Prospective Randomized Pilot Study of the Effects of Cold Vests on Cardiovascular Risk Markers and Basal Metabolic Rate
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Composite measure of cardiovascular risk factors
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy subjects that have no known metabolic relevant diseases
Exclusion Criteria
- •thyroid disease,
- •mental disorders,
- •language problems
Arms & Interventions
cold vest
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.
Intervention: cold vest (Other)
control
No intervention, just recording of risk factors and basal metabolic rate.
Outcomes
Primary Outcomes
Composite measure of cardiovascular risk factors
Time Frame: up to 1 year
Blood lipids, insulin, body weight, blood pressure
basal metabolic rate
Time Frame: up to 1 year
basal metabolic rate measured in the fasting state by indirect calorimetry
Secondary Outcomes
No secondary outcomes reported
Investigators
Fredrik H Nystrom
Professor
University Hospital, Linkoeping