UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042651 |
|---|---|
| Receipt number | R000048666 |
| Scientific Title | Effect of physical activity on brown adipose tissue |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2020/12/04 14:31:52 |
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Basic information
Public title
Effect of physical activity on brown adipose tissue
Acronym
Effect of physical activity on brown adipose tissue
Scientific Title
Effect of physical activity on brown adipose tissue
Scientific Title:Acronym
Effect of physical activity on brown adipose tissue
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the brown adipose tissue index by magnetic resonance (MR) imaging and physical activity levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI
Key secondary outcomes
Body composition
Physical function (knee extension muscle strength, toe muscle strength, grip strength, maximum oxygen intake, walking speed, measurement of vascular function, cognitive function test)
Physical activity (accelerometer and questionnaire
Taking a blood sample
Nutrition intake status (BDHQ)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Training period (2 or 3 times a week, 1 hour of exercise, 3 months)
Interventions/Control_2
Control period (normal life, 3 months)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who have consented to participate in the research
Key exclusion criteria
Underlying health conditions
BMI 30 or above
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Ogawa |
Organization
Nippon sport science university
Division name
Faculty of sport science
Zip code
158-8508
Address
7-1-1 Fukasawa,Setagaya-ku, Tokyo
TEL
03-5706-0992
yabe-ma@nittai.ac.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Ogawa |
Organization
Nippon sport science university
Division name
Sports Science Research Center
Zip code
158-8508
Address
7-1-1 Fukasawa,Setagaya-ku, Tokyo
TEL
03-5706-0992
Homepage URL
souspo@nittai.ac.jp
Sponsor or person
Institute
Nippon sport science university
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research Japan society of the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon sport science university
Address
7-1-1 Fukasawa,Setagaya-ku, Tokyo
Tel
03-5706-0992
yabe-ma@nittai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
020-H018
Org. issuing International ID_1
Nippon sport science university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048666
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
