Effect of phytosomal berberine and monacolin K association on glyco-metabolic and lipid parameters in dysglycemic and hypercholesterolemic patients

Objective To evaluate the effect of Berberol K® on glycemic and lipid parameters as well as glycemic status variation in dysglycemic and hypercholesterolemic patients. Materials and methods This study was performed on 124 patients who received placebo or Berberol K®, 1 tablet per day, for 6 months. Results In the Berberol K® group, fasting plasma glucose (FPG) and post-prandial glucose (PPG) decreased at 3 (p< 0.05) and 6 months (p< 0.01) compared to baseline and at 6 months (p< 0.05) compared to placebo. The homeostasis model assessment of insulin resistance (HOMA-IR) decreased at 6 months both compared to baseline and to placebo (p< 0.05) in the Berberol K® group. Total cholesterol (TC) and low density lipoprotein-cholesterol (LDL-C) decreased at 3 (p< 0.05) and 6 months (p< 0.01) respect to baseline and at 6 months (p< 0.05) respect to placebo. At the end of the study, IFG patients were 63.3% in the Berberol K® group and 60.0% in the placebo group, whereas those with IGT were 11.7% in the Berberol K® group and 36.7% in the placebo group. In the Berberol K® group, 21.7% and 3.3% of patients returned to a normal glycemic status from IFG and IGT group, respectively, and 21.7% come back to IFG from IGT group. In the placebo group, 3.3% of patients progressed to IGT from IFG group and 3.3% advanced to diabetic status from IGT group. The supplement decreased C-reactive protein (CRP) (p<0.05) respect to baseline. Conclusion Berberol K® was effective and safe on glucose and lipid metabolism. Registration number NCT06348550. In https://clinicaltrials.gov