0043] The dosage of a pharmaceutical agent can be appropriately determined depending on various conditions such as the patient's weight, age, sex, symptoms, administration method, and type of dosage form.

[0044] The dosage and intake of foods, beverages, and medicines is generally the amount of active ingredient contained in the preparation for humans, and is preferably 0.1 to 2000 mg / day per adult. Of course, the dosage and intake vary depending on various conditions, so there are cases where a dosage less than the above dosage and intake is sufficient, and cases where a dosage exceeding the above range is necessary.

[0045] The sleep quality improving agent of the present invention described above is applicable to mammals including humans.

[0046] The sleep quality improving agent of the present invention is effective for people who wake up during sleep, people who feel sleepy during the day, people who have light sleep, and the like.

[0047] When the sleep quality improving agent of the present invention is used as a food or drink, it may be labeled as "It has been reported to have the function of improving sleep quality" or a similar label may be used.

[0048] As shown in the examples below, the present inventors have found that a plant belonging to the genus Trapa or a processed product thereof exhibits an excellent effect of improving sleep quality. Therefore, since a plant belonging to the genus Trapa or a processed product thereof has an excellent effect of improving sleep quality, it can be suitably used as an active ingredient of a sleep quality improving agent.

[0049] In addition, plants belonging to the genus Trapa or processed products thereof are highly safe since they are naturally derived ingredients.

[0050] In addition, in this specification, the term "comprising" includes "consisting essentially of" and "consisting of." In addition, the present invention includes all arbitrary combinations of the constituent elements described in this specification.

[0051] Furthermore, the various characteristics (properties, structures, functions, etc.) described in each embodiment of the present invention above may be combined in any way to specify the subject matter included in the present invention. In other words, the present invention includes all subject matter consisting of all combinations of the combinable characteristics described in this specification. EXAMPLES

[0052] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to these examples.

[0053] I. Preparation of Water Chestnut Extract After harvesting, the fruits of Trapa bispinosa were dried and the dried skin was collected. The dried skin was crushed and extracted with hot water (6 parts by mass of 90°C hot water was used for 1 part by mass of dried skin). 33% by mass of dextrin was added to 67% by mass of the extract, and the mixture was spray-dried with a spray dryer to obtain a water chestnut skin extract powder.

[0054] As the test food, capsules (total mass 234 mg) were prepared by encapsulating 100 mg of water chestnut peel extract powder, 83.62 mg of corn starch as excipients, and 1.38 mg of calcium stearate in 49 mg of hard capsules.

[0055] II. Placebo-controlled, double-blind, randomized, parallel-group study II-1. Test Method [subject] The subjects of this study were healthy Japanese men and women aged 40 to 64 years.

[0056] [intervention] The intervention period was 8 weeks, and participants were asked to take one tablet of the test food or placebo food per day before breakfast with water or lukewarm water. The placebo food was made with an excipient that did not contain water chestnut extract and was indistinguishable in appearance, shape, color, odor, and taste.

[0057] [Evaluation items] Measurements using the Pittsburgh Sleep Quality Index (Japanese version) were conducted before intake, 4 weeks after intake, and 8 weeks after intake.

[0058] The Pittsburgh Sleep Quality Index (PSQI) allows users to self-report, score, and evaluate overall sleep quality, and has accumulated the most evidence among existing sleep scales. The Pittsburgh Sleep Quality Index (PSQI) is composed of seven subscales, such as sleep quality, sleep onset time, sleep duration, sleep efficiency, sleep difficulties, use of sleeping pills, and daytime activity disorders, and is evaluated based on the total score of these. Therefore, it is considered to be an appropriate indicator for observing "sleep quality in a broad sense (overall evaluation of sleep)" (Reference: Ministry of Health, Labor, and Welfare, Systematic review examining the relationship between "sleep quality" and health outcomes using the Pittsburgh Sleep Quality Index as an indicator, https: / / mhlw-grants.niph.go.jp / system / files / report_pdf / 202009018A-buntan2.pdf)

[0059] II-2. Test Results [Subjects for analysis of intergroup comparison] Of the 56 subjects enrolled in the study (28 in the test food group and 28 in the placebo group), one subject (test food group) did not visit the clinic for the measurement at week 4, one subject (test food group) did not visit the clinic for the measurement at week 8, and one subject (placebo group) did not visit the clinic for either the measurement at week 4 or week 8. Therefore, in the test food group, 28 subjects were included in the total number of subjects for analysis, including subjects with missing data at either week 4 or week 8, and 27 subjects each were included in the analysis data, excluding one subject each who did not visit the clinic at week 4 or week 8. In the placebo group, 27 subjects were included in the analysis, excluding one subject for whom measurement data could not be obtained at weeks 4 and 8, and an intergroup comparison analysis was performed.

[0060] [Evaluation results: comparison between groups] The Pittsburgh Sleep Quality Index scores and statistical analysis results are shown in Table 1 and Figure 1. The score for [C7: Difficulty waking during the day] four weeks after intake was significantly lower in the test food group (TBE (Trapa bispinosa Roxb. Pericarp Extract) group) compared to the placebo group, confirming an improvement in sleep quality.

[0061] [Table 1]

[0062] [Subjects for before-and-after comparison analysis] Of the 56 cases enrolled in the study (28 in the test food group, 28 in the placebo group), one case (test food group) did not visit the hospital for the measurement at week 4, one case (test food group) did not visit the hospital for the measurement at week 8, and one case (placebo group) did not visit the hospital for either the measurements at weeks 4 or 8. Therefore, 26 cases (excluding 2 cases) from the test food group were analyzed, and 27 cases (excluding 1 case) from the placebo group were analyzed, and a before-and-after comparison analysis was performed.

[0063] [Evaluation results before and after comparison] As shown in Table 1, in the test food group, the Pittsburgh Sleep Quality Index total score, C1: sleep quality, and C7: daytime awakening difficulty were significantly lower 4 and 8 weeks after intake, and C2: time to fall asleep was significantly lower 4 weeks after intake, compared to before intake.

[0064] [Consideration] The Pittsburgh Sleep Quality Index is a widely accepted method for evaluating sleep quality. A significant decrease in the Pittsburgh Sleep Quality Index was confirmed in the test food group compared to the placebo group. Since the only ingredient in the test food with health benefits was water chestnut extract, it was shown that taking water chestnut extract may have an effect of improving sleep quality.

Claims

1. A sleep quality improving agent containing a plant belonging to the genus Trapa or a processed product thereof.

2. 2. The sleep quality improving agent according to claim 1, wherein the plant belonging to the genus Trapa is Trapa.

3. 3. The sleep quality improving agent according to claim 1, wherein the plant belonging to the genus Trachyspermum or a processed product thereof is an extract of a plant belonging to the genus Trachyspermum.

4. 3. The sleep quality improving agent according to claim 1, wherein the plant belonging to the genus Trachysperm or a processed product thereof is an extract of the pericarp of a plant belonging to the genus Trachysperm.

5. 3. The sleep quality improving agent according to claim 1, wherein the plant belonging to the genus Trapa or a processed product thereof is an extract of Trapa bispinosa pericarp.

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