Compositions for improving male menopausal symptoms such as decreased libido, erectile dysfunction (ED), depression, and muscle weakness, and medicines, foods, and beverages containing the same for preventing and improving male menopausal symptoms

The use of processed Agaricus blazei mushroom fruiting bodies, especially the King·Agaricus 21 strain, addresses the safety concerns of hormone replacement therapy by improving male menopausal symptoms like erectile dysfunction and depression, as shown by symptom score improvements.

JP7818243B2Active Publication Date: 2026-02-20TOEI SHINYAKU CO LTD +1
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Patent Information

Application Number
JP2024109541
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2024-07-08
Publication Date
2026-02-20
Estimated Expiration
2044-07-08

AI Technical Summary

Technical Problem

Existing male hormone replacement therapies for treating male menopausal symptoms, such as decreased libido, erectile dysfunction, and depression, are associated with side effects like liver damage and prostate cancer, necessitating the development of safer alternatives.

Method used

A composition comprising processed Agaricus blazei mushroom fruiting bodies, particularly the King·Agaricus 21 strain, is used to improve male menopausal symptoms without side effects, formulated into pharmaceuticals, foods, or beverages.

Benefits of technology

The composition effectively alleviates symptoms like erectile dysfunction and depression, with minimal side effects, as demonstrated by AMS and SHIM score improvements over a two-month period.

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Abstract

To provide a new male climacteric disorder-ameliorating composition using a safe material free from side effects, and to provide a medicine, food and drink containing the composition.SOLUTION: The male climacteric disorder-improving composition contains a treated product of an Agaricus fruit body.SELECTED DRAWING: Figure 13
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Description

[Technical Field]

[0001] The present invention provides decreased sexual desire, Erectile dysfunction (ED) , depression, muscle weakness and a composition for improving male menopausal symptoms, such as For preventing and improving male menopausal symptoms Regarding pharmaceuticals and food and beverages. [Background technology]

[0002] Testosterone is known to affect the development of male reproductive organs, skeletal and muscular development, increased libido and sexual drive, and increased brain and mental vitality. It is also known that blood testosterone levels decrease when a man is under severe stress, and a decrease in blood testosterone can cause male menopausal symptoms.

[0003] Male menopause is characterized by a variety of symptoms, including decreased libido, erectile dysfunction (ED), hair loss, depression (including discouragement, irritability, anxiety, irritability, loss of vitality, etc.), fatigue, arthritis, myositis, muscle weakness, sweating, hot flashes, sleep disorders, memory loss, decreased concentration, and physical exhaustion. Male menopause is most commonly seen in men in their 40s and 50s, but symptoms can appear as early as their 20s or even in their 60s and older.

[0004] As a treatment for male menopausal symptoms, for example, replacement therapy with male hormones such as testosterone is known (for example, Non-Patent Document 1). [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] Medical Progress, Vol. 205, No. 6, Male Menopause, 407-410, 2003 Summary of the Invention [Problem to be solved by the invention]

[0006] However, the above-mentioned male hormone replacement therapy has concerns about side effects such as liver damage, prostate cancer, and hair loss. Therefore, it is desirable to improve male menopausal symptoms using safe materials with few side effects.

[0007] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a new composition for improving male menopausal disorders using safe materials with no side effects, and a medicine, food or drink containing the same. [Means for solving the problem]

[0008] In order to solve the above problems, the following compositions, medicines, foods and drinks for improving male menopausal disorders are provided. [1] A composition for improving male menopausal disorders, comprising a processed Agaricus blazei mushroom fruiting body. [2] The composition for improving male menopausal symptoms according to [1] above, wherein the Agaricus is King·Agaricus 21 strain (accession number: FERM P-17695). [3] The composition for improving male menopausal disorders according to [1] or [2] above, wherein the processed product is a dried product. [4] The composition for improving male menopause according to any one of [1] to [3] above, wherein the symptom of male menopause to be improved is hair loss. [5] The composition for improving male menopausal disorders according to any one of [1] to [3] above, wherein the symptom of male menopausal disorders to be improved is erectile dysfunction (ED). [6] The composition for improving male menopause according to any one of [1] to [3] above, wherein the symptom of male menopause to be improved is depression. [7] A pharmaceutical comprising the composition for improving male menopausal symptoms according to [1]. [8] A food or drink containing the composition for improving male menopausal symptoms described in [1]. [Effects of the Invention]

