Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

Sponsor

University Hospital, Linkoeping (Other)

Overall Status

Completed

CT.gov ID

NCT02340598

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Factors Basal Metabolic Rate	Other: cold vest	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: cold vest The lowering of body temperature increases basal metabolic rate
No Intervention: control No intervention, just recording of risk factors and basal metabolic rate.

Arm

Intervention/Treatment

Experimental: 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.

Other: cold vest

The lowering of body temperature increases basal metabolic rate

No Intervention: control

No intervention, just recording of risk factors and basal metabolic rate.

Outcome Measures

Primary Outcome Measures

basal metabolic rate [up to 1 year]
basal metabolic rate measured in the fasting state by indirect calorimetry
Composite measure of cardiovascular risk factors [up to 1 year]
Blood lipids, insulin, body weight, blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy subjects that have no known metabolic relevant diseases

Exclusion Criteria:

thyroid disease,
mental disorders,
language problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Linkoping	Linkoping		Sweden	58185

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

Principal Investigator: Fredrik H Nystrom, professor, Linköping University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fredrik H Nystrom, Professor, University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT02340598

Other Study ID Numbers:

2014/432-31

First Posted:

Jan 16, 2015

Last Update Posted:

Apr 24, 2019

Last Verified:

Apr 1, 2019

Study Results

No Results Posted as of Apr 24, 2019