Composition for improving men's qol

Abstract

The present disclosure addresses the problem of providing a technique for improving at least men's QOL, wherein the problem is solved by a composition for improving men's QOL, the composition containing equol.

Description

Composition for improving men's quality of life

[0001] The present disclosure relates to compositions for improving men's quality of life.

[0002] Male menopausal symptoms are thought to be caused by a decrease in testosterone, a male hormone. To alleviate or improve these symptoms, testosterone secretagogues containing euglena and / or paramylon have been developed (Patent Document 1). A composition containing elderberry extract as an active ingredient, which increases blood testosterone levels, has also been developed (Patent Document 2). Aromatase is an enzyme known to convert male hormones (androgens such as testosterone) into female hormones (estrogens) in vivo, and an aromatase inhibitor containing 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. Increased dihydrotestosterone is thought to be a cause of male pattern baldness (AGA) and benign prostatic hyperplasia, and there is a view that increasing testosterone is not always beneficial (Non-Patent Document 1). Therefore, there is a need for other compounds that have testosterone-like activity rather than increasing testosterone.

[0004] It is known that equol is a compound produced from daidzein, a type of isoflavone, by the action of intestinal bacteria, and equol is known to have high estrogenic activity (Patent Document 5). However, even if a person ingests soy isoflavones, differences in the 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).

[0005] Japanese Patent Application Laid-Open No. 2019-213518 Japanese Patent Application Laid-Open No. 2022-509468 Japanese Patent Application Laid-Open No. 2010-059192 Japanese Patent Application Laid-Open No. 2015-028007 Japanese Patent Application Laid-Open No. 2003-310177 Japanese Patent Application Laid-Open No. 2021-106538

[0006] Journal of the Japanese Dermatological Association: 127(13), 2763-2777, 2017 (Heisei 29)

[0007] The objective of the present disclosure is to provide a technology that improves at least the quality of life of men.

[0008] The present inventors conducted extensive research to solve the above-mentioned problems and found that equols can solve the above-mentioned problems. The present disclosure includes the following aspects. The present disclosure can provide a composition containing equols for improving male QOL. In a preferred aspect of the composition, the improvement in QOL is an improvement in menopausal symptoms. In a preferred aspect of the composition, the improvement in menopausal symptoms is an improvement in sense of well-being, 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 performance. In a preferred aspect of the composition, the menopausal symptoms are evaluated using the AMS score. In a preferred aspect of the composition, the improvement in QOL is an improvement in physical symptoms or improvement in mental symptoms. In a preferred embodiment of the composition, the improvement in QOL is an improvement in physical symptoms, and the improvement in physical symptoms is improvement in eye strain, bodily pain, cardiac ischemia, fatigue, skin condition, bronchitis, gray hair, autonomic nervous system 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 improvement in anger, vitality, depression, confusion, anxiety, or insomnia. In a preferred embodiment of the composition, the QOL is assessed using a common anti-aging QOL questionnaire. In a preferred embodiment of the composition, the male is 40 years of age or older and 70 years of age or younger. In a preferred embodiment of the composition, the male is experiencing subjective symptoms of menopausal disorder. In a preferred embodiment of the composition, the total daily intake of equols is 1 mg or more. In a preferred embodiment of the composition, the composition is a food or beverage.

[0009] The present disclosure can at least provide an effect of providing a technology for improving the quality of life of men. Furthermore, since the present disclosure does not increase testosterone, there is no need to assume that the onset of male pattern baldness (AGA) or benign prostatic hyperplasia due to an increase in dihydrotestosterone generated from testosterone will occur.

[0010] The configurations and combinations thereof in each embodiment are merely examples, and additions, omissions, substitutions, and other modifications of the configurations are possible as appropriate within the scope of the gist of the present disclosure. The present disclosure is not limited by the embodiments, but is limited only by the scope of the claims.

[0011] One embodiment of the present disclosure is a composition containing equols for improving men's quality of life.

[0012] Equols are represented by the following general formula (1). (In the formula, R １ ~R ７ represent a hydroxyl group or a hydrogen atom.) Specific examples of equols include all compounds included in the compound represented by general formula (1) above, specifically equol (also known as 4',7-isoflavandiol), 5-hydroxyequol, etc.

[0013] The composition according to this embodiment may contain equols alone, or may contain other ingredients, such as maca, zinc, indigestible dextrin, calcium stearate, and silicon dioxide, as long as they are capable of improving men's QOL.

[0014] The subject who takes 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 QOL is improved by taking the composition according to this embodiment, but is preferably 40 years or older, more preferably 45 years or older, even more preferably 50 years or older, and preferably 70 years or younger, more preferably 65 years or younger, and even more preferably 60 years or younger. That is, for example, 40 years or older and 70 years or younger, 45 years or older and 65 years or older, 50 years or older and 60 years or younger, etc.

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

[0017] The subject taking the composition according to this embodiment may be either an individual capable of producing equols or an individual unable to produce equols, but preferably an individual unable to produce equols. Furthermore, as individuals unable to produce equols, an individual unable to produce equols from daidzeins or genisteins is more preferred. Specific examples include individuals unable to produce equol from daidzein and individuals unable to produce 5-hydroxyequol from genistein.

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

[0019] The composition according to this embodiment may be taken preventively to prevent a decline in QOL, or may be taken to maintain QOL. In this embodiment, the improvement in QOL may be evaluated by an objective judgment by a doctor or the like, but is preferably evaluated by an objective measure such as a test or questionnaire developed by an expert.

