Objective: The effect of supplementation with saffron powder compared with placebo on liver enzymes, insulin resistance, blood lipids and liver steatosis in patients with NAFLD. Study: randomized double blind clinical trial. The study population:Women and men with Nonalcoholic Fatty Liver disease referring to Liver and Digestive clinic of
Rasoul Akram hospital. sample of people who desire to participate and have their inclusion criteria are selected.
Inclusion criteria : both sexes ; aged between 18 and 65 years; diagnosis of NAFLD by a physician; according to the high enzyme ALT, AST (> U / L 30 in men and> U / L 19 in women ) and liver ultrasonography ;willingness to participate in the study and signed a letter of conscious satisfaction.
Exclusion criteria: pregnancy and breastfeeding and those trying to conceive; The use of antioxidant supplements during the month before sampling; severe heart disease, kidney, thyroid, diabetes, infections, hepatitis B, C and other liver diseases (diagnosis by liver specialist doctors) and diseases that affect on weight ;Severe lose weight or Weight gain dieting During the 3 months prior to sampling ;The use of effective drugs against weight during the three months prior to sampling; use of drugs that may be associated with NAFLD; unwillingness to continue the study; The introduction of the anti-NASH; disease that require special treatment and intervention disrupts the process; pregnancy during the study ; Patients' acceptance of (compliance) and saffron powder or placebo by their consumption levels recommended by the Executive is less than 80%.
Intervention: 38 patients in the group receiving saffron powder (containing 100 mg of saffron) and 38 patients receiving placebo (maltodextrin). Intervention duration: 12 weeks.
The outcome of the study: factors including ALT, AST, GGT, lipid profile TC, TG, HDL, LDL, glucose and fasting insulin, insulin resistance index, quantitative index of insulin sensitivity, direct and total bilirubin, apolipoprotein a1 and the degree of fibrosis and hepatic steatosis will be measured.