Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose (BERBEVIS-DFG-0)

Azienda di Servizi alla Persona di Pavia

Status: Not yet enrolling

Conditions: Impaired Fasting Glucose (IFG)

Treatments: Dietary Supplement: Berbevis supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06955234

1508/29032024 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Berbevis 500 mg/die

Experimental group

Description:

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

Treatment:

Dietary Supplement: Berbevis supplement

Berbevis 750 mg/die

Experimental group

Description:

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

Treatment:

Dietary Supplement: Berbevis supplement

Berbevis 1000 mg/die

Experimental group

Description:

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

Treatment:

Dietary Supplement: Berbevis supplement