UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
Acronym
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
Scientific Title
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
Scientific Title:Acronym
A study of the effect of test-food on testosterone production and cognitive function in adult women and men.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on testosterone production and cognitive function in adult women and men.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
3D-Maze test
Key secondary outcomes
Testing for testosterone using saliva.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test-food (2 tablets) with (lukewarm) water, twice daily, for 8 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Komori |
Organization
DKS Co., Ltd.
Division name
Basic R&D Group R&D Department Life Sciences Headquarters
Zip code
601-8391
Address
5, Ogawara-cho, Kisshoin, Minai-ku, Kyoto, Japan
TEL
075-326-7572
nkomori@dks-web.co.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Komori |
Organization
DKS Co. Ltd
Division name
Basic R&D Group R&D Department Life Sciences Headquarters
Zip code
601-8391
Address
5, Ogawara-cho, Kisshoin, Minai-ku, Kyoto, Japan
TEL
075-326-7572
Homepage URL
nkomori@dks-web.co.jp
Sponsor or person
Institute
DKS Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
DKS Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakajima.megumi888@eps.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
第一工業製薬株式会社 (DKS Co., Ltd.)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066523
