Energy Cost for Holding a MedGem® Indirect Calorimeter

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Energy Cost for Holding a MedGem® Indirect Calorimeter

Conditions
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Resting Metabolic Rate

Intervention / Treatment
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* Device: Not holding, then holding the MedGem®
* Device: Holding, then not holding the MedGem®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-65 y BMI 25-40 kg/m2 Exclusion Criteria: Diabetes mellitus Current smoker Presently on a weight loss regimen Medications: diabetes, oral steroids, blood pressure drugs, weight loss drugs Claustrophobia Pregnant or breastfeeding Congestive heart failure Chronic kidney disease Pacemaker or other metal implants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Not holding, then holding the MedGem®<br>Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter. | Device: Not holding, then holding the MedGem®<br>* Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®<br>Device: Holding, then not holding the MedGem®<br>* Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®<br>|
| Active Comparator: Holding, then not holding the MedGem®<br>Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter. | Device: Not holding, then holding the MedGem®<br>* Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®<br>Device: Holding, then not holding the MedGem®<br>* Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting Metabolic Rate (RMR) | Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart | 3 hours |