Energy Cost for Holding a MedGem® Indirect Calorimeter

Resting Metabolic Rate Clinical Trial

— MEDGEM  

Official title:

Energy Cost for Holding a MedGem® Indirect Calorimeter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035903
• Other study ID #: PBRC 2016-086
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2018
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Resting Metabolic Rate

Intervention

Device:
• 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®
• 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®

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Metabolic Rate (RMR)	Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart	3 hours