Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-01 @ 6:02 AM
Study NCT ID:
NCT06861205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development and Evaluation of a Web-based Diet Quality Screener for Vegans - BELGIUM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine and saliva samples will be collected'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical Activity', 'timeFrame': 'Baseline', 'description': 'Physical activity will be assessed using the International Physical Activity Questionnaire (iPAQ)'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline', 'description': 'Systolic and diastolic blood pressure will be measured'}, {'measure': 'Heart rate', 'timeFrame': 'Baseline', 'description': 'Heart rate will be measured'}], 'primaryOutcomes': [{'measure': 'Validity of the vegan screener', 'timeFrame': 'Baseline', 'description': 'The validity will be assessed by calculating associations between the screener and reference method.'}], 'secondaryOutcomes': [{'measure': 'Dietary intake', 'timeFrame': 'Baseline', 'description': 'Dietary intake will be assessed using a weighed food record'}, {'measure': 'Food habits', 'timeFrame': 'Baseline', 'description': 'Food habits will be assessed using a food frequency questionnaire'}, {'measure': 'Vitamin D status', 'timeFrame': 'Baseline', 'description': 'Vitamin D status will be measured from venous blood samples'}, {'measure': 'Homocysteine status', 'timeFrame': 'Baseline', 'description': 'Homocysteine will be measured from venous blood samples'}, {'measure': 'holo-transcobalamin', 'timeFrame': 'Baseline', 'description': 'holo-transcobalamin will be measured from venous blood samples'}, {'measure': 'Methylmalonic acid', 'timeFrame': 'Baseline', 'description': 'Methylmalonic acid will be measured from venous blood samples'}, {'measure': 'Vitamin B2 status', 'timeFrame': 'Baseline', 'description': 'Vitamin B2 will be measured from venous blood samples'}, {'measure': 'Vitamin C status', 'timeFrame': 'Baseline', 'description': 'Vitamin C will be measured from venous blood samples'}, {'measure': 'Folic acid status', 'timeFrame': 'Baseline', 'description': 'Folic acid will be measured from venous blood samples'}, {'measure': 'Magnesium status', 'timeFrame': 'Baseline', 'description': 'Magnesium status will be determined from venous blood samples'}, {'measure': 'Zinc status', 'timeFrame': 'Baseline', 'description': 'Zinc status will be determined from venous blood samples'}, {'measure': 'Selenoprotein-P status', 'timeFrame': 'Baseline', 'description': 'Selenoprotein-P status will be determined from venous blood samples'}, {'measure': 'Ferritin concentration', 'timeFrame': 'Baseline', 'description': 'Ferritin concentration will be determined from venous blood samples'}, {'measure': 'Soluble transferrin receptor concentration', 'timeFrame': 'Baseline', 'description': 'Soluble transferrin receptor will be determined from venous blood samples'}, {'measure': 'Hemoglobin concentration', 'timeFrame': 'Baseline', 'description': 'Hemoglobin will be determined from venous blood samples'}, {'measure': 'Creatinine concentration', 'timeFrame': 'Baseline', 'description': 'Creatinine will be determined from venous blood samples'}, {'measure': 'Uric acid concentration', 'timeFrame': 'Baseline', 'description': 'Uric acid will be determined from venous blood samples'}, {'measure': 'Urea concentration', 'timeFrame': 'Baseline', 'description': 'Urea will be determined from urine samples samples'}, {'measure': 'Iodine concentration', 'timeFrame': 'Baseline', 'description': 'Iodine status will be determined from urine samples'}, {'measure': 'Potassium concentration', 'timeFrame': 'Baseline', 'description': 'Potassium status will be determined from urine samples'}, {'measure': 'Sodium concentration', 'timeFrame': 'Baseline', 'description': 'Sodium status will be determined from urine samples'}, {'measure': 'Calcium concentration', 'timeFrame': 'Baseline', 'description': 'Calcium status will be determined from urine samples'}, {'measure': 'Creatinine concentration (urine)', 'timeFrame': 'Baseline', 'description': 'Creatinine will be determined from urine samples'}, {'measure': 'C-reactive protein concentration', 'timeFrame': 'Baseline', 'description': 'The inflammatory marker hsCRP will be determined from serum'}, {'measure': 'Triglyceride concentration', 'timeFrame': 'Baseline', 'description': 'Triglyceride concentration will be determine from venous blood samples'}, {'measure': 'Free fatty acid concentration', 'timeFrame': 'Baseline', 'description': 'Free fatty acid concentration will be determine from venous blood samples'}, {'measure': 'Eicosapentanoic acid', 'timeFrame': 'Baseline', 'description': 'Eicosapentanoic acid (in % of total FA) will be determine from venous blood samples'}, {'measure': 'Docosahexanoic acid', 'timeFrame': 'Baseline', 'description': 'Docosahexanoic acid (in % of total FA) will be determine from venous blood samples'}, {'measure': 'LDL-cholesterol concentration', 'timeFrame': 'Baseline', 'description': 'LDL-cholesterol concentration will be determine from venous blood samples'}, {'measure': 'HDL-Cholesterol concentration', 'timeFrame': 'Baseline', 'description': 'HDL-Cholesterol concentration will be determine from venous blood samples'}, {'measure': 'Cholesterol concentration', 'timeFrame': 'Baseline', 'description': 'Cholesterol concentration will be determine from venous blood samples'}, {'measure': 'Glucose concentration', 'timeFrame': 'Baseline', 'description': 'Glucose will be measured from venous blood samples'}, {'measure': 'Well being', 'timeFrame': 'Baseline', 'description': 'Participants well being will be assessed using a questionnaire. The scale of each question ranges from 0 to 10, 10 representing the highest well being'}, {'measure': 'VEGANScreener', 'timeFrame': 'Baseline and day 2', 'description': 'The VEGANScreener assesses diet quality using 29 questions of frequency of consumption of different foods and food groups.'