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

[0021] The improvement in QOL can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a group of subjects (subject population) with a sufficient number of subjects for evaluation, as in the Examples described below. Specifically, for the total score for "physical symptoms" listed in Table 3 and the total score for "mental symptoms" listed in Table 4, let (A) (people) be the number of subjects who reported improvement (i.e., a decrease in the value) after taking equols compared to when not taking equols (or when taking a placebo), and let (B) (people) be the number of subjects who reported worsening (i.e., an increase in the value). If both {(A) - (B)} (people) are positive, it can be determined that QOL has improved. The larger this {(A) - (B)} (people) is, the better. In the examples described below, the total score for "physical symptoms" was {(A) - (B)} (people) for 7 people, and the total score for "mental symptoms" was {(A) - (B)} (people) for 10 people, and both {(A) - (B)} (people) were positive, indicating that QOL had improved.

[0022] The improvement in QOL in this embodiment is preferably an improvement in physical symptoms or an improvement in mental symptoms.

[0023] Improvement in physical symptoms can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a group of subjects (subject population) with a sufficient number of subjects for evaluation, as in the Examples described below. Specifically, when the number of subjects who reported improvement (i.e., a smaller score) in the total score for "physical symptoms" after taking equols compared to when not taking equols (or before taking equols or when taking a placebo) is defined as (A) (people), and the number of subjects who reported worsening (i.e., an increase in score) after taking equols is defined as (B) (people), improvement in physical symptoms can be determined if {(A) - (B)} (people) is positive. A larger value for {(A) - (B)} (people) is preferable. In the Examples described below, {(A) - (B)} (people) is 7 people, which is positive, indicating improvement in physical symptoms.

[0024] Improvement in the mental symptoms can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a group of subjects (subject population) with a sufficient number of subjects for evaluation, as in the Examples described below. Specifically, when the number of subjects who reported improvement (i.e., a smaller score) in the total score for "mental symptoms" after taking equols compared to when not taking equols (or before taking equols or when taking a placebo) is defined as (A) (people), and the number of subjects who reported worsening (i.e., an increased score) after taking equols is defined as (B) (people), improvement in the mental symptoms can be determined if {(A) - (B)} (people) is positive. A larger value for {(A) - (B)} (people) is preferable. In the Examples described below, {(A) - (B)} (people) is 10, which is positive, indicating improvement in the mental symptoms.

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

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

[0027] The improvement in eye strain can be determined, for example, by evaluation of a target population (subject population) using a common anti-aging QOL questionnaire, as in the Examples described below. Specifically, first, for "eye fatigue," the number of subjects who reported improvement (i.e., a smaller value) after taking equols compared to when not taking equols (or before taking equols or when taking a placebo) is defined as (A) (persons), and the number of subjects who reported worsening (i.e., an increased value) is defined as (B) (persons). Then, {(A) - (B)} (persons) is calculated. For convenience, this is referred to as (C1) (persons). Similarly, the score for "blurred vision" is calculated. For convenience, this is referred to as (C2) (persons). Similarly, the score for "eye pain" is calculated. For convenience, this is referred to as (C3) (persons). In this case, if {(C1) + (C2) + (C3)} (persons) is positive, it can be determined that eye strain has been improved. The larger the value of {(C1) + (C2) + (C3)} (people), the better. In the example described below, there are 7 people with (C1), 4 people with (C2), and 2 people with (C3), so {(C1) + (C2) + (C3)} (people) is 13 people, which is positive and indicates that eye strain has been improved.

[0028] Improvement in eye fatigue 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, when the number of subjects who reported improvement (i.e., a smaller value) in "eye fatigue" after taking equols compared to when not taking equols (or before taking equols or when taking a placebo) is defined as (A) (people), and the number of subjects who reported worsening (i.e., an increased value) after taking equols is defined as (B) (people), if {(A) - (B)} (people) is positive, it can be determined that eye fatigue has improved. A larger value of {(A) - (B)} (people) is preferable. In the Examples described below, {(A) - (B)} (people) is 7 people, which is positive, indicating that eye fatigue has improved. Improvement in blurred vision and eye pain can also be determined in a similar manner.

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

[0030] The improvement in bodily pain can be determined, for example, by evaluation using a common anti-aging QOL questionnaire administered to a target group (subject population), as in the Examples described below. Specifically, first, for "stiff shoulders," the number of subjects who reported improvement (i.e., a smaller value) after taking equols compared to when not taking equols (or when taking a placebo) is defined as (A) (persons), and the number of subjects who reported worsening (i.e., an increased value) after taking equols is defined as (B) (persons). Then, {(A) - (B)} (persons) is calculated. For convenience, this is referred to as (C1) (persons). Similarly, a calculation is made for "muscle pain / stiffness." For convenience, this is referred to as (C2) (persons). Similarly, a calculation is made for "lower back pain." For convenience, this is referred to as (C3) (persons). Similarly, a calculation is made for "joint pain." For convenience, this is referred to as (C4) (persons). In this case, if {(C1) + (C2) + (C3) + (C4)} (people) is positive, it can be determined that physical pain has improved. The larger {(C1) + (C2) + (C3) + (C4)} (people) is, the better. In the example described below, (C1) (people) is 5 people, (C2) (people) is -2 people, (C3) (people) is 3 people, and (C4) (people) is 4 people, so {(C1) + (C2) + (C3) + (C4)} (people) is 10 people, which is positive, indicating that physical pain has improved.

