Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT00222950
Status:
UNKNOWN
Last Update Posted:
2005-09-22
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Concentration of Plant Sterols in Serum and Aortic Valve Cusps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2005-09-14', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['plant sterols, serum, aortic valve cusps'], 'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '18420097', 'type': 'DERIVED', 'citation': 'Weingartner O, Lutjohann D, Ji S, Weisshoff N, List F, Sudhop T, von Bergmann K, Gertz K, Konig J, Schafers HJ, Endres M, Bohm M, Laufs U. Vascular effects of diet supplementation with plant sterols. J Am Coll Cardiol. 2008 Apr 22;51(16):1553-61. doi: 10.1016/j.jacc.2007.09.074.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue concentrations of plant sterols (sitosterol; campesterol).', 'detailedDescription': 'The role of plant sterols in cardiovascular diseases is controversially debated. There is an increasing body of evidence that indicates that increased plant sterol serum concentrations are correlated with an increased cardiovascular risk. Functional foods such as margarines supplemented with plant sterol esters are advertised to patients with hypercholesterolemia. Numerous studies show that margarines supplemented with plant sterol esters reduce serum cholesterol concentrations significantly. However, there are no studies available investigating relevant clinical endpoints. Nor are there any studies availabe investigating the effect of the consumption of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. This study is done to investigate the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: aortic valve stenosis -\n\nExclusion Criteria:familial hypercholesterolemia.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00222950', 'briefTitle': 'Concentration of Plant Sterols in Serum and Aortic Valve Cusps', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study', 'orgStudyIdInfo': {'id': 'Plant Sterols 159/04'}, 'secondaryIdInfos': [{'id': '159/04'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Oliver Weingartner, M.D.', 'role': 'CONTACT', 'email': 'oweingartner@aol.com', 'phone': '0049-(0)68411623372'}, {'name': 'Ulrich Laufs, M.D.', 'role': 'CONTACT', 'email': 'ulrich@laufs.com', 'phone': '0049-(0)68411623372'}, {'name': 'Oliver Weingartner, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of the Saarland', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'centralContacts': [{'name': 'Oliver Weingartner, M.D.', 'role': 'CONTACT', 'email': 'oweingartner@aol.com', 'phone': '0049-(0)68411623372'}, {'name': 'Ulrich Laufs, M.D.', 'role': 'CONTACT', 'email': 'ulrich@laufs.com', 'phone': '0049-(0)68411623372'}], 'overallOfficials': [{'name': 'Michael Bohm, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Saarland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}}}}