Oral composition for improving sleep quality, oral composition for improving mental health problems

Abstract

This invention provides an oral composition containing cannabidiol that offers excellent sleep quality improvement and relaxation effects. [Solution] A sleep quality improvement product characterized by containing 16 mg to 24 mg of cannabidiol per day. Also, an oral composition for improving mental health problems characterized by containing 16 mg to 24 mg of cannabidiol per day.

Description

Technical Field

[0001] The present invention relates to an oral composition for improving the quality of sleep containing cannabidiol and an oral composition for improving mental health disorders.

Background Art

[0002] As a component expected to have a new pharmacological action, cannabidiol (hereinafter sometimes referred to as CBD) has been attracting attention. Cannabidiol is a kind of cannabinoid contained in hemp, and for example, a therapeutic agent for epilepsy and a composition for treating tuberous sclerosis have been developed (Patent Document 1, Patent Document 2). In addition, although other functions have been studied, the studies are not sufficient. Also, although it is assumed that the biological reaction to a chemical substance has a dose-dependence, it is known that there are substances that do not necessarily show a dose-response relationship that applies to this. In such substances, it becomes impossible to estimate the effect of a low dose from the effect detected at a high dose, and it is also known that the efficacy of the substance cannot be accurately evaluated unless the effect at a low dose is also confirmed.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] An object of the present invention is to provide an oral composition containing cannabidiol and having an excellent effect of improving the quality of sleep and an effect of improving mental health disorders.

Means for Solving the Problems

[0005] The inventors of this invention have diligently conducted research to solve the above problems and have found that by adjusting the daily intake of cannabidiol, excellent effects on improving sleep quality and alleviating mental health problems can be obtained, leading to the present invention.

[0006] In other words, the present invention is as follows: [1] An oral composition for improving sleep quality, characterized by containing 16 mg to 24 mg of cannabidiol as a daily intake. [2] An oral composition for improving mental health disorders, characterized by containing 16 mg to 24 mg of cannabidiol as a daily intake. [3] The oral composition for improving sleep quality according to [1], wherein the improvement in sleep quality is at least one selected from: improved ability to fall asleep, reduced fatigue upon waking, increased satisfaction upon waking, improved feeling of deep sleep, reduced drowsiness upon waking, increased sleep duration, reduced dreaming, reduced nighttime awakenings, shortened duration of nighttime awakenings, reduced drowsiness during activity, and improved sleep rhythm. [4] An oral composition for improving mental health disorders according to [2], wherein the improvement of the mental health disorder is an improvement of at least one of mental health or social health. [5] An oral composition for improving mental health disorders as described in [4], wherein the improvement in mental health is at least one selected from: reduced anxiety, reduced depression, reduced tension, reduced fatigue, reduced irritability, reduced concentration, reduced psychological (mental) stress, reduced confusion, improved mental stability, improved relaxation, improved vitality and energy, improved positive emotions, improved motivation, improved daily role functioning, improved concentration, and improved well-being. [6] An oral composition for improving mental health disorders as described in [4], wherein the improvement of social health is at least one selected from: improved smooth communication with others, active participation in social activities, improved cooperation in the workplace and at home, improved satisfaction with interpersonal relationships, improved self-esteem, and reduced feelings of loneliness. [Effects of the Invention]

[0007] The oral composition of the present invention has excellent effects in improving sleep quality and alleviating mental health problems. [Brief explanation of the drawing]

[0008] [Figure 1] This is the questionnaire used in Test 1 of the present invention. [Modes for carrying out the invention]

[0009] The oral composition for improving sleep quality and the oral composition for improving mental health problems of the present invention are characterized by containing 16 mg to 24 mg of cannabidiol per day. In other words, the oral composition for improving sleep quality and the oral composition for improving mental health problems of the present invention are characterized by containing cannabidiol, with a daily intake of 16 mg to 24 mg of cannabidiol.

[0010] The oral composition of the present invention can effectively improve sleep quality and / or alleviate mental health problems. In this invention, sleep quality specifically refers to morning drowsiness, falling asleep and maintaining sleep (for example, smooth falling asleep and maintaining sleep, or falling asleep quickly and sleeping stably without waking up in the middle of the night), dreaming (for example, not having frequent dreams or nightmares), feeling tired upon waking, waking up in the middle of the night, daytime sleepiness, sleep rhythm, sleep depth, and satisfaction with sleep (for example, sleep without feeling a lack of time). In other words, the oral composition of this invention can improve falling asleep, reduce morning fatigue, improve satisfaction upon waking, enhance the feeling of deep sleep, reduce morning drowsiness, increase sleep duration, reduce dreaming, reduce waking up in the middle of the night, shorten the duration of waking up in the middle of the night, reduce sleepiness during activity, and improve the sleep rhythm. It should be noted that improving sleep quality in this invention is a concept that includes not only improving sleep quality but also suppressing (maintaining) the decline in sleep quality.