[0031] The improvement in stiff shoulders can be determined, for example, by evaluation of a target population (subject population) using a common anti-aging QOL questionnaire, as in the Examples described below. Specifically, for "stiff shoulders," let (A) (people) be the number of subjects who reported improvement (i.e., a smaller value) after taking equols compared to when not taking equols (or when taking a placebo), and (B) (people) be the number of subjects who reported worsening (i.e., an increased value). If {(A) - (B)} (people) is positive, it can be determined that stiff shoulders have improved. A larger value of {(A) - (B)} (people) is preferable. In the Examples described below, {(A) - (B)} (people) is 5, which is positive, indicating that stiff shoulders have 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 population), as in the Examples described below. Specifically, when the number of subjects who reported that their "muscle pain and stiffness" improved (i.e., their values ​​decreased) after taking equols compared to when they did not take equols (or compared to before taking equols or when they took a placebo) is defined as (A) (people), and the number of subjects who reported that their "muscle pain and stiffness" worsened (i.e., their values ​​increased) after taking equols is defined as (B) (people), if {(A) - (B)} (people) is positive, it can be determined that muscle pain and physical stiffness have improved. A larger value of {(A) - (B)} (people) is preferable.

[0033] Improvement in lower back pain can be determined, for example, by evaluation of a common anti-aging QOL questionnaire administered to a target population (subject population), as in the Examples described below. Specifically, for "lower back pain," let (A) (people) be the number of subjects who reported improvement (i.e., a decrease in the value) after taking equols compared to when not taking equols (or when taking a placebo), and let (B) (people) be the number of subjects who reported worsening (i.e., an increase in the value). If {(A) - (B)} (people) is positive, it can be determined that lower back pain has improved. A larger value for {(A) - (B)} (people) is preferable. In the Examples described below, {(A) - (B)} (people) is 3, which is positive, indicating that lower back pain has improved. Improvement in joint pain can also be determined 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 autonomic nerve balance, improvement of hearing loss, improvement of swelling, improvement of frequent urination, weight maintenance, stomach regulation, improvement of immune system, intestinal regulation, and hair growth, can also be judged in the same way as the improvement of eye fatigue, as already described. Furthermore, as will be described later, if there is another preferred aspect within the preferred aspect, the aspect can also be judged in the same way as the improvement of eye fatigue, as already described.

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

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

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

[0038] The bronchitis preferably refers to improvement in cough and phlegm, for example, improvement in coughing easily, or improvement in expectoration easily and / or improvement in phlegm not coming out easily.

[0039] The improvement in autonomic nervous balance is preferably improvement in headache, dizziness, sweating easily, hot flashes, or sensitivity to cold (for example, translated into English as "sensitivity to cold").

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

[0041] The maintenance of body weight is preferably an improvement in the tendency to gain weight, an improvement in the tendency to lose weight, or an 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 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 in the mental symptoms is preferably improvement in anger, energy, depression, friendship, confusion, anxiety, or insomnia.

[0047] These preferred aspects can be judged in the same way as the improvement of eye fatigue, as already described. Furthermore, as will be described later, if there are further preferred aspects within the preferred aspects, these aspects can also be judged in the same way as the improvement of eye fatigue, as already described.

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

[0049] The improvement in vitality is preferably an improvement in 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 improvement in depression is preferably improvement in melancholy.

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

[0052] The improvement in confusion is preferably improvement in worrying, 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 feeling nervous, feeling anxious for no reason, or feeling scared of something.

[0054] The improvement in insomnia is preferably improvement in shallow sleep, improvement in difficulty falling asleep, or improvement in difficulty sleeping due to worry.

[0055] Preferably, the subject taking the composition according to this embodiment is suffering from menopausal symptoms. Whether or not a subject is suffering from menopausal symptoms can be confirmed by conventional methods. For example, evaluation using the Simplified Menopausal Index (SMI) checklist or the Male Menopausal Questionnaire (AMS score) can be used. When using the Simplified Menopausal Index (SMI) checklist, a subject can be confirmed as suffering from menopausal symptoms if they score 71 or more. Furthermore, when using the Male Menopausal Questionnaire (AMS score), a subject can be confirmed as suffering from menopausal symptoms if they score 27 or more. Therefore, the improvement in QOL may be an improvement in menopausal symptoms.

[0056] In this embodiment, when the improvement of menopausal symptoms is evaluated by an objective scale such as a test or questionnaire developed by an expert, an example of such an evaluation is the Andromenopausal Symptom Questionnaire (AMS score). When evaluation is performed using the AMS score, the numerical values ​​of each factor and the total score obtained in the evaluation are preferably smaller when the subject takes equols than when the subject does not take equols (or before taking equols or when taking a placebo).

[0057] The improvement of menopausal symptoms can be determined, for example, by evaluation using the Male Menopausal Symptom Questionnaire (AMS score) administered to a group of subjects (subject population) large enough to be evaluated, as in the Examples described below. Specifically, for the "AMS scores" listed in Table 1, let (A) (people) be the number of subjects whose AMS scores improved (i.e., decreased) after taking equols compared to when not taking equols (or compared to before taking equols or when taking a placebo), and (B) (people) be the number of subjects whose AMS scores worsened (i.e., increased). If both {(A) - (B)} (people) are positive, it can be determined that menopausal symptoms have been improved. A larger {(A) - (B)} (people) is preferable. In the Examples described below, {(A) - (B)} (people) was 11, which is positive, indicating that menopausal symptoms have been improved.

[0058] Furthermore, improvement of the menopausal symptoms may be determined based on the number of subjects, as described above, but can also be determined based on the average score. Specifically, for the "total score" listed in Table 2, improvement of menopausal symptoms can be determined when there is greater improvement (i.e., a smaller value) when equols are taken compared to when not taken (or before taking equols or when taking a placebo). The greater the value obtained by subtracting the average score when equols are taken from the average score when not taken (or before taking equols or when taking a placebo), the better. As shown in Table 2, the factor "physical fatigue and decreased energy" is included in both the "mood" factor and the "vitality" factor, and the factor "feeling exhausted and at rock bottom" is also included in both the "mood" factor and the "vitality" factor, but these overlaps are not included when calculating the "total score" listed in Table 2. Specifically, for the pre-intake (average score), the sum of all the values ​​listed in Table 2 is 43.2, but the sum without overlaps is 39.1, and the latter is used. Similarly, for the four weeks after ingestion (average score), the sum of all the values ​​listed in Table 2 is 34.6, but the sum without overlaps is 31.5, and the latter is used. In the examples described below, as an example, the subjects were limited to those with mild to moderate symptoms. The average score before ingestion of equols was 39.1, and the average score after ingestion of equols (four weeks after ingestion) was 31.5, and the smaller values ​​indicate an improvement in menopausal symptoms.

