Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose

Lead sponsor

Azienda di Servizi alla Persona di Pavia is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Study arms

• 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

• 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

• 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

Interventions

• Dietary supplementBerbevis 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.

Primary outcomes

1. 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.

   Time frame: 4 weeks

Secondary outcomes

1. 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.

   Time frame: 4 weeks

2. 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.

   Time frame: 4 weeks

3. 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.

   Time frame: 4 weeks

4. 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.

   Time frame: 4 weeks

5. 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.

   Time frame: 4 weeks

6. 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.

   Time frame: 4 weeks

7. 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.

   Time frame: 4 weeks

8. 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.

   Time frame: 4 weeks

9. 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.

   Time frame: 4 weeks

10. 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.

    Time frame: 4 weeks

11. 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.

    Time frame: 4 weeks

12. 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.

    Time frame: 4 weeks

13. 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.

    Time frame: 4 weeks

14. 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.

    Time frame: From may 2025 to may 2026

Other outcomes

1. 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.

   Time frame: 4 weeks

2. 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.

   Time frame: 4 weeks

3. Change from baseline in waist circumference

   Waist circumference (cm) will be measured at baseline and after 4 weeks to evaluate changes in abdominal adiposity.

   Time frame: 4 weeks