ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Cold Provocation Increase Brown Adipose Tissue Volume?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01797328
Recruitment Status : Completed
First Posted : February 22, 2013
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Fredrik H Nystrom, University Hospital, Linkoeping

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Basic Science
Condition Brown Adipose Tissue, Human
Interventions Procedure: cold arm
Procedure: warm arm
Enrollment 28

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cold Provocation to Avoid Feeling Cold
Hide Arm/Group Description

cold arm

cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering

warm arm

warm arm: To the best of ability avoid feeling cold during 6 weeks

Period Title: Overall Study
Started 16 12
Completed 14 12
Not Completed 2 0
Arm/Group Title Cold Provocation to Avoid Feeling Cold Total
Hide Arm/Group Description

cold arm

cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering

warm arm

warm arm: To the best of ability avoid feeling cold during 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 16 12 28
Hide Baseline Analysis Population Description
Healthy non-obese subjects
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 12 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
12
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 26 participants
26.1  (3.9) 24.3  (2.9) 25.3  (3.5)
[1]
Measure Description: Continuous data was only available for those 14 participants who completed the study
[2]
Measure Analysis Population Description: because there were 14 who did the study
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 26 participants
Female
9
  64.3%
7
  58.3%
16
  61.5%
Male
5
  35.7%
5
  41.7%
10
  38.5%
[1]
Measure Analysis Population Description: because 2 did not do the study at all
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 16 participants 12 participants 28 participants
16 12 28
1.Primary Outcome
Title Brown Adipose Tissue, Absolute Volume
Hide Description Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)
Time Frame Baseline and 6 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Brown adipose tissue volume (liters)
Arm/Group Title Cold Provocation to Avoid Feeling Cold
Hide Arm/Group Description:

cold arm

cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering

warm arm

warm arm: To the best of ability avoid feeling cold during 6 weeks

Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: liters
0.0066  (0.012) 0.0021  (0.0086)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cold Provocation to Avoid Feeling Cold
Hide Arm/Group Description

cold arm

cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering

no reported adverse events

warm arm

warm arm: To the best of ability avoid feeling cold during 6 weeks

All-Cause Mortality
Cold Provocation to Avoid Feeling Cold
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cold Provocation to Avoid Feeling Cold
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cold Provocation to Avoid Feeling Cold
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Fredrik H Nystrom
Organization: UHLinkopeing
Phone: +46101037749
Responsible Party: Fredrik H Nystrom, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01797328     History of Changes
Other Study ID Numbers: Nystrom_koldstudie
Dnr2013/41-32 ( Other Identifier: Linkoping review board, Sweden )
First Submitted: February 18, 2013
First Posted: February 22, 2013
Results First Submitted: October 26, 2016
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017