[0059] The improvement of menopausal symptoms is preferably improvement in a sense of well-being, 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.

[0060] For these preferred aspects, and as will be described later, for any further preferred aspects within the preferred aspects, improvement can be determined based on the number of subjects, in the same way as for the improvement of eye strain and eye fatigue already described.

[0061] Furthermore, as already described, a judgment can also be made based on the average score. Specifically, for example, in the case of "improvement in sense of health," it can be judged that sense of health has improved when the average score for "sensation of health" improves (i.e., the value decreases) when equols are taken compared to when not taken (or before taking equols or when taking a placebo). The larger the value obtained by subtracting the average score when equols are taken from the average score when not taken (or before taking equols or when taking a placebo), the better. In the examples described below, as an example, the subjects were limited to those with mild to moderate symptoms. The average score before taking equols was 3.4, and the average score after taking equols was 1.9, indicating an improvement in sense of health due to the decrease in the value.

[0062] For example, in the case of "improvement in mood," first, for "irritability," the average score when equols are not taken (or before taking equols or when taking a placebo) is subtracted from the average score when equols are taken to calculate the value. For convenience, this is called (C1). A similar calculation is made for "nervousness." For convenience, this is called (C2). A similar calculation is made for "physical fatigue and decreased motivation." For convenience, this is called (C3). A similar calculation is made for "feeling exhausted and at rock bottom." For convenience, this is called (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 example 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 and indicates that mood has improved.

[0063] The improvement in feeling of well-being is preferably an improvement in feeling generally unwell.

[0064] The improvement in physical pain is preferably improvement in joint pain or muscle pain.

[0065] The improvement of the autonomic nervous system disorder is preferably an 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 often or an improvement in feeling tired often.

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

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

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

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

[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 in sexual ability, an improvement in a reduction in the number of early morning erections (morning wood), or an improvement in a decrease in sexual desire.

[0074] The content of equols relative to 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 determined depending on the age, weight, intake route, intake schedule, form, etc. of the subject, but is not particularly limited as long as ingestion improves the subject's QOL. The total amount of equols per day is preferably 1 mg or more, more preferably 2 mg or more, and even more preferably 5 mg or more, 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, etc.

[0076] The intake schedule for the composition according to this embodiment may be a single intake per day or multiple divided intakes per day. It may also be taken once every few days or weeks, but daily intake is preferred. The intake period is preferably 4 weeks or more, more preferably 8 weeks or more. While the upper limit is not particularly limited, examples include up to the age of 100, and may also be until death. That is, for example, from 4 weeks to death, or from 8 weeks to 100 years old.

[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 improving health and for beauty purposes.

[0078] 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, a person who, when ingesting the composition according to this embodiment, does not fall under the category of menopausal disorders or diseases, symptoms, signs, disorders, etc. in the preferred embodiments already exemplified for the improvement of menopausal disorders (in the present disclosure, "diseases, symptoms, signs, disorders, etc." may be referred to as "diseases, etc.") (e.g., a person who is not a patient with menopausal disorders or a patient who is not a patient with diseases, etc. in the preferred embodiments already exemplified for the improvement of menopausal disorders). When the composition according to this embodiment is used for non-therapeutic purposes, the quality of life (QOL) in healthy individuals may be improved. When the composition according to this embodiment is used for non-therapeutic purposes, menopausal disorders or diseases, etc. in the preferred embodiments already exemplified for the improvement of menopausal disorders can be prevented. When the composition according to this embodiment is used for non-therapeutic purposes, menopausal disorders or diseases, etc. in the preferred embodiments already exemplified for the improvement of menopausal disorders can be prevented in healthy individuals.

[0079] When the composition according to this embodiment is used for therapeutic purposes, the subject may be an unhealthy individual. The unhealthy individual may be, for example, an individual who, upon ingesting the composition according to this embodiment, falls under the category of menopausal disorder or a disease in a preferred embodiment already exemplified for the improvement of menopausal disorder (e.g., a patient with menopausal disorder or a patient with a disease in a preferred embodiment already exemplified for the improvement of menopausal disorder). When the composition according to this embodiment is used for therapeutic purposes, the quality of life of the unhealthy individual may be improved. When the composition according to this embodiment is used for therapeutic purposes, it becomes possible to treat menopausal disorder or a disease in a preferred embodiment already exemplified for the improvement of menopausal disorder in an unhealthy individual.

[0080] Furthermore, for example, symptoms appearing in menopausal disorders or symptoms appearing in diseases, etc., in the preferred embodiments already exemplified for improving menopausal disorders, do not necessarily have to be "symptoms caused by diseases, etc." That is, they may be divided into "symptoms caused by diseases, etc." and "symptoms caused by other than diseases, etc." For example, in the case of a food or drink composition (e.g., a health food or drink), the symptom may be directed at "symptoms caused by other than diseases, etc." and may be targeted at healthy individuals. To explain using a specific example, symptoms appearing in menopausal disorders may be divided into "symptoms caused by diseases, etc." and "symptoms caused by other than diseases, etc.", or may be divided into "symptoms caused by menopausal disorders" and "symptoms caused by other than menopausal disorders." For example, in the case of a food or drink composition (e.g., a health food or drink), the symptom may be directed at "symptoms caused by other than diseases, etc." or "symptoms caused by other than menopausal disorders," and both may be targeted at healthy individuals. Furthermore, the effect on "sleep and sleep problems" may be "helpful in maintaining sleep and sleep problems at a healthy level" in a food and drink composition (for example, a health food and drink). Similarly, for other foods and drinks, it may be "helpful in maintaining sleep and sleep problems at a level similar to that of a healthy person."

