Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-31 @ 8:05 PM
Study NCT ID:
NCT06955234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in body weight', 'timeFrame': '4 weeks', 'description': 'Body weight (kg) will be measured at baseline and after 4 weeks to evaluate potential weight changes due to the intervention.'}, {'measure': 'Change from baseline in Body Mass Index (BMI)', 'timeFrame': '4 weeks', 'description': 'BMI (kg/m²) will be calculated from weight and height measurements at baseline and after 4 weeks to assess changes in body composition.'}, {'measure': 'Change from baseline in waist circumference', 'timeFrame': '4 weeks', 'description': 'Waist circumference (cm) will be measured at baseline and after 4 weeks to evaluate changes in abdominal adiposity.'}], 'primaryOutcomes': [{'measure': 'Change in fasting blood glucose levels from baseline after 4 weeks of Berbevis™ supplementation', 'timeFrame': '4 weeks', 'description': 'Fasting blood glucose levels will be measured at baseline and after 4 weeks of supplementation with Berbevis™ using standard blood chemistry analysis.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) and serious adverse events (SAEs) during 4 weeks of Berbevis™ supplementation at different dosages', 'timeFrame': '4 weeks', 'description': 'Safety will be assessed by monitoring the occurrence of AEs and SAEs during the 4-week supplementation period. Events will be recorded by investigators and reported according to current GCP and pharmacovigilance regulations.'}, {'measure': 'Change from baseline in lipid profile (total cholesterol, HDL, LDL, Apo A, Apo B, triglycerides)', 'timeFrame': '4 weeks', 'description': 'Fasting blood samples will be collected to assess serum levels of total cholesterol (mg/dL), HDL cholesterol (mg/dL), LDL cholesterol (mg/dL), Apo A (mg/dL), Apo B (mg/dL) and triglycerides (mg/dL) after 4 weeks of supplementation compared to baseline values.'}, {'measure': 'Change from baseline in fasting blood glucose', 'timeFrame': '4 weeks', 'description': 'Fasting blood glucose levels (mg/dl) will be measured at baseline and after 4 weeks of treatment to evaluate the effect of Berbevis™. Blood samples will be collected in the morning after at least 8 hours of fasting.'}, {'measure': 'Change from baseline in fasting insulin', 'timeFrame': '4 weeks', 'description': 'Fasting insulin levels (µIU/mL) will be assessed at baseline and after 4 weeks of treatment. Blood samples will be collected under fasting conditions to evaluate insulin secretion.'}, {'measure': 'Change from baseline in HOMA-IR index', 'timeFrame': '4 weeks', 'description': 'The Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) will be calculated using fasting glucose and insulin values at baseline and after 4 weeks of treatment to evaluate insulin resistance.'}, {'measure': 'Change from baseline in glycated hemoglobin (HbA1c)', 'timeFrame': '4 weeks', 'description': 'HbA1c levels (%) will be measured at baseline and after 4 weeks of treatment to evaluate longer-term glycemic control.'}, {'measure': 'Change from baseline in C-reactive protein (CRP)', 'timeFrame': '4 weeks', 'description': 'CRP levels (mg/L) will be evaluated at baseline and after 4 weeks of treatment to assess systemic inflammation.'}, {'measure': 'Change from baseline in AST levels', 'timeFrame': '4 weeks', 'description': 'AST serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to assess liver function and potential hepatotoxicity.'}, {'measure': 'Change from baseline in ALT levels', 'timeFrame': '4 weeks', 'description': 'ALT serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to evaluate liver cell integrity and potential hepatocellular damage.'}, {'measure': 'Change from baseline in Gamma-GT levels', 'timeFrame': '4 weeks', 'description': 'Gamma-GT levels (U/L) will be analyzed at baseline and after 4 weeks of treatment to monitor cholestasis or bile duct involvement.'}, {'measure': 'Change from baseline in alkaline phosphatase levels', 'timeFrame': '4 weeks', 'description': 'Alkaline phosphatase serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to evaluate liver and bone metabolism.'}, {'measure': 'Change from baseline in serum protein fractions (protein electrophoresis)', 'timeFrame': '4 weeks', 'description': 'Serum protein fractions (e.g., albumin, alpha, beta, gamma globulins - g/dL) will be analyzed at baseline and after 4 weeks using protein electrophoresis to assess liver synthetic function and potential inflammation.'}, {'measure': 'Change from baseline in lean mass and fat mass assessed by DEXA', 'timeFrame': '4 weeks', 'description': 'Total body fat mass and whole-body lean mass (kg) will be measured using dual-energy X-ray absorptiometry (DEXA) at baseline and after 4 weeks to evaluate changes in fat-free body mass and body fat reduction or increase.'}, {'measure': 'Change from baseline in visceral adipose tissue assessed by DEXA', 'timeFrame': 'From may 2025 to may 2026', 'description': 'Visceral adipose tissue (cm²) will be estimated using DEXA at baseline and after 4 weeks to assess abdominal fat distribution and potential metabolic impact.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impaired Fasting Glucose (IFG)']}, 'descriptionModule': {'briefSummary': 'Assessing the effects of a nutraceutical supplement (Berbevis™) in adults with impaired fasting glucose (100-126 mg/dL) and BMI between 25 and 35. Ninety participants will be assigned to three parallel groups receiving Berbevis™ at increasing daily doses (500 mg, 750 mg, and 1000 mg) for 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fasting blood glucose between 100 and 126 mg/dl\n* BMI between 25 and 35 kg/m\\^2\n\nExclusion Criteria:\n\n* Fasting blood glucose below 100 mg/dl\n* BMI \\< 25 or \\> 35 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT06955234', 'acronym': 'BERBEVIS-DFG-0', 'briefTitle': 'Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'Berbevis Project: Multitarget Dose-finding Study', 'orgStudyIdInfo': {'id': '1508/29032024'}, 'secondaryIdInfos': [{'id': '1508/29032024', 'type': 'OTHER', 'domain': 'Ethics Committee IRCCS Policlinico San Matteo'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Berbevis 500 mg/die', 'description': 'Berbevis™, 250 mg x 2/day, 1 tablet in the morning and 1 in the evening.', 'interventionNames': ['Dietary Supplement: Berbevis supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Berbevis 750 mg/die', 'description': 'Berbevis™, 250 mg x 3/day, 2 tablets in the morning and 1 in the evening.', 'interventionNames': ['Dietary Supplement: Berbevis supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Berbevis 1000 mg/die', 'description': 'Berbevis™, 250 mg x 4/day, 2 tablets in the morning and 2 in the evening.', 'interventionNames': ['Dietary Supplement: Berbevis supplement']}], 'interventions': [{'name': 'Berbevis supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This intervention consists of a standardized oral dietary supplement containing Berberis aristata extract formulated in phospholipids (Berbevis™). The supplement is formulated to support metabolic balance. It is administered twice daily for 8 weeks to evaluate safety, tolerability, and dose-response effects in healthy adult volunteers.', 'armGroupLabels': ['Berbevis 1000 mg/die', 'Berbevis 500 mg/die', 'Berbevis 750 mg/die']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}