Validity and Reliability of Commercially Available Metabo... | NCT04995211

Studies
Validity and Reliability of Commercially Available Metabolic Carts

NCT04995211

Sponsor

Pennington Biomedical Research Center

Status

Completed

Last Update Posted

Jun 15, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Metabolism and Nutrition Disorder

Interventions

Assessment of resting energy expenditure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2021Actual

Primary Completion Date

Feb 7, 2022Actual

Completion Date

Feb 7, 2022Actual

First Submitted Date

Jul 29, 2021

First Submission Date that Met QC Criteria

Jul 29, 2021

First Posted Date

Aug 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2022

Last Update Posted Date

Jun 15, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eric Ravussin, Associate Executive Director for Clinical Science, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resting metabolic rate	Indirect calorimetry	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70809	United States

Condition Browse Module

MeSH Terms

ID	Term
D009748	Nutrition Disorders

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided