- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898949
Stimulation of Diet-Induced Thermogenesis by Cold-Exposure (BAT&DIT)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will have 3 phases:
Phase 1: baseline testing. This phase takes place at the beginning of the study to establish several physical, physiological and metabolic studies and includes measures of height, weight, body composition, sedentary and resting metabolic rate in a metabolic chamber as well as your metabolic and cardiac responses to cold.
Phase 2: cold exposure (treatment) phase. This phase is initiated immediately after phase 1 and will last 4 weeks. Each work day (Monday to Friday) subjects will have to spend 20 minutes in a cold room wearing light clothes.
Phase 3: post-treatment testing. The same physiological and metabolic studies measured at baseline will be repeated over 3 days.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cold Exposure
|
Participants will spend 20 minutes per day 5 times a week (workdays) in a cold room wearing light clothes (T-shirt, shorts and light shoes) for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy Expenditure
Time Frame: After 4 weeks of cold exposure
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temperature
Time Frame: After 4 weeks of cold exposure
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 10031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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