Composition for improving men's qol

Abstract

To provide a technique for improving at least men's QOL.SOLUTION: A composition for improving men's QOL contains equol.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present disclosure relates to compositions for improving male quality of life. [Background technology]

[0002] It is believed that the cause of male menopausal disorder is a decrease in testosterone, one of the male hormones. In order to alleviate or improve this condition, for example, a testosterone secretion promoter containing Euglena and / or paramylon has been developed (Patent Document 1). In addition, a composition that contains an elderberry fresh fruit extract as an active ingredient and increases the blood testosterone content has been developed (Patent Document 2). Aromatase is an enzyme that converts male hormones (androgens such as testosterone) into female hormones (estrogens) in the body, and an aromatase inhibitor containing a guarana extract has been developed (Patent Document 3).

[0003] On the other hand, it is known that dihydrotestosterone is produced from testosterone by 5α-reductase (Patent Document 4), and when testosterone increases, dihydrotestosterone also increases. An increase in dihydrotestosterone is a cause of male pattern baldness (AGA) and benign prostatic hyperplasia. It is believed to be the cause of the disease, and there is a view that increasing testosterone is not always a good thing (Non-Patent Document 1). Therefore, there is a need for other compounds that do not increase testosterone but have testosterone-like effects.

[0004] It is known that equol, a component produced by the action of intestinal bacteria from daidzein, a type of isoflavone, has high estrogenic activity (Patent Document 5). However, even if a person ingests soy isoflavones, for example, differences in intestinal bacteria mean that there are individual differences in the ability to convert daidzein contained in soy isoflavones into equol, and it has been revealed that some people can produce equol and others cannot (Patent Document 6). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2019-213518 A [Patent Document 2] Special Publication No. 2022-509468 [Patent Document 3] JP 2010-059192 A [Patent Document 4] JP 2015-028007 A [Patent Document 5] JP 2003-310177 A [Patent Document 6] JP 2021-106538 A [Non-patent literature]

[0006] [Non-Patent Document 1] Journal of the Japanese Dermatological Association: 127(13), 2763-2777, 2017 (Heisei 29) Summary of the Invention [Problem to be solved by the invention]

[0007] The objective of the present disclosure is to provide technology that improves at least men's QOL. [Means for solving the problem]

[0008] As a result of intensive research into solving the above problems, the present inventors have found that equols can solve the above problems. The present disclosure provides a composition containing equol for improving men's QOL. This can be done. In a preferred embodiment of the composition, the improvement in QOL is the improvement of menopausal symptoms. In a preferred embodiment, the improvement of the menopausal disorder in the composition is an improvement in a sense of health, an improvement in bodily pain, an improvement in autonomic nervous system disorders, an improvement in sleep, an improvement in a feeling of fatigue, an improvement in mood, an improvement in anxiety, an improvement in vitality, an improvement in muscle strength, an improvement in body hair, or an improvement in sexual ability. In a preferred embodiment of the composition, the menopausal disorder is evaluated by AMS score. In a preferred embodiment of the composition, the improvement in QOL is an improvement in physical symptoms or mental symptoms. In a preferred embodiment of the composition, the improvement in QOL is an improvement in a physical symptom, and the improvement in the physical symptom is improvement in eye fatigue, bodily pain, cardiac ischemia, fatigue, skin condition, bronchitis, gray hair, autonomic nerve balance, hearing loss, swelling, stomach regulation, intestinal regulation, or hair growth. In a preferred embodiment of the composition, the improvement in QOL is an improvement in mental symptoms, and the improvement in mental symptoms is an improvement in anger, vitality, depression, confusion, anxiety, or insomnia. In a preferred embodiment of the composition, the QOL is evaluated using a common anti-aging QOL questionnaire. In a preferred embodiment of the composition, the male is between 40 and 70 years old. In a preferred embodiment, the composition is administered to a man who is experiencing subjective symptoms of menopausal disorders. In a preferred embodiment, the composition has a total daily intake of equols of 1 mg or more. In a preferred embodiment, the composition is a food or drink. Effect of the Invention

[0009] The present disclosure can provide an effect of at least providing a technology for improving the QOL of men. In addition, since the present disclosure does not increase testosterone, it is possible to prevent androgenetic alopecia (AGA) and prostate hyperplasia caused by an increase in dihydrotestosterone produced from testosterone. There is no need to assume that the disease will develop. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Each configuration and combination thereof in each embodiment is merely an example, and addition, omission, substitution, and other modifications of the configuration are possible as appropriate within the scope of the gist of the present disclosure. The present disclosure is not limited to the embodiments, but is limited only by the scope of the claims.

[0011] One embodiment of the present disclosure is a composition containing equol for improving men's QOL.

[0012] Equols are represented by the following general formula (1). [ka] (In the formula, R 1 ~R 7 each represents a hydroxyl group or a hydrogen atom. Specific examples of equols include all of the compounds represented by the above general formula (1), specifically, equol (sometimes called 4',7-isoflavandiol), 5-hydroxyequol, etc.

[0013] The composition according to this embodiment may contain equols alone, or may contain other ingredients as long as they can improve the male's QOL, such as maca, zinc, indigestible dextrin, calcium stearate, silicon dioxide, etc.

[0014] The subject taking the composition according to this embodiment is a man (male human).

[0015] The age of the subject who takes the composition according to this embodiment is not particularly limited as long as the QOL is improved by taking the composition according to this embodiment, but is preferably 40 years old or older, more preferably 45 years old or older, even more preferably 50 years old or older, and preferably 70 years old or younger, more preferably 65 years old or younger, and even more preferably 60 years old or younger. That is, for example, 40 years old or older and 70 years old or younger, 45 years old or older and 65 years old or younger, 50 years old or older and 60 years old or younger, etc.

[0016] The subject who takes the composition according to this embodiment is preferably one who has subjective symptoms of menopausal disorder. In addition, male menopausal disorder is translated into English as, for example, late onset hypogonadism syndrome (LOH syndrome). In this specification, menopausal disorder includes menopausal symptoms. .

[0017] The subject who takes the composition according to this embodiment may be either a person who can produce equols or a person who cannot produce equols, but preferably a person who cannot produce equols.Moreover, as a person who cannot produce equols, it is more preferable that the person who cannot produce equols is a person who cannot produce equols from daidzein or genistein.Specific examples of the person who cannot produce equol from daidzein and a person who cannot produce 5-hydroxyequol from genistein are included.

[0018] QOL is an abbreviation for "Quality of Life" and generally means It is also called "quality of life." In this embodiment, improvement in QOL means that the QOL is improved when the subject takes equol compared to when the subject does not take equol (or before taking equol or when taking a placebo).

[0019] The composition according to this embodiment may be taken prophylactically to inhibit a decline in QOL, or may be taken to maintain QOL. In this embodiment, the improvement in QOL may be evaluated objectively by a doctor or the like. However, it is preferable that the assessment be based on objective measures such as tests or questionnaires developed by experts.

[0020] In the present embodiment, when the evaluation of the improvement in QOL is performed by an objective scale using tests or questionnaires developed by experts, an example of such an evaluation is the Common Anti-Aging QOL Questionnaire (issued by the Japanese Society of Anti-Aging Medicine). When the evaluation is performed using the Common Anti-Aging QOL Questionnaire, it is preferable that the numerical values ​​of each factor and the total score obtained in the evaluation are smaller when the subject takes equol than when the subject does not take equol (or before taking equol or when taking a placebo).

