Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose

NCT ID: NCT06955234

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-15

Study Completion Date

2026-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Impaired Fasting Glucose (IFG)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Berbevis 500 mg/die

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

Group Type EXPERIMENTAL

Berbevis supplement

Intervention Type 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 750 mg/die

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

Group Type EXPERIMENTAL

Berbevis supplement

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

Group Type EXPERIMENTAL

Berbevis supplement

Intervention Type 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.

Interventions

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Berbevis 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1508/29032024

Identifier Type: OTHER

Identifier Source: secondary_id

1508/29032024

Identifier Type: -

Identifier Source: org_study_id

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