Obesity Clinical Trial
— COLDBATOfficial title:
Cold Induced Activation of Brown Fat in Humans Assessed With PET/MR Scans and Skin-temperature Measure - A Cross-over Randomized Controlled Trial.
Verified date | March 2018 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 1, 2018 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 30 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Inflammation and Metabolism/ Center for Physical Activity Research | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Susanna Søberg |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Difference in BAT activity after cooling versus 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. | Difference in peak temperature after 2 hours of cooling versus 2 hours of no cooling. | |
Secondary | Difference in resting energy expenditure after cooling versus no cooling | Difference in resting energy expenditure after cooling versus no cooling, measured as mean difference in KJ/min. | Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling. |
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