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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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.
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
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
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
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
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
Change from baseline in HOMA-IR index
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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
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
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
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
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
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
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
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
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
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