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.

背景：非酒精性脂肪肝是世界上与肝有关的发病率和死亡率的最常见原因。但是，尚未找到针对这种情况的有效药理学治疗方法。

目的：这项研究评估了含有佛手柑和野生菜蓟的生物活性成分的营养保健品对脂肪肝患者的治疗效果。主要结果指标是肝脂肪含量的变化。

方法：共有102位肝脂肪变性患者参加了一项双盲安慰剂对照临床试验。干预组接受了含有佛手柑多酚成分和Cynara Cardunculus提取物，每天300 mg，持续12周。对照组每天接受安慰剂。在研究的基线和结束时通过瞬时弹性成像，血清转氨酶，脂质和葡萄糖测量肝脂肪含量。

结果： 我们发现，服用营养保健品而不是安慰剂的参与者，肝脏脂肪含量的降低更大（-48.2±39比-26.9±43 dB / m， p= 0.02）；CAP评分降低的百分比在患有Android肥胖，超重/肥胖以及女性的女性中具有统计学意义。但是，在调整了体重变化后，CAP得分降低的百分比仅在50岁以上的人群中具有统计学意义（安慰剂和营养保健品分别为44％和78％，p = 0.007）。

结论：这种含有特定成分的佛手柑和野生菜豆的生物活性成分可降低肝脂肪变性超过50年的患者在12周内的肝脏脂肪含量。如果得到证实，这种营养保健品将成为治疗肝脂肪变性患者的基石。

临床试验注册：www.isrctn.com，标识符为ISRCTN12833814。