[0081] The present disclosure provides the use of equols for producing a composition (which may be a food or beverage composition, for example, a health food or beverage) for improving QOL in healthy individuals. The present disclosure also provides the use of equols for producing a food or beverage composition (for example, a health food or beverage) for preventing or ameliorating symptoms of menopausal disorders in healthy individuals.

[0082] When the composition of this embodiment is used for non-therapeutic purposes, it may be used to prevent or improve symptoms of menopausal disorders in healthy individuals, for example.

[0083] The composition according to this embodiment can be used as a food or drink (including a supplement). For example, it can be a food or drink containing equols for improving men's quality of life. The food or drink can be used for subjects including healthy and unhealthy individuals. It can also be used for non-therapeutic purposes.

[0084] 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 include beverages.) As for the form of the food and beverage, for example, after adding appropriate auxiliary agents, they can be formed into an edible form, such as granules, particles, tablets, capsules, paste, etc. using conventional means and then provided for consumption. They can also be added to various foods, for example, 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.

[0085] Foods and beverages may contain water, proteins, carbohydrates, lipids, vitamins, minerals, organic acids, organic bases, fruit juice, flavors, etc. as their main ingredients. 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 their hydrolysates and butter. Examples of carbohydrates include sugars, modified 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, palm 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 large amounts of these may also be used.

[0086] The food and drink products can be produced according to conventional methods. The amount, method, and timing of incorporation of equols into the food and drink products can be selected as appropriate. Furthermore, the food and drink products can be packaged in appropriate containers such as bottles, bags, cans, boxes, and packs, as needed.

[0087] 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 are described in 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.

[0088] When equols are used as ingredients in foods and beverages for the above-mentioned uses, the foods and beverages may include a description of each use, or may include a description of uses that are associated with each use.

[0089] The composition according to this embodiment can be used as a pharmaceutical. For example, it is a pharmaceutical containing equols for improving the quality of life (QOL) of men. The pharmaceutical can be used for unhealthy individuals. It can also be used for therapeutic purposes.

[0090] When equols are used as pharmaceutical ingredients, they can be administered orally or parenterally. For administration, the active ingredient can be mixed with a solid or liquid non-toxic pharmaceutical carrier suitable for oral, rectal, or injection administration, and administered in the form of a conventional pharmaceutical formulation. Examples of such formulations include solids such as tablets, granules, powders, and capsules; liquids such as solutions, suspensions, and emulsions; and lyophilized preparations. These formulations can be prepared using conventional pharmaceutical techniques. Examples of such non-toxic pharmaceutical 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. Conventional additives such as stabilizers, humectants, emulsifiers, binders, and isotonicity agents can also be added as needed.

[0091] The content of equols relative to the total amount of the above-mentioned pharmaceutical, the dosage of the pharmaceutical, and the administration schedule of the pharmaceutical are referred to in 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.

[0092] 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 this disclosure, "daidzeins" includes daidzin, malonyldaidzin, acetyldaidzin, daidzein, and dihydrodaidzein; "genisteins" includes genistin, malonylgenistin, acetylgenistin, genistein, dihydrogenistein, etc.; and "glyciteins" includes glycitin, malonylglycitin, acetylglycitin, glycitein, dihydroglycitein, etc.

[0093] Therefore, the composition according to this embodiment may be a composition for improving men's QOL, which contains a composition containing equols.

[0094] The composition according to this embodiment may be a composition for improving male QOL, containing a fermented product of a composition containing daidzeins and containing equols. The composition according to this embodiment may be a composition for improving male QOL, containing a fermented product of soybean germ and containing equols. The composition according to this embodiment may be a composition for improving male QOL, containing a fermented product of soybean germ extract and containing equols.

[0095] The composition according to this embodiment may be a composition for improving male QOL, containing equols obtained by fermenting a composition containing daidzeins. The composition according to this embodiment may be a composition for improving male QOL, containing equols obtained by fermenting soybean germ. The composition according to this embodiment may be a composition for improving male QOL, containing equols obtained by fermenting soybean germ extract.

[0096] The fermented soybean germ product containing equols can be obtained according to a conventional method, and the fermentation of soybean germ can also be carried out according to a conventional method.

[0097] The soybean germ extract is not particularly limited as long as it contains equols when fermented into a fermented product. Examples include compositions containing isoflavones, such as those 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 (hypocotyls). Water, ethanol, or aqueous ethanol can be used for the extraction. Alternatively, the extract can be obtained, for example, as described in the literature "Development of Plant Polyphenol-Containing Materials - Their Functionality and Safety" (published in 2007 by CMC Publishing Co., Ltd.).

[0098] Isoflavones are a type of polyphenol, a flavonoid with an isoflavone as its basic structure. Isoflavones are found in large amounts in legumes such as soybeans, kudzu, red clover, and licorice. Therefore, the soybean germ extract containing isoflavones may be replaced by an extract of a legume such as kudzu, red clover, or licorice that contains isoflavones.

[0099] Furthermore, the soybean germ extract may be an extract or purified product of equols, as long as the soybean germ extract contains equols when fermented. That is, the soybean germ extract may be isoflavones or a composition containing isoflavones, such as the compositions described in the Examples.

[0100] 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, equol can be produced by fermenting using a microorganism capable of producing equol from daidzein. Daidzein may be obtained by hydrolyzing daidzin with a hydrolase (e.g., β-glucosidase). Equol can also be produced by fermenting using a microorganism capable of producing daidzein from the glycoside daidzin and capable of producing equol from daidzein. In such cases, the isoflavone may be daidzin.

[0101] Another example of an isoflavone is genistein. In this case, fermentation using a microorganism capable of producing 5-hydroxyequol from genistein can cause the microorganism to produce 5-hydroxyequol. Genistein may be obtained by hydrolyzing genistin with a hydrolase (e.g., β-glucosidase). Furthermore, fermentation using a microorganism capable of producing genistein from the glycoside genistin and capable of producing 5-hydroxyequol from genistein can also cause the microorganism to produce 5-hydroxyequol, and in such cases, the isoflavone may be genistin.

[0102] 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 and application of the equols obtained by fermentation. The amount and concentration of soybean germ extract used in fermentation are not particularly limited, as long as the fermented product contains equols. Furthermore, in a preferred embodiment, when the soybean germ extract contains isoflavones, the amount and concentration of isoflavones used in fermentation are also not particularly limited. Furthermore, in a preferred embodiment, when isoflavones are used alone, the amount and concentration of isoflavones used in fermentation are also not particularly limited. These can be set appropriately depending on the amount of culture medium and the amount of equol to be produced.

[0103] In the fermentation, anaerobic microorganisms are cultured in a medium containing soybean germ extract. The anaerobic microorganisms are not particularly limited as long as they are capable of producing equols at temperatures around 37°C (e.g., 30 to 42°C), but examples include microorganisms belonging to the genus Adlercreutzia, Asaccharobacter, Bacteroides, Bifidobacterium, Eggerthella, Enterococcus, Eubacterium, Lactobacillus, Lactococcus, Sharpea, Slackia, and Streptococcus. Among these, microorganisms belonging to the genus Asaccharobacter and Adlercreutzia are preferred.

[0104] Furthermore, examples of microorganisms belonging to the genus Adlercreutzia include microorganisms belonging to Adlercreutzia equolifaciens and Adlercreutzia mucosicola; examples of microorganisms belonging to the genus Asaccharobacter include microorganisms belonging to Asaccharobacter celatus; examples of microorganisms belonging to the genus Bacteroides include microorganisms belonging to Bacteroides ovatus; examples of microorganisms belonging to the genus Bifidobacterium include microorganisms belonging to Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium pseudolongum; examples of microorganisms belonging to the genus Enterococcus include microorganisms belonging to Enterococcus faecalis; and examples of microorganisms belonging to the genus Lactobacillus include microorganisms belonging to Lactobacillus fermentum, Lactobacillus intestinalis, Lactobacillus plantarum, and Lactobacillus Examples of microorganisms belonging to the genus Lactococcus include microorganisms belonging to Lactococcus garvieae, examples of microorganisms belonging to the genus Sharpea include microorganisms belonging to 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 microorganisms belonging to Streptococcus constellatus and Streptococcus intermedius.

[0105] Furthermore, 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, examples of microorganisms belonging to Asaccharobacter celatus include the Asaccharobacter celatus AHU 1763 strain and the Asaccharobacter celatus DSM 18785 strain, examples of microorganisms belonging to Bacteroides ovatus include the Bacteroides ovatus E-23-15 strain, examples of microorganisms belonging to Bifidobacterium breve include the Bifidobacterium breve ATCC 15700 strain, examples of microorganisms belonging to Bifidobacterium longum include the Bifidobacterium longum BB536 strain, and examples of microorganisms belonging to the genus Eggerthella include Eggerthella sp. Examples of microorganisms belonging to the genus Enterococcus faecalis include the Enterococcus faecalis INIA P333 strain, and examples of microorganisms belonging to the genus Eubacterium include Eubacterium sp.Examples of microorganisms belonging to Lactobacillus fermentum include the Lactobacillus fermentum DPPMA114 strain, examples of microorganisms belonging to Lactobacillus intestinalis include the Lactobacillus intestinalis KTCT13676BP strain, examples of microorganisms belonging to Lactobacillus plantarum include the Lactobacillus plantarum DPPMA24W strain and the Lactobacillus plantarum DPPMASL33 strain, examples of microorganisms belonging to Lactobacillus rhamnosus include the Lactobacillus rhamnosus INIA P540 strain and the Lactobacillus rhamnosus DPPMAAZ1 strain, examples of microorganisms belonging to Lactococcus garvieae include the Lactococcus garvieae 20-92 strain, examples of microorganisms belonging to Sharpea azabuensis include the Sharpea azabuensis ST18 strain, and Slackia Examples of microorganisms belonging to the genus Slackia include the Slackia equolifaciens DZE strain, examples of microorganisms belonging to the genus Slackia include the Slackia isoflavoniconvertens HE8 strain, examples of microorganisms belonging to the genus Slackia include the Slackia sp. TM-30 strain, the Slackia sp. FJK1 strain, the Slackia sp. NATTS strain, and the Slackia sp. YIT 11861 strain, examples of microorganisms belonging to the genus Streptococcus constellatus include the Streptococcus constellatus E-23-17 strain, and examples of microorganisms belonging to the genus Streptococcus intermedius include the Streptococcus intermedius A6G-225 strain.

[0106] The anaerobic microorganisms may be cultured in a medium containing 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 microorganisms with equol-producing activity are maintained. More specifically, these conditions refer to maintaining gas-phase conditions (anaerobic conditions) that allow the survival of the anaerobic microorganisms and providing nutrients to support the activity and growth of the anaerobic microorganisms. Various medium compositions suitable for the survival of 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 or GAM bouillon medium manufactured by Nissui Pharmaceutical Co., Ltd., as used in the examples, can be used.

