Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT01600820
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2012-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010840', 'term': 'Phytosterols'}], 'ancestors': [{'id': 'D013261', 'term': 'Sterols'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D064209', 'term': 'Phytochemicals'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Plant sterol', 'Hypercholesterolemia', 'diet', 'dairy', 'LDL-C', 'Mildly hypercholesterolemic subjects'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects 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;\n* BMI between 19 and 30 kg/m2 ,\n* LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or\n* higher than 100 mg/dl in individuals with a 10-year risk \\> 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),\n* with or without statin monotherapy,\n* willing to respect the dietary advising delivered at the screening visit,\n* agreeing to a written informed consent\n\nExclusion Criteria:\n\n* subject with plasma triglycerides (TG) levels \\> 400 mg/dL,\n* with any cardiovascular event in the last 6 months,\n* subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,\n* diabetic (type I and type II),\n* presenting known allergy or hypersensitivity to milk proteins, soy or lactose,\n* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,\n* with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,\n* pregnant or breast feeding women'}, 'identificationModule': {'nctId': 'NCT01600820', 'briefTitle': 'Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects', 'orgStudyIdInfo': {'id': 'NU146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 = Tested product 1', 'interventionNames': ['Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit']}, {'type': 'EXPERIMENTAL', 'label': '2 = tested product 2', 'interventionNames': ['Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3 = Control product', 'interventionNames': ['Other: 3- Low fat drinkable fermented dairy product without plant sterols(control)']}], 'interventions': [{'name': '1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit', 'type': 'OTHER', 'description': '1 = Intervention 1 (1 test product/day)', 'armGroupLabels': ['1 = Tested product 1']}, {'name': '2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit', 'type': 'OTHER', 'description': '2 = Intervention 2 (1 test product/day)', 'armGroupLabels': ['2 = tested product 2']}, {'name': '3- Low fat drinkable fermented dairy product without plant sterols(control)', 'type': 'OTHER', 'description': '3 = Intervention 3 (1 control product/day)', 'armGroupLabels': ['3 = Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43201', 'city': 'Reus', 'country': 'Spain', 'facility': 'Hospital de Sant Joan', 'geoPoint': {'lat': 41.15612, 'lon': 1.10687}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Spain', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}