Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT06348550
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2024-03-23', 'studyFirstSubmitQcDate': '2024-03-31', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of LDL cholesterol', 'timeFrame': '12 months', 'description': 'Reduction of LDL-cholesterol after the nutraceutical or placebo intake'}], 'secondaryOutcomes': [{'measure': 'Variation of lipid profile', 'timeFrame': '12 months', 'description': 'Reduction of total cholesterol, HDL-cholesterol, triglycerides after the nutraceutical or placebo intake'}, {'measure': 'Change in glycemic status', 'timeFrame': '12 months', 'description': 'To evaluate the number of subjects changing from impaired fasting glucose or impaired glucose tolerance to type 2 diabetes mellitus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Dysglycemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.', 'detailedDescription': 'The objective of this study is to evaluate the effectiveness of the association Berberina Fitosoma® and monacolin K MonaKoPure® (Berberol® K supplement) compared to placebo on glucidic and lipid parameters in subjects with fasting blood glucose (FPG) values between 100 and 125 mg/dl and with total cholesterol (TC) values ≥ 200 mg/dl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight or obese subjects \\[according to body mass index (BMI)\\]\n* Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT)\n* Total cholesterol values ≥ 200 mg/dl\n\nExclusion Criteria:\n\n* Patients with neoplastic and liver diseases, renal failure\n* Patients with type 1 or 2 diabetes mellitus\n* Pregnant or breastfeeding women\n* Hypersensitivity to any of the ingredients\n* Therapy with lipid-lowering drugs\n* Use of products containing red yeast rice'}, 'identificationModule': {'nctId': 'NCT06348550', 'briefTitle': 'Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. Single-center, Randomized, Double-blind Study.', 'orgStudyIdInfo': {'id': 'BFMKP 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active treatment', 'interventionNames': ['Dietary Supplement: Berberol® K']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo treatment', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Berberol® K', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutraceutical containing an association of Berberine Fitosoma® and Monacolin K MonaKoPure®', 'armGroupLabels': ['Active treatment']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it'}, {'name': 'Pamela Maffioli, MD', 'role': 'CONTACT', 'email': 'p.maffioli@smatteo.pv.it'}, {'name': 'Giuseppe Derosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pamela Maffioli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico S. Matteo Foundation', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Giuseppe Derosa', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it', 'phone': '+390382502614'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}