Cold Induced Activation of Brown Adipose Tissue in Humans
COLDBAT
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
1 active site
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
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedStudy Start
First participant enrolled
April 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 26, 2018
March 1, 2018
11 months
February 23, 2017
March 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in brown adipose tissue (BAT) activity after cooling versus 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.
Difference in SUV mean after 2 hours of cooling versus 2 hours of no cooling.
Secondary Outcomes (2)
Difference in BAT activity after cooling versus no cooling.
Difference in peak temperature after 2 hours of cooling versus 2 hours of no cooling.
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.
Study Arms (2)
Cooling
EXPERIMENTALIndividualized cooling protocol.
Thermoneutral
EXPERIMENTALThermoneutral condition day.
Interventions
Individualized cooling protocol.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Susanna Søberglead
Study Sites (1)
Center for Inflammation and Metabolism/ Center for Physical Activity Research
Copenhagen, 2100, Denmark
Related Publications (1)
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.
PMID: 34755128DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanna Søberg, MSc.
Center for Inflammation and Metabolism/Center for physical activity research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 23, 2017
First Posted
March 30, 2017
Study Start
April 2, 2017
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
March 26, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share