[0009] According to the composition for improving male menopausal disorders of the present invention and the medicines, foods and drinks containing the same, by administering or ingesting them, male menopausal disorders can be improved safely and without side effects. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 shows the questions and scores used to calculate the AMS score, which is an index for evaluating male menopausal symptoms. [Figure 2] FIG. 1 shows changes in male menopausal symptoms (physical and mental discomfort) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 3] FIG. 1 is a graph showing changes in male menopausal symptoms (irritability, bad mood) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 4] FIG. 1 is a graph showing changes in male menopausal symptoms (nervousness) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 5] FIG. 1 is a graph showing changes in male menopausal symptoms (prone to anxiety) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 6] FIG. 1 is a graph showing changes in male menopausal symptoms (decreased muscle strength) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 7] FIG. 1 is a graph showing changes in male menopausal symptoms (depressed mood, helplessness) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 8] FIG. 1 is a graph showing changes in male menopausal symptoms (feeling that one's symptoms have peaked) one month and two months after ingestion of the composition for improving male menopausal symptoms of the present invention. [Figure 9] FIG. 1 is a graph showing changes in male menopausal symptoms (slower beard growth) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 10]FIG. 1 is a graph showing changes in male menopausal symptoms (decline in sexual ability) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 11] FIG. 1 is a graph showing changes in male menopausal symptoms (reduction in the number of morning erections) one month and two months after ingestion of the composition for improving male menopausal symptoms of the present invention. [Figure 12] FIG. 1 is a graph showing changes in male menopausal symptoms (decreased libido) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 13] FIG. 1 shows the results of the overall AMS evaluation one month and two months after ingestion of the composition for improving male menopausal symptoms of the present invention. [Figure 14] FIG. 1 shows scores for evaluating hair loss. [Figure 15] FIG. 1 is a graph showing changes in male menopausal symptoms (situation of hair loss) one month and two months after ingestion of the composition for improving male menopausal disorders of the present invention. [Figure 16] This figure shows the questions and scores used to calculate the EHS score, which is an index for evaluating erectile hardness. [Figure 17] FIG. 1 shows the results of evaluation of erectile hardness one month and two months after ingestion of the composition for improving male menopausal symptoms of the present invention. [Figure 18] This figure shows the questions and scores used to calculate the SHIM score, an index of men's sexual health assessment. [Figure 19] FIG. 1 shows the results of SHIM (with sexual intercourse) one month and two months after ingestion of the composition for improving male menopausal symptoms of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present inventors have made the novel discovery that the fruiting bodies of Agaricus (preferably Agaricus brasiliensis) have an effect of improving male menopausal symptoms, and have completed the present invention.

[0012] Hereinafter, one embodiment of the composition for improving male menopausal disorders of the present invention will be described.

[0013] In the present invention, "amelioration of male menopause" means preventing, treating, improving, or alleviating various symptoms caused by male menopause, such as decreased libido, erectile dysfunction (ED), hair loss, depression (including despondency, irritability, anxiety, irritability, loss of vitality, etc.), fatigue, arthritis, myositis, muscle weakness, sweating, hot flashes, sleep disorders, decreased memory, decreased concentration, and physical exhaustion. The composition for improving male menopause of the present invention can improve the above symptoms, and in particular, shows significant effects in improving erectile dysfunction (ED), hair loss, and depression. Note that male menopause includes all disorders in which the above symptoms are observed, regardless of age. Methods for confirming whether or not a patient is experiencing male menopause include, for example, measuring blood testosterone levels by blood test or by questionnaire.

