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NCT06350253 Clinical Trial

Comparison Of Measured To Predicted Resting Metabolism

Body Weight Clinical Trial

Official title:
Comparison Of Measured To Predicted Resting Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06350253
Other study ID # 22-X-187
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 14, 2023
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source Ohio University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.

Description:

Resting metabolic rate (RMR) describes the number of calories a person utilizes while at rest. The gold standard measurement is via inspired and expired air using a metabolic cart. However, researchers have established estimation equations and the use of body composition analysis to predict RMR when a metabolic cart is unavailable. The accuracy of the predicted equations and whole-body bioelectrical impedance (BIA) machines that produce this data is unknown. Therefore, the purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry. Aim 1: to compare measured RMR from indirect calorimetry to values provided by the InBody 770 BIA machine and to established gender and age-appropriate prediction equations. Aim 2: to compare RMR measured from indirect calorimetry using a metabolic cart (Gold Standard) to the Medgem handheld indirect calorimeter (FDA approved device).

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Men & women, aged 18-60 Exclusion Criteria: - Have any known or suspected metabolic diseases such as diabetes, thyroid disorder, or high cholesterol - Have any known or suspected cardiovascular or pulmonary diseases such as hypertension - Are currently on beta blockers, taking antihypertensives, or antidepressants - Current smoker or quit less than a year ago - Unwilling to provide finger stick and urine sample

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Metabolic cart
RMR measurement via metabolic cart
• MedGem
RMR measurement via MedGem
• BIA
RMR estimation from BIA analysis

Locations
Country Name City State
United States Ohio University Exercise Physiology Lab Athens Ohio

Sponsors (1)
Lead Sponsor Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resting metabolic rate day 1
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