[0011] Furthermore, in this invention, improvement of mental health problems means improving at least one of mental health and social health. Improving mental health includes reducing feelings of anxiety, depression, tension, fatigue, irritability, difficulty concentrating, psychological stress, and confusion, as well as improving feelings of mental stability, relaxation, vitality, positive emotions, motivation, role functioning, concentration, and well-being. Furthermore, improving social health includes improving social adaptability, such as smooth communication with others, active participation in social activities, improved cooperation in the workplace and at home, increased satisfaction with interpersonal relationships, increased self-esteem, and reduced feelings of loneliness. Furthermore, improvement of mental health problems refers to a state where mental health is no longer impaired, and is a concept that includes improvement and alleviation of mental health problems.

[0012] The evaluation of the sleep quality improvement effect and the mental health improvement effect of the present invention can be carried out by conventionally known methods and is not particularly limited. The sleep quality improvement effect can be evaluated by, for example, the OSA Sleep Questionnaire, VAS, etc. The mental health improvement effect can be evaluated by, for example, the POMS2, WEMWBS, Rosenberg Self-Esteem Scale, UCLA Loneliness Scale, Subjective Well-being Scale, SF-36, VAS, etc.

[0013] <Cannabidiol> Cannabidiol is a type of cannabinoid and is known to be found in hemp. Cannabidiol is known to have different pharmacological effects from tetrahydrocannabinol, another type of cannabinoid. In this invention, cannabidiol can be extracted and purified from plants such as hemp or citrus peels, or synthesized, but it is preferable to use a synthesized form in order to enhance safety and improve sleep quality and mental health problems.

[0014] As described above, the content of cannabidiol in the oral composition of the present invention is 16 mg to 24 mg as the daily intake. When the content of cannabidiol as the daily intake is less than 16 mg or exceeds 24 mg, a satisfactory sleep quality improvement effect or a mental health disorder improvement effect cannot be obtained. By setting the intake amount within a predetermined range per day, the oral composition of the present invention can obtain an excellent sleep quality improvement effect and a mental health disorder improvement effect.

[0015] From the viewpoint of obtaining a better sleep quality improvement effect and a mental health disorder improvement effect, the content of cannabidiol in the oral composition of the present invention is preferably 16 mg to 24 mg, more preferably 18 mg to 22 mg, and even more preferably 19 mg to 21 mg as the daily intake.

[0016] The oral composition of the present invention may be appropriately designed so that the daily intake of cannabidiol falls within the above range. It may be a mode of ingesting the above intake amount at one time, or a mode of ingesting the above intake amount in multiple divided doses. That is, for example, it can be contained as one day's portion in one packaging container or divided into 2 to 4 multiple packaging containers.

[0017] The packaging form is not particularly limited and can be appropriately selected according to the dosage form, etc. Examples include blister packs such as PTP; strip packaging; heat sealing; aluminum pouches; film packaging using plastics or synthetic resins, etc.; glass containers such as vials; plastic containers such as ampoules.

[0018] The content of cannabidiol in the oral composition of the present invention can be quantified, for example, by high performance liquid chromatography (HPLC). As the HPLC conditions, for example, a column of Unison UK-C18HT (particle size 3 μm) φ4.6 × 150 mm manufactured by Intact Co., Ltd. is used, and a water / acetonitrile mixed solution is used as the liquid medium for the mobile phase. The gradient conditions are as shown in Table 1 below, and the column temperature is 55°C and the flow rate is 1.0 ml / min for analysis.

[0019]

Table 1

[0020] The oral composition for improving sleep quality and the oral composition for improving mental health disorders of the present invention are used for improving sleep quality and mental health disorders. For example, they can be used as pharmaceuticals (including quasi-drugs), functional foods with efficacy indications recognized by a predetermined institution such as foods for specified health use, nutritional functional foods, and foods with functional claims, so-called health foods, or general foods.

[0021] The oral composition for improving sleep quality and the oral composition for improving mental health disorders of the present invention are not particularly limited as long as they contain a predetermined amount of cannabidiol and can be distinguished from other products as a product in terms of exerting the function of improving sleep quality and mental health disorders. For example, any of the main body, packaging, instruction manual, and promotional materials (advertising media) of the product according to the present invention that display the function of improving sleep quality and mental health disorders is included in the scope of the present invention.

