The effects of probiotic, prebiotic and concomitant supplementation of probiotic, Prebiotic on the oxidative stress, inflammatory and insulin resistance indices, lipid profile and liver function in non-alcoholic fatty liver. patients.

1) Objectives: Compared dietary supplementation with probiotic, prebiotic and Concomitant supplementation of probiotic and prebiotic on the oxidative stress, inflammatory and insulin resistance indices, lipid profile and liver function in NAFLD patients; 2) Design: Randomized double-blind placebo controlled trial; 3) Setting and conduct: Subjects will randomly divide into 4 groups including 22 subjects: Group1 will receive probiotic and placebo of prebiotic; Group 2 will receive prebiotic and placebo of probiotic; Group 3 will receive probiotic and prebiotic; Group 4 will receive placebo of probiotic and placebo of prebiotic. For each patient anthropometric measurements (height, weight and BMI) will be assessed and general characteristics and 24-h food record questionnaire in order to assessment of food intake for 3 days a week at the baseline and end of the study will be filled; 4) Participants including inclusion criteria: NAFLD patients with age between 20-60 (both of gender) years agreed to participate the study. Exclusion criteria: Pregnancy and lactation; viral hepatitis B and C; cardiovascular; thyroid; renal; autoimmune and inflammatory disorders; hemochromatosis; Wilson disease; usage of alcohol and supplements of A, E, C, 5). Intervention: Group1 will receive 1 gr of probiotic (107 Bifidobacterium longum and Lactobacillus acidophilus) and 5 gr of prebiotic placebo (multodextrose) twice daily; Group 2 will receive 5 gr of prebiotic (inulin HP) and 1 gr of probiotic placebo (powder milk free fat and sugar) twice daily; Group 3 will receive 1 gr of probiotic (107 Bifidobacterium longum and Lactobacillus acidophilus) and 5 gr of prebiotic (inulin HP) twice daily and group 4 will receive 1 gr of probiotic placebo (powder milk free fat and sugar) and 5 gr of prebiotic placebo (multodextrose) twice daily; All of patients will follow up for 3 months. 6) Main outcome measures variables: Obesity indices (body mass indices, west to hip ratio) and the experiments of oxidative stress (MDA، TAC), inflammatory testes (hs-CRP ،TNF-α IL-6), insulin resistance indices (FBS, Insulin), lipid profile (TC، TG، LDL ، HDL ), ultrasound of liver and liver function testes (ALP، AST، BIL ، ALB، γGT،ALT) before and after of intervention.

Nutrition research center university medicinal science Tabriz