UMIN-CTR Clinical Trial

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
Email	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
Email	souspo@nittai.ac.jp

Sponsor
Institute	Nippon sport science university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048666