- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995211
Validity and Reliability of Commercially Available Metabolic Carts
June 12, 2022 updated by: Eric Ravussin, Pennington Biomedical Research Center
The validity (by alcohol burning and gas infusions) and reliability (day-to-day variability in healthy subjects) of six metabolic carts will be compared.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70809
- Pennington Biomedical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adults
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting metabolic rate
Time Frame: 30 minutes
|
Indirect calorimetry
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 22, 2021
Primary Completion (ACTUAL)
February 7, 2022
Study Completion (ACTUAL)
February 7, 2022
Study Registration Dates
First Submitted
July 29, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (ACTUAL)
August 6, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 12, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC2020-036
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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