UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054151 |
|---|---|
| Receipt number | R000061688 |
| Scientific Title | Survey research on the body perception of the general adult male population |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/10/15 09:51:54 |
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Basic information
Public title
Survey research on the body perception of the general adult male population
Acronym
Survey research on the body perception of the general adult male population
Scientific Title
Survey research on the body perception of the general adult male population
Scientific Title:Acronym
Survey research on the body perception of the general adult male population
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To understand individual differences and age-related changes in body perception in healthy adult male subjects, and to explore the relationship between body perception and various indices such as subject background. Also, to search for genes associated with the body perception.
Basic objectives2
Others
Basic objectives -Others
Survey research
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Body perception
Key secondary outcomes
Volunteer background
Life skills scale for adolescents and adults
International physical activity questionnaire
Type A tendency discrimination chart
Core LUTS symptom score
International index of erectile function
Aging males' symptoms scale
Perceived stress scale
Apparent age
Blood test results
Urinalysis results
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy adult males
2) Those who have already given written consent to participate in the MYCODE study.
3) Who have been fully informed of the purpose and content of this study, have the capacity to consent, and are willing and able to voluntarily agree to participate in this study upon full understanding of the purpose and content of the study.
4) Those who are able to come to the clinic on the designated examination date and undergo the examination.
Key exclusion criteria
1) Persons taking high blood pressure medication.
2) Persons wearing a pacemaker or other medical electrical device.
3) Persons with severe anemia.
4) Persons who are judged to be inappropriate as subjects by the principal investigator and the principal researcher.
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Yoshinogari-cho Kanzaki-gun, Saga
TEL
0952-52-1522
Mizokami.Tsubasa@otsuka.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Matsuda |
Organization
Allm Inc.
Division name
Medical Pharma DX Department
Zip code
150-0043
Address
16F Shibuya Mark City West, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-4361-2650
Homepage URL
IRB_dls@dena.com
Sponsor or person
Institute
Allm Inc.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
DeNA Life Science, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
DeNA Life Science, Inc. Ethics review committee
Address
Shibuya scramble square, 12-24-2 Shibuya, Shibuya-ku, Tokyo
Tel
03-6758-7200
IRB_dls@dena.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | 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
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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 21 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Volunteers will be measured on items related to body perception, etc., to ascertain actual conditions such as individual differences and aging changes, as well as to search for genes associated with body perception.
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061688
