Overview

This trial is active, not recruiting.

Conditions cardiovascular risk factors, basal metabolic rate
Treatment cold vest
Sponsor University Hospital, Linkoeping
Start date January 2015
End date June 2016
Trial size 50 participants
Trial identifier NCT02340598, 2014/432-31

Summary

Randomized trial of supplying a cold vest as compared with controls (no cold vest) on cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are checked at baseline, after 2 months and after 1 year.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants are given a cold vest that the pre-cool in a freezer. They are encouraged to use it daily to activate metabolism through brown adipose tissue and shivering.
cold vest
The lowering of body temperature increases basal metabolic rate
(No Intervention)
No intervention, just recording of risk factors and basal metabolic rate.

Primary Outcomes

Measure
basal metabolic rate
time frame: up to 1 year
Composite measure of cardiovascular risk factors
time frame: up to 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - healthy subjects that have no known metabolic relevant diseases Exclusion Criteria: - thyroid disease, - mental disorders, - language problems

Additional Information

Official title Prospective Randomized Pilot Study of the Effects of Cold Vests on Cardiovascular Risk Markers and Basal Metabolic Rate
Principal investigator Fredrik H Nystrom, professor
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Hospital, Linkoeping.