[0022] Specifically, regarding improving sleep quality, health foods that display claims such as "improvement of sleep quality," "improvement of sleep quality (sleep depth, satisfaction with sleep upon waking)," "improvement of feeling of deep sleep," "reduction of the number of awakenings during sleep," "reduction of the duration of awakenings during sleep," "improvement of sleep depth," "improvement of satisfaction with sleep depth," "improvement of sleep rhythm," "improvement of daytime sleepiness," "improvement of satisfaction upon waking," "improvement of feeling of extended sleep duration," "support for good quality sleep at night," "sleep support," "sleep improvement," "reduction of sleepiness upon waking," "reduction of fatigue upon waking," "support for good quality sleep," "alleviates daytime sleepiness," "improvement of satisfaction with sleep," "a refreshing and good awakening upon waking," "promptly induces deep sleep," "increases REM sleep time," "increases the ratio of deep sleep to REM sleep," "increases total sleep time," etc., or health foods that display claims that the listed functions have been reported, and regarding improving mental health problems, health foods that display claims such as "alleviation of mental health problems," "improvement of mental health," "alleviation of mental health problems," "alleviation of mental stress," "alleviation of psychological stress," "stress reduction," "transient "Stress reduction," "Relief of temporary stress (irritability)," "Relief of temporary psychological (mental) stress," "Relief of irritability," "Relief of tension," "Relaxation effect," "Improved sense of relaxation," "Relief of anxiety," "Relief of anxiety," "Relief of depressed mood," "Relief of depressed mood," "Relief of confusion," "Relief of confusion," "Relief of bewildered state (state of being unable to organize thoughts)," "Relief of anxiety, tension, and depressed mood," "(Temporary) improvement of vitality and energy," "Reduction of decline in vitality and energy," "Maintaining vitality and energy" Maintaining (a positive mood, feeling lively, relaxed, full of energy, mentally sharp, feeling good without worries), improving a gloomy mood, maintaining vitality in middle-aged and elderly people (a feeling of energy and vitality), maintaining mental health (being in a cheerful and calm mood), maintaining a positive mood, maintaining a lively mood, maintaining motivation, supporting a positive mindset (a bright and cheerful mood, a motivated and active state, etc.), supporting a positive attitude (optimism, feeling useful, confidence, having plenty of energy),Examples of health foods that display claims such as "supports happiness (feeling happy, enjoying life)", "improves social health", "improves social well-being", "reduces social health problems", "supports positive feelings in interpersonal relationships (enjoying socializing, trusting others)", "enhances self-esteem (being satisfied with oneself, feeling one's strengths, feeling oneself as valuable as others)", "reduces feelings of loneliness (feeling that one has close friends, feeling that one has someone to talk to, feeling that one has someone to rely on)", "improves daily role functioning", "improves social functioning", "maintains social relationships", "maintains social skills", "maintains sociability", "maintains relationship building", "maintains communication", "enjoys socializing", "deepens bonds with others", "maintains cooperation with others", "makes socializing less burdensome", "can fulfill one's role", "no health problems in work or life", "can live daily life without difficulty", "can maintain work-life balance", "can live a normal life as normal", and "does not feel any discomfort in daily life", or health foods that display claims that the listed functions have been reported. Furthermore, functional foods include those whose functionality is based on scientific evidence such as improving sleep quality or alleviating mental health problems.

[0023] The oral compositions for improving sleep quality and improving mental health problems of the present invention may be labeled as containing cannabidiol as an active ingredient, but are not limited to those in which cannabidiol is labeled as an active ingredient on the product packaging, etc. For example, the active ingredient may not be specified. Furthermore, even general food products are included in the scope of the present invention if they are manufactured and sold with indications of their intended use. For example, food products sold with testimonials on websites, etc., mentioning improvements in sleep quality or mental health problems as personal experiences of those who have consumed them are also included in the scope of the present invention.