[0021] The improvement in QOL can be assessed, for example, by evaluation using a common anti-aging QOL questionnaire administered to a group of subjects (subject group) whose numbers are sufficient for evaluation, as in the Examples described below. Specifically, for the total score of "physical symptoms" listed in Table 3 and the total score of "mental symptoms" listed in Table 4, if the number of subjects who improved (i.e., the value became smaller) when taking equol compared to not taking equol (or before taking equol or when taking a placebo) is taken as (A) (people), and the number of subjects who worsened (i.e., the value became larger) is taken as (B) (people), then if both {(A) - (B)} (people) are positive, it can be determined that QOL has improved. The larger {(A) - (B)} (people) is, the better. In the examples described below, the total score for "physical symptoms" was {(A)-(B)} (people) of 7, and the total score for "mental symptoms" was {(A)-(B)} (people) of 10. Since both {(A)-(B)} (people) were positive, it was shown that QOL had improved.

[0022] In this embodiment, improvement in QOL is preferably improvement in physical symptoms or improvement in mental symptoms.

[0023] The improvement of the physical symptoms can be assessed, for example, by evaluation using a common anti-aging QOL questionnaire administered to a group of subjects (subject group) large enough to be evaluated, as in the Examples described below. Specifically, if the number of subjects whose "physical symptoms" total score improved (i.e., the value decreased) when taking equol compared to not taking equol (or before taking equol or when taking a placebo) is (A) (people), and the number of subjects whose symptoms worsened (i.e., the value increased) is (B) (people), then if {(A) - (B)} (people) is positive, it can be determined that the physical symptoms have improved. A larger value of {(A) - (B)} (people) is preferable. In the examples described later, {(A)-(B)} (people) is 7 people, which is positive, indicating that physical symptoms have improved.

[0024] The improvement of the mental symptoms can be assessed, for example, by evaluation using a common anti-aging QOL questionnaire administered to a group of subjects (subject group) whose number is sufficient for evaluation, as in the Examples described below. Specifically, if the number of subjects whose "mental symptoms" total score improved (i.e., the value decreased) when taking equol compared to not taking equol (or before taking equol or when taking a placebo) is (A) (people), and the number of subjects whose symptoms worsened (i.e., the value increased) is (B) (people), then if {(A) - (B)} (people) is positive, it can be determined that mental symptoms have improved. A larger value of {(A) - (B)} (people) is preferable. In the example described below, {(A)-(B)}(people) is 10 people, which is positive, so Symptoms have been shown to improve.

[0025] The improvement of physical symptoms is preferably improvement of eye fatigue, improvement of bodily pain, improvement of cardiac ischemia, improvement of fatigue, improvement of dry mouth, improvement of skin condition, improvement of bronchitis, improvement of gray hair, improvement of autonomic nerve balance, improvement of hearing loss, improvement of swelling, improvement of frequent urination, maintenance of weight, stomach regulation, improvement of immunity, intestinal regulation, or hair growth. The physical pain may be a physical pain other than one or more selected from the group consisting of eye pain, headache, and stomach pain, and the fatigue may be fatigue other than one or more selected from the group consisting of eye strain and eye fatigue.

[0026] The improvement in eyestrain is preferably improvement in eye fatigue, blurred vision, or eye pain.

[0027] The improvement of eye strain can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target group (subject group), as in the Examples described below. Specifically, first, for "eye fatigue," let (A) (people) be the number of subjects who reported improvement (i.e., smaller values) when taking equol compared to not taking equol (or compared to before taking equol or when taking a placebo), and (B) (people) be the number of subjects who reported worsening (i.e., larger values), and then calculate {(A)-(B)} (people). For convenience, this is called (C1) (people). In the same way, calculate "blurred vision." For convenience, call this (C2) (person). Similarly, calculate "eye pain." For convenience, call this (C3) (persons). In this case, if {(C1)+(C2)+(C3)}(people) is positive, it can be determined that eye strain has been improved. The larger {(C1)+(C2)+(C3)}(people) is, the better. In the examples described below, there were 7 (C1) (people), 4 (C2) (people), and 2 (C3) (people), so {(C1) + (C2) + (C3)} (people) is 13, which is positive, indicating that eye strain has improved.

[0028] Improvement in eye fatigue can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target group (subject group), as in the Examples described below. Specifically, for "eye fatigue," let (A) (people) be the number of subjects who reported improvement (i.e., smaller values) when taking equol compared to not taking equol (or before taking equol or when taking a placebo), and (B) (people) be the number of subjects who reported worsening (i.e., larger values) for eye fatigue. If {(A)-(B)} (people) is positive, it can be determined that eye fatigue has improved. A larger value for {(A)-(B)} (people) is preferable. In the examples described later, {(A)-(B)} (people) is 7 people, which is positive, and therefore it is shown that eye fatigue has been improved. Improvement in blurred vision and eye pain can also be judged in a similar manner.

[0029] The improvement in physical pain is preferably improvement in muscle pain, improvement in physical stiffness (which may exclude stiffness in the shoulders, and may also be, for example, stiffness in the whole body, stiffness in the shoulders, stiffness in the back, stiffness in the lower back, etc.), improvement in lower back pain, or improvement in joint pain.

[0030] The improvement of the physical pain can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target group (subject group), as in the Examples described below. Specifically, first, the symptom of "stiff shoulders" was improved when taking equol compared to when not taking equol (or before taking equol or when taking a placebo). Let the number of subjects whose condition improved (i.e., the value decreased) be (A) (people) and the number of subjects whose condition worsened (i.e., the value increased) be (B) (people). Then, calculate {(A)-(B)} (people). For convenience, call this (C1) (people). Similarly, calculate "muscle pain and stiffness." For convenience, call this (C2) (persons). Similarly, calculate "lower back pain." For convenience, call this (C3) (persons). Similarly, calculate "joint pain." For convenience, call this (C4) (persons). In this case, if {(C1)+(C2)+(C3)+(C4)}(person) is positive, it can be determined that the physical pain has improved. The larger {(C1)+(C2)+(C3)+(C4)}(person) is, the better. In the examples described below, (C1) (people) was 5 people, (C2) (people) was -2 people, (C3) (people) was 3 people, and (C4) (people) was 4 people, so {(C1) + (C2) + (C3) + (C4)} (people) is 10 people, which is positive, indicating that physical pain has improved.

[0031] The improvement of stiff shoulders can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target group (subject group), as in the Examples described below. Specifically, for "stiff shoulders," let (A) (people) be the number of subjects who reported improvement (i.e., smaller values) when taking equol compared to not taking equol (or before taking equol or when taking a placebo), and (B) (people) be the number of subjects who reported worsening symptoms (i.e., larger values) when taking equol. If {(A)-(B)} (people) is positive, it can be determined that stiff shoulders have improved. A larger value for {(A)-(B)} (people) is preferable. In the example described later, {(A)-(B)} (people) is 5, which is positive, and therefore it is shown that stiff shoulders have been improved.

[0032] The improvement in muscle pain and physical stiffness can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target group (subject group), as in the Examples described below. Specifically, for "muscle pain and stiffness," if the number of subjects who reported improvement (i.e., smaller values) when taking equol compared to not taking equol (or before taking equol or when taking a placebo) is (A) (people), and the number of subjects who reported worsening symptoms (i.e., larger values) is (B) (people), then if {(A) - (B)} (people) is positive, it can be determined that muscle pain and stiffness have improved. The larger the value of {(A) - (B)} (people), the better.

