Effect of Citrus Bergamot Polyphenol Extract on Patients With Nonalcoholic Fatty Liver Disease

Abstract

Introduction: To determine whether bergamot polyphenolic fraction (BPF), a proprietary extract from a unique antioxidant-rich citrus fruit (bergamot) known to be beneficial in subjects with metabolic syndrome and dyslipidemias, could significantly improve hepatic structure and function in patients with both metabolic syndrome and non-alcoholic fatty liver disease (NAFLD). Methods: One hundred seven patients who met the NCEP-ATP III criteria for metabolic syndrome and had ultrasonic evidence of severe NAFLD (hepato-renal index 2.5-3.5) after exclusion of alcohol, viral, and immune disorders were admitted to the study. Before and after 120 days of BPF 650 mg twice a day, all patients had full lipid analysis including lipoprotein fractionation (NMR), fasting glucose, ALT, AST, steato test, γ-GT, TNF-α (ELISA), CRP, and ultrasonographic hepatorenal tests. Results: Hepatic tests include: steato test (baseline: 0.74 ± 0.12; after 120 days BPF: 0.44 ± 0.09), ALT (U/L) (baseline: 54 ± 5.4; after 120 days BPF: 36 ± 5.3), AST (U/L) (baseline: 52. ± 6.4; after 120 days BPF: 41 ± 5.2), γ-GT (IU/L) (baseline: 38 ± 5.2; after 120 days BPF: 29.33 ± 1.1), hepatorenal index (baseline: 2.8 ± 0.4; after 120 days BPF: 1.5 ± 0.5). Inflammatory tests include: Hs-CRP (mcg/dL) (baseline: 1.2 + 0.8; after 120 days BPF: 0.94 + 0.6) and TNF-α (pg/mL) (baseline: 14.4 ± 1.9; after 120 days BPF: 10.7 ± 1.7). Metabolic tests include: fasting glucose (mg/mL) (baseline: 118 ± 1.4; after 120 days BPF: 98 ± 0.8). All values p<0.05. Standard lipid levels (TC, LDL, HDL, TG, IDL, VLDL) were significantly improved as were the size, density and number of all atherogenic lipoprotein particles (e.g., small dense LDL, NMR, LDL particle number). Conclusion: Bergamot polyphenolic extract (BPF) derived from the Calabrian bergamot citrus fruit is a potent anti-oxidant, AMP kinase activator, and HMG-CoA reductase inhibitor that has been proven to address all components of the metabolic syndrome. In a group of 107 patients with confirmed NAFLD and metabolic syndrome, BPF given twice per day before meals significantly improved all measured biochemical and ultrasonographic characteristics of both NAFLD and metabolic syndrome in 120 days without reported side effects. There was a striking improvement in hepatic function (biochemical) and structure (echogenic visual loss of hepatic fat) accompanied by lower levels of inflammation. As there is a dearth of proven therapeutic options for NAFLD and metabolic syndrome, this study suggests that BPF may be a safe and important therapeutic option for these conditions. Disclosure - James E. Ehrlich--consultant for Nat Health Solutions, distributor of BergaMet. Ross Walker--consultant for Nat Health Solutions. Vincenzo Mollace--consultant for Nat Health Solutions.Figure 1