Energy Cost for Holding a MedGem® Indirect Calorimeter (MEDGEM)

Pennington Biomedical Research Center

Status: Completed

Conditions: Resting Metabolic Rate

Treatments: Device: Holding, then not holding the MedGem®; Device: Not holding, then holding the MedGem®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03035903

PBRC 2016-086

Details and patient eligibility

About

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.

Full 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:

1. RMR with MedGem® Indirect Calorimeter
2. 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Not holding, then holding the MedGem®

Experimental group

Description:

Subjects will be seated in an armless chair and have a RMR measurement taken while not holding, then holding a MedGem® Indirect Calorimeter.

Treatment:

Device: Not holding, then holding the MedGem®

Device: Holding, then not holding the MedGem®

Holding, then not holding the MedGem®

Active Comparator group

Description:

Subjects will be seated in an armless chair and have a RMR measurement taken holding, then not holding a MedGem® Indirect Calorimeter.

Treatment:

Device: Not holding, then holding the MedGem®

Device: Holding, then not holding the MedGem®