Outdoor Cultivated Agaricus blazei KA21 Receives Patent Allowance for Improving Symptoms of Andropause Including Erectile Dysfunction and Decreased Libido

Toei Shinyaku Co., Ltd. has confirmed through a human clinical study that intake of outdoor cultivated Agaricus blazei KA21 contributes to the improvement of symptoms associated with male menopause, including decreased libido, erectile dysfunction (ED), depressive mood, and reduced muscle strength, which are characteristic of Andropause.

Based on these findings, the company has received a Notice of Patent Allowance from the Japan Patent Office for inventions related to these effects and is currently proceeding with patent registration procedures.

■Receipt of Patent Allowance

Toei Shinyaku Co., Ltd. (Headquarters: Mitaka City, Tokyo; President & CEO: Akitomo Motoi), in collaboration with the Faculty of Health Sciences at Shigakkan University, has confirmed that intake of the outdoor cultivated Agaricus blazei KA21 strain (hereinafter “King Agaricus KA21”) may contribute to the improvement of multiple symptoms associated with male menopause.

Based on the outcomes of this research, the company announces that it has received a patent allowance from the Japan Patent Office for the following invention:

“A composition for improving male menopausal symptoms such as decreased libido, erectile dysfunction (ED), depressive mood, and reduced muscle strength, and pharmaceutical and food/beverage compositions for preventing or improving male menopausal disorders containing the same.”

Patent registration procedures are currently underway, and the patent certificate is expected to be issued within approximately 1 to 1.5 months.

Overview

<Patent application number> Japanese Patent application No.2024-109541

<Filing Date> July 8, 2024

<Inventors> Hirobumi Tada, Akitomo Motoi

＜Applicants>Toei Shinyaku Co., Ltd.; Shigakkan Educational Corporation

＜Title of Invention>

A composition for improving male menopausal symptoms such as decreased libido, erectile dysfunction (ED), depressive mood, and reduced muscle strength, and pharmaceutical and food/beverage compositions for preventing or improving male menopausal disorders containing the same

■Summary of human clinical trial data

A total of 24 men aged 50 to under 70 years participated in a clinical study in which they consumed 900 mg per day of outdoor cultivated King Agaricus KA21 for two months. Indicators related to andropausal symptoms were compared before and after intake.

As a result, statistically significant improvements were observed in the following evaluation indices:

AMS score (Aging Males’ Symptoms scale; comprehensive assessment of andropausal symptoms) ***

EHS score (Erection Hardness Score) *

SHIM score (Sexual Health Inventory for Men) *

Hair shedding condition *

* P < 0.05, *** P < 0.001

These results were presented at the 25th Annual Meeting of the Japanese Society of Anti-Aging Medicine.

■About Andropause

Testosterone, the primary male sex hormone, plays a crucial role in maintaining physical and mental functions in men. However, testosterone levels gradually decline with age and are also influenced by external factors such as lifestyle and stress.

Reduced testosterone levels are closely associated with conditions such as loss of muscle mass and strength (sarcopenia) and have been implicated in the development and prevention of a wide range of disorders, including angina pectoris, arteriosclerosis, obesity, metabolic syndrome, and dementia.

This condition, characterized by age-related testosterone decline accompanied by clinical symptoms, is referred to as Late-Onset Hypogonadism (LOH). It has been reported that approximately 10% of working middle-aged and older men suffer from symptoms of male menopause. LOH is considered to occur frequently from the late 40s onward and has attracted attention from both social and economic perspectives.

LOH presents with a wide variety of symptoms, including chronic fatigue, decreased libido, lack of motivation, erectile dysfunction (ED), reduced concentration, insomnia, irritability, shoulder stiffness, urinary problems, a sensation of heaviness in the head, and reduced frequency of morning erections. In addition, age-related testosterone decline increases the risk of numerous health issues such as depressive states, impaired sexual function, cognitive decline, cardiovascular disease, increased visceral fat, worsened insulin resistance, decreased HDL cholesterol, and elevated total and LDL cholesterol levels.

(Source: Japanese Society of Men’s Health)

https://jsmh.jp/loh/

■About Agaricus blazei / brasilensis / subrufescens

Agaricus blazei is a type of mushroom that has long been used as a health food in the field of complementary and alternative medicine. Its compositional characteristics and quality are known to vary significantly depending on strain, cultivation conditions, and region of origin.

■Outdoor Cultivated King Agaricus KA21 (Brazil)

Outdoor cultivated King Agaricus KA21 is produced in Brazil using the King Agaricus 21 (KA21) strain and cultivated outdoors under natural sunlight. Compared with conventionally grown Agaricus cultivated indoors in dark environments, outdoor cultivated King Agaricus KA21 develops larger fruiting bodies and has been confirmed to contain higher levels of key components such as β-glucan and vitamin D (*1).

Outdoot coltivated King Agaricus KA21 by Toei Shinyaku

Difference in size of Agaricus

Left: General agaricus (indoor cultivated) Right: Outdoor cultivated agaricus

Difference in β-glucan content

Difference in vitamins and minerals

Furthermore, outdoor cultivated King Agaricus KA21 has been reported to exhibit more than five times higher antioxidant activity compared with indoor-cultivated products (*2), suggesting that cultivation environment significantly influences its compositional characteristics and functional properties.

Differences in Antioxidant Activity

*(1) Japan Food Research Laboratories*(2) International Journal of Medicinal Mushrooms, 2019; 21(3): 31–43

■About Toei Shinyaku Co.Ltd.

Toei Shinyaku Co., Ltd. is a manufacturer specializing in the outdoor cultivated Agaricus balzei KA21 strain (=King Agaricus KA21) and has been engaged in research and development on KA21 for over 30 years, publishing 34 international scientific papers to date.

The company has conducted collaborative research with numerous academic and medical institutions, including Azabu University (Faculty of Veterinary Medicine), Keio University SFC Research Institute, National Center for Geriatrics and Gerontology, Shigakkan University (Faculty of Health Sciences), Juntendo University School of Medicine, the University of Tokyo Food Safety Research Center, and the Department of Immunology at Tokyo University of Pharmacy and Life Sciences, and has published extensive scientific data on outdoor cultivated King Agaricus KA21.

Company name: Toei Shinyaku Co.Ltd.

Website: https://www.agaricus.co.jp/

Head Office: 1-11-23 Shimorenjaku, Mitaka-shi, Tokyo 181-0013, Japan

Representative: Akitomo Motoi, President

Capital ： 10 million yen