Stimulation of Diet-Induced Thermogenesis by Cold-Exposure (BAT&DIT)

January 6, 2016 updated by: Eric Ravussin, Pennington Biomedical Research Center

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

Completed

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

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 7, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

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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