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.
fasting blood glucose between 100 and 126 mg/dl
BMI between 25 and 35 kg/m²
Fasting blood glucose below 100 mg/dl
BMI < 25 or > 35 kg/m²
Parallel
Berbevis supplement
Dietary supplementThis 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.
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.
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.
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.
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.
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.
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.
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.
Change from baseline in waist circumference
Waist circumference (cm) will be measured at baseline and after 4 weeks to evaluate changes in abdominal adiposity.
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