Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-06 @ 9:38 PM
Study NCT ID:
NCT02689934
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2016-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blind (subjects, investigators)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in LDL-C From Baseline', 'timeFrame': '12 weeks', 'description': 'Percent change from baseline in LDL-C after 12 weeks of treatment in patients with moderate hypercholesterolemia'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of Lactoflorene colesterolo (Incidence of treatment-related adverse events)', 'timeFrame': '12 weeks', 'description': 'Incidence of treatment-related adverse events'}, {'measure': 'Changes in Other Lipids (non HDL-C, TG, HDL-C) and Apolipoproteins', 'timeFrame': '12 weeks'}, {'measure': 'Changes in Vital Signs', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['hypercholesterolemia', 'bifidobacterium longum BB536', 'red yeast rice', 'monacolin K', 'lactoflorene colesterolo'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '30795775', 'type': 'RESULT', 'citation': "Ruscica M, Pavanello C, Gandini S, Macchi C, Botta M, Dall'Orto D, Del Puppo M, Bertolotti M, Bosisio R, Mombelli G, Sirtori CR, Calabresi L, Magni P. Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study. Nutr J. 2019 Feb 22;18(1):13. doi: 10.1186/s12937-019-0438-2."}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/30795775', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of a red yeast rice based nutraceutical (monacolin K 10 mg/dose) plus probiotic (Bifidobacterium longum BB536 ®), versus placebo, in patients with moderate hypercholesterolemia, in terms of improvement of the lipid profile and cardiovascular risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 ≤ men or women ≤ 70\n* men or female. Female must be postmenopausal or surgically sterile\n* 130 mg/dl ≤ LDL-C ≤ 200 mg/dl\n* patients in primary cardiovascular prevention\n\nExclusion Criteria:\n\n* pregnancy and lactating\n* patients with chronic diseases\n* patients with serious hepatic diseases\n* patients with serious renal diseases\n* patients with thyroid diseases\n* diabetes mellitus or glycemia \\>126 mg/dl\n* uncontrolled or severe hypertension\n* obesity(BMI\\>30)\n* smoking status\n* drug or nutraceutical that can interfere with the experimental treatment'}, 'identificationModule': {'nctId': 'NCT02689934', 'briefTitle': 'Efficacy of a Red Yeast Rice Based Nutraceutical Plus Probiotic in Patients With Moderate Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Montefarmaco OTC SpA'}, 'officialTitle': 'Efficacy of Red Yeast Rice Based Nutraceutical (Monacolin K 10 mg/Dose) Plus Probiotic (Bifidobacterium Longum BB536 ®) in Patients With Moderate Hypercholesterolemia.', 'orgStudyIdInfo': {'id': 'PROBIOTICO - BB536'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactoflorene colesterolo', 'description': 'Red Yeast Rice titrated in 10 mg monacolin K per daily dose plus Bifidobacterium longum 50 mg, powder form, 1 packet per day', 'interventionNames': ['Dietary Supplement: Lactoflorene colesterolo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Lactoflorene colesterolo', 'description': 'placebo, powder form, 1 packet per day', 'interventionNames': ['Dietary Supplement: Placebo lactoflorene colesterolo']}], 'interventions': [{'name': 'Lactoflorene colesterolo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.8 g + 1.8 g once a day per os', 'armGroupLabels': ['Lactoflorene colesterolo']}, {'name': 'Placebo lactoflorene colesterolo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1.8 g + 1.8 g once a day per os', 'armGroupLabels': ['Placebo Lactoflorene colesterolo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20162', 'city': 'Milan', 'state': 'Mi', 'country': 'Italy', 'facility': 'Centro Dislipidemie Dip. Cardiotoracovasc ASST Grande Ospedale Metropolitano Niguarda Cà Granda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Giuliana G Mombelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASST Grande Ospedale Metropolitano Niguarda Cà Granda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefarmaco OTC SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}