Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

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.

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Key information

Conditions

Cardiovascular Risk Factors Basal Metabolic Rate

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Linkoping

Linköping, 58185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy subjects that have no known metabolic relevant diseases

Exclusion criteria

thyroid disease,
mental disorders,
language problems

Treatment and study plan

cold vest

Other

The lowering of body temperature increases basal metabolic rate

Primary outcomes

basal metabolic rate

Time frame: up to 1 year

basal metabolic rate measured in the fasting state by indirect calorimetry
Composite measure of cardiovascular risk factors

Time frame: up to 1 year

Blood lipids, insulin, body weight, blood pressure

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

Prospective Randomized Pilot Study of the Effects of Cold Vests on Cardiovascular Risk Markers and Basal Metabolic Rate

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Jan 16, 2015
Registry last updated: Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed