Energy Cost for Holding a MedGem® Indirect Calorimeter

Not Applicable

Completed

• Conditions: Resting Metabolic Rate
• Interventions: Device: Not holding, then holding the MedGem®; Device: Holding, then not holding the MedGem®

• Registration Number: NCT03035903
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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.

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:

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).

Study Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Study Start: 2017-02-13
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Holding, then not holding the MedGem®	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.
Not holding, then holding the MedGem®	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®	Not holding, then 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.
Not holding, then holding the MedGem®	Not holding, then 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.

Primary Outcome Measures

Name	Time	Method
Resting Metabolic Rate (RMR)	3 hours	Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States