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Does Cold Provocation Increase Brown Adipose Tissue Volume?

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cold Provocation

cold arm

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

to Avoid Feeling Cold

warm arm

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


Participant Flow:   Overall Study
    Cold Provocation   to Avoid Feeling Cold
STARTED   16   12 
COMPLETED   14   12 
NOT COMPLETED   2   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Healthy non-obese subjects

Reporting Groups
  Description
Cold Provocation

cold arm

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

to Avoid Feeling Cold

warm arm

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

Total Total of all reporting groups

Baseline Measures
   Cold Provocation   to Avoid Feeling Cold   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   12   28 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed   16   12   28 
<=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 [1] [2] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   14   12   26 
   26.1  (3.9)   24.3  (2.9)   25.3  (3.5) 
[1] Continuous data was only available for those 14 participants who completed the study
[2] because there were 14 who did the study
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   14   12   26 
Female      9  64.3%      7  58.3%      16  61.5% 
Male      5  35.7%      5  41.7%      10  38.5% 
[1] because 2 did not do the study at all
Region of Enrollment 
[Units: Participants]
     
Sweden       
Participants Analyzed   16   12   28 
Sweden   16   12   28 


  Outcome Measures

1.  Primary:   Brown Adipose Tissue, Absolute Volume   [ Time Frame: Baseline and 6 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: fredrik.h.nystrom@liu.se



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