Energy Cost for Holding a MedGem® Indirect Calorimeter

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03035903

Acronym

MEDGEM

Enrollment

Registered

2017-01-30

Start date

2017-02-13

Completion date

2017-12-31

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resting Metabolic Rate

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).

Interventions

DEVICENot holding, then holding the MedGem®

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

DEVICEHolding, 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 design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026