[0024] In addition to cannabidiol, the oral composition of the present invention may contain other components as needed. These other components may include, for example, dietary fiber such as water-soluble and insoluble dietary fiber, proteins, various vitamins and minerals, algae, lactic acid bacteria, yeast and other microorganisms. Furthermore, as needed, other components commonly used in the food industry may be included, such as dextrin, sugars like starch, oligosaccharides, sweeteners, acidulants, nutritional supplements, stabilizers, lubricants, binders, glazing agents, thickeners, colorants, excipients, diluents, fillers, emulsifiers, food additives, and seasonings. The content of these other components can be appropriately selected depending on the form of the oral composition of the present invention. Furthermore, from the viewpoint of safety, it is preferable that the oral composition of the present invention substantially contains no cannabinoids other than cannabidiol. Examples of cannabinoids other than cannabidiol include cannabidivarin (CBDV), cannabigerol (CBG), cannabinol (CBN), tetrahydrocannabinol (THC), hexahydrocannabinol (HHC), tetrahydrocannabivarin (THCV), cannabichromene (CBC), cannabidiolic acid (CBDa), cannabicitran (CBT), tetrahydrocannabihexol (THCH), tetrahydrocannabutol (THCB), tetrahydrocannabinol acetate (THCO), hexahydrocannabihexol (HHCH), tetrahydrocannabinolic acid (THCA), and hexahydrocannabinol acetate (HHCO). Substantially containing no cannabinoids means that the amount is less than 0.1% by mass of the total composition, and more preferably 0.01% by mass or less.

[0025] Examples of the oral composition of the present invention include tablets, capsules, powders, granules, liquids, granular preparations, rod-shaped preparations, plate-shaped preparations, block-shaped preparations, solid preparations, round preparations, paste-like preparations, cream-like preparations, caplet-like preparations, gel-like preparations, chewable preparations, stick-shaped preparations, and the like. Among these, the forms of tablets, capsules, powders, granules, and liquids are particularly preferred. Examples of oral compositions used as tablets, capsules, powders, granules, and liquids include supplements; beverages in containers such as PET bottles, cans, and glass bottles; and powdered beverages to be dissolved in water (hot water), milk, fruit juice, etc. These are preferred because they are easy to consume with meals and can enhance palatability.

[0026] The oral composition of the present invention may be in the form of a general food. Examples of food include tea bags, bread and confectionery, noodles, and other various foods and prepared foods. Examples of bread and confectionery include sliced ​​bread, sweet bread, French bread, English bread, muffins, steamed buns, donuts, waffles, and other types of bread; cakes such as butter cake, sponge cake, chiffon cake, and pancakes; frozen desserts such as chocolate, sherbet, and ice cream; jelly, cookies, and gummies. Examples of noodles include udon and somen. Examples of prepared foods include soups such as curry, stew, miso soup, and vegetable soup, as well as their bases and seasonings. [Examples]

[0027] The present invention will be described in more detail below based on examples, but the present invention is not limited thereto. We investigated the effects of changing the daily intake of cannabidiol on improving sleep quality and alleviating mental health problems.

[0028] [Test 1. Evaluation of the effect on improving sleep quality] <Test material> Commercially available CBD powder was used as the cannabidiol. The above CBD powder was encapsulated in a pullulan-based hard capsule shell (No. 1) to produce hard capsules. The cannabidiol content in the test material was 15 mg (Reference Example 1), 16 mg (Example 1), 20 mg (Example 2), 24 mg (Example 3), and 25 mg (Reference Example 2) per capsule.

[0029] <Exam> The study involved five healthy adults. Participants were given one hard capsule containing cannabidiol daily with water. The following day served as a washout period, during which a questionnaire regarding sleep symptoms was administered. This alternating-day administration process was repeated a total of five times (10 days), with the dosage varying each time. The questionnaire, based on the one shown in Figure 1, was used to assess the effects on improving sleep quality and mental health issues. In Figure 1, the evaluation of nine items related to sleep state and physical and mental state was conducted with the left end representing "best feeling" and the right end representing "worst feeling." Participants were asked to indicate where their current state was located on the line segment, the length from the left end was measured, and a score was assigned. The time of falling asleep was recorded for the night before and the night of cannabidiol intake.

[0030] Table 2 shows the questionnaire results for the evaluation items shown in Figure 1. For each case, the average values ​​after ingestion were calculated and shown. The coefficient of variation (standard deviation / mean) of the change in sleep onset time before and after ingestion is also shown.

[0031] [Table 2]

[0032] As shown in Table 2, the following were significantly shortened in Examples 1-3 (CBD 16-24 mg / day) compared with Reference Example 1 (CBD 15 mg / day) and Reference Example 2 (CBD 25 mg / day) for "time to fall asleep," "feeling refreshed upon waking," "frequent awakenings during sleep," "physical condition during the day," "ability to answer survey questions promptly and quickly upon waking," "time felt slept," "strange dreams," "waking up during the night," "daytime sleepiness: when sitting and talking to someone," and "coefficient of variation of change in time to fall asleep." The examples showed a greater shortening than Reference Example 2, which contained a higher amount of CBD, which was an unexpected result. Furthermore, since the examples showed improvements in sleep quality, including time to fall asleep, fatigue upon waking, sleep maintenance, feeling of deep sleep, sleepiness upon waking, sleep duration, dreams, awakenings during the night, daytime sleepiness, and sleep rhythm, it can be expected that it will affect the mental state during wakefulness and have an effect on improving mental health problems.

