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Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

U

University Hospital, Linkoeping

Status

Completed

Conditions

Cardiovascular Risk Factors
Basal Metabolic Rate

Treatments

Other: cold vest

Study type

Interventional

Funder types

Other

Identifiers

NCT02340598
2014/432-31

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy subjects that have no known metabolic relevant diseases

Exclusion criteria

  • thyroid disease,
  • mental disorders,
  • language problems

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

cold vest
Experimental group
Description:
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.
Treatment:
Other: cold vest
control
No Intervention group
Description:
No intervention, just recording of risk factors and basal metabolic rate.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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