UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063175 |
|---|---|
| Receipt number | R000072301 |
| Scientific Title | A prospective single-arm pilot study to evaluate the effects of test food intake on semen parameters and to assess safety in healthy adult males |
| Date of disclosure of the study information | 2026/10/06 |
| Last modified on | 2026/10/05 11:48:01 |
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Basic information
Public title
A prospective single-arm pilot study to evaluate the effects of test food intake on semen parameters and to assess safety in healthy adult males
Acronym
A prospective single-arm pilot study to evaluate the effects of test food intake on semen parameters and to assess safety in healthy adult males
Scientific Title
A prospective single-arm pilot study to evaluate the effects of test food intake on semen parameters and to assess safety in healthy adult males
Scientific Title:Acronym
A prospective single-arm pilot study to evaluate the effects of test food intake on semen parameters and to assess safety in healthy adult males
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate, in an exploratory manner, the effects of test food intake on sperm motility, basic semen parameters, sperm DNA fragmentation, oxidative stress markers, and blood concentrations of sex hormones in adult males.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sperm motility (PR and PR + NP)
Key secondary outcomes
Basic semen parameters (sperm concentration, normal sperm morphology rate, and semen volume), sperm DNA fragmentation rate, oxidative stress markers, and serum sex hormone concentrations (total testosterone, FSH, LH, and estradiol)
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
Participants will take 3 tablets of the test food once daily after breakfast for 8 weeks with water or lukewarm water.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male individuals aged 20 years or older and 50 years or younger at the time of informed consent
2. Individuals who have received sufficient explanation about the purpose and content of this study, understood the explanation, and voluntarily provided written informed consent
Key exclusion criteria
1. Individuals with azoospermia or a sperm motility rate of 0% (complete asthenozoospermia)
2. Individuals with leukocytospermia (defined as 1x10^6 or more leukocytes per mL of semen) or active genitourinary infection
3. Individuals with serious hepatic, renal, cardiac, endocrine, or metabolic disease
4. Individuals with a risk of allergic symptoms related to silkworm (silk), mushrooms, other foods, or drugs
5. Individuals who have continuously used supplements that may affect spermatogenesis (e.g., CoQ10, vitamins, maca, zinc, ginseng, or Cordyceps), Kampo medicines, or hormonal agents within the past 4 weeks
6. Individuals who are currently participating in another clinical trial or have participated in another clinical trial within the past 3 months
7. Individuals who are judged by the principal investigator to be unsuitable for participation in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Saito |
Organization
DKS Co. Ltd.
Division name
General Manager, Research Department, Life Science Division
Zip code
601-8391
Address
5, Kisshoin Ogawara-cho, Minami-ku, Kyoto 601-8391, Japan
TEL
075-326-7572
d.saito@dks-web.co.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Yamamoto |
Organization
DKS Co. Ltd.
Division name
Basic R&D Group R&D Department Life Sciences Headquarters
Zip code
601-8391
Address
5, Kisshoin Ogawara-cho, Minami-ku, Kyoto 601-8391, Japan
TEL
075-326-7572
Homepage URL
m-yamamoto@dks-web.co.jp
Sponsor or person
Institute
DAIZUMOTO CLINIC
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
epmd_fd-erb@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
だいずもとクリニック（徳島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 05 | Day |
Last modified on
| 2026 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072301
