Cold Induced Activation of Brown Adipose Tissue in Humans

NCT ID: NCT03096535

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-02
• Study Completion Date: 2018-03-01

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.

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.

Conditions

Adipose Tissue, Brown; Brown Adipose Tissue; Brown Fat; Uncoupling Protein 1; Adipokines; Proteomics; Infrared Thermography; BAT; Obesity; Type 2 Diabetes; Proteins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Cooling

Individualized cooling protocol.

Group Type: EXPERIMENTAL

Cooling

Intervention Type: PROCEDURE

Individualized cooling protocol.

Thermoneutral

Thermoneutral condition day.

Group Type: EXPERIMENTAL

Thermoneutral

Intervention Type: PROCEDURE

Thermoneutral control day.

Interventions

Cooling

Individualized cooling protocol.

Intervention Type: PROCEDURE

Thermoneutral

Thermoneutral control day.

Intervention Type: PROCEDURE

Other Intervention Names

Cold activation; Cold stimulation; Cold activation of BAT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Susanna Søberg

OTHER

Sponsor Role: lead

Responsible Party

Susanna Søberg

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susanna Søberg, MSc.

Role: PRINCIPAL_INVESTIGATOR

Center for Inflammation and Metabolism/Center for physical activity research

Locations

Center for Inflammation and Metabolism/ Center for Physical Activity Research

Copenhagen, , Denmark

Countries

Denmark

References

Soberg S, Lofgren J, Philipsen FE, Jensen M, Hansen AE, Ahrens E, Nystrup KB, Nielsen RD, Solling C, Wedell-Neergaard AS, Berntsen M, Loft A, Kjaer A, Gerhart-Hines Z, Johannesen HH, Pedersen BK, Karstoft K, Scheele C. Altered brown fat thermoregulation and enhanced cold-induced thermogenesis in young, healthy, winter-swimming men. Cell Rep Med. 2021 Oct 11;2(10):100408. doi: 10.1016/j.xcrm.2021.100408. eCollection 2021 Oct 19.

Reference Type: DERIVED

PMID: 34755128 (View on PubMed)

Other Identifiers

H-16038581-COLDBAT

Identifier Type: -

Identifier Source: org_study_id