Nonalcoholic fatty liver disease. Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention 1: Intervention group: receiving one pill containing 100 mg powder of Saffron daily with meal for 12 weak. Intervention 2: Placebo group: receiving one pill containing 100 mg maltodextri
Treatment - Drugs
Intervention group: receiving one pill containing 100 mg powder of Saffron daily with meal for 12 weak.
Placebo group: receiving one pill containing 100 mg maltodextrin daily with meal for12 weak.
Sponsors
Vice-chancellor for research Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Apo a1. Timepoint: Before intervention and three months after intervention. Method of measurement: Immunoturbidometry.;FBS. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry.;GGT. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry.;Insulin. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: ELISA.;Insulin resistance. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: calculation.;Quicki index. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: calculation.;Lipid profile(LDL-c, HDL-c, TG, total cholestrol). Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry(LDL by calculation).;Systolic and diastolic blood pressure. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Mercury sphygmomanometer.;Sleep quality. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: The Pittsburgh Sleep Quality questionnaire.;Life quality. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: quality of life sf 12 questionnaire.;Hepatic steatosis. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: ultrasonography.;Liver fibrosis. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: fibroscan.;Direct bilirubin and total bilirubin. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Nahid Aryaeian
Iran University of Medical Sciences
Outcome results
None listed