Unique ID issued by UMIN | UMIN000058200 |
---|---|
Receipt number | R000066523 |
Scientific Title | A study of the effect of test-food on testosterone production and cognitive function in adult women and men. |
Date of disclosure of the study information | 2025/06/17 |
Last modified on | 2025/07/01 15:54:51 |
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
Japan |
Healthy volunteer
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on testosterone production and cognitive function in adult women and men.
Efficacy
Confirmatory
Pragmatic
Not applicable
3D-Maze test
Testing for testosterone using saliva.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food |
Intake of test-food (2 tablets) with (lukewarm) water, twice daily, for 8 weeks.
35 | years-old | <= |
70 | years-old | > |
Male and Female
1.Men and women aged 35 to under 70 years at the time of providing consent to participate in the study.
2.Individuals whose written informed consent has been obtained.
3.Individuals judged appropriate for the study by the principal.
1. Individuals with comorbid or suspected neurodegenerative diseases presenting dementia-like symptoms, such as Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, or multiple sclerosis.
2.Individuals undergoing hormone replacement therapy, including testosterone replacement therapy.
3.Individuals with a history of treatment for psychiatric disorders, sleep apnea syndrome, diabetes, taste disorders, anemia, or other serious illnesses within the past year.
4.Individuals with a history or current diagnosis of serious hepatic, renal, cardiac, pulmonary, hematologic, or other systemic diseases.
5.Individuals with serious comorbid or past gastrointestinal diseases.
6.Individuals who may experience allergic reactions to silkworm (silk), mushrooms, or other foods or medications.
7.Individuals who are currently, or have within the past month, habitually consumed foods containing Cordyceps sinensis, or health functional foods, dietary supplements, Foods for Specified Health Uses (FOSHU), or other health foods that are highly enriched with ingredients suggested to have similar effects to the investigational product-such as Cordyceps sinensis, isoflavones, Pycnogenol, zinc, Korean ginseng, maca extract, coenzyme Q10, ginkgo biloba extract,or DHA/EPA-or individuals who plan to consume such products during the study period.
8.Pregnant or lactating women, or women who intend to become pregnant during the study period.
9.Individuals currently participating in another clinical trial or who have participated in another clinical trial within the past three months.
10.Individuals who are unable to attend the scheduled study visits.
11.Individuals who are unable to comply with the instructions of the principal investigator or clinical trial staff.
12.Any other individuals deemed inappropriate for participation by the principal investigator.
29
1st name | Noriaki |
Middle name | |
Last name | Komori |
DKS Co., Ltd.
Basic R&D Group R&D Department Life Sciences Headquarters
601-8391
5, Ogawara-cho, Kisshoin, Minai-ku, Kyoto, Japan
075-326-7572
nkomori@dks-web.co.jp
1st name | Noriaki |
Middle name | |
Last name | Komori |
DKS Co. Ltd
Basic R&D Group R&D Department Life Sciences Headquarters
601-8391
5, Ogawara-cho, Kisshoin, Minai-ku, Kyoto, Japan
075-326-7572
nkomori@dks-web.co.jp
DKS Co. Ltd.
DKS Co., Ltd.
Profit organization
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguroku, Tokyo
03-6452-2712
nakajima.megumi888@eps.co.jp
NO
第一工業製薬株式会社 (DKS Co., Ltd.)
2025 | Year | 06 | Month | 17 | Day |
Unpublished
No longer recruiting
2025 | Year | 06 | Month | 10 | Day |
2025 | Year | 06 | Month | 12 | Day |
2025 | Year | 06 | Month | 18 | Day |
2025 | Year | 08 | Month | 19 | Day |
2025 | Year | 06 | Month | 16 | Day |
2025 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066523