NCT02340598

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

3.9 years

First QC Date

January 13, 2015

Last Update Submit

April 23, 2019

Conditions

Cardiovascular Risk FactorsBasal Metabolic Rate

Outcome Measures

Primary Outcomes (2)

  • basal metabolic rate

    basal metabolic rate measured in the fasting state by indirect calorimetry

    up to 1 year

  • Composite measure of cardiovascular risk factors

    Blood lipids, insulin, body weight, blood pressure

    up to 1 year

Study Arms (2)

cold vest

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

cold vestOTHER

The lowering of body temperature increases basal metabolic rate

cold vest

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects that have no known metabolic relevant diseases

You may not qualify if:

  • thyroid disease,
  • mental disorders,
  • language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Linkoping

Linköping, 58185, Sweden

Location

Study Officials

  • Fredrik H Nystrom, professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 24, 2019

Record last verified: 2019-04

Locations

SE(1)