Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-05 @ 4:08 AM
Study NCT ID:
NCT03005535
Status:
UNKNOWN
Last Update Posted:
2016-12-29
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-25', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-25', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period', 'timeFrame': 'At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)'}, {'measure': '12 hour fasting lipid profile change from the baseline to the end of the intervention period', 'timeFrame': 'At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks)'}, {'measure': 'PCSK9 levels change from the baseline to the end of the intervention period', 'timeFrame': 'At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period', 'timeFrame': 'At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)'}, {'measure': 'Blood pressure change from the baseline to the end of the intervention period', 'timeFrame': '6 months'}, {'measure': 'Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period', 'timeFrame': 'At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'This will be a randomized clinical trial carried out on subjects with suboptimal control of cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9', 'detailedDescription': 'In order to assess the mid term effects of vitaminized corn oil on endothelial function and on early markers of functional damage of the arterial wall, moderately hypercholesterolemic subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus B6 and E vitamins) or olive oil. The two intervention periods will be spaced by a 4 week washout period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total cholesterol between 200 and 280 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL\n* Triglycerides lower than 200 mg/dL\n* Cardiovascular risk at 10 years lower than 10%\n* Informed consent\n\nExclusion Criteria:\n\n* Secundary prevention for cardiovascular diseases\n* BMI higher than 30\n* Assumption of lipid lowering drug or supplement\n* Alcohol abuse\n* Alterations in thyroid, liver or kidney functions, muscle diseases'}, 'identificationModule': {'nctId': 'NCT03005535', 'acronym': 'ECLIPSE', 'briefTitle': 'Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Randomised Clinical Trial to Assess the Medium-term Effect of 30 g/Day of a Vitaminised Corn Oil or Olive Oil, on Lipid Parameters, Vascular Risk Markers Blood Pressure and Endothelial Function, in Moderately Hypercholesterolemic Subjects', 'orgStudyIdInfo': {'id': 'ECLIPSE_2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vitaminized corn oil', 'description': 'Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)', 'interventionNames': ['Other: Vitaminized corn oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil', 'description': 'Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)', 'interventionNames': ['Other: Olive oil']}], 'interventions': [{'name': 'Vitaminized corn oil', 'type': 'OTHER', 'description': 'Oil consumption at the two main meals, lunch and dinner (15gx2 per day)', 'armGroupLabels': ['Vitaminized corn oil']}, {'name': 'Olive oil', 'type': 'OTHER', 'description': 'Oil consumption at the two main meals, lunch and dinner (15gx2 per day)', 'armGroupLabels': ['Olive oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'S. Orsola-Malpighi University Hospital', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Internal Medicine Unit', 'investigatorFullName': 'Claudio Borghi', 'investigatorAffiliation': 'University of Bologna'}}}}