Comparison of Indirect Calorimetry by Q-NRG With Deltatra... | NCT05008757

Studies
Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II

NCT05008757

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Jun 27, 2023Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Indirect Calorimetry

Interventions

no drug

Countries

Belgium

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2021Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Jul 9, 2021

First Submission Date that Met QC Criteria

Aug 16, 2021

First Posted Date

Aug 17, 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 25, 2023

Last Update Posted Date

Jun 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison of indirect calorimetry by Q-NRG (Cosmed) with Deltatrac II (Datex)

Detailed Description

The aim of the present study is to compare the measured resting energy expenditure by Q-NRG (Cosmed) with Deltatrac II (Datex), in healthy volunteers.

Q-NRG is a new device. It is relevant to compare its results with the blog standard calorimeter, the Deltratrac II.

The study will include sports healthy subjects. The could benefit from the determination of their resting energy expenditure in order to adapt their nutritional intakes.

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

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
no drug	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
resting energy expenditure	comparison of resting energy expenditure measured using Q-NRG calorimeter with resting energy expenditure measured using Deltatrac II	during the calorimetry

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy adult
sport practice > 1h per day at moderate intensity

Exclusion Criteria:

refusal to participate
unable to give a consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Healthy volunteers who practice more than 1 hour per day at moderate intensity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marjorie Fadeur, RD	Contact	+33042843413		marjorie.fadeur@chuliege.be

Overall Officials

Name	Affiliation	Role
Anne-Françoise Rousseau, MD, PhD	University Hospital of Liège, Belgium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marjorie Fadeur	Recruiting	Liège		4000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided