Human Energy ExpenditureNCT04469452
Validation of a Portable Indirect Calorimeter
An observational study of Human Energy Expenditure, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to test the accuracy of a new device (the Apollo EE Device) that measures resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study will help determine how this new device compares to the gold standard, indirect calorimetry, which measures REE using VO2 and carbon… Read more about this study
- Who is it for?
- Ages 19 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Energy Expenditure
- What is being tested?
- Apollo Device
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 28 Nov 2023
- 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 19 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Only individuals who are enrolled in a separate study using indirect calorimetry to measure RMR within our lab will be eligible to participate in this study.
Who may be able to join
- Males and females
- 19-99 yrs of age
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Validation of the Apollo EE Device, Indirect Calorimetry
This study plans to test the accuracy of a new device (the Apollo EE Device) that measures resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study will help determine how this new device compares to the gold standard, indirect calorimetry, which measures REE using VO2 and carbon dioxide production (VCO2). Findings may help develop less expensive and more accessible means of measuring energy expenditure.
Read the detailed description
The gold standard for measuring resting metabolic rate (RMR) is metabolic carts that measure oxygen consumption (VO2) and carbon dioxide production (VCO2). The energy equivalent of VO2 ranges from ~4.7-5.0 kcals/L, depending on the ratio of carbohydrate, fat, and protein oxidized. However, RMR can be measured based solely on VO2, because VCO2 has a relatively small effect on energy expenditure estimation. A device that measures RMR based on VO2 and eliminates the need for measuring VCO2 could provide a simple and less expensive alternative to metabolic carts and may have important clinical applications. The overarching goal of this proposal is to validate such a metabolic system by comparing its ability to accurately measure RMR against a metabolic cart.
- Conditions
- Human Energy Expenditure
- Being tested
- Apollo Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo DeviceDevice
Comparisons will be made between the Apollo EE Device (Sable Systems International, Las Vegas, NV) and the TrueOne 2400 metabolic cart (Parvo Medics, Salt Lake City, UT)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults (19-99yrs) | Healthy adults already enrolled in separate studies using indirect calorimetry to measure RMR within our lab will be recruited for this study. Fifty participants (25 male, 25 female) will be heterogeneous in age, body composition, and physical activity based on the inclusion and exclusion of their respective studies. To test reliability, 25 of the 50 participants will repeat RMR measurements within 1 week of initial measurements. Receives: Device: Apollo Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
Measurement of RMR
Measured: Baseline
Reliability of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
Repeated measurement of RMR
Measured: Repeated Measure obtained within 1 week of baseline measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Sep 2020
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: Halted by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Energy ExpenditureStudies 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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Melanson, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469452
- Sponsor's protocol ID
- 20-0317
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Apollo EE Device, Indirect Calorimetry
- ClinicalTrials.gov ID
- NCT04469452
- Acronym / sponsor ID
- 20-0317
- Conditions
- Human Energy Expenditure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Halted by sponsor
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
This study plans to test the accuracy of a new device (the Apollo EE Device) that measures resting energy expenditure (REE) using only oxygen consumed (VO2). Findings from this study will help determine how this new device compares to the gold standard, indirect calorimetry, which measures REE using VO2 and carbon dioxide production (VCO2). Findings may help develop less expensive and more accessible means of measuring energy expenditure.
Detailed description
The gold standard for measuring resting metabolic rate (RMR) is metabolic carts that measure oxygen consumption (VO2) and carbon dioxide production (VCO2). The energy equivalent of VO2 ranges from ~4.7-5.0 kcals/L, depending on the ratio of carbohydrate, fat, and protein oxidized. However, RMR can be measured based solely on VO2, because VCO2 has a relatively small effect on energy expenditure estimation. A device that measures RMR based on VO2 and eliminates the need for measuring VCO2 could provide a simple and less expensive alternative to metabolic carts and may have important clinical applications. The overarching goal of this proposal is to validate such a metabolic system by comparing its ability to accurately measure RMR against a metabolic cart.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults (19-99yrs) | – | Device: Apollo DeviceHealthy adults already enrolled in separate studies using indirect calorimetry to measure RMR within our lab will be recruited for this study. Fifty participants (25 male, 25 female) will be heterogeneous in age, body composition, and physical activity based on the inclusion and exclusion of their respective studies. To test reliability, 25 of the 50 participants will repeat RMR measurements within 1 week of initial measurements. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Only individuals who are enrolled in a separate study using indirect calorimetry to measure RMR within our lab will be eligible to participate in this study.
Key inclusion criteria (2 listed)
- Males and females
- 19-99 yrs of age
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Apollo DeviceComparisons will be made between the Apollo EE Device (Sable Systems International, Las Vegas, NV) and the TrueOne 2400 metabolic cart (Parvo Medics, Salt Lake City, UT) | Device | Healthy Adults (19-99yrs) |
Primary outcome
Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
Time frame: Baseline
Measurement of RMR
Reliability of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)
Time frame: Repeated Measure obtained within 1 week of baseline measure
Repeated measurement of RMR
Results and safety
The study was stopped early (reason given: Halted by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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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 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 Human Energy Expenditure, 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 Dec 2023. 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 was stopped early (reason given: Halted by sponsor). Results are not available in the source record.
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?
Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 4 Dec 2023.