Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose (BERBEVIS-DFG-0)

Berbevis Project: Multitarget Dose-finding Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Impaired Fasting Glucose (IFG)
• Intervention / Treatment: Dietary supplement: Berbevis supplement

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• fasting blood glucose between 100 and 126 mg/dl
• BMI between 25 and 35 kg/m^2

Exclusion Criteria:

• Fasting blood glucose below 100 mg/dl
• BMI < 25 or > 35 kg/m^2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Berbevis 500 mg/die; Berbevis™, 250 mg x 2/day, 1 tablet in the morning and 1 in the evening.	Dietary supplement: Berbevis supplement; 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.
Experimental: Berbevis 750 mg/die; Berbevis™, 250 mg x 3/day, 2 tablets in the morning and 1 in the evening.	Dietary supplement: Berbevis supplement; 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.
Experimental: Berbevis 1000 mg/die; Berbevis™, 250 mg x 4/day, 2 tablets in the morning and 2 in the evening.	Dietary supplement: Berbevis supplement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting blood glucose levels from baseline after 4 weeks of Berbevis™ supplementation	Fasting blood glucose levels will be measured at baseline and after 4 weeks of supplementation with Berbevis™ using standard blood chemistry analysis.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs) and serious adverse events (SAEs) during 4 weeks of Berbevis™ supplementation at different dosages	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.	4 weeks
Change from baseline in fasting blood glucose	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.	4 weeks
Change from baseline in fasting insulin	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.	4 weeks
Change from baseline in HOMA-IR index	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.	4 weeks
Change from baseline in glycated hemoglobin (HbA1c)	HbA1c levels (%) will be measured at baseline and after 4 weeks of treatment to evaluate longer-term glycemic control.	4 weeks
Change from baseline in C-reactive protein (CRP)	CRP levels (mg/L) will be evaluated at baseline and after 4 weeks of treatment to assess systemic inflammation.	4 weeks
Change from baseline in AST levels	AST serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to assess liver function and potential hepatotoxicity.	4 weeks
Change from baseline in ALT levels	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.	4 weeks
Change from baseline in Gamma-GT levels	Gamma-GT levels (U/L) will be analyzed at baseline and after 4 weeks of treatment to monitor cholestasis or bile duct involvement.	4 weeks
Change from baseline in alkaline phosphatase levels	Alkaline phosphatase serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to evaluate liver and bone metabolism.	4 weeks
Change from baseline in serum protein fractions (protein electrophoresis)	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.	4 weeks
Change from baseline in lean mass and fat mass assessed by DEXA	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.	4 weeks
Change from baseline in visceral adipose tissue assessed by DEXA	Visceral adipose tissue (cm²) will be estimated using DEXA at baseline and after 4 weeks to assess abdominal fat distribution and potential metabolic impact.	From may 2025 to may 2026
Change from baseline in lipid profile (total cholesterol, HDL, LDL, Apo A, Apo B, triglycerides)	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.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in body weight	Body weight (kg) will be measured at baseline and after 4 weeks to evaluate potential weight changes due to the intervention.	4 weeks
Change from baseline in Body Mass Index (BMI)	BMI (kg/m²) will be calculated from weight and height measurements at baseline and after 4 weeks to assess changes in body composition.	4 weeks
Change from baseline in waist circumference	Waist circumference (cm) will be measured at baseline and after 4 weeks to evaluate changes in abdominal adiposity.	4 weeks

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1508/29032024 (Other Identifier: Ethics Committee IRCCS Policlinico San Matteo)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No