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

June 1, 2018 updated by: Eric Ravussin, Pennington Biomedical Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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®
Device: 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®
ACTIVE_COMPARATOR: 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.
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®
Device: 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®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Weight Watchers International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 13, 2017

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PBRC 2016-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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