The effect of total anthocyanin-base standardized (Cornus mas L.) fruit extract on liver function, tumor necrosis factor α, malondealdehyde, and adiponectin in patients with non-alcoholic fatty liver: a study protocol for a double-blind randomized clinical trial

Nutrition Journal

Ali Mohammad Ranjbar¹  Mohsen Akhondi-Meybodi²  Mahdieh Hosseinzadeh³  Zohreh Sadat Sangsefidi³  Hassan Mozaffari-Khosravi³  Hossein Fallahzadeh⁴ 

[1] Department of Pharmacognosy, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences;Gastroentrology Department, Shahid Sadoughi Hospital, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences;Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences;Research Center of Prevention and Epidemiology of Non-Communicable Disease, Departments of biostatistics and Epidemiology, School of Public Health, Shahid Sadoughi University of Medical Sciences;

关键词: Nonalcoholic fatty liver disease;    Anthocyanins;    Cornelian cherry;    Cornus mas L;   

DOI  :  10.1186/s12937-019-0465-z

来源: DOAJ

【 摘 要 】

Abstract Background 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. Methods 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− 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. Discussion 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. Trial registration Iranian Registry of Clinical Trials (IRCT20180419039359N1).

【 授权许可】

Unknown