Energy Cost for Holding a MedGem® Indirect Calorimeter

NCT ID: NCT03035903

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2017-12-31

Brief Summary

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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

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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).

Conditions

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Resting Metabolic Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Not holding, then holding the MedGem®

Intervention Type 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®

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Not holding, then holding the MedGem®

Intervention Type 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®

Intervention Type DEVICE

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

Interventions

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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®

Intervention Type 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®

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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WW International Inc

INDUSTRY

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Eric Ravussin

Associate Executive Director for Clinical Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Ravussin, PhD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 2016-086

Identifier Type: -

Identifier Source: org_study_id

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