JP7423731B2 - Agents to improve fatigue, lack of motivation, or drowsiness - Google Patents

Description

The present invention relates to an oral composition suitably used for preventing or ameliorating mental fatigue. The present invention also relates to an oral composition suitably used for preventing or ameliorating loss of appetite or sleepiness.

Fatigue is not just physical fatigue due to exercise, but also mental fatigue such as infectious fatigue associated with immune disease or functional decline, mental/environmental stress, and fatigue due to sleep/rhythm disorders. In recent years, stress has not only been caused by mental tension in interpersonal relationships, but also mental stress caused by long hours of desk work, especially long hours of VDT (Visual Display Terminal) work that uses display devices such as computer displays. Sexual fatigue is increasing. When this mental fatigue becomes chronic, it causes a decline in energy, motivation, concentration, mental anxiety, and drowsiness, which not only interferes with daily life but also increases the risk of developing depression. There is a growing demand for drugs, foods and drinks that can effectively improve symptoms.

Taking pharmaceuticals such as tranquilizers, anti-anxiety agents, and chemically synthesized drugs such as sleeping pills is known as a way to improve mental fatigue, but there is generally a deep-rooted resistance to pharmaceuticals, and they can also be addictive and cause side effects. The problem is that it is not possible to eliminate the risk of Therefore, it is desired to find a naturally derived ingredient, especially from a safety perspective, a natural material such as a plant that has been eaten, and which has the effect of improving mental fatigue. Beverages and health foods that contain ingredients that are said to improve mental fatigue include, for example, γ-aminobutyric acid (GABA) (Patent Document 1), caffeine, theanine and arginine (Patent Document 2), flavonoids, and A method of orally ingesting a transglycosylated flavonoid (Patent Document 3) has also been proposed.

Furthermore, it is known that mental fatigue not only causes a decline in concentration and thinking ability and emotional instability, but also has physical effects, and that mental fatigue can lead to physical fatigue. When the condition is complex, it can be perceived as a decrease in the desire for physical activity, such as drowsiness, general malaise, malaise, and a feeling of weakness. Beverages and health foods that contain ingredients that are said to have an ameliorating effect on such symptoms include, for example, those containing chili pepper extract and/or ginger extract and theanine to suppress drowsiness and improve concentration. A method of orally ingesting a composition (Patent Document 4) or an improving agent containing Yerba mate extract (Patent Document 5) for improving motivation reduction during fatigue or stress has also been proposed.

By the way, many of the ingredients that have a fatigue-improving effect are known to have high antioxidant ability. Black soybean seed coat extract contains large amounts of polyphenols such as proanthocyanidins and anthocyanins, and these components have high antioxidant capacity, so black soybean seed coat extract is also expected to have a fatigue-improving effect. Research is underway. For example, a physical fatigue-improving composition containing black ginger, black pepper, black soybean seed coat, black sesame, and fermented black onion (Patent Document 6), which reduces fatigue markers after exercise load, and astaxanthin, lutein, and black soybean seed coat. An agent for improving stiff shoulders and/or eye congestion (Patent Document 7) containing bilberry extract, bilberry extract, and DHA has been proposed.

However, it is not known that black soybean hull extract has the effect of preventing or improving mental fatigue, loss of motivation, or sleepiness.

JP2006-273733A Japanese Patent Application Publication No. 2002-322063 International Publication No. 2010/029913 Japanese Patent Application Publication No. 2013-180960 Japanese Patent Application Publication No. 2008-019190 JP 2015-110536 Publication Japanese Patent Application Publication No. 2016-183121

An object of the present invention is to provide an oral composition suitably used to prevent or improve mental fatigue, loss of motivation, or sleepiness. More specifically, it is an object of the present invention to provide an oral composition that can prevent or improve mental fatigue, loss of motivation, or sleepiness caused by VDT (Visual Display Terminal) workload.

