- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01797328
Does Cold Provocation Increase Brown Adipose Tissue Volume?
April 24, 2017 updated by: Fredrik H Nystrom, University Hospital, Linkoeping
Study of the Effects of Temperature on Amount of Brown Adipose Tissue in Humans
About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks.
Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Linköping, Sweden, 58185
- Faculty of Health Science, Linköping
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: healthy subjects -
Exclusion Criteria: any significant disease, ot other conditions that interferes with magnetic resonance imaging
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: cold provocation
cold arm
|
1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering
|
Active Comparator: to avoid feeling cold
warm arm
|
To the best of ability avoid feeling cold during 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brown Adipose Tissue, Absolute Volume
Time Frame: Baseline and 6 week
|
Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)
|
Baseline and 6 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
February 18, 2013
First Submitted That Met QC Criteria
February 20, 2013
First Posted (Estimate)
February 22, 2013
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nystrom_koldstudie
- Dnr2013/41-32 (Other Identifier: Linkoping review board, Sweden)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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