Abstract
Background: Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. However, no effective pharmacological treatment for this condition has been found.Purpose: This study evaluated the effect of a nutraceutical containing bioactive components from Bergamot citrus and wild cardoon as a treatment for individuals with fatty liver disease. The primary outcome measure was the change in liver fat content.Methods: A total of 102 patients with liver steatosis were enrolled in a double-blind placebo controlled clinical trial. The intervention group received a nutraceutical containing a Bergamot polyphenol fraction and Cynara Cardunculus extract, 300 mg/day for 12 weeks. The control group received a placebo daily. Liver fat content, by transient elastography, serum transaminases, lipids and glucose were measured at the baseline and the end of the study.Results: We found a greater liver fat content reduction in the participants taking the nutraceutical rather than placebo (−48.2 ± 39 vs. −26.9 ± 43 dB/m, p = 0.02); The percentage CAP score reduction was statistically significant in those with android obesity, overweight/obesity as well as in women. However, after adjustment for weight change, the percentage CAP score reduction was statistically significant only in those over 50 years (44 vs. 78% in placebo and nutraceutical, respectively, p = 0.007).Conclusions: This specific nutraceutical containing bioactive components from Bergamot and wild cardoon reduced the liver fat content during 12 weeks in individuals with liver steatosis over 50 years. If confirmed, this nutraceutical could become the cornerstone treatment of patients affected by liver steatosis.Clinical Trial Registration: www.isrctn.com, identifier ISRCTN12833814.
Highlights
Non-alcoholic fatty liver disease (NAFLD) is becoming the leading cause of liver damage in Western countries [1]
After adjustment for weight change, the percentage controlled attenuation parameter” (CAP) score reduction was statistically significant only in those over 50 years (44 vs. 78% in placebo and nutraceutical, respectively, p = 0.007). This specific nutraceutical containing bioactive components from Bergamot and wild cardoon reduced the liver fat content during 12 weeks in individuals with liver steatosis over 50 years. This nutraceutical could become the cornerstone treatment of patients affected by liver steatosis
Ninety-five subjects completed the first part of the study
Summary
Non-alcoholic fatty liver disease (NAFLD) is becoming the leading cause of liver damage in Western countries [1]. Despite the genetic heri-tability predisposition to progressive NAFLD [3], the factors leading to the progression from simple liver steatosis to severe liver scarring and cirrhosis are not fully clear. Additional factors involved in the pathogenesis of NAFLD are obesity and obesity-related metabolic disorders [6, 7]. Non-alcoholic fatty liver disease is the most common cause of liver-related morbidity and mortality in the world. Purpose: This study evaluated the effect of a nutraceutical containing bioactive components from Bergamot citrus and wild cardoon as a treatment for individuals with fatty liver disease. The primary outcome measure was the change in liver fat content
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