The present inventors have conducted extensive studies to solve the above problems, and have discovered that ingesting a black soybean seed coat extract prevents or improves mental fatigue, loss of motivation, or drowsiness. Furthermore, it was discovered that mental fatigue, loss of motivation, or drowsiness caused by VDT (Visual Display Terminal) work can be prevented or improved, and the present invention was completed based on these findings. From this, it is thought that by ingesting black soybean hull extract, mental fatigue, loss of motivation, or sleepiness can be prevented or improved, and health can be improved.

The present invention was completed based on these findings, and includes the following embodiments.
(1) Agents for improving mental fatigue, loss of motivation and sleepiness
(1-1) An ameliorating agent used for the purpose of preventing or ameliorating at least one of mental fatigue, loss of motivation, and drowsiness, which contains black soybean hull extract as an active ingredient.
(1-2) The improving agent according to 1-1, wherein the mental fatigue, decreased motivation, or sleepiness is caused by VDT (Visual Display Terminal) workload.
(1-3) The improving agent according to 1-1 or 1-2, wherein the black soybean seed coat extract is an acidic extract of black soybean seed coats.
(1-4)) The improving agent according to any one of 1-1 to 1-3, which is a drug, a quasi-drug, or a food or drink.

(2) Method of using black soybean seed coat extract (2-1) Black soybean seed coat extract is blended into an oral composition to cause at least one of mental fatigue, loss of motivation, and drowsiness to the oral composition. A method of using black soybean seed coat extract to impart preventive or ameliorative effects.

According to the agent for improving mental fatigue, decreased motivation, or drowsiness of the present invention, the improving agent of the present invention containing black soybean seed coat extract as an active ingredient is orally ingested. can be prevented or ameliorated. In particular, it is possible to prevent or improve at least one of mental fatigue, loss of motivation, and sleepiness caused by VDT (Visual Display Terminal) workload. Further, according to the method of using the black soybean hull extract of the present invention, it can be used to impart an effect of preventing or improving at least one of mental fatigue, loss of motivation, and drowsiness to an oral composition. That is, the method of use of the present invention can be used to prepare an oral composition for preventing or ameliorating mental fatigue, decreased motivation, or sleepiness, and thus prevents at least one of mental fatigue, decreased motivation, or sleepiness. It is possible to prepare and provide oral compositions (oral pharmaceuticals, oral quasi-drugs, food and drink products) that are highly effective in preventing or improving any of the following.

Figure 1 shows the study design. FIG. 2 is a diagram showing a flowchart for the subject. Figure 3 is a diagram showing actual measured values for the 2-back task. FIG. 4 is a diagram showing changes from the pre-intake test day in data compiled from two sets of ATMT (ABC tasks) (average reaction time until the next trial C-solution-A task). FIG. 5 is a diagram showing the evaluation results of "feeling of mental fatigue" by the VAS method. FIG. 6 is a diagram showing the evaluation results of "drowsiness" by the VAS method. FIG. 7 is a diagram showing the evaluation results of "decreased motivation" using the VAS method. FIG. 8 is a diagram showing actual values measured by the VAS method.

EMBODIMENT OF THE INVENTION Hereinafter, embodiments will be shown and explained about the method for using and producing the agent for improving mental fatigue, decreased motivation, or sleepiness, and the black soybean seed coat extract of the present invention. However, the present invention is not limited to the embodiments described below.
In addition, in the present invention, "prevention" means the effect of reducing mental fatigue and sleepiness and improving motivation (preventive effect) in normal times before fatigue and stress loads occur, and "improvement" means the effect (improving effect) of suppressing mental fatigue and drowsiness and maintaining or suppressing the decline of motivation after (immediately after) fatigue and stress loads occur.

(1) Agent for improving mental fatigue, decreased motivation, or drowsiness The agent for improving mental fatigue, decreased motivation, or drowsiness of the present invention (hereinafter also simply referred to as "this improving agent") is an effective agent for improving mental fatigue, decreased motivation, or drowsiness (hereinafter also simply referred to as "this improving agent"). It is characterized by being an ingredient.

The black soybean used in the present invention is the black seed (grain) (black soybean) of a short-day annual plant belonging to the family Fabaceae, genus Glycine max (L.) Merrill. There are varieties of black soybeans, such as Nakasei Kokuro, Tokachikuro, Iwaikuro, Tamadaikoku, Tambaguro, Shinanoguro, and Gankui, but seeds of any black soybean variety may be used.

