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NCT Number: NCT06955234

Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose

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.

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Key information

Conditions

Impaired Fasting Glucose (IFG)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Berbevis supplement

Dietary 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

    Time frame: 4 weeks

    Fasting blood glucose levels will be measured at baseline and after 4 weeks of supplementation with Berbevis™ using standard blood chemistry analysis.

Secondary outcomes

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) during 4 weeks of Berbevis™ supplementation at different dosages

    Time frame: 4 weeks

    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.

  2. Change from baseline in lipid profile (total cholesterol, HDL, LDL, Apo A, Apo B, triglycerides)

    Time frame: 4 weeks

    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.

  3. Change from baseline in fasting blood glucose

    Time frame: 4 weeks

    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. Change from baseline in fasting insulin

    Time frame: 4 weeks

    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.

  5. Change from baseline in HOMA-IR index

    Time frame: 4 weeks

    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.

  6. Change from baseline in glycated hemoglobin (HbA1c)

    Time frame: 4 weeks

    HbA1c levels (%) will be measured at baseline and after 4 weeks of treatment to evaluate longer-term glycemic control.

  7. Change from baseline in C-reactive protein (CRP)

    Time frame: 4 weeks

    CRP levels (mg/L) will be evaluated at baseline and after 4 weeks of treatment to assess systemic inflammation.

  8. Change from baseline in AST levels

    Time frame: 4 weeks

    AST serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to assess liver function and potential hepatotoxicity.

  9. Change from baseline in ALT levels

    Time frame: 4 weeks

    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.

  10. Change from baseline in Gamma-GT levels

    Time frame: 4 weeks

    Gamma-GT levels (U/L) will be analyzed at baseline and after 4 weeks of treatment to monitor cholestasis or bile duct involvement.

  11. Change from baseline in alkaline phosphatase levels

    Time frame: 4 weeks

    Alkaline phosphatase serum levels (U/L) will be measured at baseline and after 4 weeks of treatment to evaluate liver and bone metabolism.

  12. Change from baseline in serum protein fractions (protein electrophoresis)

    Time frame: 4 weeks

    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.

  13. Change from baseline in lean mass and fat mass assessed by DEXA

    Time frame: 4 weeks

    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.

  14. Change from baseline in visceral adipose tissue assessed by DEXA

    Time frame: From may 2025 to may 2026

    Visceral adipose tissue (cm²) will be estimated using DEXA at baseline and after 4 weeks to assess abdominal fat distribution and potential metabolic impact.

Other outcomes

  1. Change from baseline in body weight

    Time frame: 4 weeks

    Body weight (kg) will be measured at baseline and after 4 weeks to evaluate potential weight changes due to the intervention.

  2. Change from baseline in Body Mass Index (BMI)

    Time frame: 4 weeks

    BMI (kg/m²) will be calculated from weight and height measurements at baseline and after 4 weeks to assess changes in body composition.

  3. Change from baseline in waist circumference

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

Berbevis Project: Multitarget Dose-finding Study

Acronym: BERBEVIS-DFG-0

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 2, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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