UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062002 |
|---|---|
| Receipt number | R000070948 |
| Scientific Title | Effects of test food consumption on male menopause and sperm quality in healthy adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 11:48:31 |
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Basic information
Public title
Effects of test food consumption on male menopause and sperm quality in healthy adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Acronym
Effects of test food consumption on male menopause and sperm quality in healthy adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title
Effects of test food consumption on male menopause and sperm quality in healthy adults: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of test food consumption on male menopause and sperm quality in healthy adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of test food consumption on sperm motility in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured values of Aging Males' Symptoms (AMS) score at 8 weeks after consumption (8w)
Key secondary outcomes
1. The measured values of progressive motility rate, sperm concentration, non-progressive motility rate, immotile rate, motile sperm concentration, progressive motile sperm concentration, normal morphology rate, Sperm Motility Index (SMI), total sperm count per ejaculation, motile sperm count per ejaculation, erectile rigidity, duration of erection, satisfaction with ejaculation, interest in women, frequency of morning erections, frequency of erections, psychological factors, physical factors, sexual function factors at 8w
2. Individuals whose response to the AMS improved by one or more scales at 8w compared to screening (Scr)
3. The measured value of free testosterone and testosterone at 8w
4. Individuals who experienced adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test product: Product containing
Administration:
Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water.
*If a take is missed, it should be consumed as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day.
Interventions/Control_2
Duration: 8 weeks
Test product: Product not containing
Administration:
Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water.
*If a take is missed, it should be consumed as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day.
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese
2. Men
3. Individuals aged 40 or more and less than 60
4. Healthy individuals
5. Individuals who are concerned about infertility
6. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory-II (BDI-II) at Scr
7. Individuals whose blood concentration of total testosterone is 250 ng/dL or more at Scr
8. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at Scr
9. Individuals whose AMS score is between 27 and 49 at Scr
10. Individuals whose psychological factors of the AMS is bad at Scr
Key exclusion criteria
1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently undergoing treatment for any of the following chronic diseases:
cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are diagnosed with azoospermia
5. Individuals who are diagnosed with erectile dysfunction (ED)
6. Individuals undergoing treatment for ED
7. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
8. Individuals who are taking or using medications (including herbal medicines) or supplements
9. Individuals who are allergic to medications or foods related to the test product, particularly those allergic to citrus fruit
10. Individuals who regularly take long hot baths or use saunas
11. Individuals who are excessive exercising or training for diet
12. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles
13. Individuals who currently smoke or began smoking cessation within three months before providing informed consent
14. Individuals who habitually drink >= 60 g/day of alcohol
15. Individuals who are taking supplements containing zinc, folic acid, arginine, etc.
16. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Toyo Sugar Refining Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical Analysis Details>
Subgroup analysis will be performed for the following two populations. Each subgroup will be constructed based on full analysis set (FAS) or per protocol set (PPS).
a. Subgroup of individuals whose sperm progressive motility rate prior to intervention was at or above the median for their group
b. Subgroup of individuals whose sperm progressive motility rate prior to intervention was below the median for their group
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070948
