Resting Metabolic RateNCT00502931
A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices
An observational study of Resting Metabolic Rate, run by Microlife at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resting Metabolic Rate
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Resting Metabolic Rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resting Metabolic RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Microlife
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott O McDoniel, M.Ed., Principal investigator, Microlife USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502931
- Sponsor's protocol ID
- ML003
- Status last verified
- Jul 2007
- First submitted
- 16 Jul 2007
- Last updated
- 18 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Review on the Accuracy and Reliability of a Hand-Held Indirect Calorimeter for Assessing Energy Needs in Adults & Children
- ClinicalTrials.gov ID
- NCT00502931
- Acronym / sponsor ID
- ML003
- Conditions
- Resting Metabolic Rate
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- MicrolifeIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2007.
Related trials for Resting Metabolic Rate
Recruiting
Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism
Insulin Resistance
RecruitingObservational study
Changes in Energy Expenditure in Response to Physical Activity in Healthy Adults
Physical Activities
Active, not recruitingObservational study
Resting Metabolic Rate in Bodybuilders Using Performance-Enhancing Drugs
Athlete Assessment, Body Composition
Not yet recruiting
Acute Effects of Caffeine on Mitochondrial Function in Peripheral Blood Mononuclear Cells
Energy Metabolism
Not yet recruiting
Weight Loss Composition and Metabolic Adaptation During Hypocaloric Dieting
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott O McDoniel, M.Ed. principal investigator
Microlife USA, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resting Metabolic Rate, run by Microlife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2007.