Black soybeans can be separated into seed coats and embryos (cotyledons and hypocotyls) by, for example, using a sorting machine. In the present invention, the seed coat of black soybean obtained by the separation can be used as a processing raw material. During processing, black soybean seed coats may be separated and left as they are (raw or dried), or they may be crushed or ground (crushed, pulverized, or powdered). ).

As a method for extraction from black soybean seed coat, commonly used methods can be used. Examples include, but are not limited to, a method of immersing raw or dried black soybean seed coat (as is, or in coarse, finely chopped, crushed, or pulverized form) in a water-soluble solvent; a method of extraction with stirring as necessary; ; or a percolation method. The temperature conditions used for extraction are not particularly limited, and may be any of low temperature, room temperature, and heating conditions (including high temperatures), but preferably heating conditions (including high temperatures) that increase extraction efficiency. More specifically, in the case of extraction with a water-containing lower alcohol described below, the temperature is 30°C or higher, preferably in the range of 40°C to 60°C, and although not limited, extraction at such temperature conditions is carried out for 60 minutes or more, preferably 90°C. The desired black soybean seed coat component (extract) can be sufficiently extracted by performing this for about 120 minutes. In addition, when extracting with an acidic aqueous solution, the temperature is 50° C. or higher, preferably in the range of 50 to 80° C., and although not limited, extraction is carried out at such temperature conditions for 10 minutes or more, preferably about 20 minutes to 120 minutes.

The water-soluble solvent used for extraction includes, but is not particularly limited to, water, lower alcohols, or mixtures thereof. Examples of the lower alcohol include lower alcohols having 1 to 4 carbon atoms such as methanol, ethanol, propanol, isopropyl alcohol, and butanol. Ethanol can be preferably mentioned as the lower alcohol. The water-soluble solvent is preferably water or a water-containing lower alcohol (especially water-containing ethanol), and more preferably water because of its ease of extraction or purification. In addition, when using a water-containing lower alcohol as a solvent, it is preferable that the amount of lower alcohol contained therein is 80% by volume or less.

The water-soluble solvent used for extraction is preferably adjusted to be acidic for the purpose of increasing the stability of the black soybean seed coat component (extract). Although not particularly limited, the pH range of the water-soluble solvent is preferably about 1 to 4, particularly preferably about 1 to 2. In order to adjust the pH of the water-soluble solvent to fall within this range, an appropriate acidic substance such as an organic acid or an inorganic acid can usually be used.

Examples of acidic substances include inorganic acids such as hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, and boric acid; as well as methanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, 10-camphorsulfonic acid, and fluorosulfonic acid ( Examples include organic acids such as sulfonic acid), formic acid, acetic acid, citric acid, and oxalic acid (carboxylic acid). Acids having a sulfo group are preferred, and specific examples include sulfuric acid, methanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, 10-camphorsulfonic acid, and fluorosulfonic acid. Among them, sulfuric acid is preferred. Note that the normality of the acid in the water-soluble solvent is not particularly limited as long as the pH of the water-soluble solvent is within the above pH range, but is preferably in the range of 0.01 to 0.5N, more preferably 0.03N. ~0.5N.

The obtained extract can be used as it is as this improving agent, but if necessary, it can be further purified by filtration, coprecipitation or centrifugation to remove solids, activated carbon treatment, adsorption treatment, etc. It's okay.

The black soybean seed coat extract prepared in this manner can be used as it is as the present improving agent, but from the viewpoint of administration and food and drink production, it may be subjected to concentration treatment and/or drying treatment. Furthermore, if necessary, for the purpose of reducing the number of bacteria and improving the preservability of the extract, a known method such as UHT sterilization or retort sterilization may be applied before or after the processing to the extent that the effects of the present invention are not impaired. Sterilization treatment may also be performed. In addition, the black soybean seed coat extract in the present invention shall mean either an extract, a diluted or concentrated solution of the extract, or a dried product obtained by drying the extract.