[0014] The composition for improving male menopausal disorders of the present invention contains a processed Agaricus blazei mushroom fruiting body. Agaricus blazei mushroom fruiting body has been consumed as food for a long time, and is a safe material with no side effects.

[0015] Examples of Agaricus fruiting bodies (fruiting bodies of Agaricus blazei Murill, Agaricus brasiliensis, Agaricus subrufescens, etc.) include wild fruiting bodies and fruiting bodies obtained by cultivation.

[0016] Among these, it is preferable that the Agaricus is the King Agaricus 21 strain deposited with the National Institute of Technology and Evaluation under accession number FERM P-17695 (deposit date: January 13, 2000, re-deposit date: July 1, 2016). When the composition for improving male menopausal disorders of the present invention contains a processed product of King Agaricus 21 (FERM P-17695), it achieves a superior effect on improving male menopausal disorders compared to other strains of Agaricus.

[0017] Furthermore, the processed Agaricus fruiting body may be any of various processed products obtained by physically, chemically, or biologically treating the fruiting body.

[0018] Specifically, examples of physically or chemically treated products include dried products obtained by sun drying, air drying, freeze drying, etc., freeze-dried products, and pulverized products obtained by using a blender, homogenizer, ball mill, etc. Biological treatment methods include fermentation methods, etc. Among these, the fruiting bodies are preferably in the form of dried products (including freeze-dried products).

[0019] Furthermore, processed products of Agaricus fruiting bodies include extracts obtained from fruiting bodies by various extraction methods, so long as they contain the active ingredients. Examples of extraction methods include various solvent extractions and supercritical fluid extraction. Extracts may also be processed by various solid-liquid separation methods, such as sedimentation, cake filtration, clarification filtration, centrifugal filtration, centrifugal sedimentation, compression separation, and filter presses; various concentration methods; various drying methods; formulation methods, such as granulation or powdering; and various purification methods.

[0020] Furthermore, processed Agaricus fruiting bodies may be added to a solvent such as water to prepare a liquid composition for improving male menopausal disorders.

[0021] The method for producing the composition for improving male menopausal disorders of the present invention includes a step of blending a processed product of Agaricus blazei mushroom fruiting bodies, and may also include various other conventionally known steps.

[0022] The composition for ameliorating male menopausal symptoms of the present invention can be administered or ingested by humans (men suffering from menopausal symptoms) in the form of a medicine or food or drink. That is, the medicine, food or drink of the present invention contains the composition for ameliorating male menopausal symptoms described above.

[0023] (Pharmaceuticals) The medicament of the present invention is a medicament for preventing or ameliorating male menopausal disorders, and includes the above-mentioned composition for ameliorating male menopausal disorders of the present invention.

[0024] The pharmaceutical of the present invention may use the composition for ameliorating male menopausal disorders of the present invention as an active ingredient as it is, or may be formulated by adding pharmaceutically acceptable ingredients.

[0025] The pharmaceutical of the present invention may be in a dosage form for oral administration or a dosage form for parenteral administration. Oral dosage forms include, for example, powders, granules, tablets, capsules, elixirs, microcapsules, etc. Parenteral dosage forms include, for example, injections, drip infusions, ointments, inhalants, suppositories, etc.

[0026] The medicament of the present invention may contain a pharmaceutically acceptable carrier, such as a known excipient, disintegrant, binder, lubricant, surfactant, buffer, solubilizer, stabilizer, isotonicity agent, suspending agent, emulsifier, solvent, thickener, mucolytic agent, wetting agent, preservative, etc.

[0027] The medicament of the present invention may further contain additives, such as lubricants such as magnesium stearate, sweeteners such as sucrose, lactose, and saccharin, flavorings such as peppermint and rhododendron oil, stabilizers for benzyl alcohol and phenol, buffers such as phosphates and sodium acetate, solubilizers such as benzyl benzoate and benzyl alcohol, antioxidants, and preservatives.

[0028] The pharmaceutical of the present invention can be formulated by appropriately combining the above-mentioned carriers, additives, etc. and mixing them in a unit dose form required for generally accepted pharmaceutical practice.