[0033] Improvement in lower back pain can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target population (subject population), as in the Examples described below. Specifically, for "lower back pain," if the number of subjects whose condition improved (i.e., the value decreased) when taking equol compared to not taking equol (or before taking equol or when taking a placebo) is (A) (people), and the number of subjects whose condition worsened (i.e., the value increased) is (B) (people), then if {(A) - (B)} (people) is positive, it can be determined that lower back pain has improved. The larger the value of {(A) - (B)} (people), the more preferable it is. In the example described later, {(A)-(B)} (people) is 3, which is positive, and therefore it is shown that the lower back pain has improved. Improvement in joint pain can be judged in a similar manner.

[0034] Other preferred aspects, such as improvement of cardiac ischemia, improvement of fatigue, improvement of dry mouth, improvement of skin condition, improvement of bronchitis, improvement of gray hair, improvement of balance of autonomic nerves, improvement of hearing loss, improvement of swelling, improvement of frequent urination, maintenance of weight, stomach regulation, improvement of immunity, regulation of intestines, and hair growth, have already been described. In addition, the improvement can be judged in the same manner as the improvement of eye fatigue. In addition, as described below, when there is another preferred embodiment among the preferred embodiments, the improvement can be judged in the same manner as the improvement of eye fatigue already described.

[0035] The improvement in cardiac ischemia is preferably an improvement in palpitations or shortness of breath.

[0036] The improvement of fatigue is preferably improvement of lethargy or improvement of a feeling of lack of health, the former being, for example, improvement of a feeling of lethargy in the body.

[0037] The improvement in skin condition is preferably the improvement in an unhealthy skin condition.

[0038] The bronchitis is preferably improvement of cough or phlegm, for example, improvement of coughing easily, or improvement of phlegm easily produced and / or improvement of phlegm not easily cleared.

[0039] The improvement of the balance of the autonomic nerves is preferably achieved by improving headaches, dizziness, sweating easily, hot flashes, or poor circulation (e.g., sensitivity to cold, etc.). (translated into English.)

[0040] The improvement in hearing loss is preferably an improvement in tinnitus or difficulty in hearing conversation.

[0041] The maintenance of body weight is preferably improvement in the tendency to gain weight, improvement in the tendency to lose weight, or improvement in weight loss.

[0042] The stomach regulation is preferably improvement of anorexia, improvement of gastric bloating, or improvement of stomach pain.

[0043] The improvement of immunity is preferably an improvement in susceptibility to catching colds.

[0044] The aforementioned intestinal regulation is preferably improvement of diarrhea or improvement of constipation.

[0045] The hair growth is preferably an improvement in hair loss (hair loss).

[0046] The improvement of the mental symptoms is preferably improvement of anger, improvement of vitality, improvement of depression, improvement of friendship, improvement of confusion, improvement of anxiety, or improvement of insomnia.

[0047] These preferred aspects can be judged in the same manner as the improvement of eye fatigue already described. In addition, as described below, if there are further preferred aspects among the preferred aspects, the further preferred aspects can be judged in the same manner as the improvement of eye fatigue already described.

[0048] The improvement in anger is preferably an improvement in irritability or an improvement in irritability.

[0049] The improvement in vitality is preferably an improvement in a lack of motivation, an improvement in not feeling happy, an improvement in feeling that there is no meaning in life, an improvement in feeling that daily life is not enjoyable, an improvement in feeling that one has lost confidence, or an improvement in feeling that one is not a useful person.

[0050] The amelioration of depression is preferably amelioration of sadness.

[0051] The improvement in friendliness is preferably an improvement in reluctance to talk to people.

[0052] The improvement in confusion is preferably improvement in brooding, improvement in forgetfulness, improvement in inability to concentrate, improvement in inability to solve problems, or improvement in inability to make easy decisions.

[0053] The improvement in anxiety is an improvement in a feeling of tension, an improvement in feeling anxious for no reason, or an improvement in feeling scared of something.

[0054] The improvement of insomnia is preferably improvement of light sleep, improvement of difficulty in falling asleep, or improvement of insomnia caused by worry.

[0055] The subject who takes the composition according to this embodiment is preferably suffering from menopausal disorder. Whether or not the subject is suffering from menopausal disorder can be confirmed by a conventional method. For example, evaluation using the Simplified Menopausal Index (SMI) checklist or the Male Menopausal Disorder Questionnaire (AMS score) can be mentioned. When using the Simplified Menopausal Index (SMI) checklist, a subject can be confirmed to be suffering from menopausal disorder if the score is 71 points or more. When using the Male Menopausal Disorder Questionnaire (AMS score), a subject can be confirmed to be suffering from menopausal disorder if the score is 27 points or more. Therefore, the improvement in the QOL may be an improvement in menopausal disorder.

[0056] In the present embodiment, when the improvement of menopausal symptoms is evaluated by objective measures such as tests or questionnaires developed by experts, an example of such an evaluation is the Androgenic Menopause Questionnaire (AMS score). When evaluation is performed using the AMS score, it is preferable that the numerical values ​​of each factor and the total score obtained in the evaluation are smaller when the subject takes equol than when the subject does not take equol (or before taking equol or when taking a placebo).

[0057] The improvement of the menopausal disorder can be determined, for example, by evaluation using the Androgenic Menopausal Disorder Questionnaire (AMS score) administered to a group of subjects (subject population) that is large enough to be evaluated, as in the Examples described below. Specifically, for the "AMS score" listed in Table 1, if the number of subjects whose condition improved (i.e., the value became smaller) when taking equol compared to when not taking equol (or before taking equol or when taking a placebo) is (A) (people), and the number of subjects whose condition worsened (i.e., the value became larger) is (B) (people), then if both {(A)-(B)} (people) are positive, it can be determined that menopausal symptoms have improved. The larger {(A)-(B)} (people) is, the more preferable it is. In the Examples described later, {(A)-(B)} (people) is 11, which is positive, indicating that menopausal symptoms were improved.

[0058] Furthermore, the improvement of the menopausal disorder may be judged based on the number of subjects as described above, but it can also be judged based on the average score. Specifically, it can be determined that menopausal symptoms have improved when the "total score" shown in Table 2 improves (i.e., the value is smaller) when equol is taken compared to when it is not taken (or before taking equol or when a placebo is taken). The greater the value obtained by subtracting the average score when equol is taken from the average score when not taken (or before taking equol or when a placebo is taken), the more preferable it is. As shown in Table 2, the factor "physical fatigue and reduced motivation" is included in both the "mood" and "vitality" factors, and the factor "feeling exhausted and at rock bottom" is also included. is included in both the "mood" factor and the "vitality" factor, but the overlaps are not included when calculating the "total score" in Table 2. Specifically, for before intake (average score), the sum of all the values ​​listed in Table 2 is 43.2, but the total without the overlaps is 39.1, and the latter is used. The same is true for 4 weeks after intake (average score), where the sum of all the values ​​listed in Table 2 is 34.6, but the total without the overlaps is 31.5, and the latter is used. In the examples described below, as an example, when the subjects were limited to those with mild to moderate symptoms, the average score before taking equol was 39.1 and after taking equol (4 weeks after intake) the average score was 31.5, indicating that the values ​​had decreased and that menopausal symptoms had improved.

