Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-04 @ 12:42 PM
Study NCT ID:
NCT05008757
Status:
UNKNOWN
Last Update Posted:
2023-06-27
First Post:
2021-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'resting energy expenditure', 'timeFrame': 'during the calorimetry', 'description': 'comparison of resting energy expenditure measured using Q-NRG calorimeter with resting energy expenditure measured using Deltatrac II'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['indirect calorimetry'], 'conditions': ['Indirect Calorimetry']}, 'descriptionModule': {'briefSummary': 'Comparison of indirect calorimetry by Q-NRG (Cosmed) with Deltatrac II (Datex)', 'detailedDescription': '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.\n\nQ-NRG is a new device. It is relevant to compare its results with the blog standard calorimeter, the Deltratrac II.\n\nThe study will include sports healthy subjects. The could benefit from the determination of their resting energy expenditure in order to adapt their nutritional intakes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers who practice more than 1 hour per day at moderate intensity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adult\n* sport practice \\> 1h per day at moderate intensity\n\nExclusion Criteria:\n\n* refusal to participate\n* unable to give a consent'}, 'identificationModule': {'nctId': 'NCT05008757', 'briefTitle': 'Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B7072021000024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no drug', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Marjorie Fadeur', 'role': 'CONTACT', 'email': 'marjorie.fadeur@chuliege.be', 'phone': '+3243662942'}], 'facility': 'Marjorie Fadeur', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Marjorie Fadeur, RD', 'role': 'CONTACT', 'email': 'marjorie.fadeur@chuliege.be', 'phone': '+33042843413'}], 'overallOfficials': [{'name': 'Anne-Françoise Rousseau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Liège, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinic', 'investigatorFullName': 'Anne-Françoise Rousseau', 'investigatorAffiliation': 'University of Liege'}}}}