Objective: Assessing the effect of probiotic and prebiotic supplementation on liver enzymes and inflammatory markers (hsCRP), leptin, adiponectin, insulin resistance, lipid profile in patients with NAFLD.
2.Double blind randomized clinical trial, a placebo-controlled, single-center.
3.105 patients with Non-alcoholic fatty liver disease that will be reffered to Afzalipour hospital in Kerman and having inclusion criteria are selected.They were divided into 3 groups randomely: intervention 1 (probiotic supplementation and prebiotic placebo) intervention 2 (prebiotic supplementation and probiotic placebo) and control group ( probiotic and prebiotic placebo) And the 3-month intervention done. Before and after the intervention, 10 ml of fasting blood was taken from them. For Dietary assessment of patients and control potential confounding factors of diet, 3- day dietary recall questionnaire and physical activity questionnaire( IPAQ) is completed. Patient anthropometric data including weight, height, waist circumference, hip circumference, body fat and blood pressure will be measured.
4. Main inclusion criteria: Patients with Non-alcoholic fatty liver disease, body mass index above 25 and below 40, the absence of other diseases, not pregnancy and lactation, aged 20 -60, Lack of drug use. Main Exclusion criteria: Pregnancy, the use of antibiotics over 1 week, Any changes in diet and physical activity.
5. Outcome: Liver enzymes ( GGT, ALP, ALT, AST ), lipid profile ( LDL, HDL, TG, Chol ), Adipocitokines (leptin and adiponectin), Insulin resistance ( FBS, insulin, HOMA-IR, QUICKI ), inflammatory marker hs-CRP, anthropometric measures ( percent body fat, waist circumference, weight) and blood pressure.