Validation of a Portable Indirect Calorimeter

NCT04469452 | Terminated

• 1 other identifier: 20-0317
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 dioxide production (VCO2). Findings may help develop less expensive and more accessible means of measuring energy expenditure.

Conditions

Human Energy Expenditure

Outcome Measures

Primary Outcomes (2)

• Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)

  Measurement of RMR

  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

  Repeated Measure obtained within 1 week of baseline measure

Study Arms (1)

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.

Device: Apollo Device

Interventions

Apollo Device DEVICE

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)

Healthy Adults (19-99yrs)

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Males and females
• yrs of age

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Study Officials

• Edward Melanson, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: September 1, 2020
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)