Measuring Free-living Energy Expenditure Using Direct Calorimetry

January 7, 2016 updated by: University of Colorado, Denver
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.

Study Overview

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 Doubly Labeled Water (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.

Study Type

Observational

Enrollment (Actual)

39

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

    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver Anschutz Medical Campus

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

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

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Behavioral 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
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
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
Behavioral 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).
This will be a randomized study with two within subject conditions (high and low physical activity levels)
This will be a randomized study with two within subject conditions (high and low physical activity levels)
Effects of 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy expenditure
Time Frame: 24 hrs to 2 weeks
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.
24 hrs to 2 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Edward L Melanson, Ph.D., University of Colorado - Anschutz Medical Campus

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.

Helpful Links

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

January 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 11-1324
  • R01DK091287 (U.S. NIH Grant/Contract)

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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