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The Hepatic Effects of Citrus Bergamot Polyphenol Fraction (BPF) on Patients with Non-alcoholic Fatty Liver Disease and Metabolic Syndrome

      Lead Author’s Financial Disclosures

      None

      Study Funding

      None

      Background/Synopsis

      A highly concentrated extract of Bergamot, a citrus fruit endemic to Calabria, Italy has been shown to be a “natural statin” that is beneficial in patients with dyslipidemia while addressing all the components of the metabolic syndrome. There are no approved drugs or adequate treatment for non-alcoholic fatty liver disease (NAFLD), a disorder considered the “hepatic manifestation” of metabolic syndrome.

      Objective/Purpose

      To determine whether bergamot polyphenolic fraction (BPF), a proprietary extract from a unique antioxidant rich citrus fruit (bergamot), could significantly improve hepatic structure and function in patients with both metabolic syndrome and non-alcoholic fatty liver disease (NAFLD).

      Methods

      There were 107 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 and were admitted to the study. Before and after 120 days of BPF 650 mg twice/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

      Tabled 1
      TestBaselineAfter 120 days BPF
      HEPATIC
      Steato Test:0.74 ± 0.120.44 ± 0.09*
      ALT (U/L)54 ± 5.436 ± 5.3*
      AST (U/L)52. ± 6.441 ± 5.2*
      γ-GT (IU/L)38 ± 5.229.33 ± 1.1*
      Hepatorenal index2.8 ± 0.41.5 ± 0.5*
      INFLAMMATORY
      Hs-CRP (mcg/dl)1.2 + 0.80.94 + 0.6*
      TNF-α (pg/mL)14.4 ± 1.910.7 ± 1.7*
      * (p < 0.05)

      Conclusions

      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 NAFLD 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 are no proven therapies for patients with NAFLD and metabolic syndrome, this study suggests that BPF may be a safe and important.