UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009005 |
|---|---|
| Receipt number | R000010567 |
| Scientific Title | Effects of cold exposure on energy expenditure by brown adipose tissue in humans |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/09/29 11:25:13 |
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Basic information
Public title
Effects of cold exposure on energy expenditure by brown adipose tissue in humans
Acronym
Brown adipose tissue and cold exposure
Scientific Title
Effects of cold exposure on energy expenditure by brown adipose tissue in humans
Scientific Title:Acronym
Brown adipose tissue and cold exposure
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the acute and chronic effects of cold exposure on energy expenditure and to analyze its relation to brown adipose tissue activity and adiposity in humans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Whole body energy expenditure assessed from respiratory gas analysis.
Activity of brown adipose tissue assessed by FDG-PET/CT.
Key secondary outcomes
Body fat content
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants were exposed to cold at 15-17C for 2 hr every day. After 6 weeks, their brown adipose tissue activity, body fat content, and whole-body energy expenditure were measured at a resting state and after 2-hr cold exposure.
Interventions/Control_2
Participants maintained their usual daily life without any cold exposure. After 6 weeks, their brown adipose tissue activity, body fat content, and whole-body energy expenditure were measured at a resting state and after 2-hr cold exposure.
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy male volunteers
2. Aged 20-30 years
3. Be able to provide written informed consent
Key exclusion criteria
Body mass index >=30
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saito, Masayuki |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
Address
Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL
011-741-1051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saito, Masayuki |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
Address
TEL
Homepage URL
saito@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Grants-In-Aid for Scientific Research from the 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
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
天使大学（北海道） Tenshi College (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | 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
Nineteen adult males subjects with low activities of brown adipose tissue were randomly assigned to two groups: one (n=9) was exposed to cold at 15-17 C for 2 h every day, while the other (n=10) maintained their usual daily life without cold exposure. After 6 wk under exposure to cold, cold-induced thermogenesis and BAT activity assessed by FDG-PET/CT increased compared with those at 0 wk and also with those in the control group without exposure. During the 6-wk period, body fat mass decreased more in the cold-exposed group than the control group. Moreover, the change in body fat mass negatively correlated with those in the BAT activity and cold-induced thermogenesis. These findings suggest that chronic cold exposure recruits brown adipose tissue, thereby contributing to the reduction of body fat in humans.
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 29 | Day |
Last modified on
| 2012 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010567
