Impaired Fasting Glucose (IFG)
Conditions
Brief summary
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.
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.
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting blood glucose levels from baseline after 4 weeks of Berbevis™ supplementation | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in C-reactive protein (CRP) | 4 weeks | CRP levels (mg/L) will be evaluated at baseline and after 4 weeks of treatment to assess systemic inflammation. |
| Change from baseline in serum protein fractions (protein electrophoresis) | 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. |
| Change from baseline in lean mass and fat mass assessed by DEXA | 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. |
| Change from baseline in visceral adipose tissue assessed by DEXA | 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. |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) during 4 weeks of Berbevis™ supplementation at different dosages | 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. |
| Change from baseline in lipid profile (total cholesterol, HDL, LDL, Apo A, Apo B, triglycerides) | 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. |
| Change from baseline in fasting blood glucose | 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. |
| Change from baseline in fasting insulin | 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. |
| Change from baseline in HOMA-IR index | 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. |
| Change from baseline in glycated hemoglobin (HbA1c) | 4 weeks | HbA1c levels (%) will be measured at baseline and after 4 weeks of treatment to evaluate longer-term glycemic control. |
| Change from baseline in AST levels | 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. |
| Change from baseline in ALT levels | 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. |
| Change from baseline in Gamma-GT levels | 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. |
| Change from baseline in alkaline phosphatase levels | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in waist circumference | 4 weeks | Waist circumference (cm) will be measured at baseline and after 4 weeks to evaluate changes in abdominal adiposity. |
| Change from baseline in body weight | 4 weeks | 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) | 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. |
Outcome results
None listed