Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

Cardiovascular Risk Factors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340598
• Other study ID #: 2014/432-31
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• healthy subjects that have no known metabolic relevant diseases

Exclusion Criteria:

• thyroid disease,

• mental disorders,

• language problems

Related Conditions & MeSH terms

• Basal Metabolic Rate
• Cardiovascular Risk Factors

Intervention

Other:
• cold vest
The lowering of body temperature increases basal metabolic rate

Locations

Country	Name	City	State
Sweden	University Hospital of Linkoping	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	basal metabolic rate	basal metabolic rate measured in the fasting state by indirect calorimetry	up to 1 year
Primary	Composite measure of cardiovascular risk factors	Blood lipids, insulin, body weight, blood pressure	up to 1 year