The form of the improving agent is not particularly limited as long as it is in an oral administration form. In addition, as long as it has an oral administration (oral ingestion) form, it can be classified according to its use (drugs, quasi-drugs, food and drink [foods with health functions such as foods for specified health uses, foods with functional claims, and foods with nutritional functions)]. and supplements]) are not particularly limited. Further, the present improving agent may be applied to feed or pet food for animals other than humans (including livestock, poultry, and pets). Furthermore, the improving agent may be an additive added to pharmaceuticals, quasi-drugs, foods and drinks, feed, or pet food.

Specifically, the oral dosage form includes the extract prepared by the above extraction method in the form of a liquid (including extract form and syrup) or jelly; Powders, fine granules, or granules formulated into capsules; capsules (hard capsules, soft capsules) filled with liquids, powders, or granules; or powders or granules that are further compressed to form tablets. (solid preparations).

The present improving agent is prepared into various dosage forms (oral dosage forms) by combining the black soybean seed coat extract with conventionally known edible carriers, excipients, etc. that are pharmaceutically acceptable or acceptable as food or feed. You can also do that.

When the present improving agent is in the form of a liquid preparation, a wide variety of carriers conventionally known in the art can be used as carriers. By way of example, suitable additives for the production of solutions and syrups can be used, such as water, ethanol, sucrose, invert sugar, glucose, maltose, reduced starch syrup, and the like.

When the present improving agent is in the form of a solid preparation, for example, in the case of a tablet, a wide variety of carriers conventionally known in the art can be used as the carrier. Such carriers include, for example, excipients such as lactose, sucrose, sodium chloride, glucose, urea, starch, calcium carbonate, kaolin, and silicic acid; water, ethanol, propanol, simple syrup, glucose solution, starch solution, and gelatin. Solution, binder such as carboxymethylcellulose, shellac, methylcellulose, potassium phosphate, polyvinylpyrrolidone, crystalline cellulose, hydroxypropylcellulose, hypromellose, sodium alginate; dried starch, agar powder, laminaran powder, sodium bicarbonate, polyoxyethylene sorbitan fatty acid Disintegrants such as esters, sodium lauryl sulfate, stearic acid monoglyceride, starch, crospovidone, povidone, and low-substituted hydroxypropylcellulose; disintegration inhibitors such as stearin, cocoa butter, and hydrogenated oil; quaternary ammonium salts, lauryl Absorption enhancers such as sodium sulfate; humectants such as glycerin; adsorbents such as starch, lactose, kaolin, bentonite, colloidal silicic acid; lubricants such as purified talc, stearate, boric acid powder, polyethylene glycol, etc. can be used. Furthermore, the tablets may be coated with a conventional coating if necessary, such as sugar-coated tablets, gelatin-encapsulated tablets, enteric-coated tablets, film-coated tablets, double tablets, or multilayer tablets. Further, the composition containing the above-mentioned active ingredient can be filled into conventionally known capsules made from gelatin, pullulan, starch, gum arabic, hydroxypropyl methyl cellulose (HPMC), etc., to form capsules.

In addition, when it is in the form of a pill, a wide variety of carriers conventionally known in the art can be used as carriers. Examples include excipients such as glucose, lactose, starch, cocoa butter, hydrogenated vegetable oil, kaolin, and talc, binders such as gum arabic powder, tragacanth powder, gelatin, and ethanol, and disintegrants such as laminaran and agar. can be used.

In addition to the above, additives such as surfactants, absorption enhancers, adsorbents, fillers, preservatives, stabilizers, emulsifiers, and solubilizers may be selected and used as appropriate depending on the form of the formulation. can.

All of these forms can be prepared using methods commonly used in the field; for example, tablets can be prepared by adding the above active ingredient and other excipients necessary to obtain tablets, mixing and dispersing them thoroughly, and then It can be obtained by compressing into tablets. Further, the powder can be obtained by appropriately adding the above-mentioned active ingredient and other excipients necessary for obtaining the powder, and mixing and pulverizing the mixture by a suitable method.

In addition to the above-mentioned formulation form, the present improving agent may be in the form of a normal food or drink. The food and drink can be produced by adding an additive containing the black soybean seed coat extract described above or the black soybean seed coat extract described below to various foods and drinks. The food and drink may be in any form that can be orally ingested, such as a solution, suspension, emulsion, jelly (gel), sol, powder, or solid molded product, and is not particularly limited. Specifically, instant foods such as instant noodles, retort foods, canned foods, microwave foods, instant soups/miso soups, and freeze-dried foods; soft drinks, fruit juice drinks, vegetable drinks, soy milk drinks, coffee drinks, and tea. Beverages such as beverages, powdered drinks, concentrated drinks, nutritional drinks, and alcoholic drinks; Flour products such as bread, pasta, noodles, cake mixes, fried chicken powder, and bread crumbs; Candy, caramel, chewing gum, chocolate, cookies, biscuits, and cakes Confectionery such as pies, snacks, crackers, Japanese sweets, and desserts; Seasonings such as sauces, processed tomato seasonings, flavor seasonings, cooking mixes, sauces, dressings, soups, and curry/stew ingredients; Fats and oils such as processed oils, butter, margarine, and mayonnaise; Dairy products such as milk drinks, yogurts, cheese, fermented milk, lactic acid bacteria drinks, ice creams, and creams; Processed egg products such as puddings and mayonnaise; Fish, meat, ham, Processed seafood products such as sausages and fish paste products; Processed livestock products such as meat hams and sausages; Processed agricultural products such as canned agricultural products, jams and marmalades, pickles, boiled beans, and cereals; Frozen foods, nutritional foods, etc. . Although not limited, polyphenols derived from black soybean seed coat extract are highly stable on the acidic side, so it is preferable to use acidic foods from the viewpoint of suppressing precipitation and deterioration of color.

Further, the present improving agent may be in the form of ordinary feed or pet food. These feeds and pet foods can also be produced by adding the above-mentioned black soybean husk extract to various feeds and pet foods.

The content of black soybean husk extract in this improving agent can be set as appropriate depending on the type of form and type of use (medicines, foods, feed/pet food, etc.) mentioned above, with the upper limit being 100% by mass. can. The dose (intake amount) of the present improving agent may be changed as appropriate depending on the type of human or animal, the sex and age of the subject, and the condition and severity of symptoms of the subject. Although not limited, for example, the daily dose (intake) for one adult human (body weight 50 kg) is usually 10 to 10% in terms of the amount of black soybean hull extract (dry amount) contained in this improving agent. About 500 mg can be mentioned. It is usually administered orally (ingested) once a day or in two to three divided doses. The time of administration is not particularly limited, and can be exemplified, for example, during one or more of the morning, noon, and evening meal times. Although not limited, it may be taken together with a meal, or within 30 minutes before or after a meal.

The subject of this improving agent may be a person who has subjective symptoms of fatigue or stress, or a person who desires the prevention of such fatigue or stress, and is not particularly limited in this regard. These include those who engage in VDT (Visual Display Terminal) work or similar desk work, and those who suffer from decreased cognitive function, chronic fatigue syndrome, depression, chronic fatigue, feeling of restlessness, decreased motivation, decreased concentration, and poor memory. This also includes people who have subjective symptoms of brain function decline, such as decline in brain function and impaired judgment, and people who need or desire to enjoy these preventive effects.

By orally taking (administering, ingesting) this improving agent, mental fatigue, loss of motivation, or drowsiness can be prevented or improved. The effect of preventing or improving mental fatigue, loss of motivation, or sleepiness by taking (administering, ingesting) the present improving agent can be evaluated and confirmed by a VAS (Visual Analogue Scale) test.

(2) Method of using black soybean seed coat extract The present invention also provides a method of using black soybean seed coat extract.
One method of using the black soybean hull extract is to impart an effect of preventing or improving mental fatigue, loss of motivation, or drowsiness to an oral composition.

The method involves using the method for using the extract to produce a target oral composition based on the effect of black soybean seed coat extract to prevent or improve mental fatigue, loss of motivation, or sleepiness. Can be done. In addition, instead of the black soybean seed coat extract, the above-mentioned present improving agent containing a black soybean seed coat extract as an active ingredient can also be used.