[0059] The improvement of menopausal symptoms is preferably improvement in a sense of health, improvement in bodily pain, improvement in autonomic nerve disorders, improvement in sleep, improvement in a sense of fatigue, improvement in mood, improvement in anxiety, improvement in vitality, improvement in muscle strength, improvement in body hair, or improvement in sexual ability.

[0060] With regard to these preferred aspects, and as described below, with regard to further preferred aspects within the preferred aspects, improvement with respect to those aspects can be judged based on the number of subjects, in the same manner as with the improvement of eye fatigue and eye tiredness already described.

[0061] As already mentioned, the decision can also be based on the average score. Specifically, for example, in the case of "improvement in sense of health," it can be determined that sense of health has improved when the average score for "sense of health" improves (i.e., the value becomes smaller) when equol is taken compared to when it is not taken (or before taking equol or when a placebo is taken). It is preferable that the value obtained by subtracting the average score when equol is taken from the average score when equol is not taken (or before taking equol or when a placebo is taken) is larger. In the examples described below, as an example, when the subjects were limited to those with mild to moderate symptoms, the average score before taking equol was 3.4 and the average score after taking equol was 1.9, indicating that the values ​​had decreased and that the sense of health had improved.

[0062] For example, in the case of "improvement of mood," first, for "irritability," calculate the average score when equol is not taken (or before taking equol or when taking a placebo) minus the average score when taking equol. For convenience, this is called (C1). In the same way, calculate the score for "became nervous." For convenience, call this score (C2). In the same way, calculate "physical fatigue and reduced motivation." For convenience, call this (C3). In the same way, calculate the score for "feeling exhausted and at rock bottom." For convenience, call this score (C4). In this case, if {(C1)+(C2)+(C3)+(C4)} is positive, it can be determined that there has been an improvement. The larger {(C1)+(C2)+(C3)+(C4)} is, the better. In the examples described below, (C1) is 0.3, (C2) is 0.4, (C3) is 0.6, and (C4) is 0.4, so {(C1) + (C2) + (C3) + (C4)} is 1.7, which is positive, indicating that mood has improved.

[0063] The improvement in sense of well-being is preferably an improvement in overall feeling of poor health.

[0064] The amelioration of physical pain is preferably amelioration of joint pain or muscle pain.

[0065] The improvement of the autonomic nervous system disorder is preferably the improvement of severe sweating.

[0066] The improvement in sleep is preferably an improvement in sleep distress.

[0067] The improvement in fatigue is preferably an improvement in feeling sleepy frequently or an improvement in feeling tired frequently.

[0068] The improvement in mood is preferably improvement in irritability, improvement in nervousness (nervousness), improvement in physical fatigue, improvement in decreased motivation, or improvement in "feeling exhausted and at rock bottom."

[0069] The amelioration of anxiety is preferably an amelioration of anxiety, an amelioration of depressed mood, or an amelioration of feeling that "the peaks in life have passed".

[0070] The improvement in vitality is preferably an improvement in physical fatigue, an improvement in reduced motivation, or an improvement in "feeling exhausted and at rock bottom."

[0071] The improvement in muscle strength is preferably an improvement in decreased muscle strength.

[0072] The improvement in body hair is preferably an improvement in slower beard growth (slower beard growth).

[0073] The improvement in sexual ability is preferably an improvement in decline of sexual ability, an improvement in a reduction in the number of early morning erections (morning erections), or an improvement in a decrease in sexual desire.

[0074] The content of equols in the total amount of the composition according to this embodiment is not particularly limited, but is preferably 0.001% by mass or more, more preferably 0.01% by mass or more, and even more preferably 0.1% by mass or more, as the total amount of equols, and is preferably 20% by mass or less, more preferably 10% by mass or less, and even more preferably 5% by mass or less, i.e., for example, 0.001% by mass or more and 20% by mass or less, 0.01% by mass or more and 10% by mass or less, 0.1% by mass or more and 5% by mass or less, etc.

[0075] The intake amount of the composition according to this embodiment is appropriately set according to the age, weight, intake route, intake schedule, form, etc. of the subject, but is not particularly limited as long as the intake improves the QOL of the subject. The total amount of equols is preferably 1 mg or more, more preferably 2 mg or more, and even more preferably 5 mg or more per day, while it is preferably 40 mg or less, more preferably 20 mg or less, and even more preferably 10 mg or less. That is, for example, 1 mg or more and 40 mg or less, 2 mg or more and 20 mg or less, 5 mg or more and 10 mg or less per day.

[0076] The intake schedule of the composition according to this embodiment may be one intake per day or several divided intakes per day. It may be once every few days or weeks, but is preferably taken every day. The intake period is preferably 4 weeks or more, more preferably 8 weeks or more, while the upper limit is not particularly limited, for example, until the age of 100, or until death. That is, for example, 4 weeks or more until death, 8 weeks or more until the age of 100, etc.

[0077] The use of the composition according to this embodiment may be for either therapeutic or non-therapeutic purposes. "Non-therapeutic purposes" refers to actions that do not include medical treatment. Examples of actions that do not include medical treatment include actions for health promotion and beauty treatment.

[0078] When the composition according to this embodiment is used for non-therapeutic purposes, the subject may be a healthy person. A healthy person may refer to a person who does not fall under, for example, menopausal disorder or the diseases, symptoms, signs, disorders, etc. in the preferred embodiments already exemplified as the improvement of menopausal disorder (in this disclosure, "diseases, symptoms, signs, disorders, etc." may be described as "diseases, etc.") when taking the composition according to this embodiment. When the composition according to this embodiment is used for non-therapeutic purposes, it is possible to prevent menopausal disorder or the diseases, etc. in the preferred embodiments already exemplified as the improvement of menopausal disorder.

[0079] When the composition according to this embodiment is used for therapeutic purposes, the subject may be an unhealthy person. When the composition according to this embodiment is used for therapeutic purposes, it becomes possible to treat menopausal disorders and diseases in the preferred embodiments already exemplified as the improvement of menopausal disorders in unhealthy people.

[0080] The composition according to this embodiment can be used as a food or drink (including a supplement), for example, a food or drink containing equol for improving men's QOL. The food and drink can be used for subjects including healthy and unhealthy individuals, and can also be used for non-therapeutic purposes.

[0081] When equols are used as ingredients in foods and beverages, they can be used not only in general foods and beverages, but also as foods for specified health uses, nutritional supplements, functional foods, foods for the sick, food additives, etc. (these also include beverages.) As for the form of foods and beverages, for example, after adding appropriate auxiliary agents, they may be formed into edible forms, such as granules, particles, tablets, capsules, pastes, etc., using conventional means and then provided for consumption, or they may be added to various foods, such as processed meat foods such as ham and sausage, processed seafood foods such as kamaboko and chikuwa, bread, confectionery, butter, powdered milk, fermented dairy products, or beverages such as water, fruit juice, milk, and soft drinks.

