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CompletedNCT02340598Updated Apr 24, 2019

Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

An interventional study of cold vest in Cardiovascular Risk Factors and Basal Metabolic Rate, sponsored by University Hospital, Linkoeping. Completed at 1 site in Sweden. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-24.

Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Risk Factors
  • Basal Metabolic Rate
03

In context

Lead sponsor

University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy subjects that have no known metabolic relevant diseases

Exclusion criteria

Exclusion Criteria:

  • thyroid disease,
  • mental disorders,
  • language problems
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • No intervention
    control

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

Interventions

  • Othercold vest

    The lowering of body temperature increases basal metabolic rate

06

What researchers measure

Primary outcomes

  1. basal metabolic rate

    basal metabolic rate measured in the fasting state by indirect calorimetry

    Time frame: up to 1 year

  2. Composite measure of cardiovascular risk factors

    Blood lipids, insulin, body weight, blood pressure

    Time frame: up to 1 year

07

Study locations

1 site
  • University Hospital of Linkoping
    Linkoping, 58185, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02340598
Lead sponsor
University Hospital, Linkoeping
Responsible party
Fredrik H Nystrom (Professor, University Hospital, Linkoeping) — Principal investigator
First posted
Jan 16, 2015
Start date
Jan 2015
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Apr 24, 2019

Study contacts

Fredrik H Nystrom, professor
principal investigator · Linköping University, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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