UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019364 |
|---|---|
| Receipt number | R000022392 |
| Scientific Title | Effect of brown adipose tissue on energy metabolism in human |
| Date of disclosure of the study information | 2015/10/18 |
| Last modified on | 2019/08/20 17:07:54 |
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Basic information
Public title
Effect of brown adipose tissue on energy metabolism in human
Acronym
BAT on EE
Scientific Title
Effect of brown adipose tissue on energy metabolism in human
Scientific Title:Acronym
BAT on EE
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of activity of brown adipose tissue on energy expenditure and substrate utilization in humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diet-induced thermogenesis (DIT) assessed by respiratory gas analysis and physical activity ratio.
Key secondary outcomes
Total energy expenditure, activity-induced thermogenesis, respiratory quotient, fat oxidation assessed by respiratory gas analysis, physical activity ratio and urine nitrogen.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
An activity of brown adipose tissue
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
1.BMI >=18.5 and <25kg/m2
2.Age>=20 and <50
3.Subjects who provide informed consent by a document
Key exclusion criteria
1.Subjects who are difficult to participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions
2.Subjects who take medication for glucose or fat metabolism, or hypertension
3.Subjects have allergy against any food in the test diet
4.Heavy smoker (over 21 cigarettes/d)
5.Subjects who drink a lot of alcohol(more than 30 g/day alcohol)
6.Shift worker
7.Subjects judge as unsuitable for the study by the investigator or medical doctor for other reason
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeho TANAKA |
Organization
National Insutitute of Health and Nutrition
Division name
Department of Nutritional Science
Zip code
Address
1-23-1 Toyama Shinjuku-ku Tokyo 162-8636, Japan
TEL
03-3203-5725
tanakas@nih.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanobu Hibi |
Organization
Kao Corporation
Division name
Health Care Food Research Labs.
Zip code
Address
2-1-3 Bunka Sumida-ku Tokyo
TEL
03-5630-7266
Homepage URL
hibi.masanobu@kao.co.jp
Sponsor or person
Institute
National Institute of Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Grant-In-Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Nutrition, School of Nursing and Nutriton, Tenshi College
Kao Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
花王株式会社(東京都)
LSIクリニック(北海道)
国立国際医療研究センター病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/ijo2016124
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nature.com/articles/ijo2016124
Number of participants that the trial has enrolled
21
Results
Diet induced thermogenisis was significantly higher in the brown adipose tissue (BAT)-positive group. The 24-h respiratory quotient was significantly lower in the BAT-positive group than in the BAT-negative group.
Results date posted
| 2019 | Year | 08 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 07 | Month | 19 | Day |
Baseline Characteristics
healthy male adults
Participant flow
Participants assessed for eligibility (n=46), Participants enrolled (n=21), Data available for analysis (n=21)
Adverse events
None
Outcome measures
DIT, Energy expenditure, respiratory quotient
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2015 | Year | 10 | Month | 15 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022392
| 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 |
