Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02720250
Status:
UNKNOWN
Last Update Posted:
2016-03-30
First Post:
2016-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-29', 'studyFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'microvascular reactivity', 'timeFrame': 'Three weeks', 'description': 'Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperaemia - PORH) and in response to iontophoresis of acetylcholine (ACh) (endothelium dependent vasodilation).'}], 'secondaryOutcomes': [{'measure': 'lipid profile', 'timeFrame': 'Three weeks', 'description': 'Measurement of plasma cholesterol, HDL cholesterol, LDL cholesterol and triglycerides level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['omega-3 fatty acids, microcirculation, laser Doppler flowmetry, lipid profile'], 'conditions': ['Omega-3 Polyunsaturated Fatty Acids']}, 'referencesModule': {'references': [{'pmid': '26498129', 'type': 'BACKGROUND', 'citation': 'Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients.\n\nHowever, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in healthy population.\n\nThis study aimed to determine the effect of omega-3 enriched chicken eggs consumption on microvascular reactivity and lipid profile in young healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- healthy volunteers\n\nExclusion Criteria:\n\n* oral contraceptives\n* drugs that could affect endothelium\n* hypertension\n* coronary artery disease\n* diabetes\n* hyperlipidaemia\n* renal impairment\n* cerebrovascular and peripheral artery disease'}, 'identificationModule': {'nctId': 'NCT02720250', 'briefTitle': 'Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity', 'organization': {'class': 'OTHER', 'fullName': 'Josip Juraj Strossmayer University of Osijek'}, 'officialTitle': 'Effect of Omega-3 Fatty Acids Enriched Chicken Eggs Consumption on Microvascular Reactivity and Lipid Profile in Young Healthy Subjects', 'orgStudyIdInfo': {'id': '2158610714114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3', 'description': 'Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.', 'interventionNames': ['Dietary Supplement: Omega-3 chicken eggs']}, {'type': 'EXPERIMENTAL', 'label': 'Regular', 'description': 'Intake of 3 regular chicken eggs per day for three weeks.', 'interventionNames': ['Dietary Supplement: Regular chicken eggs']}], 'interventions': [{'name': 'Omega-3 chicken eggs', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.', 'armGroupLabels': ['Omega-3']}, {'name': 'Regular chicken eggs', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intake of 3 regular chicken eggs per day for three weeks.', 'armGroupLabels': ['Regular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Osijek', 'status': 'RECRUITING', 'country': 'Croatia', 'contacts': [{'name': 'Ana Stupin, MD, PhD', 'role': 'CONTACT', 'email': 'anacavka@mefos.hr', 'phone': "'385915134598"}, {'name': 'Ines Drenjancevic, MD, PhD', 'role': 'CONTACT', 'email': 'ines.drenjancevic@mefos.hr', 'phone': "'385912241406"}, {'name': 'Marko Stupin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}], 'centralContacts': [{'name': 'Ana Stupin, MD, PhD', 'role': 'CONTACT', 'email': 'anacavka@mefos.hr', 'phone': '+385915134958'}, {'name': 'Ines Drenjancevic, MD, PhD', 'role': 'CONTACT', 'email': 'ines.drenjancevic@mefos.hr', 'phone': '+385912241406'}], 'overallOfficials': [{'name': 'Ines Drenjancevic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, University of Osijek, Croatia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Josip Juraj Strossmayer University of Osijek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek', 'investigatorFullName': 'Ines Drenjancevic', 'investigatorAffiliation': 'Josip Juraj Strossmayer University of Osijek'}}}}