UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054771 |
|---|---|
| Receipt number | R000062576 |
| Scientific Title | The effects of consumption of the test food on male menopause and sexual function in healthy Japanese men: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/08/30 16:23:07 |
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Basic information
Public title
The effects of consumption of the test food on male menopause and sexual function in healthy Japanese men
Acronym
The effects of consumption of the test food on male menopause and sexual function in healthy Japanese men
Scientific Title
The effects of consumption of the test food on male menopause and sexual function in healthy Japanese men: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
The effects of consumption of the test food on male menopause and sexual function in healthy Japanese men
Region
| Japan |
Condition
Condition
Healthy Japanese
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 male menopause and sexual function in healthy Japanese men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Aging males symptoms (AMS) at 12 weeks after consumption (12w)
Key secondary outcomes
1. The measured values of International Index of Erectile Function (IIEF) score, each question item of IIEF, Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH), total testosterone, and free testosterone at 12w
2. Individuals who answered "no" to each question item of Androgen Deficiency in Aging Males (ADAM)
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
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Active food
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo food
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Japanese
2. Men
3. Individuals aged 40 or more
4. Healthy individuals
5. Individuals whose blood concentration of total testosterone is 250 ng/dL or more at screening (before consumption; Scr)
6. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at Scr
7. Individuals whose total score in aging males symptoms (AMS) is less than 50 and relatively high
8. Individuals who are suffering from erectile dysfunction, decreased libido, delayed ejaculation, or decreased semen volume
Key exclusion criteria
Individuals (who/whose)
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes, dyslipidemia, hypertension, autoimmune disease, hemorrhagic disease, benign prostatic hyperplasia, or other chronic diseases
4. have treatment histories of the following diseases within last one year: male menopause, sleep apnea syndrome, erectile dysfunction
5. use "Foods for Specified Health Uses," or "Foods with Functional Claims"
6. are currently taking medications (including herbal medicines) and supplements
7. are allergic to medicines and/or the test food related products
8. have participated in other clinical studies within the last 28 days before agreeing to participate in this study or plan to participate another study during this study
9. are currently taking, or have taken in the past month, any foods/supplements that may affect male function (e.g., foods rich in ingredients with suggested effects similar to the test product (Pycnogenol, zinc, Korea ginseng, maca extract, coenzyme Q10)
10. have mental health issues (e.g., depression disorder, attention deficit/hyperactivity disorder)
11. total AMS score is >=50 (severe)
12. International Index of Erectile Function score is 10~15 (severe)
13. sleeping time or habit is irregular due to work such as a late-night shift or three shifts
14. are smokers or have quit smoking within 3 months before agreeing to participate
15. usually drink more than 60 g/day of alcohol
16. may undergo surgery (including tooth extraction, endoscopic examination, or others) during the study or within 4 weeks after the end of consumption
17. are judged as ineligible to participate in this study by the physician
18. body mass index (BMI) is >=30 kg/m^2
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
ORTHOMEDICO Inc.
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
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
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
| 2024 | Year | 07 | Month | 01 | 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
68
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
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062576
