Evaluating a supplement for improving blood sugar and cholesterol levels in certain patients
Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients. Single-center, Randomized, Double-blind Study.
This study is testing a new supplement to see if it can help overweight or obese adults with high blood sugar and cholesterol levels feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06348550 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of a combination of Berberine Fitosoma® and Monacolin K MonaKoPure® (Berberol® K supplement) compared to a placebo in improving glycemic and lipid parameters in individuals with elevated fasting blood glucose and cholesterol levels. Participants will be overweight or obese adults with specific metabolic conditions. The study will measure changes in blood glucose and cholesterol levels over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults with fasting blood glucose levels between 100 and 125 mg/dl and total cholesterol levels of 200 mg/dl or higher.
Not a fit: Patients with diabetes, liver or kidney diseases, or those on lipid-lowering medications are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary supplement option for managing dysglycemia and dyslipidemia.
How similar studies have performed: Other studies have explored the effects of similar supplements on metabolic parameters, but the specific combination in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Overweight or obese subjects \[according to body mass index (BMI)\] * Fasting plasma glucose value between 100 and 125 mg/dl, with impaired fasting glucose or impaired glucose tolerance confirmed with oral glucose tolerance test (OGTT) * Total cholesterol values ≥ 200 mg/dl Exclusion Criteria: * Patients with neoplastic and liver diseases, renal failure * Patients with type 1 or 2 diabetes mellitus * Pregnant or breastfeeding women * Hypersensitivity to any of the ingredients * Therapy with lipid-lowering drugs * Use of products containing red yeast rice
Where this trial is running
Pavia
- IRCCS Policlinico S. Matteo Foundation — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Giuseppe Derosa
- Email: giuseppe.derosa@unipv.it
- Phone: +390382502614
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.