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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03035903
Other study ID # PBRC 2016-086
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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