Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:29 AM
Study NCT ID:
NCT07312994
Status:
RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of NfL and GFAP in Different Dietary Patterns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-17', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood levels of the following biomarkers: neurofilament light chain (NfL) in pg/mL, glial fibrillary acidic protein (GFAP) in pg/mL.', 'timeFrame': 'Once at baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurofilament Light Chain', 'Glial Fibrillary Acidic Protein', 'GFAP', 'Vegan Diet', 'Vegetarian Diet']}, 'descriptionModule': {'briefSummary': 'This observational study aims to investigate the impact of different dietary patterns on brain tissue biomarkers in healthy young adults by measuring blood levels of NfL and GFAP.\n\nThe primary research question is: Do vegan, vegetarian, or omnivorous diets influence NfL and GFAP levels?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Young and healthy individuals aged between 18 and 40 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals who have followed a vegan, vegetarian, or omnivorous diet for at least one consecutive year\n* Aged between 18 and 40 years\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Diagnose neurological disorders (e.g. neurodegenerative, inflammatory, autoimmune, infectious, vascular)\n* Eating disorders\n* Excessive alcohol consumption\n* Pregnancy\n* Recent moderate to severe infection (within the past 12 weeks) , including SARS-CoV-2\n* Recent trauma, injury, or surgery (within the past 12 weeks)\n* Significant BMI fluctuations (\\>5 points) within the last year\n* Patients who have been using Proton pump inhibitors (PPIs) for an extended period (e.g., 1 month).'}, 'identificationModule': {'nctId': 'NCT07312994', 'briefTitle': 'Analysis of NfL and GFAP in Different Dietary Patterns', 'organization': {'class': 'OTHER', 'fullName': 'Salzburger Landeskliniken'}, 'officialTitle': 'Vegan, Vegeratian, or Omnivore: Dietary Effects on the Brain Tissue Biomarkers', 'orgStudyIdInfo': {'id': '1119/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Omnivore'}, {'label': 'Vegan'}, {'label': 'Vegetarian'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Fabio Rossini, MD', 'role': 'CONTACT', 'email': 'f.rossin@salk.at'}], 'facility': 'Christian-Doppler-Klinik', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'centralContacts': [{'name': 'Tobias Moser, Prof.', 'role': 'CONTACT', 'email': 't.moser@salk.at', 'phone': '+435725534720'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salzburger Landeskliniken', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medizinische Einrichtungen der Universität Düsseldorf', 'class': 'UNKNOWN'}, {'name': 'Medizinische Fakultät der Universität zu Köln', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinkum Münster - Medizinische Klinik und Poliklinik B', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'apl. Prof.', 'investigatorFullName': 'Tobias Moser', 'investigatorAffiliation': 'Salzburger Landeskliniken'}}}}