Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose

NCT06955234 | Not Yet Recruiting

• 1 other identifier: 1508/29032024
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impaired Fasting Glucose (IFG)

Outcome Measures

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.

  4 weeks

Secondary Outcomes (14)

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

  4 weeks

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

  4 weeks

• Change from baseline in fasting blood glucose

  4 weeks

• Change from baseline in fasting insulin

  4 weeks

• Change from baseline in HOMA-IR index

  4 weeks

Other Outcomes (3)

• Change from baseline in body weight

  4 weeks

• Change from baseline in Body Mass Index (BMI)

  4 weeks

• Change from baseline in waist circumference

  4 weeks

Study Arms (3)

Berbevis 500 mg/die

EXPERIMENTAL

Berbevis™, 250 mg x 2/day, 1 tablet in the morning and 1 in the evening.

Dietary Supplement: Berbevis supplement

Berbevis 750 mg/die

EXPERIMENTAL

Berbevis™, 250 mg x 3/day, 2 tablets in the morning and 1 in the evening.

Dietary Supplement: Berbevis supplement

Berbevis 1000 mg/die

EXPERIMENTAL

Berbevis™, 250 mg x 4/day, 2 tablets in the morning and 2 in the evening.

Dietary Supplement: Berbevis supplement

Interventions

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.

Berbevis 1000 mg/die; Berbevis 500 mg/die; Berbevis 750 mg/die

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fasting blood glucose between 100 and 126 mg/dl
• BMI between 25 and 35 kg/m\^2

You may not qualify if:

• Fasting blood glucose below 100 mg/dl
• BMI \< 25 or \> 35 kg/m\^2

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 2, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-04