Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-08 @ 1:35 AM
Study NCT ID:
NCT06485960
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Experience Sampling Dietary Assessment Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Timing of glucose peaks', 'timeFrame': '2 weeks', 'description': 'Timing of glucose peaks registered by Continuous Glucose Monitoring'}, {'measure': 'Timing of eating-related motion', 'timeFrame': '2 weeks', 'description': 'Timing of eating-related motion monitored by wrist-worn motion sensors'}], 'primaryOutcomes': [{'measure': 'Daily dietary energy intake based on the Experience Sampling Dietary Assessment Method', 'timeFrame': '2 weeks', 'description': 'Daily dietary energy intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to the Doubly-labeled Water Method'}, {'measure': 'Daily dietary protein intake based on the Experience Sampling Dietary Assessment Method', 'timeFrame': '2 weeks', 'description': 'Daily dietary protein intake estimated by the Experience Sampling Dietary Assessment Method (ESDAM) compared to urinary nitrogen'}, {'measure': 'Daily energy expenditure derived from the doubly-labeled water method', 'timeFrame': '2 weeks', 'description': 'Daily energy expenditure (kcal/day) measured by the doubly-labeled water method'}, {'measure': 'Daily dietary protein intake based on urinary nitrogen analysis', 'timeFrame': '2 weeks', 'description': 'Daily dietary protein intake based on urinary nitrogen analysis'}], 'secondaryOutcomes': [{'measure': 'Dietary intake based on Experience Sampling Dietary Assessment Method', 'timeFrame': '2 weeks', 'description': 'Daily nutrient and food group consumption estimated by the Experience Sampling Dietary Assessment Method ESDAM'}, {'measure': 'Dietary intake based on 24-hour dietary recalls', 'timeFrame': '2 weeks', 'description': 'Energy, nutrient and food group consumption measured by the 24-hour dietary recalls'}, {'measure': 'Serum Beta-carotenoid concentration', 'timeFrame': '4 weeks', 'description': 'Serum Beta-carotenoids as biomarker of fruit and vegetable consumption'}, {'measure': 'Erythrocyte membrane fatty acid composition', 'timeFrame': '4 weeks', 'description': 'Erythrocyte membrane fatty acid composition as biomarker of fatty acid consumption'}, {'measure': 'Plasma polyphenol concentration', 'timeFrame': '4 weeks', 'description': 'Plasma polyphenol concentration as an indication of dietary polyohenol intake'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary assessment', 'Validation', 'Experience Sampling', 'digital health', 'digital biomarkers', 'doubly-labeled water', 'ESM'], 'conditions': ['Validation Study']}, 'referencesModule': {'references': [{'pmid': '41194100', 'type': 'DERIVED', 'citation': 'Verbeke J, Verbeke K, Van der Schueren B, Vangoitsenhoven R, Matthys C. Protocol of the validation of the experience sampling-based dietary assessment method (ESDAM) against doubly labeled water, urinary protein, and biomarkers. Nutr J. 2025 Nov 5;24(1):169. doi: 10.1186/s12937-025-01232-3.'}]}, 'descriptionModule': {'briefSummary': 'A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.', 'detailedDescription': 'The purpose of this research project is to advance nutritional research by delivering an improved, accurate, feasible and reliable method to assess dietary intake. Our newly developed approach to collate dietary intake based on experience sampling methodology (ESM) will serve this purpose.\n\nTherefore, this research aims to validate the newly developed Experience Sampling Dietary Assessment Method (ESDAM) by assessing construct validity compared to blood and urine biomarkers representing dietary intake. This will eventually result in the newly developed dietary assessment method being evidence-based and validated and, thus, ready-to-use as a reliable method for research and clinical practice.\n\nTherefore, the ESDAM will be validated against repeated 24-hour dietary recalls, the doubly-labelled water method, urinary nitrogen and blood biomarkers. The study has a duration of four weeks. The first two weeks will be used to collect baseline data including socio-demographic, biometric data and three 24-hour recalls to assess dietary intake. During the last two weeks the Experience Sampling Dietary Assessment Method will be evaluated against urine biomarkers (Doubly-labeled water and urinary nitrogen), blood biomarkers (erythrocyte membrane fatty acid composition, beta-carotenoids, polyphenols) together with continuous glucose monitoring and two wrist-worn motion sensor devices to track eating- related movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Having a smartphone and being capable of using the smartphone and apps\n* Having a freezer at home\n* Sufficient knowledge of the Dutch language to understand and participate in the study\n* Having a stable body weight (body weight not changed by 5% last 3 months)\n* Not aiming to gain or lose weight during the study period\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Not following a specific diet for medical reasons (i.e. coeliac disease)'}, 'identificationModule': {'nctId': 'NCT06485960', 'acronym': 'YONAS', 'briefTitle': 'Validation of the Experience Sampling Dietary Assessment Method', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Validation of the Experience Sampling Dietary Assessment Method (ESDAM)', 'orgStudyIdInfo': {'id': 'S68363'}, 'secondaryIdInfos': [{'id': 'C3/22/050', 'type': 'OTHER_GRANT', 'domain': 'KU Leuven'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'YONAS 1', 'description': 'ESDAM validation', 'interventionNames': ['Other: ESDAM validation']}], 'interventions': [{'name': 'ESDAM validation', 'type': 'OTHER', 'description': '* 3\\* 24-Hour Dietary Recalls\n* Experience Sampling Dietary Assessment Method (mobile application)\n* Continuous Blood Glucose Monitoring\n* Wrist- worn motion sensors\n* Doubly-labeled water administration\n* Blood drawings (Erythrocyte Membrane Fatty Acid composition, Carotenoids, polyphenols)\n* Urine sampling (Doubly-labeled water, urinary nitrogen)', 'armGroupLabels': ['YONAS 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Christophe Matthys, Professor', 'role': 'CONTACT', 'email': 'christophe.matthys@uzleuven.be', 'phone': '+3216347205'}, {'name': 'Joanna M Eksteen, MSc', 'role': 'CONTACT', 'email': 'jo.eksteen@kuleuven.be', 'phone': '+3216347205'}, {'name': 'Christophe Matthys, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Christophe Matthys, PhD', 'role': 'CONTACT', 'email': 'christophe.matthys@uzleuven.be', 'phone': '+32 16 34 26 55'}], 'overallOfficials': [{'name': 'Christophe Matthys, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven/UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor dr.', 'investigatorFullName': 'Christophe Matthys', 'investigatorAffiliation': 'KU Leuven'}}}}