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

This study has been completed.

First Received: July 16, 2007 No Changes Posted

Sponsored by:	Microlife
Information provided by:	Microlife
ClinicalTrials.gov Identifier:	NCT00502931

Purpose

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.

Condition
Resting Metabolic Rate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Case Control, Retrospective Study
Official Title:	A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children

Further study details as provided by Microlife:

Study Start Date:

November 2006

Eligibility

Genders Eligible for Study:

Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502931

Locations

United States, Colorado
Microlife Health Solutions
Golden, Colorado, United States, 80401

Sponsors and Collaborators

Microlife

Investigators

Principal Investigator:

Scott O McDoniel, M.Ed.

Microlife USA, Inc.

More Information

No publications provided

Study ID Numbers:	ML003
Study First Received:	July 16, 2007
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00502931 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 07, 2009