Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-02 @ 11:05 AM
Study NCT ID:
NCT00485095
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Plant Sterol Supplement on Blood Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2007-06-11', 'studyFirstSubmitQcDate': '2007-06-11', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['High Blood Cholesterol Level']}, 'referencesModule': {'references': [{'pmid': '23623012', 'type': 'DERIVED', 'citation': 'Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstol K. Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial. Atherosclerosis. 2013 Jun;228(2):421-5. doi: 10.1016/j.atherosclerosis.2013.03.001. Epub 2013 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18-80 years old\n* Total cholesterol: 4.5-7.5 mmol/l\n* Triglycerides at or below 4.0 mmol/l\n\nExclusion Criteria:\n\n* BMI at or above 35 kg/m2\n* Secondary hyperlipidemia, included diabetes\n* Hypertension (at og higher than 170/110)\n* Coronar, perifery or cerebral vascular disease last 3 months\n* Familial hypercholesterolemia\n* Change in dose of statins, oestrogen or contraceptives last 3 months\n* Taking drugs which are known to interfere with the plasma level of cholesterol\n* Chronic rheumatoid diseases or other diseases known to affect c-reactive protein\n* Pregnancy\n* Lactation\n* Planning to reduce weight\n* Taking plant sterols'}, 'identificationModule': {'nctId': 'NCT00485095', 'briefTitle': 'The Effect of Plant Sterol Supplement on Blood Cholesterol', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol', 'orgStudyIdInfo': {'id': '2.2006.3407'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intake of plant sterols', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Lipidklinikken, Rikshospitalet Radiumhospitalet HF', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Rikshospitalet Radiumhospitalet HF, Oslo, Norway', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Leiv Ose, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lipidklinikken, Rikshospitalet-Radiumhospitalet HF'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mills DA', 'class': 'INDUSTRY'}]}}}