Validation of a Portable Indirect Calorimeter

Human Energy Expenditure Clinical Trial

Official title:

Validation of the Apollo EE Device, Indirect Calorimetry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04469452
• Other study ID #: 20-0317
• Status: Terminated
• Start date: September 1, 2020
• Est. completion date: November 28, 2023

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

• Males and females

• 19-99 yrs of age

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Human Energy Expenditure

Intervention

Device:
• Apollo 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)

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of a new indirect calorimeter, the Apollo EE Device, when compared to the gold standard (TrueOne 2400 metabolic cart)	Measurement of RMR	Baseline
Primary	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