[0029] The dosage of the pharmaceutical of the present invention varies depending on the patient's weight and age, symptoms of the patient, administration method, etc., but a person skilled in the art can appropriately select an appropriate dosage. The dosage when administering the composition for ameliorating male menopausal symptoms of the present invention varies depending on the symptoms, the patient's age, sex, weight, and sensitivity, the administration method, administration interval, the type of active ingredient, and the type of formulation, and is not particularly limited. For example, when administered or ingested orally, an amount selected from 0.1 mg / kg to 100 g / kg per day can be administered or ingested once or multiple times (e.g., 2 to 5 times, preferably 2 to 3 times).

[0030] Furthermore, the period for administering or taking the pharmaceutical of the present invention is not limited, and for example, the pharmaceutical of the present invention can be administered or taken continuously for a period of one week or more, two weeks or more, one month or more, two months or more, six months or more, one year or more, or longer, in accordance with the dosage and administration described above.

[0031] (food and drink) The food and drink of the present invention is a food and drink for preventing or ameliorating male menopausal disorders, and includes the above-mentioned composition for ameliorating male menopausal disorders of the present invention.

[0032] Examples of foods and beverages include health foods and beverages (supplements, dietary supplements, health supplements, nutritionally balanced foods, etc.) in the form of tablets, tablets, chewable tablets, tablets, powders, powders, capsules, granules, drinks, etc., soft drinks, tea drinks, jelly drinks, sports drinks, coffee drinks, carbonated drinks, vegetable drinks, fruit juice drinks, fermented vegetable drinks, fermented fruit juice drinks, fermented milk drinks (yogurt, etc.), lactic acid bacteria drinks, milk drinks, powdered drinks, cocoa drinks, alcoholic drinks, confectionery, jelly, etc. In particular, foods and beverages are preferably in the form of health functional foods (foods for specified health uses, foods with nutrient functions, foods with functional claims) or health foods.

[0033] Furthermore, the "food and drink" of the present invention may contain ingredients commonly used in the field of food engineering. Specific examples include various oils and fats (e.g., vegetable oils such as soybean oil, corn oil, safflower oil, olive oil, etc., and animal oils and fats such as beef tallow and sardine oil), herbal medicines (e.g., royal jelly, ginseng, etc.), amino acids (e.g., glutamine, cysteine, leucine, arginine, etc.), polyhydric alcohols (e.g., ethylene glycol, polyethylene glycol, propylene glycol, glycerin, sugar alcohols such as sorbitol, erythritol, xylitol, maltitol, mannitol, etc.), natural polymers (e.g., gum arabic, agar, water-soluble corn fiber, gelatin, xanthan gum, etc.), and the like. Examples of suitable surfactants include gluten, gluten hydrolysates, lecithin, starch, dextrin, etc.), vitamins (e.g., vitamin C, B vitamins, etc.), minerals (e.g., calcium, magnesium, zinc, iron, etc.), dietary fiber (e.g., mannan, pectin, hemicellulose, etc.), surfactants (e.g., glycerin fatty acid esters, sorbitan fatty acid esters, etc.), purified water, diluents, stabilizers, isotonicity agents, pH adjusters, buffers, humectants, solubilizers, suspending agents, colorants, flavoring agents, odorants, fragrances, antioxidants, sweeteners, taste-providing components, and acidulants.

[0034] The intake amount of the food or drink varies depending on the patient's weight, age, symptoms, administration method, etc., but a person skilled in the art can appropriately select an appropriate dose. Specifically, the intake amount and intake period may be the same as those of the medicament of the present invention.

[0035] The dosage or intake of the medicine and food and drink of the present invention can be adjusted as appropriate, taking into consideration the age and body weight of the subject, the route of administration, the number of times of administration or intake, etc.

