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Completed

NCT Number: NCT03035903

Energy Cost for Holding a MedGem® Indirect Calorimeter

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.

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Key information

Conditions

Resting Metabolic Rate

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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:

  • RMR with MedGem® Indirect Calorimeter
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not holding, then holding the MedGem®

Device

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®

Device

Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®

Primary outcomes

  1. Resting Metabolic Rate (RMR)

    Time frame: 3 hours

    Resting metabolic rate will be assessed via a DeltaTrac Metabolic Cart

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • WW International Inc

Registry information

Acronym: MEDGEM

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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