Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT02990260
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2016-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2016-12-12', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma LDL cholesterol', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'LDL cholesterol', 'timeFrame': '4 weeks'}, {'measure': 'Total cholesterol', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Triglycerides', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'HDL cholesterol', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Apo B', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'Apo A1', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'gamma GT', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'ASAT', 'timeFrame': '4 weeks, 8 weeks'}, {'measure': 'ALAT', 'timeFrame': '4 weeks, 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.\n\nExclusion Criteria:\n\n* Total cholesterol \\> 3.5 g/L (on an empty stomach)\n* Triglycerides \\> 3 g/L (on an empty stomach)\n* Familial hypercholesterolemia (IIa type)\n* Diabete mellitus treated or not\n* Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study\n* Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study\n* Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study\n* Subjects following a low diet regimen (intakes \\< 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study\n* Food behaviour disorders diagnosed\n* Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery\n* Subjects having endure bariatric surgery or having a gastric bypass in place\n* Pregnant or lactating women\n* Women willing a pregnancy Excessive alcohol consumption\n* Susceptible to modify their tobacco consumption before the end of the study'}, 'identificationModule': {'nctId': 'NCT02990260', 'acronym': 'HONEY', 'briefTitle': 'Effect of Saccharomyces Cerevisiae in LDL Cholesterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lesaffre International'}, 'orgStudyIdInfo': {'id': '2016-A011094-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Live Saccharomyces cerevisiae', 'description': 'Live Saccharomyces cerevisiae. 2 capsules per day (1 g).', 'interventionNames': ['Dietary Supplement: Saccharomyces cerevisiae']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Yeast cell wall', 'description': 'Yeast cell wall. 2 capsules a day (700 mg).', 'interventionNames': ['Dietary Supplement: Lynside Wall Basic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Maize starch and magnesium stearate. 2 capsules a day.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Saccharomyces cerevisiae', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Live Saccharomyces cerevisiae', 'armGroupLabels': ['Live Saccharomyces cerevisiae']}, {'name': 'Lynside Wall Basic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'yeast cell walls', 'armGroupLabels': ['Yeast cell wall']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maize starch and magnesium stearate', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Institut Pasteur de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lesaffre International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}