Abstract
BackgroundNonalcoholic 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.MethodsIn 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− 1 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.DiscussionConsidering 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.Trial registrationIranian Registry of Clinical Trials (IRCT20180419039359N1).
Highlights
Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide
The present double-blind randomized clinical trial will be conducted to investigate the effect of supplementation with total anthocyanin-base standardized cornelian cherry fruit extract on the liver function (Serum levels of Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and CK-18 Cytokeratin-18 fragment M30 (M30); steatosis and fibrosis of liver), tumor necrosis factor α (TNF-α), MDA, and adiponectin in patients with NAFLD
The protective effects of cornelian cherry fruit extract, as an anthocyanins-rich source, on liver were reported in animal studies
Summary
Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. 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. The present double-blind randomized clinical trial will be conducted to investigate the effect of supplementation with total anthocyanin-base standardized cornelian cherry fruit extract on the liver function (Serum levels of AST, ALT and CK-18 M30; steatosis and fibrosis of liver), TNF-α, MDA, and adiponectin in patients with NAFLD. Serum concentrations of glucose, total cholesterol (TC), High density lipoprotein (HDL-C), low density lipoprotein (LDL-C), triglyceride (TG), insulin, and insulin resistance will be evaluated as the secondary outcomes
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