Brown Adipose Tissue Clinical Trial
— BAT&DITOfficial title:
BAT&DIT: Stimulation of Diet-Induced Thermogenesis by Cold-Exposure
Human fat tissue is essentially white fat, the main function of which is to store excess
energy intake, and to release it when necessary. Brown fat is far less abundant and is
present in the body to burn fat (and thus energy) to generate heat to maintain body
temperature around 96 degrees. This phenomenon is called thermogenesis. When humans are
exposed to cold on a chronic basis, brown fat expands and becomes more active, and
consequently burns more energy. The amount of brown fat is higher during winter, and daily
short (20 minutes) exposures to cold might be sufficient to induce its activity.
We hypothesized that daily short term (20 minutes) exposure to a cold environment (4 °C) for
four weeks increases adaptive BAT-mediated thermogenesis. CIT and DIT will be increased
proportionally (the increase in CIT and DIT will be correlated).
Status | Completed |
Enrollment | 9 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Men between the ages of 18-35 years, inclusive - Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive, with a stable weight (<2kg variation) within the past 3-6 months - Non smokers - On no medication or recreational drugs - Healthy as assessed by a standard self-reported screening health questionnaire - Provide written informed consent Exclusion Criteria: - Smokers - Individuals taking any medications - Individuals taking any stimulants - Individuals taking beta-blockers - Individuals with diabetes or impaired fasting glucose as defined by theADA criteria, i.e. fasting plasma glucose concentration = 5.6 mmol/L (100 mg/dl). - Individuals with chronic alcohol consumption (> 3 drinks per day) or drug abuse - Individuals unable to abstain from caffeinated beverage or alcohol the days of study - Individuals with pacemakers or defibrillators - Individuals with history of heart disease or history of stroke - Individuals having a significant recent loss or gain of weight - Individuals involved in regular (> 3 times per week), intense competitive sporting activities. - Individuals involved in intensive exercise activity. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pennington Biomedical Research Center | Baton Rouge | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Pennington Biomedical Research Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Energy Expenditure | Change in energy expenditure is measured within 24 hours (acute) and after 4 weeks (chronic) of cold exposure with either bed-side calorimeter or whole-room calorimeter. | After 4 weeks of cold exposure | No |
Secondary | Temperature | Change in temperature acute (within 24 hours) and chronic (after 4 weeks) temperature from baseline as measured by either capsule (core body temperature) or infrared imaging (surface temperature). | After 4 weeks of cold exposure | No |
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