}, {'measure': 'Weight', 'timeFrame': 'Baseline', 'description': 'Weight will be measured in kg'}, {'measure': 'Height', 'timeFrame': 'Baseline', 'description': 'Height will be measured in m'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline', 'description': 'Waist circumference will be measured in cm'}, {'measure': 'Hip circumference', 'timeFrame': 'Baseline', 'description': 'Hip circumference will be measured in cm'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'availIpds': [{'url': 'https://doi.org/10.3389/fnut.2024.1438740', 'type': 'Study Protocol'}], 'references': [{'pmid': '38732591', 'type': 'BACKGROUND', 'citation': 'Kronsteiner-Gicevic S, Bogl LH, Wakolbinger M, Muller S, Dietrich J, De Keyzer W, Bullon-Vela V, Selinger E, Keller V, Martinez Tabar A, Asif T, Craig L, Kyle J, Schlesinger S, Koder C, Ouradova A, Henikova M, Van Lippevelde W, Cahova M, Martinez Gonzalez MA, Willett W, Bes-Rastrollo M, Gojda J, De Henauw S, Keller M, Kuzma M, Schernhammer E. Development of the VEGANScreener, a Tool for a Quick Diet Quality Assessment among Vegans in Europe. Nutrients. 2024 Apr 29;16(9):1344. doi: 10.3390/nu16091344.'}], 'seeAlsoLinks': [{'url': 'https://www.veganscreener.eu/', 'label': 'Project website'}]}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to assess the construct validity and criterion validity for associations of the VEGANScreener with nutrient intakes from reference methods and associations with biomarkers of dietary intake. The investigators hypothesize that the screener is a valid tool to assess diet quality in the vegan population. The study will assess construct validity by testing whether the measure relates as it should to other measures (e.g., age, gender, education, socioeconomic status differences).\n\nThe investigators will assess concurrent and predictive validity (types of criterion validity) by evaluating associations and agreement between 'gold standards', such as diet records, biomarkers, and multi-metabolite signatures of intake. The investigators will examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans is associated with a more favourable profile among vegans, for example, a lower blood pressure. This study is part of the European VEGANScreener Consortium."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy participants following a vegan or omnivours diet (ratio 1:1).', 'genderDescription': 'An equal number of male and female participants will be included. Inclusion is based on self-representation of gender identity.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Self-reported vegans (≥2 years on a vegan diet; vegan diet defined as not consuming any dietary animal products more often than once/month, honey excluded)\n2. Self-reported omnivores. Consuming on average daily (at least 5 times/week) meat/meat products.\n3. Age 18 to 65 years (1:1 ratio 18-35,99 and 36-65)\n4. Males and females (1:1 ratio)\n\nExclusion Criteria:\n\n1. Self-identified pescatarians (excluding all meat, except for fish/seafood) and reductarians/flexitarians (intentionally reducing intake of animal-based products)\n2. History of a disease known to affect intermediary metabolism (e.g., any diabetes on treatment, i.e. medication or lifestyle recommendations, thyreopathies, cancer etc.)\n3. BMI\\>30 kg/m2\n4. History of disease of intestinal integrity (i.e., inflammatory bowel disease, chronic pancreatitis, other malabsorption, etc.).\n5. Pregnant or breastfeeding females.'}, 'identificationModule': {'nctId': 'NCT06861205', 'acronym': 'VEGANScreener', 'briefTitle': 'Development and Evaluation of a Web-based Diet Quality Screener for Vegans - BELGIUM', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Development and Evaluation of a Web-based Diet Quality Screener for Vegans (VEGANScreener): a Cross-sectional, Observational, Multicenter, Clinical Study', 'orgStudyIdInfo': {'id': 'ONZ-2023-0169'}, 'secondaryIdInfos': [{'id': 'G0G5121N', 'type': 'OTHER_GRANT', 'domain': 'Research Foundation Flanders FWO'}, {'id': 'No. 727565', 'type': 'OTHER_GRANT', 'domain': "European Union's Horizon 2020 Research and Innovation Programme ERA-Net HDHL-INTIMIC"}, {'id': 'HOGENT', 'type': 'OTHER_GRANT', 'domain': 'University of Applied Sciences and Arts'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Omnivorous', 'description': 'Participants following an omnivor diet', 'interventionNames': ['Other: This is an observational study']}, {'label': 'Vegan', 'description': 'Participants following a vegan diet', 'interventionNames': ['Other: This is an observational study']}], 'interventions': [{'name': 'This is an observational study', 'type': 'OTHER', 'description': 'This is an observational study', 'armGroupLabels': ['Omnivorous', 'Vegan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Stefaan De Henauw, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Data transfer agreements are made with all parties within the VEGANScreener consortium'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hogeschool Gent', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}