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NCT00502931 Clinical Trial

A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices

Resting Metabolic Rate Clinical Trial

Official title:
A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00502931
Other study ID # ML003
Secondary ID
Status Completed
Phase N/A
First received July 16, 2007
Last updated July 16, 2007
Start date November 2006

Study information
Verified date July 2007
Source Microlife
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

With the number of individuals becoming overweight or obese, healthcare professionals are in need of accurate, reliable, and convenient tools to help personalize weight loss programs. Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka “Gem”) was introduced as a convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy needs. Several validation and comparison studies were conducted to determine if the Gem device is accurate and reliable. The purpose of this study was to conduct a systematic review of previous studies that evaluated the accuracy and reliability of the Gem devices.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Random or counterbalanced assignment of participants to eliminate measurement bias; similar subject positioning for both Gem and reference system measurement or adjustment to a measurement for positioning differences; and use of a measurement protocol that is similar to the established “best practice” guidelines for employing indirect calorimetry

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Microlife Health Solutions Golden Colorado

Sponsors (1)
Lead Sponsor Collaborator
Microlife

Country where clinical trial is conducted

United States, 

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