COLDBAT: Cold Induced Activation of Brown Adipose Tissue in Humans

Sponsor
Susanna Søberg (Other)
Overall Status
Completed
CT.gov ID
NCT03096535
Collaborator
(none)
16
1
2
10.9
1.5

Study Details

Study Description

Brief Summary

This study investigates cold-induced brown fat activation assessed using PET/MR scans. Subjects will participate in an acute cooling intervention day and a thermoneutral intervention day with PET/MR scans on both days. A secondary purpose is to make a validation of an infrared thermography camera by comparison of skin temperatures and SUV of the supraclavicular brown adipose tissue.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cooling
  • Procedure: Thermoneutral
N/A

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 and even less is known about the endocrine capacities of human BAT.

Cold induced brown fat activity will be assessed with PET/MR scans and validate an infra-red thermography camera, as well as perform a proteomic screening using blood samples under these two intervention days.

15 healthy lean male subjects will serve as their own control in a cross-over randomized control study, including a pre-examination day, a thermoneutral-day and a cooling test-day with cold exposure followed by a PET/MR scan to determine BAT activity. An extra cooling day is applied for the external validation of the infrared thermography camera. Blood samples and abdominal fat-biopsies will be taken at thermoneutral condition and under cold stimulation of brown fat.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Cold Induced Activation of Brown Fat in Humans Assessed With PET/MR Scans and Skin-temperature Measure - A Cross-over Randomized Controlled Trial.
Actual Study Start Date :
Apr 2, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cooling

Individualized cooling protocol.

Procedure: Cooling
Individualized cooling protocol.
Other Names:
  • Cold activation
  • Cold stimulation
  • Cold activation of BAT
  • Experimental: Thermoneutral

    Thermoneutral condition day.

    Procedure: Thermoneutral
    Thermoneutral control day.

    Outcome Measures

    Primary Outcome Measures

    1. Difference in brown adipose tissue (BAT) activity after cooling versus no cooling. [Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.]

      BAT activity is measured by standard fluorodeoxyglukose uptake volume (SUV mean) in the supraclavicular BAT depot using PET/MR scans. Difference between scans performed after 2 hours of cooling and 2 hours of no cooling is calculated.

    Secondary Outcome Measures

    1. Difference in BAT activity after cooling versus no cooling. [Difference in peak temperature after 2 hours of cooling versus 2 hours of no 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 and 2 hours of no cooling is calculated.

    2. Difference in resting energy expenditure after cooling versus no cooling [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, measured as mean difference in KJ/min.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 18-30 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.

    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, eCRF <60 ml/min, in the preliminary investigation.

    • Use of daily medications, except for seasonal use of antihistamines.

    • Diagnosed sleep disturbances.

    • Pacemaker or other electronics implanted in the body.

    • Magnetic impressionable metal implants or foreign objects in the body inconsistent with completion of MR.

    • Claustrophobia

    • Communication problems, including understanding the experimental protocol

    • History of contrast allergy.

    • Winter swimmers.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Inflammation and Metabolism/ Center for Physical Activity Research Copenhagen Denmark 2100

    Sponsors and Collaborators

    • Susanna Søberg

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susanna Søberg, Principal Investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT03096535
    Other Study ID Numbers:
    • H-16038581-COLDBAT
    First Posted:
    Mar 30, 2017
    Last Update Posted:
    Mar 26, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 26, 2018