Targeted oral compositions include compositions that are orally administered to humans or compositions that are ingested by humans, specifically oral pharmaceuticals, oral quasi-drugs, and foods and drinks. Preferably it is food or drink. Furthermore, when targeting non-human animals, feed or pet food can be used as the oral composition.

The type of black soybean used as a raw material for the black soybean seed coat extract used in the method of the present invention, the method for obtaining black soybean seed coat, the black soybean seed coat extract, especially the black soybean seed coat acidic extract that is a preferred embodiment of the extract. The preparation method is as explained in (1) above, and can be cited in this section. The amount of the black soybean hull extract added to the oral composition is not particularly limited as long as it can impart an effect of improving fatigue to the oral composition. The evaluation was conducted when subjects continuously ingested an oral composition containing black soybean seed coat extract (target composition) and when subjects took an oral composition containing no black soybean coat extract (comparison composition). It can be evaluated and confirmed by VAS (Visual Analogue Scale) test.

The present invention will be explained in more detail by showing experimental examples below, but the present invention is not limited thereto.

[Example 1] Effect of black soybean hull extract on improving mental fatigue, decreased motivation, and sleepiness Firstly, a method for preparing black soybean hull extract and test food, and then a test method for improving mental fatigue, decreased motivation, and sleepiness. and the results will be explained.

[Black soybean seed coat extract]
A black soybean seed coat extract (acidic hot water extract) was prepared by the following method.
(1) Immerse 1 kg of black soybean seed coat (raw) in 30 L of dilute sulfuric acid (0.3% w/v) as an extraction solvent, and stir and extract for 20 minutes while heating to 55-60°C.
(2) After extraction, solid-liquid separation is performed between black soybean seed coat and liquid, and the liquid is collected.
(3) The collected liquid is centrifuged to remove suspended solids that cannot be removed by solid-liquid separation.
(4) The obtained extract is put into a column containing a synthetic adsorption resin (Sepabeads SP700: manufactured by Mitsubishi Chemical Corporation) and adsorbed by the resin.
(5) To wash away the sulfuric acid remaining in the column, water is passed through the column to wash the resin.
(6) Aqueous alcohol solution with a concentration of 59% by volume is passed through the column to elute polyphenols adsorbed on the resin.
(7) The collected eluate (alcohol solution) is evaporated and concentrated by heating under reduced pressure.
(8) Add dextrin as an excipient to the obtained concentrate.
(9) Heat sterilize.
(10) The concentrated solution after heat sterilization was spray-dried to obtain a black soybean hull extract (85 g, polyphenol content 61.1%).

[Test meal]
The test foods used were a black soybean husk extract-containing food (test food) and a control food (placebo). The composition of the test food is shown below.
(Test food) Capsules containing 100 mg of black soybean seed coat extract (polyphenol content 61.1%) and 110 mg of dextrin (210 mg in total)
(Placebo) Capsules containing 250 mg of dextrin The placebo was prepared so that there was no significant difference from the test food in terms of calorific value, etc. Table 1 shows the nutritional information for each test meal.

〔Test method〕
(subject)
The subjects were a total of 21 healthy men and women aged 20 to 65 years old, and those who participated in this study were required to receive an explanation of the study in advance, understand its contents, and agree with its purpose. Subjects were required to provide written informed consent. However, those deemed unsuitable for this study, such as those with a soybean allergy, those who regularly take medicine, and those who are pregnant, were excluded.
(Intake of test food)
The test food was one tablet per day after dinner for 4 weeks. During the test period, participants were prohibited from consuming foods and drinks that may have anti-fatigue effects, such as health foods rich in antioxidants.
(Test method)
The study design was a randomized, double-blind, parallel-group comparative study. Figure 1 shows the study design.
As for the test method, mental workload was set on the test day at the start of intake, and on the test day 2 weeks and 4 weeks after intake. In addition, consumption of alcohol and coffee was prohibited on the test day and the day before.
(mental workload)
The mental workload was calculated as fatigue load due to VDT (Visual Display Terminal) work, and 2 sets (2 time) was carried out.
(1) 2-back task An alphabet is displayed randomly on the computer screen every 3 seconds. If the currently displayed alphabet is the same as the alphabet displayed two places ago, right-click; if they are different, click the right button. The short-term memory task consisted of left-clicking.
(2) ATMT (ABC assignment)
A visual search task in which you quickly click on 25 numbers from 1 to 25 displayed randomly on a computer screen in order. Three types of tasks, A, B, and C, were performed in order. Task A is a task where the arrangement of numbers 1 to 25 does not change, task B is a task where the arrangement of numbers 1 to 25 does not change, but the clicked number disappears and new numbers after 26 are added, task C is a task. In addition to the B task, we also created a task in which the arrangement of the numbers up to 25 changed.

