- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502931
A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices
July 16, 2007 updated by: Microlife
A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Golden, Colorado, United States, 80401
- Microlife Health Solutions
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott O McDoniel, M.Ed., Microlife USA, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Registration Dates
First Submitted
July 16, 2007
First Submitted That Met QC Criteria
July 16, 2007
First Posted (Estimate)
July 18, 2007
Study Record Updates
Last Update Posted (Estimate)
July 18, 2007
Last Update Submitted That Met QC Criteria
July 16, 2007
Last Verified
July 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- ML003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.