TemperatureNCT01454882
Measuring Free-living Energy Expenditure Using Direct Calorimetry
An observational study of Temperature and Clothing, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temperature, Clothing, Sex
- What is being tested?
- Effects of Clothing, Effects of Temperature and Low Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Body mass index (BMI) 19-25 kg/m2
- Age 18-45 years
- Age ≥18 yrs
Who cannot join
- 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)
Show all 17Show fewer
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Temperature, Clothing, Sex, Age, Adiposity
- Being tested
- Effects of Clothing, Effects of Temperature, Low Physical Activity, High Physical Activity, Direct calorimetry and doubly labeled water
- Keywords
- Direct calorimetry, Indirect calorimetry, Energy Expenditure
- Medical subject headings
- Coitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of ClothingBehavioural
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 TemperatureBehavioural
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
Low Physical ActivityBehavioural
This will be a randomized study with two within subject conditions (high and low physical activity levels)
High Physical ActivityBehavioural
This will be a randomized study with two within subject conditions (high and low physical activity levels)
Direct calorimetry and doubly labeled waterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Effects of Clothing; Behavioral: Effects of Temperature | |
| 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). Receives: Behavioral: Low Physical Activity; Behavioral: High Physical Activity | |
| 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). Receives: Behavioral: Direct calorimetry and doubly labeled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure
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.
Measured: 24 hrs to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TemperatureStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Edward L Melanson, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454882
- Sponsor's protocol ID
- 11-1324
- Other IDs
- R01DK091287
- Status last verified
- Jan 2016
- First submitted
- 14 Oct 2011
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Free-living Energy Expenditure Using Direct Calorimetry
- ClinicalTrials.gov ID
- NCT01454882
- Acronym / sponsor ID
- 11-1324
- Conditions
- Temperature, Clothing, Sex, Age, Adiposity
- Keywords
- Direct calorimetry, Indirect calorimetry, Energy Expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral effects of clothing and temperature | – | Behavioral: Effects of Clothing, Behavioral: Effects of TemperatureIn 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 |
| Behavioral effects of age, sex, and adiposity | – | Behavioral: Low Physical Activity, Behavioral: High Physical ActivityTHe 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). |
| Effects of free living energy expenditure | – | Behavioral: Direct calorimetry and doubly labeled waterThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Body mass index (BMI) 19-25 kg/m2
- Age 18-45 years
- Age ≥18 yrs
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effects of ClothingThere 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 | Behavioural | Behavioral effects of clothing and temperature |
| Effects of TemperatureThere 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 | Behavioural | Behavioral effects of clothing and temperature |
| Low Physical ActivityThis will be a randomized study with two within subject conditions (high and low physical activity levels) | Behavioural | Behavioral effects of age, sex, and adiposity |
| High Physical ActivityThis will be a randomized study with two within subject conditions (high and low physical activity levels) | Behavioural | Behavioral effects of age, sex, and adiposity |
| Direct calorimetry and doubly labeled waterTDEE 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. | Behavioural | Effects of free living energy expenditure |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Screening formLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward L Melanson, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature and Clothing, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (time frame: 24 hrs to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.