(Inspection item)
In this study, based on the anti-fatigue clinical evaluation guidelines established by the Japan Fatigue Society, the primary endpoint was the fatigue score in the VAS (Visual Analogue Scale) test, and the secondary endpoint was the work efficiency evaluation (ATM (Advanced Trail Making Test). ABC assignment).
(1) VAS (Visual Analogue Scale) Test VAS tests were conducted before and after the test on the test day at the start of intake, on the test day 2 weeks after intake, and on the test day 4 weeks after intake. Questions included fatigue, motivation, and sleepiness.
VAS is recommended by the Japan Fatigue Society as a method for evaluating fatigue. For the VAS self-evaluation score, a horizontal straight line with a length of 10.0 cm is presented, with the left end being the most negative (not feeling) and the right end being the most positive (feeling). The students were asked to draw a mark on the line to indicate the level of their sensation. The evaluation results were measured by measuring the position of the point marked by each subject as the distance from the left edge and converting it into a numerical value. The most negative end (left end) was given 0 points, and the most positive end (right end) was given 10.0 points.
(2) Work efficiency evaluation (ATMT (Advanced Trail Making Test, ABC task))
Work efficiency was evaluated based on the average reaction time, number of trials, and number of errors in ATMT (ABC task) during 2 hours of VDT (Visual Display Terminal) work on the test day, and motivation was objectively evaluated based on the intention time between tasks.
(3) Daily life record diary During the test period, subjects were asked to fill in their sleeping hours, working hours, life events, and test food intake status every day.
(4) Statistical processing Test data were aggregated and statistical analysis was performed for each item. SPSS Ver. 22.0 (IBM Japan, Inc.) was used as the statistical processing software, and an unpaired t-test was performed for comparisons between test conditions. However, if the data were considered to deviate from a normal distribution, a Mann-Whitney U test was performed. The significance level was 5% with a two-sided test, and 10% was considered to be a trend. In addition, when testing the mean of unpaired data using a t-test, use G*Power 3.1.9.6 to determine the statistically significant difference when α = 0.05 and 1-β = 0.8. Sample size estimation was performed to obtain the results.

〔result〕
(subject)
Twenty-one subjects were randomly assigned to two groups (10 in the test food group and 11 in the placebo group). Subjects with a correct answer rate of 2/3 (0.666) or less in the 2-back task or who were not properly loaded with a transition time of 5 seconds or more in the ATMT (ABC task) were excluded from the effectiveness evaluation. As a result, the number of subjects for analysis in the efficacy evaluation was 13 (7 in the test food group, 6 in the placebo group). Figure 2 shows a flowchart for the subjects.

(1) 2-back task For both the test food group and the placebo group, the average correct answer rate for the 2-back task was 0.882 in all tests on the pre-intake test, the 2-week test, and the 4-week post-intake test. The percentage of correct answers was high. Therefore, it was confirmed that an appropriate load was applied in this test. The results are shown in Figure 3.

