Berberine phospholipid exerts a positive effect on the glycemic profile of overweight subjects with impaired fasting blood glucose (IFG): a randomized double-blind placebo-controlled clinical trial

Objective: Berberine is a plant alkaloid known to exert positive metabolic effects. Human studies have confirmed its ability to improve the lipid and glycemic profile. This study aimed to evaluate the potential benefit of oral supplementation of Berberine PhytosomeTM (2 tablets/day, 550 mg/tablet) on the metabolic profile of subjects with impaired fasting blood glucose (IFG). Patients and methods: A total of 49 overweight subjects, 28 females and 21 males, were randomly assigned to either the supplemented group (n=24) or placebo (n=25). We considered glycemia as the primary endpoint and total cholesterol, high-density lipoprotein (HDL), total cholesterol/HLD, low-density lipoprotein (LDL), LDL/HDL, triglycerides, insulin, glycated hemoglobin, Homeostasis Model Assessment (HOMA), ApoA, ApoB, ApoB/ApoA, androgen suppression treatment (AST), alternative lengthening of telomeres (ALT), gamma-glutamyl transferase (GGT), creatinine, and body composition by dual-energy X-ray absorptiometry (DXA) as secondary endpoints. These parameters have been assessed at baseline, after 30 days, and after 60 days. Results: After two months of treatment, through the use of linear mixed effect models, a statistically significant difference between supplemented and placebo groups was observed for glycemia [β=-0.2495% C.I. (-0.47; -0.06), p=0.004], total cholesterol [β=-0.25, 95% C.I. (-0.45; -0.04), p=0.05], total cholesterol/HDL [β=-0.25, 95% C.I. (-0.43; -0.06), p=0.04], triglycerides [β=-0.14, 95% C.I. (-0.25; -0.02), p=0.05], insulin [β=-1.78, 95% C.I. (-2.87; -0.66), p=0.009], ApoB/ApoA [β=-0.08, 95% C.I. (-0.13; -03), p=0.004], Visceral adipose tissue (VAT) [β=-91.50, 95% C.I. (-132.60; -48.19), p<0.0001] and fat mass [β=-945.56, 95% C.I. (-1,424.42; -441.57), p=0.004]. Conclusions: The use of berberine had no adverse events, supporting its use as a natural alternative to pharmacological therapies in the case of IFG.