Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01353820
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2011-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2011-05-13', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Midly hypercholesterolemic subjects', 'Probiotic', 'Cholesterol lowering', 'Dairy'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.'}, '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 plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,\n* stabilized hypercholesterolemia (since more than 3 months),\n* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),\n* used to consume dairy products,\n* for female: effective contraceptive methods used,\n* agreeing to a written informed consent\n\nExclusion Criteria:\n\n* plasma triglycerides (TG) levels \\> 350 mg/dL (4 mmol//L),\n* any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,\n* known allergy or hypersensitivity to milk proteins,\n* systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,\n* subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,\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* diabetic subjects (type I and type II),\n* 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 become pregnant during the study,\n* for female subject: subject likely to change her contraceptive method during the study,\n* active heavy cigarette smokers (reported more than 20 cigarettes / day),\n* subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study"}, 'identificationModule': {'nctId': 'NCT01353820', 'briefTitle': 'Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Global Research & Innovation Center'}, 'officialTitle': 'Proof of Concept -Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults.', 'orgStudyIdInfo': {'id': 'NU280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 = Tested product', 'interventionNames': ['Dietary Supplement: 1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL']}, {'type': 'SHAM_COMPARATOR', 'label': '2 = Control product', 'interventionNames': ['Dietary Supplement: 2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus']}], 'interventions': [{'name': '1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL', 'type': 'DIETARY_SUPPLEMENT', 'description': '1- Intervention with test product ( \\>10E8 to \\<5.10E9 cfu/ml of L. delbruckii lactis )', 'armGroupLabels': ['1 = Tested product']}, {'name': '2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus', 'type': 'DIETARY_SUPPLEMENT', 'description': '2- Intervention with control product', 'armGroupLabels': ['2 = Control product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '104 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'AMED s.r.o (Poliklinika Budějovická)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Global Research & Innovation Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}