Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT01574469
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2012-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2012-04-07', 'studyFirstSubmitQcDate': '2012-04-07', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plant sterol - Cholesterol absorption - diet - dairy - LDL'], 'conditions': ['Mildly Hypercholesterolemic Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female aged 18-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent\n\nExclusion Criteria:\n\n* Subject with plasma triglycerides (TG) levels\\>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study'}, 'identificationModule': {'nctId': 'NCT01574469', 'briefTitle': 'Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'NU114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 = Tested product', 'interventionNames': ['Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 = Control product', 'interventionNames': ['Other: 2-Low fat fermented dairy product (control)']}], 'interventions': [{'name': '1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)', 'type': 'OTHER', 'description': '1 = Intervention 1 (2 test products / day)', 'armGroupLabels': ['1 = Tested product']}, {'name': '2-Low fat fermented dairy product (control)', 'type': 'OTHER', 'description': '2 = Intervention 2 (2 control products/day)', 'armGroupLabels': ['2 = Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}