[0082] The main components of foods and beverages may be water, proteins, carbohydrates, lipids, vitamins, minerals, organic acids, organic bases, fruit juice, flavors, etc. Examples of proteins include animal and vegetable proteins such as whole milk powder, skim milk powder, partially skim milk powder, casein, soy protein, egg protein, and meat protein, as well as hydrolysates thereof, and butter. Examples of carbohydrates include sugars, processed starch (dextrin, soluble starch, British starch, oxidized starch, starch ester, starch ether, etc.), and dietary fiber. Examples of lipids include vegetable oils and fats such as lard, safflower oil, corn oil, rapeseed oil, coconut oil, fractionated oils thereof, hydrogenated oils, and interesterified oils. Examples of vitamins include vitamin A, carotenes, B vitamins, vitamin C, D vitamins, vitamin E, K vitamins, vitamin P, vitamin Q, niacin, nicotinic acid, pantothenic acid, biotin, inositol, choline, and folic acid. Examples of minerals include calcium, potassium, magnesium, sodium, copper, iron, manganese, zinc, selenium, and whey minerals. Examples of organic acids include malic acid, citric acid, lactic acid, and tartaric acid. Two or more of these components may be used in combination, and synthetic products and / or foods and beverages containing a large amount of these may be used.

[0083] The food and drink can be produced according to a conventional method. The amount, method, and timing of incorporation of equols into the food and drink can be appropriately selected. Furthermore, the food and drink can be packaged in an appropriate container such as a bottle, bag, can, box, or pack, as necessary.

[0084] With regard to the content of equols relative to the total amount of food and beverages, the intake amount of food and beverages, and the intake schedule for food and beverages, the descriptions of the content of equols relative to the total amount of the composition of this embodiment, the intake amount of the composition of this embodiment, and the intake schedule for the composition of this embodiment are incorporated herein by reference.

[0085] When equols are used as ingredients in foods and beverages for the above-mentioned uses, the foods and beverages may state each of those uses, or may state uses that are inspired by those uses.

[0086] The composition according to this embodiment can be used as a medicine, for example, a medicine containing equol for improving men's QOL. The pharmaceutical can be used for non-healthy individuals and for therapeutic purposes.

[0087] When equols are used as a pharmaceutical material, the application method as a pharmaceutical can be either oral or parenteral administration. When administering, the active ingredient can be mixed with a solid or liquid pharmaceutical non-toxic carrier suitable for administration methods such as oral administration, rectal administration, and injection, and administered in the form of a conventional pharmaceutical preparation. Such preparations include, for example, solid preparations such as tablets, granules, powders, and capsules, liquid preparations such as solutions, suspensions, and emulsions, and freeze-dried preparations, and these preparations can be prepared by conventional pharmaceutical methods. Examples of the pharmaceutical non-toxic carriers include glucose, lactose, sucrose, starch, mannitol, dextrin, fatty acid glycerides, polyethylene glycol, hydroxyethyl starch, ethylene glycol, polyoxyethylene sorbitan fatty acid esters, amino acids, gelatin, albumin, water, and physiological saline. In addition, conventional additives such as stabilizers, wetting agents, emulsifiers, binders, and isotonicity agents can be added as necessary.

[0088] With regard to the content of equols relative to the total amount of the pharmaceutical, the dosage of the pharmaceutical, and the dosage schedule of the pharmaceutical, the descriptions of the content of equols relative to the total amount of the composition of this embodiment, the intake amount of the composition of this embodiment, and the intake schedule of the composition of this embodiment are incorporated by reference.

[0089] The equols contained in the composition according to this embodiment may be a composition containing equols, for example a fermented product of a composition containing daidzeins (e.g., soybeans, soybean germ, soybean germ extract, tofu, fried tofu, soy milk, natto, soy sauce, miso, tempeh, red clove or an extract thereof, alfalfa or an extract thereof, etc.) that contains equols, and is preferably a fermented product of soybean germ that contains equols, or a fermented product of soybean germ extract that contains equols. In the present disclosure, "daidzeins" include daidzin, malonyldaidzin, acetyldaidzin, daidzein, and dihydrodaidzein, "genisteins" include genistin, malonylgenistin, acetylgenistin, genistein, dihydrogenistein, and the like, and "glyciteins" include glycitin, malonylglycitin, acetylglycitin, glycitein, dihydroglycitein, and the like.

[0090] Therefore, the composition according to this embodiment may be a composition for improving men's QOL, which contains an equol-containing composition.

[0091] Furthermore, the composition according to this embodiment may be a composition for improving male QOL, which contains a fermentation product of a composition containing daidzeins and which also contains equols. Furthermore, the composition according to this embodiment may be a composition for improving men's QOL, which contains a fermented soybean germ product that contains equols. Furthermore, the composition according to this embodiment may be a composition for improving men's QOL, which contains a fermented soybean germ extract that contains equols.

[0092] Furthermore, the composition according to this embodiment may be a composition for improving men's QOL, which contains equols obtained by fermenting a composition containing daidzeins. Furthermore, the composition according to this embodiment may be a composition for improving men's QOL, which contains equols obtained by fermenting soybean germ. Furthermore, the composition according to this embodiment may be a composition for improving men's QOL, which contains equols obtained by fermenting soybean germ extract.

[0093] The fermented soybean germ product containing equols can be obtained according to a conventional method. The fermentation of soybean germ can also be carried out according to a conventional method.

[0094] The soybean germ extract is not particularly limited as long as it contains equols when it becomes a fermented product by fermentation, and examples thereof include compositions containing isoflavones as described in the Examples, and more specifically, soybean germ extracts containing isoflavones. Such soybean germ extracts containing isoflavones can be extracted from soybeans and soybean germs (hypopyle). For the extraction, water, ethanol, or aqueous ethanol can be used. Also, for example, it can be obtained as described in the literature "Development of Plant Polyphenol-Containing Materials - Their Functionality and Safety" (published in 2007 by CMC Publishing Co., Ltd.).

[0095] Isoflavones are a type of polyphenol, and are flavonoids with isoflavone as the basic structure. Isoflavones are abundantly contained in legumes such as soybeans, kudzu, red clover, and licorice. Therefore, the soybean germ extract containing isoflavones may be replaced by an extract of legumes such as kudzu, red clover, and licorice that contains isoflavones.

[0096] In addition, the soybean germ extract may be one in which the components are extracted or purified, so long as the soybean germ extract contains equols when it is fermented to produce a fermented product. That is, the soybean germ extract may be isoflavones or a composition containing isoflavones, such as a composition containing isoflavones as described in the Examples.

[0097] The isoflavones are not particularly limited as long as they can be converted into equols by fermentation. An example of an isoflavone is daidzein. In this case, fermentation can be performed using a microorganism capable of producing equol from daidzein, allowing the microorganism to produce equol. Daidzein may be obtained by hydrolyzing daidzin with a hydrolase (e.g., β-glucosidase, etc.). Furthermore, by fermenting with a microorganism that has the ability to produce daidzein from the glycoside daidzin and the ability to produce equol from daidzein, the microorganism can be made to produce equol. In such a case, the isoflavone may be daidzin.

[0098] In addition, an example of isoflavones is genistein. In this case, fermentation can be performed using a microorganism capable of producing 5-hydroxyequol from genistein, allowing the microorganism to produce 5-hydroxyequol. Genistein may be obtained by hydrolyzing genistin with a hydrolase (e.g., β-glucosidase, etc.). In addition, by fermenting using a microorganism that has the ability to produce genistein from the glycoside genistin and the ability to produce 5-hydroxyequol from genistein, the microorganism can be made to produce 5-hydroxyequol, and in such a case the isoflavone may be genistin.

