Resting Metabolic RateMEDGEMNCT03035903
Energy Cost for Holding a MedGem® Indirect Calorimeter
A study testing Not holding, then holding the MedGem® and Holding, then not holding the MedGem® in people with Resting Metabolic Rate, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Resting Metabolic Rate
- What is being tested?
- Not holding, then holding the MedGem® and Holding, then not holding the MedGem®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 31 Dec 2017
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65 y
- BMI 25-40 kg/m2
Who cannot join
- Diabetes mellitus
- Current smoker
- Presently on a weight loss regimen
- Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs
- Claustrophobia
- Pregnant or breastfeeding
Show all 9Show fewer
- Congestive heart failure
- Chronic kidney disease
- Pacemaker or other metal implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.
Read the detailed description
Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:
- RMR with MedGem® Indirect Calorimeter
- RMR without MedGem® Indirect Calorimeter
Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).
- Conditions
- Resting Metabolic Rate
- Being tested
- Not holding, then holding the MedGem®, Holding, then not holding the MedGem®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not holding, then holding the MedGem®Device
Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®
Holding, then not holding the MedGem®Device
Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®
| Study group | Role | What they receive |
|---|---|---|
| Not holding, then holding the MedGem® | Experimental | Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter. Receives: Device: Not holding, then holding the MedGem®; Device: Holding, then not holding the MedGem® |
| Holding, then not holding the MedGem® | Active comparator | Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter. Receives: Device: Not holding, then holding the MedGem®; Device: Holding, then not holding the MedGem® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Metabolic Rate (RMR)
Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start13 Feb 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Eric Ravussin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035903
- Sponsor's protocol ID
- PBRC 2016-086
- Acronym
- MEDGEM
- Status last verified
- Jun 2018
- First submitted
- 26 Jan 2017
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Cost for Holding a MedGem® Indirect Calorimeter
- ClinicalTrials.gov ID
- NCT03035903
- Acronym / sponsor ID
- MEDGEM / PBRC 2016-086
- Conditions
- Resting Metabolic Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 30 Jan 2017 (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.
The goal of this clinical protocol is to perform a randomized crossover study to determine the energy cost of holding the MedGem® device above a person's normal resting metabolic rate (RMR) compared to not holding the MedGem® device.
Detailed description
Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute rest (washout) period. The two RMR evaluation periods are as follows:
- RMR with MedGem® Indirect Calorimeter
- RMR without MedGem® Indirect Calorimeter
Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects will be introduced to the ventilated hood to determine presence of claustrophobia prior to enrollment (i.e., signing of the consent form).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not holding, then holding the MedGem® | Experimental | Device: Not holding, then holding the MedGem®, Device: Holding, then not holding the MedGem®Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter. |
| Holding, then not holding the MedGem® | Active comparator | Device: Not holding, then holding the MedGem®, Device: Holding, then not holding the MedGem®Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-65 y
- BMI 25-40 kg/m2
Key exclusion criteria (9 listed)
- Diabetes mellitus
- Current smoker
- Presently on a weight loss regimen
- Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not holding, then holding the MedGem®Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem® | Device | Holding, then not holding the MedGem®, Not holding, then holding the MedGem® |
| Holding, then not holding the MedGem®Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem® | Device | Holding, then not holding the MedGem®, Not holding, then holding the MedGem® |
Primary outcome
Resting Metabolic Rate (RMR)
Time frame: 3 hours
Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart
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 6 Jun 2018.
- Individual participant dataSharing planned: No. The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.
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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.
Eric Ravussin, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Not holding, then holding the MedGem® and Holding, then not holding the MedGem® in people with Resting Metabolic Rate, run by Pennington Biomedical Research Center 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 2 inclusion and 9 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 6 Jun 2018. 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.
What does the primary outcome measure?
Resting Metabolic Rate (RMR) (time frame: 3 hours). It is what the study was designed to measure, not a finding.
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 6 Jun 2018.