[0033] [Test 2. Evaluation of the effect on improving mental health problems] <Test material> Commercially available CBD powder was used as the cannabidiol. The above CBD powder was encapsulated in a pullulan-based hard capsule shell (No. 1) to produce hard capsules. The cannabidiol content in the test material was 18 mg (Example 4), 20 mg (Example 5), 22 mg (Example 6), 25 mg (Reference Example 3), and 100 mg (Reference Example 4) per capsule. In addition, a hard capsule without cannabidiol (Comparative Example 3) was also produced as a comparative example.

[0034] <Exam> The study involved 16 healthy adults as subjects. Participants took one hard capsule daily with water, and the following day served as a washout period. A questionnaire regarding mental health symptoms was administered to assess the effectiveness of the medication in improving mental health issues. Each questionnaire item was rated on a five-point scale. 1: Not applicable at all 2: Not really applicable 3: I can't say either way. 4: Somewhat applicable 5: Very much applies

[0035] Table 3 shows the survey results. For each item, the average change before and after intake was calculated and shown. [Table 3]

[0036] As shown in Table 3, in all evaluation items, Examples 4-6 (CBD 18-22 mg / day), Reference Example 3 (CBD 25 mg / day), and Reference Example 4 (CBD 100 mg / day) showed improvement in mental health problems compared to Comparative Example 1 (CBD 0 mg / day). Furthermore, Examples 4-6 showed even better improvement in mental health problems compared to Reference Examples 3 and 4. In particular, the fact that Examples 4-6 showed better improvement than Reference Examples 3 and 4, which contained large amounts of CBD, was an unexpected result.

[0037] The results of Tests 1 and 2 clearly demonstrate that the oral composition of the present invention exhibits excellent effects in improving sleep quality and alleviating mental health problems.

[0038] <Manufacturing example> Based on the results of the examples, a manufacturing example of the present invention is shown below.

[0039] <Manufacturing Examples 1-4> The granules were prepared according to the composition shown in Table 3 below. The granules obtained in the following manufacturing example provide excellent sleep quality improvement and relief from mental health problems when taken once a day at a dose of 2g.

[0040] [Table 3]

[0041] <Manufacturing Examples 5-8> Tablets (250 mg per tablet) were manufactured according to the composition shown in Table 4 below. The tablets obtained in the manufacturing example below, when taken two tablets once a day, provide excellent effects in improving sleep quality and alleviating mental health problems.

[0042] [Table 4]

[0043] <Manufacturing Examples 9-11> Granules were prepared according to the composition shown in Table 5 below, and encapsulated in a pullulan-based hard capsule shell to produce hard capsules (250 mg per capsule; 180 mg granules, 70 mg shell). The hard capsules obtained in the following manufacturing example provide excellent sleep quality improvement and relief from mental health problems when taken twice a day, one capsule at a time.

[0044] [Table 5]

[0045] <Manufacturing Examples 12-14> The liquid contents of the soft capsules were prepared according to the composition shown in Table 6 below, and then enclosed in a porcine gelatin soft capsule shell to produce soft capsule preparations (350 mg per capsule; 220 mg liquid contents, 130 mg shell). The soft capsule preparations obtained in the following manufacturing example provide excellent effects in improving sleep quality and alleviating mental health problems when taken as two capsules once a day.

[0046] [Table 6]

[0047] <Manufacturing Examples 15-17> Chocolate was manufactured according to the composition shown in Table 7 below. The chocolate obtained in the manufacturing example below, when taken once a day at a dose of 10g, provides excellent effects in improving sleep quality and alleviating mental health problems.

[0048] [Table 7]

[0049] <Manufacturing Examples 18-20> The gummies were manufactured according to the composition listed in Table 8 below. The gummies obtained in the manufacturing example below, when taken once a day at a dose of 4g, provide excellent effects in improving sleep quality and alleviating mental health problems.

[0050] [Table 8] [Industrial applicability]

[0051] The oral composition of the present invention has high industrial utility because it can improve sleep quality and alleviate mental health problems.

Claims

1. An oral composition for improving sleep quality, characterized by containing 16 mg to 24 mg of cannabidiol per day.

2. An oral composition for improving mental health problems, characterized by containing 16 mg to 24 mg of cannabidiol per day.

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