- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454882
Measuring Free-living Energy Expenditure Using Direct Calorimetry
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver Anschutz Medical Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
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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)
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure
Time Frame: 24 hrs to 2 weeks
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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.
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24 hrs to 2 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward L Melanson, Ph.D., University of Colorado - Anschutz Medical Campus
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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