The study of 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.

Objective: evaluating 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 (NAFLD).

Patients are randomly assigned into 2 groups (n=40 in each group) using a software to receive total anthocyanin base standardized (cornus mas L.) fruit extract (equal to 320 mg/d anthocyanins) or placebo daily for 12 weeks.

In a randomized double-blind clinical trial, 80 patients with NAFLD will be recruited from Diabetes Research Center, Shahid Sadoughi university of medical sciences, Yazd. The subjects are randomly divided into two groups to take total anthocyanin base standardized (cornus mas L.) fruit extract or placebo.

Study population: patients with NAFLD (n=80). Inclusion criteria: ALT levels more than 30 U / L in men and more than 19 U / L in women, age 25-26 years, the patients with grade 1, 2 and 3 fatty liver, the consent of subject to participate in the study, the patients are from Yazd. Exclusion criteria: The history of diseases including cirrhosis, viral hepatitis, cardiovascular disease, diabetes, Wilson and cancer; Consumption of medications including corticosteroids, nonsteroidal anti-inflammatory drugs, hypoglycemic agents, tamoxifen, sodium valproate, methotrexate, probiotics, any medicine or supplement that affect liver function, supplements with antioxidant and anti-inflammatory properties; Following a special diet; Pregnancy and breastfeeding; Alcohol consumption.

Intervention group with total anthocyanin base standardized (cornus mas L.) fruit extract or placebo group.

Liver function (liver enzymes and cytokeratin-18 levels, liver steatosis and fibrosis); tumor necrosis factor α, malondealdehyde and adiponectin levels.

A secondary outcome was modified without changing other sections of the protocol.

Randomization is performed using Random allocation software. Also, randomization is stratified by age gender.

The products ((cornus mas L.) fruit extract and placebo) are packed in the bottles that are same in terms of color, shape and size and labeled with "A" and "B" by an outside person who dose not know the details of the study. Therefore, participants and researchers will not be aware of the nature of the products in bottles.