[0099] The isoflavones do not necessarily need to be purified pure products. The type, form, degree of purification, etc. of the isoflavones can be selected as desired depending on the intended use or application of the equol obtained by fermentation. The amount and concentration of soybean germ extract used for fermentation are not particularly limited as long as the fermented product contains equols. In addition, in a preferred embodiment, when the soybean germ extract contains isoflavones, the amount and concentration of isoflavones used for fermentation are not particularly limited. In a preferred embodiment, when isoflavones alone are used, the amount and concentration of isoflavones used for fermentation are not particularly limited. They can be appropriately set depending on the amount of culture medium and the amount of equols to be produced.

[0100] In the fermentation, anaerobic microorganisms are cultured in a medium containing a soybean germ extract. The anaerobic microorganisms are not particularly limited as long as they are anaerobic microorganisms capable of producing equols at a temperature of about 37° C. (e.g., 30 to 42° C.). For example, microorganisms belonging to the genus Adlercreutzia are microorganisms belonging to the genus Asaccharobacter, microorganisms belonging to the genus Bacteroides, microorganisms belonging to the genus Bifidobacterium, microorganisms belonging to the genus Eggerthella, microorganisms belonging to the genus Enterococcus, microorganisms belonging to the genus Eubacterium, microorganisms belonging to the genus Lactobacillus, microorganisms belonging to the genus Lactococcus Microorganisms, microorganisms belonging to the genus Sharpea, microorganisms belonging to the genus Slackia, microorganisms belonging to the genus Streptococcus Among these, microorganisms belonging to the genera Asaccharobacter and Adlercreutzia are preferred.

[0101] Microorganisms belonging to the genus Adlercreutzia include microorganisms belonging to Adlercreutzia equolifaciens and Adlercreutzia mucosicola, and microorganisms belonging to the genus Asaccharobacter. Examples of microorganisms belonging to the genus include those belonging to Asaccharobacter celatus, examples of microorganisms belonging to the genus Bacteroides include those belonging to Bacteroides ovatus, examples of microorganisms belonging to the genus Bifidobacterium include those belonging to Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium pseudolongum, examples of microorganisms belonging to the genus Enterococcus include those belonging to Enterococcus faecalis, and examples of microorganisms belonging to the genus Lactobacillus include those belonging to Lactobacillus fermentum and Lactobacillus intestinalis. Microorganisms that belong to the genus Lactococcus include microorganisms belonging to Lactobacillus plantarum and microorganisms belonging to Lactobacillus rhamnosus. Examples of microorganisms that belong to the genus Lactococcus include microorganisms belonging to Lactococcus garvieae. Examples of microorganisms that belong to the genus Sharpea include those belonging to the genus Sharpea, such as those belonging to the genus Sharpea azabuensis. Examples of microorganisms belonging to the genus Slackia include microorganisms belonging to Slackia equolifaciens and Slackia isoflavoniconvertens, and examples of microorganisms belonging to the genus Streptococcus include Examples of microorganisms belonging to the genus Streptococcus include those belonging to Streptococcus constellatus and those belonging to Streptococcus intermedius.

[0102] In addition, examples of microorganisms belonging to Adlercreutzia equolifaciens include the Adlercreutzia equolifaciens FJC-B9T strain, examples of microorganisms belonging to Adlercreutzia mucosicola include the Adlercreutzia mucosicola Mt1B8 strain, and examples of microorganisms belonging to Asaccharobacter celatus include the Adlercreutzia mucosicola Mt1B8 strain. Asaccharobacter celatus AHU 1763 strain and Asaccharobacter celatus DSM 18785 strain Examples of microorganisms belonging to Bacteroides ovatus include Bacteroides ovatus E-23-15 strain, and examples of microorganisms belonging to Bifidobacterium breve include Bifidobacterium breve strain. Examples of microorganisms belonging to the genus Bifidobacterium longum include the ATCC 15700 strain, examples of microorganisms belonging to the genus Bifidobacterium longum include the Bifidobacterium longum BB536 strain, and examples of microorganisms belonging to the genus Eggerthella include the Eggerthella strain YY7918 and Eggerthella sp. D1. Examples of the organism include the Enterococcus faecalis INIA P333 strain, examples of the microorganisms belonging to the Eubacterium genus include the Eubacterium sp. D2 strain, and examples of the microorganisms belonging to the Lactobacillus fermentum genus include the Lactobacillus sp. Examples of the microorganisms include the Lactobacillus fermentum DPPMA114 strain, examples of the microorganisms belonging to Lactobacillus intestinalis include the Lactobacillus intestinalis KTCT13676BP strain, examples of the microorganisms belonging to Lactobacillus plantarum include the Lactobacillus plantarum DPPMA24W strain and the Lactobacillus plantarum DPPMASL33 strain, and examples of the microorganisms belonging to Lactobacillus rhamnosus include the Lactobacillus fermentum DPPMA114 strain, the Lactobacillus intestinalis KTCT13676BP ... Examples of microorganisms belonging to the genus Lactobacillus include the Lactobacillus rhamnosus INIA P540 strain and the Lactobacillus rhamnosus DPPMAAZ1 strain. Examples of microorganisms belonging to the genus Lactococcus garvieae include the Lactococcus garvieae 20-92 strain, Sharpea azabuensis ST18 strain, Slackia equolifaciens ST18 strain, Slackia As a microorganism belonging to the genus Slackia, the strain Slackia isoflavoniconvertens HE8 is an example. Examples of microorganisms belonging to Streptococcus constellatus include Streptococcus constellatus E-23-17 strain, and examples of microorganisms belonging to Streptococcus intermedius include Streptococcus intermedius A6G-225 strain.

[0103] The anaerobic microorganism may be cultured in a medium containing a soybean germ extract under conditions suitable for the production of equols. The conditions suitable for the production of equols refer to conditions under which the survival and activity of the anaerobic microorganism having the activity of producing equols is maintained. More specifically, the conditions refer to conditions under which a gas phase condition (anaerobic condition) in which the anaerobic microorganism can survive is maintained, and nutrients for supporting the activity and growth of the anaerobic microorganism are provided. Various medium compositions suitable for the survival of the anaerobic microorganisms are known. Therefore, when using the anaerobic microorganisms, those skilled in the art can select an appropriate medium composition. For example, BHI medium manufactured by Difco Alternatively, the GAM bouillon medium manufactured by Nissui Pharmaceutical Co., Ltd. used in the examples can be used.

[0104] In addition, the medium may contain, for example, water-soluble organic substances as a carbon source, such as sugars, such as sorbose, fructose, and glucose, alcohols, such as methanol, and organic acids, such as valeric acid, butyric acid, propionic acid, acetic acid, and formic acid. The concentration of the organic matter added to the medium as a carbon source can be appropriately adjusted to efficiently grow the anaerobic microorganism in the medium. In general, excess or deficiency can be avoided by selecting the amount added from the range of 0.1 to 10 wt / vol%.

[0105] In addition to the carbon sources, a nitrogen source is added to the medium. As the nitrogen source, various nitrogen compounds that can be used in normal fermentation can be used. Preferred inorganic nitrogen sources are ammonium salts and nitrate salts. More preferred inorganic nitrogen sources are ammonium sulfate, ammonium chloride, ammonium phosphate, ammonium hydrogen phosphate, potassium nitrate, and sodium nitrate. On the other hand, preferred organic nitrogen sources are amino acids, yeast extract, peptones (e.g., polypeptone N, etc.), meat extract, liver extract, digested serum powder, etc. More preferred organic nitrogen sources are Arginine, cysteine, citrulline, lysine, yeast extract, and peptones (such as polypeptone N).

