NCT01898949

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

July 7, 2013

Last Update Submit

January 6, 2016

Conditions

ThermogenesisBrown Adipose Tissue

Keywords

Diet-induced thermogenesisCold-induced thermogenesisBrown adipose tissueBrown fat

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Temperature

    After 4 weeks of cold exposure

Study Arms (1)

Cold Exposure

EXPERIMENTAL
Other: Cold Exposure

Interventions

Cold ExposureOTHER

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.

Cold Exposure

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

    PMID: 24500151DERIVED

Study Officials

  • Eric Ravussin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2013

First Posted

July 15, 2013

Study Start

November 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(1)