Effect of the Association of Berberine Fitosoma® and Monacolin K MonaKoPure® on Glyco-metabolic Parameters in Dysglycemic and Dyslipidemic Patients.

Launched by UNIVERSITY OF PAVIA · Mar 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a dietary supplement called Berberol® K, which contains two natural ingredients—Berberine Fitosoma® and Monacolin K MonaKoPure®—affects blood sugar and cholesterol levels in people who have mild issues with these measurements. Specifically, it’s looking at individuals with slightly high fasting blood sugar (between 100 and 125 mg/dl) and high total cholesterol (200 mg/dl or more). The goal is to see if this supplement can help improve these health markers compared to a placebo, which is a dummy treatment with no active ingredients.

To participate in the trial, candidates should be overweight or obese and meet the criteria for blood sugar and cholesterol levels mentioned above. However, certain people are excluded, such as those with specific diseases, pregnant or breastfeeding women, and anyone currently taking certain cholesterol medications. If you qualify and decide to join, you can expect to take the supplement for a set period and have regular check-ups to monitor your blood sugar and cholesterol levels. This study aims to provide valuable insights into managing blood sugar and cholesterol through natural supplements.

Gender

ALL

Eligibility 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