Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT01521156
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2012-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols
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']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2012-01-26', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plant sterols - Hypercholesterolemia - Diet - Dairy'], 'conditions': ['Mild Hypercholesterolemic Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.\n* Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.\n* Subject used to consume dairy products.\n* For female subjects: effective contraceptive methods used.\n* Subject having given written consent to take part in the study.\n\nExclusion Criteria:\n\n* Subject with blood triglycerides levels above 350 mg/dL.\n* Subject having experienced any cardiovascular event in the last 6 months.\n* Subject having sitosterolemia.\n* Subject taking any hypocholesterolemic treatment drugs.\n* Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.\n* Diabetic subject (type I and type II).\n* Subject smoking strictly more than 10 cigarettes / day.\n* Subject with heavy alcohol intake (\\> 40 g / day for men ; \\> 30 g / day for women).\n* Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.\n* Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).\n* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.\n* Subject receiving a transplant and under immunosuppressor treatment.\n* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.\n* Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.\n* Subject with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product.\n* For female subject: pregnancy, breast feeding or intention to be pregnant during the study.\n* For female subject: subject likely to change her contraceptive method during the study."}, 'identificationModule': {'nctId': 'NCT01521156', 'briefTitle': 'Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols', 'orgStudyIdInfo': {'id': 'NU312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 = Control product', 'interventionNames': ['Other: 1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).']}, {'type': 'EXPERIMENTAL', 'label': '2 = Tested product', 'interventionNames': ['Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).']}], 'interventions': [{'name': '1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).', 'type': 'OTHER', 'description': '1 = Intervention 1 (1 test product/day)', 'armGroupLabels': ['1 = Control product']}, {'name': '2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).', 'type': 'OTHER', 'description': '2 = Intervention 2 (1 test product/day)', 'armGroupLabels': ['2 = Tested product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Harrison Clinical Research Clinical Unit', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}