Impaired Fasting Glucose (IFG)BERBEVIS-DFG-0NCT06955234
Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose
A study testing Berbevis supplement in people with Impaired Fasting Glucose (IFG), run by Azienda di Servizi alla Persona di Pavia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Fasting Glucose (IFG)
- What is being tested?
- Berbevis supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fasting blood glucose between 100 and 126 mg/dl
- BMI between 25 and 35 kg/m^2
Who cannot join
- Fasting blood glucose below 100 mg/dl
- BMI < 25 or > 35 kg/m^2
About this study
Official title: Berbevis Project: Multitarget Dose-finding Study
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)
- Being tested
- Berbevis supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berbevis supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Berbevis 500 mg/die | Experimental | Berbevis™, 250 mg x 2/day, 1 tablet in the morning and 1 in the evening. Receives: 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. Receives: 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. Receives: Dietary Supplement: Berbevis supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Change from baseline in HOMA-IR index
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From may 2025 to may 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Fasting Glucose (IFG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955234
- Sponsor's protocol ID
- 1508/29032024
- Other IDs
- 1508/29032024
- Acronym
- BERBEVIS-DFG-0
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berbevis Project: Multitarget Dose-finding Study
- ClinicalTrials.gov ID
- NCT06955234
- Acronym / sponsor ID
- BERBEVIS-DFG-0 / 1508/29032024
- Conditions
- Impaired Fasting Glucose (IFG)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Berbevis 500 mg/die | Experimental | Dietary Supplement: Berbevis supplementBerbevis™, 250 mg x 2/day, 1 tablet in the morning and 1 in the evening. |
| Berbevis 750 mg/die | Experimental | Dietary Supplement: Berbevis supplementBerbevis™, 250 mg x 3/day, 2 tablets in the morning and 1 in the evening. |
| Berbevis 1000 mg/die | Experimental | Dietary Supplement: Berbevis supplementBerbevis™, 250 mg x 4/day, 2 tablets in the morning and 2 in the evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fasting blood glucose between 100 and 126 mg/dl
- BMI between 25 and 35 kg/m^2
Key exclusion criteria (2 listed)
- Fasting blood glucose below 100 mg/dl
- BMI < 25 or > 35 kg/m^2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berbevis supplementThis 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. | Dietary supplement | Berbevis 1000 mg/die, Berbevis 500 mg/die, Berbevis 750 mg/die |
Primary outcome
Change in fasting blood glucose levels from baseline after 4 weeks of Berbevis™ supplementation
Time frame: 4 weeks
Fasting blood glucose levels will be measured at baseline and after 4 weeks of supplementation with Berbevis™ using standard blood chemistry analysis.
14 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAEs) during 4 weeks of Berbevis™ supplementation at different dosages
Time frame: 4 weeks
Change from baseline in lipid profile (total cholesterol, HDL, LDL, Apo A, Apo B, triglycerides)
Time frame: 4 weeks
Change from baseline in fasting blood glucose
Time frame: 4 weeks
Change from baseline in fasting insulin
Time frame: 4 weeks
Change from baseline in HOMA-IR index
Time frame: 4 weeks
Change from baseline in glycated hemoglobin (HbA1c)
Time frame: 4 weeks
Change from baseline in C-reactive protein (CRP)
Time frame: 4 weeks
Change from baseline in AST levels
Time frame: 4 weeks
Change from baseline in ALT levels
Time frame: 4 weeks
Change from baseline in Gamma-GT levels
Time frame: 4 weeks
Change from baseline in alkaline phosphatase levels
Time frame: 4 weeks
Change from baseline in serum protein fractions (protein electrophoresis)
Time frame: 4 weeks
Change from baseline in lean mass and fat mass assessed by DEXA
Time frame: 4 weeks
Change from baseline in visceral adipose tissue assessed by DEXA
Time frame: From may 2025 to may 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Berbevis supplement in people with Impaired Fasting Glucose (IFG), run by Azienda di Servizi alla Persona di Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood glucose levels from baseline after 4 weeks of Berbevis™ supplementation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.