Validity and Reliability of Commercially Available Metabolic Carts

NCT04995211 | Completed FDA Device

• 1 other identifier: PBRC2020-036
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolism and Nutrition Disorder

Outcome Measures

Primary Outcomes (1)

• Resting metabolic rate

  Indirect calorimetry

  30 minutes

Interventions

Assessment of resting energy expenditure DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Executive Director for Clinical Science

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: July 22, 2021
• Primary Completion: February 7, 2022
• Study Completion: February 7, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

US (1)