Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

NCT ID: NCT02340598

Last Updated: 2019-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Risk Factors Basal Metabolic Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cold vest

Intervention Type OTHER

The lowering of body temperature increases basal metabolic rate

control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cold vest

The lowering of body temperature increases basal metabolic rate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy subjects that have no known metabolic relevant diseases

Exclusion Criteria

* thyroid disease,
* mental disorders,
* language problems
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Fredrik H Nystrom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fredrik H Nystrom, professor

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

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University Hospital of Linkoping

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2014/432-31

Identifier Type: -

Identifier Source: org_study_id

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