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

Email

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


Email

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

Email

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