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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resting Metabolic Rate (RMR) | Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart | 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Ravussin, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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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| 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® |
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