[0036] The composition for improving male menopausal disorders, medicines, and foods and beverages of the present invention are not limited to the above embodiments. Note that, since the composition for improving male menopausal disorders, medicines, and foods and beverages of the present invention contain processed Agaricus blazei mushroom fruiting bodies, they may also achieve conventionally known medicinal effects such as strengthening and improving the liver, heart, gastrointestinal tract, stabilizing blood pressure and blood sugar levels, relieving lower back pain and stiff shoulders, improving immunity, antitumor activity, reducing the side effects of anticancer drugs, and healing wounds. [Example]

[0037] The composition for ameliorating male menopausal disorders of the present invention will be described in detail below with reference to examples, but the composition for ameliorating male menopausal disorders of the present invention is not limited to the following examples.

[0038] <1> Agaricus fruiting body The dried fruiting bodies used were from Agaricus brasiliensis KA21, cultivated outdoors in Brazil. This Agaricus was deposited at the National Institute of Technology and Evaluation (NIET) (Accession No. FERM P-17695 King·Agaricus 21).

[0039] <2> Subjects: 24 men aged 50 to 70 years ingested dried Agaricus blazei fruiting bodies for two months.

[0040] <3> Male menopausal evaluation test For the above subjects, the AMS (Aging males symptoms) score (Figure 1), which is an index of male menopausal symptoms evaluation, the hair loss evaluation score (Figure 14), the EHS (Election Hardness) score (Figure 16), which is an index of erectile hardness evaluation, and the SHIM (Sexual Health Inventory for Men) score (Figure 18), which is an index of male sexual health evaluation, were calculated before, one month after, and two months after ingestion of dried Agaricus fruiting bodies (AMS, erectile hardness evaluation: 24 people, hair loss evaluation: 17 people, SHIM (with sexual intercourse) evaluation: 14 people).

[0041] Figures 2-12 show the changes in each male menopausal symptom (before intake, one month after intake, and two months after intake) based on a portion of the questions regarding the AMS score. Figure 13 shows the results of the overall evaluation using the AMS score (before intake, one month after intake, and two months after intake). As shown in Figures 2-12 and 13, it was confirmed that intake of dried Agaricus blazei mushroom fruiting bodies can improve each symptom of male menopause.

[0042] Figure 15 shows the results of evaluating hair loss before, one month after, and two months after intake of dried Agaricus blazei fruiting bodies. As shown in Figure 15, it was confirmed that intake of dried Agaricus blazei fruiting bodies can improve hair loss.

[0043] Figure 17 shows the results of evaluation of erectile hardness before, one month after, and two months after ingestion of dried Agaricus blazei fruiting bodies. As shown in Figure 17, it was confirmed that ingestion of dried Agaricus blazei fruiting bodies can improve erectile hardness.

[0044] Figure 19 shows the results of SHIM (with sexual intercourse) before, one month after, and two months after intake of dried Agaricus blazei fruiting bodies. As shown in Figure 19, it was confirmed that intake of dried Agaricus blazei fruiting bodies can improve erectile function.

Claims

1. A composition for improving male menopausal symptoms, Contains processed Agaricus fruiting bodies, The Agaricus blazei Murill strain is King Agaricus blazei Murill strain 21 (accession number: FERM P-17695), The symptoms of male menopause that are improved are at least one of the following: decreased libido, erectile dysfunction (ED), depression, and muscle weakness. A composition for improving male menopausal symptoms.

2. The processed product is a dried processed product. The composition for improving male menopausal symptoms according to claim 1.

3. A pharmaceutical for preventing and ameliorating male menopausal disorders, comprising the composition for ameliorating male menopausal disorders according to claim 1, The symptoms of male menopause that are improved are at least one of the following: decreased libido, erectile dysfunction (ED), depression, and muscle weakness. A medicine for preventing and improving male menopausal symptoms.

4. A food or drink for preventing and improving male menopausal disorders, comprising the composition for improving male menopausal disorders of claim 1, The symptoms of male menopause that are improved are at least one of the following: decreased libido, erectile dysfunction (ED), depression, and muscle weakness. Food and drink for preventing and improving male menopausal symptoms.

Citation Information

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