[0107] Furthermore, for example, a water-soluble organic substance can be added to the medium as a carbon source. Examples of water-soluble organic substances include 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 substance added to the medium as a carbon source can be appropriately adjusted to efficiently grow the anaerobic microorganism in the medium. Generally, excess or deficiency can be avoided by selecting the amount added from the range of 0.1 to 10 wt / vol%.

[0108] In addition to the carbon source, a nitrogen source is added to the medium. Various nitrogen compounds commonly used in fermentation can be used as the nitrogen source. Preferred inorganic nitrogen sources are ammonium salts and nitrates. More preferred inorganic nitrogen sources are ammonium sulfate, ammonium chloride, ammonium phosphate, ammonium hydrogen phosphate, potassium nitrate, and sodium nitrate. Preferred organic nitrogen sources are amino acids, yeast extract, peptones (e.g., polypeptone N), meat extract, liver extract, and digested serum powder. More preferred organic nitrogen sources are arginine, cysteine, citrulline, lysine, yeast extract, and peptones (e.g., polypeptone N).

[0109] In addition to the carbon and nitrogen sources, other organic or inorganic substances suitable for culturing the anaerobic microorganisms can also be added to the medium. For example, the growth and activity of the anaerobic microorganisms can sometimes be enhanced by adding cofactors such as vitamins or inorganic compounds such as various salts to the medium. Examples of inorganic compounds, vitamins, and animal and plant-derived microbial growth cofactors include the following: 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 Thioctoic acid Sodium molybdate p-aminobenzoic acid Potassium chloride Boric acid Nickel chloride Sodium tungstate Sodium selenate Ferrous ammonium sulfate

[0110] 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.

[0111] The anaerobic microorganisms can be cultured according to known methods for culturing anaerobic microorganisms. For industrial production, a continuous fermentation system is suitable, which can continuously supply the medium and substrate gas and is equipped with a mechanism for recovering the culture. When 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 culture vessel. 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 mixed into the culture tank with an inert gas such as nitrogen or a substrate gas.

[0112] Culture tanks with additional functions can be used. For example, in addition to commonly used agitation and mixing tanks, bubble column-type culture tanks and draft tube-type culture tanks can be used. The anaerobic microorganisms are liberated and dispersed by the gas mixture blown into the liquid medium, allowing sufficient contact between the anaerobic microorganisms and the medium. Alternatively, the anaerobic microorganisms can be cultured by dripping water onto a biotrickling filter, such as a highly breathable slag filter, or a packed bed of ceramic inorganic filler or organic synthetic material such as polypropylene, and then cultured while gas is passed through the filter. Furthermore, the anaerobic microorganisms can be immobilized in carrageenan gel, alginate gel, acrylamide gel, chitin, cellulose, agar, or the like by conventional methods.

[0113] 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 are increased, thereby optimizing the efficiency of equol production. The substrate gas can also be supplied in the form of nanobubbles.

[0114] To ensure 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, more preferably 33°C to 38°C, to increase the amount of equols recovered. The fermentation time can be appropriately set depending on the amount of equols produced, the amount of remaining soybean germ extract, etc. It is, for example, 8 to 120 hours, preferably 12 to 72 hours, and particularly preferably 16 to 60 hours.

[0115] The anaerobic microorganism is preferably cultured in a gas phase containing one or more gases including hydrogen, with no particular limitation on the hydrogen concentration.

[0116] The obtained culture solution may be subjected to solid-liquid separation by filtration or centrifugation, and the liquid phase may be recovered. 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. Alternatively, the obtained culture solution may be used as is without solid-liquid separation.

[0117] The fermented product of soybean germ extract can be used by subjecting the obtained culture solution to 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 heat dried, spray dried, or freeze dried can be subjected to a powdering process as necessary.

[0118] The heat-dried, spray-dried, or freeze-dried fermented product obtained by such a method can contain 0.05 to 50% by mass of equols in the dry powder. For example, the mass % concentration is preferably represented by a concentration range with a lower limit (greater than or equal to) and an upper limit (less than or equal to) 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%.

[0119] As shown in the examples described below, subjects who ingested the composition according to this embodiment experienced an improvement in the diversity of their intestinal microbiota. Therefore, the composition according to this embodiment can be used to improve the intestinal microbiota. The improvement of the intestinal microbiota is preferably an improvement in the diversity of the intestinal microbiota. Therefore, the present disclosure can provide a composition for improving the intestinal microbiota that contains equols.

[0120] 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, a person who does not suffer from irritable bowel syndrome, constipation, diarrhea, or food allergies when ingesting 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 allergies, etc. can be prevented.

[0121] When the composition according to this embodiment is used for therapeutic purposes, the subject may be an unhealthy 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 unhealthy individuals.

[0122] Since the Shannon Idex increases when the diversity of the intestinal microbiota is improved, the improvement of the diversity of the intestinal microbiota 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.

[0123] As shown in the examples described below, subjects who ingested a composition according to this embodiment experienced an increase in Firmicutes bacteria in their intestinal flora. Therefore, the composition according to this embodiment can be used to promote the growth of Firmicutes bacteria. Furthermore, this disclosure can provide a composition for promoting the growth of Firmicutes bacteria, which contains equols.

[0124] For analyzing 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.

[0125] In addition to the above-mentioned aspects, the present disclosure can also provide the following aspects, for example: Use of equols for producing a composition for improving male QOL. Use of equols for improving male QOL. Use of a composition containing equols for improving male QOL. Non-therapeutic use of equols for improving male QOL. Non-therapeutic use of a composition containing equols for improving male QOL. Equols for use in improving male QOL. A composition containing equols for use in improving male QOL. A method for improving male QOL, comprising administering an effective amount of equols to a subject in need of improvement. A method for improving male QOL, comprising administering an effective amount of a composition containing equols to a subject in need of improvement.

