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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 26, 2017
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date June 5, 2018
Actual Study Start Date  ICMJE February 13, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
Resting Metabolic Rate (RMR) [ Time Frame: 3 hours ]
Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03035903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Energy Cost for Holding a MedGem® Indirect Calorimeter
Official Title  ICMJE Energy Cost for Holding a MedGem® Indirect Calorimeter
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Resting Metabolic Rate
Intervention  ICMJE
  • 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®
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Not holding, then holding the MedGem®
    • Device: Holding, then 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.
    Interventions:
    • Device: Not holding, then holding the MedGem®
    • Device: Holding, then not holding the MedGem®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03035903
Other Study ID Numbers  ICMJE PBRC 2016-086
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Eric Ravussin, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Weight Watchers International
Investigators  ICMJE
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP