Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers (COLDBAT_WS)

March 23, 2018 updated by: Susanna Søberg, Rigshospitalet, Denmark

Cold Induced Activation of Brown Fat in Winter Swimmers

This study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.

Study Overview

Detailed Description

The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood.

Cold induced brown fat activity will be measured by skin temperature measures by means of infra-red thermography imaging and skin temperature.

15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be included in the study.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • Center for Inflammation and Metabolism/ Center for Physical Activity Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Age 18-35 years. Men Caucasian white Body Mass Index 19-25 kg/m2. Moderate physical activity level (not more than 8-10 hours of training pr. Week) Ability to give informed consent. Ability to follow verbal and written instructions in Danish. Body fat percent under 21% measured at the pre-examination day. Winter swimmers: Min. 2 swim/ week. Swimming in winter-season in open water outdoor in Denmark from September/October until study start in March.

Not-winter swimmers: Not winter-swimmers or taken cold showers on a regular basis.

Exclusion Criteria:

  • Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.

Tobacco, marijuana or intravenous drug use within 1 year of screening. Dieting, recent weight loss (>3 kg within 3 month) or a history of an eating disorder.

Dietary supplements. History of depression, psychosis, or other psychiatric illness requiring hospitalization.

Alcohol consumption >14 units/week. History of alcohol abuse within the past 3 years. Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.

Known kidney disease or elevated kidney biomarkers, in the preliminary investigation.

Use of daily medications, except for seasonal use of antihistamines. Diagnosed sleep disturbances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Winter Swimmers
Individualized cooling protocol
Individualized cooling protocol
Other Names:
  • Cold activation
  • Cold stimulation
  • Cold activation of BAT
Experimental: Not-winter Swimmers
Individualized cooling protocol
Individualized cooling protocol
Other Names:
  • Cold activation
  • Cold stimulation
  • Cold activation of BAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5. Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS).
Time Frame: Difference in peak temperature after 2 hours of cooling.
BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 2 hours of cooling is calculated.
Difference in peak temperature after 2 hours of cooling.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in glucose control between WS and NWS.
Time Frame: Difference in glucose control between WS and NWS after a 2 hours glucose tolerance test under thermoneutral conditions.
Difference in glucose control between WS and NWS in an oral glucose tolerance test measured as incremental area under the curve (iAUC).
Difference in glucose control between WS and NWS after a 2 hours glucose tolerance test under thermoneutral conditions.
Difference in resting energy expenditure after cooling versus no cooling
Time Frame: Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.
Difference in resting energy expenditure after cooling versus no cooling between WS and NWS measured as mean difference in kilojoule per minute.
Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susanna Søberg, MSc., Center for Inflammation and Metabolism/Center for physical activity research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 23, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H-16038581-COLDBAT_WS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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