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Completed

NCT Number: NCT01898949

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).

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Key information

Conditions

Thermogenesis Brown Adipose Tissue

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cold exposure

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

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

Acronym: BAT&DIT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 15, 2013
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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