Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-29 @ 5:27 PM
Study NCT ID:
NCT01558050
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2012-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C117343', 'term': 'red yeast rice'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2012-03-16', 'studyFirstSubmitQcDate': '2012-03-16', 'lastUpdatePostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fasting cholesterol, LDL, HDL, TG level', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cholesterol Level', 'HDL Level', 'LDL Level', 'TG Level']}, 'referencesModule': {'references': [{'pmid': '23866314', 'type': 'DERIVED', 'citation': 'Verhoeven V, Lopez Hartmann M, Remmen R, Wens J, Apers S, Van Royen P. Red yeast rice lowers cholesterol in physicians - a double blind, placebo controlled randomized trial. BMC Complement Altern Med. 2013 Jul 18;13:178. doi: 10.1186/1472-6882-13-178.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators investigate the effect of a red rice product on plasma lipids in a sample of physicians and/or their family members.\n\nAfter a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to receive a commercially available red rice product or placebo. After a period of 8 weeks, lipid levels are measured again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* total fasting cholesterol \\> 200mg/dl'}, 'identificationModule': {'nctId': 'NCT01558050', 'briefTitle': 'the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids', 'orgStudyIdInfo': {'id': 'RR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'red rice', 'description': 'commercially available red rice nutritionial supplement', 'interventionNames': ['Dietary Supplement: red rice supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo capsules', 'interventionNames': ['Dietary Supplement: red rice supplement']}], 'interventions': [{'name': 'red rice supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patricipants take a red rice supplement or placebo daily for 8 weeks', 'armGroupLabels': ['placebo', 'red rice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'University of Antwerp', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor dr', 'investigatorFullName': 'Veronique Verhoeven', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}