Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-28 @ 1:08 PM
Study NCT ID:
NCT00441857
Status:
COMPLETED
Last Update Posted:
2007-07-06
First Post:
2007-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Plant Stanols on Cholesterol Absorption
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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-04', 'studyFirstSubmitDate': '2007-02-28', 'studyFirstSubmitQcDate': '2007-02-28', 'lastUpdatePostDateStruct': {'date': '2007-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cholesterol absorption efficiency'}], 'secondaryOutcomes': [{'measure': 'changes in blood lipids'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plant sterols', 'plant stanols', 'cholesterol absorption'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations', 'detailedDescription': 'Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.\n\nSubjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.\n\nCholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy adults with mild to moderate hypercholesterolemia\n\nExclusion Criteria:\n\n* lipid lowering medication\n* pregnancy or lactation\n* severe diseases (inc. diabetes, unstable CVD, malignant diseases)\n* severe obesity\n* regular plant sterol consumption'}, 'identificationModule': {'nctId': 'NCT00441857', 'acronym': 'DOSE', 'briefTitle': 'Effect of Plant Stanols on Cholesterol Absorption', 'organization': {'class': 'OTHER', 'fullName': 'Oy Foodfiles Ltd'}, 'officialTitle': 'The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency', 'orgStudyIdInfo': {'id': 'DOSE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'plant stanol consumption', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Oy Foodfiles Ltd', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Sakari A Nieminen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oy Foodfiles Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oy Foodfiles Ltd', 'class': 'OTHER'}}}}