[0106] In addition to the carbon and nitrogen sources, other organic or inorganic substances suitable for culturing the anaerobic microorganisms can be added to the medium. For example, the growth and activity of the anaerobic microorganisms can be enhanced by adding cofactors such as vitamins and inorganic compounds such as various salts to the medium. For example, the following inorganic compounds, vitamins, and microbial growth cofactors derived from animals and plants can be mentioned. Inorganic compounds Vitamins Potassium dihydrogen phosphate Biotin Magnesium Sulfate Folic Acid Manganese Sulfate Pyridoxine Sodium Chloride Thiamine Cobalt chloride Riboflavin Calcium chloride Nicotinic acid Zinc Sulfate Pantothenic Acid Copper Sulfate Vitamin B12 Alum Thioctic acid Sodium molybdate p-aminobenzoic acid Potassium chloride Boric acid etc. Nickel chloride Sodium Tungstate Sodium Selenite Ammonium Ferrous Sulfate

[0107] Methods for preparing culture media by adding these inorganic compounds, vitamins, or growth cofactors are known. The medium can be liquid, semi-solid, or solid. The preferred form of the medium is a liquid medium.

[0108] The anaerobic microorganisms can be cultured according to known methods for culturing anaerobic microorganisms. For industrial production, a continuous fermentation system capable of continuously supplying the medium and substrate gas and having a mechanism for recovering the culture is suitable. It is. In culturing anaerobic microorganisms, it is necessary to prevent oxygen from being mixed into the continuous culture system. A commonly used culture tank can be used as the incubator. Culture tanks that can also be used to cultivate the anaerobic microorganisms are commercially available. An anaerobic atmosphere can be created by replacing the oxygen that is mixed into the culture tank with an inert gas such as nitrogen or a substrate gas.

[0109] The culture tank may be one with additional functions. For example, in addition to the commonly used stirring and mixing tank, a bubble column type culture tank, a draft tube type culture tank, etc. may be used. The anaerobic microorganisms are dissociated and dispersed by the mixed gas blown into the liquid medium, allowing sufficient contact between the anaerobic microorganisms and the medium. Also, highly breathable slag such as a biotrickling filter, or other ceramic inorganic filling tanks may be used. The anaerobic microorganisms can be cultured by inhabiting a packed bed of a bed of a synthetic organic material such as polypropylene or the like while dripping water into the packed bed and then passing gas through the packed bed. Furthermore, the anaerobic microorganisms used can be immobilized in carrageenan gel, alginic acid gel, acrylamide gel, chitin, cellulose, agar, or the like by a conventional method.

[0110] Depending on the shape of the culture tank, a stirrer or the like can be used to thoroughly stir the medium. By stirring the culture in the culture tank, the opportunities for the medium components and substrate gas to come into contact with the anaerobic microorganisms can be increased, optimizing the efficiency of equol production. The substrate gas can also be supplied as nanobubbles.

[0111] For sufficient growth of the anaerobic microorganisms, the pH of the culture is preferably 5.0 to 8.0, more preferably 6.0 to 7.5, and even more preferably 6.5 to 7.5. The temperature of the culture tank is not particularly limited, but is preferably 30° C. to 40° C., and even more preferably 33° C. to 38° C., in order to increase the amount of equols recovered. The fermentation time can be appropriately set depending on the amount of equols produced, the remaining amount of soybean germ extract, etc. For example, it is 8 to 120 hours, preferably 12 to 72 hours, and particularly preferably 16 to 60 hours.

[0112] The anaerobic microorganism may be cultured in a gas phase containing one or more gases including hydrogen. The hydrogen concentration is not particularly limited.

[0113] The obtained culture solution may be subjected to solid-liquid separation by filtration or centrifugation to recover the liquid phase. Examples of filtration include filtration using filter paper or an ultrafiltration membrane, and examples of centrifugation include centrifugation using a centrifuge such as a super decanter. The obtained culture solution may be used as it is without solid-liquid separation.

[0114] The fermented soybean germ extract can be used by converting the resulting culture solution into a solid form by heat drying, spray drying, or freeze drying, as necessary. Both heat drying and spray drying can be carried out using, for example, a spray dryer. Freeze drying can be carried out using a freeze dryer. The fermented product that has been subjected to heat drying, spray drying, or freeze drying may be subjected to a powdering process, if necessary.

[0115] The fermented product obtained by such a method and subjected to heat drying, spray drying, or freeze drying can contain 0.05 to 50% by mass of equols in the dry powder. For example, the mass % concentration is preferably indicated by a concentration range with a lower limit (above or above or higher than) and an upper limit (below or below or lower than) of two mass % concentrations selected from 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, and 50%.

[0116] As shown in the examples described below, the diversity of the intestinal flora is improved in subjects who ingest the composition according to this embodiment. Therefore, the composition according to this embodiment can be used for improving the intestinal flora. The improvement of the intestinal flora is preferably the improvement of the diversity of the intestinal flora. Furthermore, as a result, the present disclosure can provide a composition for improving intestinal flora that contains equols.

[0117] When the composition according to this embodiment is used for non-therapeutic purposes, the subject may be a healthy individual. A healthy individual may refer to, for example, an individual who does not suffer from irritable bowel syndrome, constipation, diarrhea, or food allergy when taking the composition according to this embodiment. When the composition according to this embodiment is used for non-therapeutic purposes, irritable bowel syndrome, constipation, diarrhea, food allergy, etc. can be prevented.

[0118] When the composition according to this embodiment is used for therapeutic purposes, the subject may be a non-healthy individual. When the composition according to this embodiment is used for therapeutic purposes, it becomes possible to treat irritable bowel syndrome, constipation, diarrhea, food allergies, and the like in a non-healthy individual.

[0119] When the diversity of the intestinal flora is improved, the Shannon Idex increases, so the improvement of the diversity of the intestinal flora can be confirmed by analyzing the Shannon Idex. For example, the intestinal flora test "Mykinso Pro" (manufactured by Cykinso Co., Ltd.) can be used for the analysis.

[0120] As shown in the examples described below, subjects who ingested the composition according to this embodiment experienced an increase in Firmicutes bacteria in their intestinal flora. Thus, the composition according to this embodiment is an effective antibacterial agent for the proliferation of bacteria of the phylum Firmicutes. It can be used for promoting reproduction. Furthermore, based on this, the present disclosure can provide a composition for promoting the growth of bacteria belonging to the phylum Firmicutes, which contains equols.

[0121] For the analysis of the number of bacteria belonging to the phylum Firmicutes, for example, the intestinal flora test "Mykinso Pro" (manufactured by Cykinso Co., Ltd.) can be used. EXAMPLES

[0122] Examples are set forth below, but none of the examples are to be construed in a limiting sense.

[0123] [Production Example 1] Production of a composition for improving men's QOL The raw materials used were a fermented soybean germ extract (product name: Aquaequol) containing equol (5 mg), maltitol, crystalline cellulose, corn protein, calcium stearate, silicon dioxide, and carnauba wax, which were formed into tablets and manufactured as a composition for improving men's QOL, which was used as the test food in the tests described below.

