Measuring Free-living Energy Expenditure Using Direct Calorimetry

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Colorado, Denver
Sponsor:
Collaborators:
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01454882
First received: October 14, 2011
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

Although instruments such as pedometers and heart rate monitors are helpful for those who use exercise to maintain their weight, they do not actually measure calories expended, which is a critical piece of information necessary for sustained weight management. The purpose of this study is to determine the accuracy of a new device that measures calories burned based upon heat produced by the body. Since heat production is directly proportional to calories burned, this device has the potential to accurately measure energy expended in many different settings.


Condition
Temperature
Clothing
Sex
Age
Adiposity

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Measuring Free-living Energy Expenditure Using Direct Calorimetry

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Energy expenditure [ Time Frame: 24 hrs to 2 weeks ] [ Designated as safety issue: No ]
    The aim of this trial is to determine the accuracy of measuring energy expenditure using portable direct calorimetry. Energy expenditure will be measured with a new device worn on the arm that measures heat flux. The accuracy of the new device will be compared against simultaneous measurements of energy expenditure made using indirect calorimetry and doubly labeled water.


Estimated Enrollment: 165
Study Start Date: January 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Effects of clothing and temperature
In this first study, we will determine how variations in clothing and ambient temperature influence the accuracy of EE determined from measurements of total heat production. 65 individuals will be studied. This will be a randomized cross-over trial with two within subject factors: 1) ambient temperature and 2) amount of clothing. There will be two temperature conditions; warm temperature [WT, 75°F (24°C)] and cool temperature [CT, 60°F (16°C)]. During each condition, subjects will vary the amount of clothing they are wearing at specified times
Effects of age, sex, and adiposity
THe aim of this study is to Determine how age, sex, and adiposity influence the accuracy of EE determined from measurements of total heat production . This will be a randomized study with two within subject conditions(high and low physical activity levels). A heterogenous sample of adult men and women in stable health will be studied. We will study subjects across a wide range of weight (up to 300 lbs) and age range (≥ 18 yrs).
Free living energy expenditure
The primary aim of this study is to compare the accuracy of measuring free-living energy expenditure in humans measured using portable direct calorimetry. This will be a comparison study; TDEE will be measured simultaneously for 14 days using direct calorimetry and doubly labeled water. A heterogeneous sample of adult men and women in stable health will be studied. We will study subjects across a wide range of weight (up to 300 lbs) and age (>18 yrs).

Detailed Description:

Current approaches to measuring total daily energy expenditure (TDEE) in free-living individuals are limited by cost, accuracy, and lack of sensitivity to specific activities. Accurate, reliable, and low cost approaches for measuring TDEE are needed not only to improve clinical outcomes (e.g. weight management), but also to meet public health research objectives. In humans, EE is proportional to total heat loss, which is the sum of conductive, convective, radiant and evaporative heat flows, and measurement of heat loss is the basis of direct calorimetry. However, it has not been possible to accurately measure all forms of heat flux in free-living humans, particularly evaporative heat loss, which can be a substantial component of total heat production. A recently developed heat flow gauge with the capacity to measure all forms of heat flux has shown promise in proof of concept trials and pilot studies, but its accuracy in measuring TDEE has not yet been thoroughly tested. Moreover, how accuracy is affected by factors such as clothing, ambient temperature, and adiposity has not been studied. The objectives of the proposed research are to a) refine the measurement of TDEE based on total heat flux by determining how factors such as clothing, ambient temperature, age, sex, and body composition influence accuracy; b) compare the accuracy of this approach against the criterion measurements of DLW and whole-room indirect calorimetry; and c) compare the accuracy against a similar instrument that measures heat flux, but is not capable of directly measuring the evaporative component. The proposed research is innovative because it will test the accuracy of an approach that is based on a physiological signal (heat production) which is directly proportional to EE. In addition to accurately measuring TDEE, identifying and distinguishing different types of physical activity is an important goal of physical activity related research, but the capacity to do so is limited. Thus, an additional goal of the proposed research is to determine if measurement of changes in heat flux can be used to identify EE in specific bouts of activity and to differentiate between upper body and lower body activity. The proposed studies will permit refinement of a technology that will have major impact in both clinical practice and research. This new approach will potentially provide substantive improvements in the measurement of TDEE in free-living humans and in the assessment of physical activity and the associated energy cost.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Study #1: Lean (body mass index (BMI) < 25.0 kg/m2), adult men and women (18-45 yrs) in stable health will be studied.

Study #2 & #3: A heterogenous sample of adult men and women in stable health will be studied. We will study subjects across a wide range of weight (up to 300 lbs) and age range (≥ 18 yrs).

Criteria

These studies will be conducted in Denver. CO. Eligible participants will be those local to the University.

Study #1 (Effects of clothing and temperature)

Inclusion Criteria

  • Body mass index (BMI) 19-25 kg/m2
  • Age 18-45 years

Exclusion criteria

  • Self-reported acute or chronic disease (e.g. diabetes, heart disease, thyroid disease)
  • Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
  • Females who are or who were recently (past year) pregnant or lactating.
  • Resting diastolic blood pressure > 100 mm HG or resting systolic blood pressure > 160 mm HG
  • Contra-indications to exercise (e.g. orthopedic limitations)

Study #2 (Effect of age, sex, and adiposity)

Inclusion Criteria • Age ≥18 yrs

Exclusion criteria

  • Weight > 300 lbs (due to DXA limitations)
  • Self-reported acute or chronic disease (diabetes, heart disease, thyroid disease)
  • Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
  • Females who are or who were recently (past year) pregnant or lactating.
  • Resting diastolic blood pressure > 100 mm HG or resting systolic blood pressure > 160 mm HG
  • Contra-indications to exercise (e.g. orthopedic limitations)

Study #3 (Doubly labeled water)

Inclusion Criteria

• Age ≥18 yrs

Exclusion criteria

  • Weight > 300 lbs (due to DXA limitations)
  • Self-reported acute or chronic disease (diabetes, heart disease, thyroid disease)
  • Tobacco use (cigarettes, cigars, or chewing tobacco) within the past 6 months
  • Females who are or who were recently (past year) pregnant or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454882

Contacts
Contact: Tracy Swibas, M.S. tracy.swibas@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01454882     History of Changes
Other Study ID Numbers: 11-1324, R01DK091287
Study First Received: October 14, 2011
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Direct calorimetry
Indirect calorimetry
Energy Expenditure

ClinicalTrials.gov processed this record on October 29, 2014