Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Nutr J. 2019 Jul 19;18(1):39. doi: 10.1186/s12937-019-0465-z.
Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Evidence showed that anthocyanins might have effects on NAFLD. Protective effects of Cornelian cherry (Cornus mas L.) extract, as an anthocyanins-rich source, on liver were reported in animal studies. However, very few clinical trials were conducted in this regard. Thus, the aim of this research will be to evaluate the effect of supplementation with total anthocyanin-base standardized cornelian cherry fruit extract on liver function (Serum levels of Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), cytokeratin-18 fragment M30 (CK-18 M30), as well as steatosis and fibrosis of liver), tumor necrosis factor α (TNF-α), malondealdehyde (MDA), and adiponectin in patients with NAFLD.
In a double-blind randomized clinical trial, 80 NAFLD patients will be studied. The patients will be randomly assigned into two groups. The intervention group will receive the cornelian cherry extract, containing 320 mg.d anthocyanins, per day for 12 weeks. The control group will also take the placebo daily for 12 weeks. Liver function (Serum levels of AST, ALT and CK-18 M30; steatosis and fibrosis of liver), serum levels of TNF-α, MDA, and adiponectin will be measured at the baseline and the end of trial for both groups and their results will be compared.
Considering evidences about the useful impacts of anthocyanins on NAFLD, the effects of supplementation with cornelian cherry extract will be investigated on the important variables related to NAFLD.
Iranian Registry of Clinical Trials ( IRCT20180419039359N1 ).
非酒精性脂肪性肝病（NAFLD）是全球最常见的慢性肝病之一。有证据表明，花色苷可能对 NAFLD 有作用。在动物研究中，已报道了作为花色苷丰富来源的山楂提取物对肝脏的保护作用。然而，在这方面进行的临床试验却很少。因此，本研究的目的将评估补充总花色苷基标准化山楂果提取物对肝功能（血清丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、细胞角蛋白 18 片段 M30（CK-18M30）以及肝脏脂肪变性和纤维化）、肿瘤坏死因子-α（TNF-α）、丙二醛（MDA）和脂联素的影响在 NAFLD 患者中。
在一项双盲随机临床试验中，将研究 80 例 NAFLD 患者。患者将被随机分为两组。干预组每天服用山楂提取物，含 320mg.d 花色苷，持续 12 周。对照组也将每天服用安慰剂，持续 12 周。在基线和试验结束时，将测量两组患者的肝功能（血清 AST、ALT 和 CK-18M30 水平；肝脏脂肪变性和纤维化）、血清 TNF-α、MDA 和脂联素水平，并比较其结果。
考虑到花色苷对 NAFLD 的有益影响的证据，将研究山楂提取物补充剂对与 NAFLD 相关的重要变量的影响。
伊朗临床试验注册中心（IRCT20180419039359N1）。
