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

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 ).

The Effects of Natural Iridoids and Anthocyanins on Selected Parameters of Liver and Cardiovascular System Functions

“…The intake of especially anthocyanidins was associated with a statistically significant reduction of cardiovascular disease risk [67,68]. Anthocyanin's ability to reduce insulin resistance, improve glycemic control, decrease lipid accumulation in the liver, constrain inflammation (manifested as a lessening of inflammatory markers such as TNF-α), decrease oxidative stress in the liver (including stress markers such as MDA), and decrease levels of liver enzymes (such as ALT and AST) was also confirmed [69][70][71].…”

The investigation of the antitumoral effect of Cornus mas L in mice with ehrlich solid tumor

“…The stock cells were thawed at room temperature to give the stock animal 0.1 cc as i.p through the joining place of the left hind leg and the abdominal region. After 7 days, 1x10 6 EAT cell in ascites fl uid, drawn with the help of an injector from the stock animal, was administered to the nape area in 0.1 ml phosphate buffer saline (PBS) and the tumor was formed.…”

“…Group 3: Treatment group (100 mg/kg C. mas L) (n = 10): On day 0, 0.1 ml of ascites fl uid with 1x10 6 EAT cells were applied to the nape area as s.c. From day 0, 100 mg/kg/day C. mas L was injected to the mice as i.p. for 14 days.…”

“…In addition to chemotherapeutic agents in cancer treatment, herbal treatment methods, which are defi ned as complementary medicine, are among the subjects frequently studied in the world. C. mas L is a plant among these herbal agents and has antioxidant properties (5,6). C. mas L, is part of the Cornaceae family and commonly known as Cornelian cherry, is a medicinal plant containing a high level of antioxidant activity.…”

“…The origin of this tumor is hyperdiploid, which has a high rate of transplantation, rapid proliferation, but no regression with a short life span, is 100 % fatal, and without tumor specifi c transplantation antigens (TSTA) (3,12). In studies, it was observed that the number of cells on average increased exponentially until the 9th day after the i.p injection of the 1x10 6 EAT cells and that the plateau phase was entered on the 9th and 10th days (13).…”