The effect of saffron supplementation on liver enzymes, insulin resistance, lipid profile and The degree of hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

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 (hyperprolactinemia, Cushing's syndrome) ;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 (steroids, antidepressants, antipsychotics); use of drugs that may be associated with NAFLD (glucocorticoid, methotrexate, amidarone systemic, tetracycline, valporic acid anabolic steroids, estrogen, tamoxifen, or other known hepatotoxic); unwillingness to continue the study; The introduction of the anti-NASH (vitamin E, thiazolidindiones milkthistle, betaine, SAM-E, UDCA, gemfibrozil,, Anti-TNF-a, probiotic) ; 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%.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ALT. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Enzymatic photometry.;AST. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Enzymatic photometry.

Secondary Outcome Measures