[0124] The fermented soybean germ extract was prepared as follows. First, a seed culture of the anaerobic microorganism to be used for fermentation was prepared. 5.9 g of L-arginine hydrochloride (manufactured by Nissui Pharmaceutical Co., Ltd.) and 1.2 g of L-arginine hydrochloride were dissolved in 100 mL of pure water, and 10 mL was dispensed into 18 mm test tubes for culturing anaerobic bacteria (manufactured by Sanshin Kogyo Co., Ltd.) while passing nitrogen gas through them. The tubes were then sealed with butyl rubber stoppers and plastic caps and sterilized at 115°C for 15 minutes. The anaerobic microorganism Asaccharobacter celatus DSM 18785 strain, which had been frozen and stored at -80°C, was inoculated into this medium, and the gas phase was replaced with hydrogen gas passed through a sterile filter for at least 2 minutes (hydrogen A seed culture was prepared by shaking culture at 37°C and 250 spm for 18 hours (partial pressure percent concentration 100%). Next, 11 g of Isoflavone-80 (manufactured by J-Oil Mills), 3 g of yeast extract, and L-cysteine ​​were added. A medium containing 0.5 g of arginine hydrochloride, 0.002 g of hemin, 16.5 g of β-cyclodextrin, 12.1 g of L-arginine hydrochloride, 0.1 g of oleic acid, and 0.2 g of antifoaming agent was adjusted to 1000 mL with deionized water, and the pH was adjusted to 7.1. 1000 mL of the medium was placed in a 2 L pressure mini jar (manufactured by Automatic System Research), and nitrogen gas was passed through the medium for 20 minutes or more, followed by sterilization at 115°C for 15 minutes. The above-mentioned Isoflavone-80 (manufactured by J-Oil Mills) is a powder containing high-purity soy isoflavone glycosides (daidzin, glycitin, and genistin) extracted and refined in Japan using North American soybean germ as a raw material (Soybean Functional Ingredients (Fine), [online], J-Oil Mills Co., Ltd., [searched on August 9, 2023], Internet<https: / / www.j-oil.com / prosumer / fine / > In this test, the glycosides were hydrolyzed in advance using a commercially available β-glucosidase to form aglycons (daidzein, glycitein, and genistein, respectively). Inoculate 20 mL of the above seed culture solution into this medium, and add hydrogen / nitrogen [2:98] (volume ratio) through the sparger. ) gas was aseptically aerated at 0.1 L / min, and the culture was carried out at 37°C, 500 rpm, and 50 kPa. The pH during the culture was adjusted to 7.2 with sulfuric acid. After 48 hours, the culture medium was removed. The culture medium was adjusted to pH 5.0 with sulfuric acid, and then heated at 105°C for 1 minute. After cooling to room temperature, the medium was centrifuged at 15,000 x g for 10 minutes at 20°C. The supernatant was spray-dried to obtain the fermented medium. The equol content was 6.5%.

[0125] Example 1 Seventeen healthy men aged 40 or over were asked to take the test food for four weeks, two tablets per day (10 mg per day as equol) with water or lukewarm water. Before and four weeks after intake, the male menopause questionnaire (AMS score) and the common anti-aging QOL questionnaire were used to evaluate the condition.

[0126] The evaluation was carried out according to the respective manuals. For the AMS score, subjects were asked to answer on a 5-point scale: "1. None," "2. Mild," "3. Moderate," "4. Severe," and "5. Very severe." 1 to 5 were assigned points. The scores were calculated based on the results. In the common anti-aging QOL questionnaire, subjects were asked to answer on a 5-point scale: "1. Not at all," "2. Almost none," "3. A little," "4. Moderately," and "5. Highly." Each was scored from 1 to 5 points.

[0127] (Results based on AMS scores) The results based on the AMS scores are shown in Table 1. Compared to before intake, items with a lower score were considered "improved" and items with an increased score were considered "worsened." The total score for each person was also judged in the same way. As a result, the number of people who improved exceeded the number of people who worsened in all items. In particular, for the total score, 12 out of 17 people improved and one person worsened, and since the number of people who improved exceeded the number of people who worsened, it was found that the composition of this example improves the male menopausal disorder of the subjects. Furthermore, looking only at the mild to moderate subjects (11 people) who had a score of 27 or more before intake, as shown in Table 2, the average scores for the items "physical fatigue and decreased motivation," "depressed mood," "feeling exhausted and at rock bottom," and the total score improved significantly compared to before intake (p<0.05).

[0128] [Table 1]

[0129] [Table 2]

[0130] (Results based on the common anti-aging QOL questionnaire) The results based on the Anti-Aging QOL Common Questionnaire are shown in Tables 3 and 4. Items with a decreased score were marked as "improved," and items with an increased score were marked as "worsened." The total score for each person was also judged in the same way. As can be seen from Table 3, in 24 of the 34 physical symptoms, the number of people whose symptoms improved exceeded the number of people whose symptoms worsened compared to before intake. Also, as can be seen from Table 4, in 18 of the 21 mental symptoms, the number of people whose symptoms improved exceeded the number of people whose symptoms worsened compared to before intake. Furthermore, since the number of people whose symptoms improved exceeded the number of people whose symptoms worsened in terms of the total score, it was found that the composition according to this example improves the QOL of the subjects.

[0131] [Table 3]

[0132] [Table 4]

[0133] Example 2 Of the subjects in Example 1, 15 who provided their consent were subjected to an analysis of the intestinal flora using the intestinal flora test "Mykinso Pro" provided by Cykinso Co., Ltd., following the manual.

[0134] (result) The results of the analysis of the intestinal flora are shown in Table 5. It was found that the composition according to this embodiment improves the diversity of the intestinal flora of the subjects. In addition, "Firmicutes bacteria" in the table indicates the number of "Firmicutes bacteria".

[0135] [Table 5]

Claims

1. A composition for improving men's quality of life, comprising equols.

2. The composition according to claim 1 , wherein the improvement in QOL is improvement in menopausal symptoms.

3. The composition according to claim 2, wherein the improvement of the menopausal symptoms is improvement in sense of health, improvement in bodily pain, improvement in autonomic nervous system disorders, improvement in sleep, improvement in fatigue, improvement in mood, improvement in anxiety, improvement in vitality, improvement in muscle strength, improvement in body hair, or improvement in sexual ability.

4. The composition according to claim 2 or 3, wherein the menopausal symptoms are evaluated by AMS score.

5. The composition according to claim 1 , wherein the improvement in QOL is an improvement in physical symptoms or an improvement in mental symptoms.

6. The improvement in QOL is an improvement in physical symptoms, The composition according to claim 5, wherein the improvement of physical symptoms is improvement of eye fatigue, improvement of bodily pain, improvement of cardiac ischemia, improvement of fatigue, improvement of skin condition, improvement of bronchitis, improvement of gray hair, improvement of autonomic nerve balance, improvement of hearing loss, improvement of swelling, stomach regulation, intestinal regulation, or hair growth.

7. The improvement in QOL is an improvement in mental symptoms, The composition according to claim 5 , wherein the improvement in mental symptoms is improvement in anger, improvement in vitality, improvement in depression, improvement in confusion, improvement in anxiety, or improvement in insomnia.

8. The composition according to any one of claims 5 to 7, wherein the QOL is evaluated by an anti-aging QOL common questionnaire.

9. The composition of claim 1, 2, or 5, wherein the male is 40 years of age or older and 70 years of age or younger.

10. The composition according to claim 9, wherein the male is experiencing subjective symptoms of menopause.

11. The composition according to claim 1 , 2 or 5 , wherein the total daily intake of the equols is 1 mg or more.

12. The composition according to claim 1 , 2 or 5 , which is a food or drink.

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