Metabolism and Nutrition DisorderNCT04995211
Validity and Reliability of Commercially Available Metabolic Carts
An observational study of Metabolism and Nutrition Disorder, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism and Nutrition Disorder
- What is being tested?
- Assessment of resting energy expenditure
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2021to 7 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70809
About this study
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
- Being tested
- Assessment of resting energy expenditure
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of resting energy expenditureDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting metabolic rate
Indirect calorimetry
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start22 Jul 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995211
- Sponsor's protocol ID
- PBRC2020-036
- Status last verified
- Jun 2022
- First submitted
- 29 Jul 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Commercially Available Metabolic Carts
- ClinicalTrials.gov ID
- NCT04995211
- Acronym / sponsor ID
- PBRC2020-036
- Conditions
- Metabolism and Nutrition Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of resting energy expenditureWe 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. | Device | – |
Primary outcome
Resting metabolic rate
Time frame: 30 minutes
Indirect calorimetry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolism and Nutrition Disorder, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting metabolic rate (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.