[0126] The following examples are provided, but none of the examples should be construed as limiting.

[0127] [Production Example 1] Production of a composition for improving men's quality of life The raw materials used were a fermented soybean germ extract (trade name: Aquaequol) containing equol (5 mg), maltitol, crystalline cellulose, corn protein, calcium stearate, silicon dioxide, and carnauba wax, and these were molded into tablets to produce a composition for improving men's quality of life, which was used as the test food in the test described below.

[0128] The fermented soybean germ extract was prepared as follows. First, a seed culture of anaerobic microorganisms for fermentation was prepared. Specifically, 5.9 g of GAM bouillon medium (Nissui Pharmaceutical Co., Ltd.) and 1.2 g of L-arginine hydrochloride were dissolved in 100 mL of purified water. The mixture was dispensed into 18 mm anaerobic culture tubes (Sanshin Kogyo Co., Ltd.) in 10 mL aliquots while passing nitrogen gas through them. The tubes were then fitted with butyl rubber stoppers and plastic caps and sterilized at 115°C for 15 minutes. The anaerobic microorganism Asaccharobacter celatus DSM 18785, which had been frozen and stored at -80°C, was inoculated into the medium. The gas phase was replaced with sterile-filtered hydrogen gas (100% hydrogen partial pressure) for at least 2 minutes. The seed culture was then cultured at 37°C and 250 spm for 18 hours with shaking to prepare the seed culture. Next, a medium containing 11 g of Isoflavone-80 (manufactured by J-Oil Mills), 3 g of yeast extract, 0.5 g of L-cysteine ​​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 prepared by adding deionized water to 1000 mL and adjusting the pH 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 at least 20 minutes. The medium was then sterilized at 115°C for 15 minutes. The Isoflavone-80 (manufactured by J-Oil Mills) is a powder containing highly purified soy isoflavone glycosides (daidzein, glycitein, and genistein) extracted and purified domestically from North American soybean germ (Soybean Functional Ingredients (Fine), [online], J-Oil Mills, Inc., [searched August 9, 2023], Internet: <https: / / www.j-oil.com / prosumer / fine / >). In this study, the glycosides were hydrolyzed using commercially available β-glucosidase to form aglycones (daidzein, glycitein, and genistein, respectively). 20 mL of the seed culture was inoculated into this medium, and the medium was aseptically aerated with hydrogen / nitrogen gas (2:98 by volume) at 0.1 L / min through a sparger. The culture was conducted at 37°C, 500 rpm, and 50 kPa. The pH during cultivation 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, it was centrifuged at 15,000 x g for 10 minutes at 20°C. The supernatant was spray-dried to obtain the fermented product. The equol content was 6.5%.

[0129] Example 1 Seventeen healthy men aged 40 or older were given the test diet two tablets (10 mg of equol per day) with water or lukewarm water for four weeks. Before and four weeks after ingestion, they were evaluated using the Male Menopausal Symptom Questionnaire (AMS score) and the Anti-Aging QOL Common Questionnaire.

[0130] Evaluations were conducted according to the respective manuals. For the AMS score, subjects were asked to respond on a five-point scale: "1. None," "2. Mild," "3. Moderate," "4. Severe," and "5. Very severe," with scores of 1 to 5 being calculated as 1 to 5 points. For the Anti-Aging QOL Common Questionnaire, subjects were asked to respond on a five-point scale: "1. None at all," "2. Almost none," "3. A little," "4. Moderately severe," and "5. Severely severe," with scores of 1 to 5 being calculated as 1 to 5 points.

[0131] (Results Based on AMS Scores) The results based on AMS scores are shown in Table 1. Compared to pre-intake, items with a lower score were considered "improved," and items with an increase were considered "worsened." The same assessment was made for each subject's total score. As a result, the number of subjects who improved exceeded the number of those who worsened in all categories. In particular, for the total score, 12 out of 17 subjects improved and one subject worsened. This indicates that the composition of this example improves the male menopausal symptoms of the subjects. Furthermore, for the 11 subjects with mild to moderate symptoms who scored 27 or higher before ingestion, as shown in Table 2, the average scores for the categories "physical fatigue and decreased energy," "depressed mood," "feeling exhausted and at rock bottom," and the total score significantly improved compared to pre-ingestion (p<0.05).

[0132]

[0133]

[0134] (Results Based on the Anti-Aging QOL Common 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 subject was also evaluated in the same manner. As a result, as shown in Table 3, for 24 of the 34 physical symptoms, the number of subjects who improved exceeded the number of subjects who worsened compared to before intake. Furthermore, as shown in Table 4, for 18 of the 21 mental symptoms, the number of subjects who improved exceeded the number of subjects who worsened compared to before intake. Furthermore, since the number of subjects who improved exceeded the number of subjects who worsened in terms of the total score, it was found that the composition according to this example improves the QOL of the subjects.

[0135]

[0136]

[0137] Example 2 Of the subjects in Example 1, 15 subjects who provided consent were subjected to an analysis of the intestinal bacterial flora using the intestinal flora test "Mykinso Pro" provided by Cykinso Co., Ltd., according to the manual.

[0138] (Results) The analysis results of the intestinal microbiota are shown in Table 5. It was found that the composition according to this example improved the diversity of the intestinal microbiota of the subjects. In the table, "Firmicutes bacteria" indicates the number of "Firmicutes bacteria."

[0139]

Claims

1. A composition containing equol for improving men's quality of life.

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 a sense of well-being, improvement in bodily pain, improvement in autonomic nervous system 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.

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 composition according to claim 5, wherein the improvement in QOL is an improvement in a physical symptom, and the improvement in the physical symptom is an 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.

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

8. The composition according to any one of claims 5 to 7, wherein the QOL is evaluated using the 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 amount of the equols is 1 mg or more.

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

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