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NCT04995211 Clinical Trial

Validity and Reliability of Commercially Available Metabolic Carts

Metabolism and Nutrition Disorder Clinical Trial

Official title:
Validity and Reliability of Commercially Available Metabolic Carts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04995211
Other study ID # PBRC2020-036
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 22, 2021
Est. completion date February 7, 2022

Study information
Verified date June 2022
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The validity (by alcohol burning and gas infusions) and reliability (day-to-day variability in healthy subjects) of six metabolic carts will be compared.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 7, 2022
Est. primary completion date February 7, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy male or female. - Age 18-65 y. - BMI between 18.5 kg/m2 and 40 kg/m2 (inclusive). - Are willing to fast and not consume non-caloric stimulant for 10h before the assessments, and during the stay in the center. - Are willing to avoid moderate or vigorous physical activity during 24h before the visits. Exclusion Criteria: - Smoking or use of tobacco products within the last 3 months - Diagnosed with diabetes. - Previous bariatric surgery (or other surgeries) for obesity or weight loss. - Use of medications affecting metabolism or sleep. - History of neurological disease. - History of cardiovascular disease, including hypertension, or other chronic diseases. - Pregnant, planning to become pregnant, or breastfeeding - Claustrophobia impeding to stay calm under a plastic canopy.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Assessment of resting energy expenditure
We will assess the resting metabolic rate and respiratory exchange ratio of twenty healthy adults, with every metabolic cart on two days in the morning. The assessment will last 30 minutes on each metabolic cart, with 15-minute breaks between measurements. The order of the metabolic carts will be randomly selected and replicated the second day.

Locations
Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resting metabolic rate Indirect calorimetry 30 minutes
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