(2) Work efficiency evaluation [AMT (ABC task)]
Regarding changes from the pre-intake test date in the two sets of data, compared to the placebo group in the test food group, the number of incorrect digit pressing errors in task A decreased on the test day 4 weeks after ingestion, and the number of incorrect digits in task B decreased on the test day 4 weeks after ingestion. There was a tendency for the number of pressing errors to decrease on the test day 4 weeks after intake, and a tendency for the total average reaction time until the next trial to shorten on the test day 2 weeks after intake. In particular, the average reaction time until the next trial in task C-A was significantly shortened on the test day 2 weeks after ingestion (Figure 4). Since the transition time between tasks is recognized as an objective indicator of motivation, the motivation-enhancing effect of black soybean husk extract was confirmed. The results are shown in Table 2 and FIG. 4 (the numerical values are the average value and its standard error).

(3) VAS (Visual Analogue Scale) test Regarding the actual measured values, compared to the placebo group, the test food group had lower mental fatigue and sleepiness after 4 weeks of intake and on the test day (Figure 5, 6), there was a tendency for decreased motivation to be low on the day of the test two weeks after intake (Figure 7). From these results, it was confirmed that the black soybean seed coat extract has an effect of suppressing (improving) mental fatigue, an effect of increasing motivation (prevention), and an effect of suppressing (improving) sleepiness. FIG. 8 shows the results of actual VAS measurements (the numerical values are the average value and its standard error).

These results show that oral intake of the test food (black soybean seed coat extract) prevents or improves mental fatigue, loss of motivation, and sleepiness. As for the dosage range, at least according to the black soybean seed coat extract (acidic hot water extract) examined this time, it can be seen that the desired effects of the present invention can be obtained in a range of 100 mg or more in terms of dry weight.

A formulation example of black soybean seed coat extract is shown below.
Formulation Example 1 Soft Capsules Soft capsules were prepared according to a conventional method using the following raw materials. In addition, the black soybean seed coat extract prepared according to the method of Experimental Example 1 was used as the black soybean seed coat extract.
Vegetable oil: 158.6mg
Gelatin: 135.2mg
Black soybean seed coat extract: 100mg
Glycerin: 30.2mg
Lecithin: 30mg
Beeswax: 26mg
Vitamin E: 20mg.

Formulation Example 2 Tablets Tablets were prepared according to a standard method using the following raw materials. In addition, the black soybean seed coat extract prepared according to the method of Example 1 was used as the black soybean seed coat extract.
Dextrin: 179.69mg
Black soybean seed coat extract: 100mg
Kangen starch syrup: 28.56mg
Crystalline cellulose: 26.51mg
Calcium stearate: 5.25mg
Fine silicon dioxide: 5.25mg
Hydroxypropyl cellulose: 4.77 mg.

Formulation Example 3 Individually packaged stick jelly Individually packaged stick jelly was prepared according to a standard method using the following raw materials. In addition, the black soybean seed coat extract prepared according to the method of Example 1 was used as the black soybean seed coat extract.
Rare sugar-containing syrup: 1000mg
Black soybean seed coat extract: 100mg
Gelling agent (polysaccharide thickener): 100mg
Sweeteners (xylitol, sucralose, thaumatin, acesulfame potassium): 70mg
Fragrance: 20mg
Water: 8710mg

The improving agent containing the black soybean hull extract of the present invention as an active ingredient can prevent or improve mental fatigue, loss of motivation, or sleepiness. Therefore, the agent for improving mental fatigue, loss of motivation, or sleepiness of the present invention is useful because it can be used in a wide range of applications such as pharmaceuticals, quasi-drugs, foods with functional claims, and supplements.

Claims (4)

A product that contains black soybean hull extract extracted with water containing sulfuric acid as an active ingredient, and is used for the purpose of reducing fatigue or drowsiness in normal conditions before fatigue load , or improving motivation . Preventive agent for depression or drowsiness . The preventive agent according to claim 1, wherein the feeling of fatigue, decreased motivation, or drowsiness is the feeling of fatigue, decreased motivation, or drowsiness of a healthy person. The prophylactic agent according to claim 1 or 2, which is a pharmaceutical, a quasi-drug, or a food or drink. A method of using a black soybean hull extract extracted with water containing sulfuric acid in the manufacture of an oral composition for preventing fatigue, loss of motivation, or drowsiness , the prevention comprising: Methods of use include reducing feeling or drowsiness or improving motivation .

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