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

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ClinicalTrials.gov Identifier: NCT03035903
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Weight Watchers International
Information provided by (Responsible Party):
Eric Ravussin, 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.

Condition or disease Intervention/treatment Phase
Resting Metabolic Rate Device: Not holding, then holding the MedGem® Device: Holding, then not holding the MedGem® Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Energy Cost for Holding a MedGem® Indirect Calorimeter
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

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®




Primary Outcome Measures :
  1. Resting Metabolic Rate (RMR) [ Time Frame: 3 hours ]
    Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035903


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Weight Watchers International
Investigators
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Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center

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Responsible Party: Eric Ravussin, Associate Executive Director for Clinical Science, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT03035903     History of Changes
Other Study ID Numbers: PBRC 2016-086
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be not be shared outside of Weight Watchers and the Investigators listed on the protocol for this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No