Clinical Trial Details

Trial ID: L0617
Source ID: IRCT201410052394N13
Associated Drug: Probiotic
Title: Assessing the Effects of probiotic and prebiotic supplementation on serum hepatic enzymes, Insulin resistance, hs-CRP, Lipid profile, leptin and Adiponectin in patients with NAFLD
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non alcoholic fatty liver. <br>Other diseases of liver;Other diseases of liver
Interventions: Intervention 1: Intervention group 1:<br>Patients in the group receiving the probiotic supplement, 1 capsule contains a combination of probiotics comprising of five bacterial species ( 5 billion active cell, containing Lactobacillus casei, Lactobacillus r
Outcome Measures: ALT. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;AST. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;?GT. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;ALP. Timepoint: At baseline, after 12 weeks. Method of measurement: photometric assay.;Hs-CRP. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Leptin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Adiponectin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;Insulin. Timepoint: At baseline, after 12 weeks. Method of measurement: ELISA.;HOMA-IR. Timepoint: At baseline, after 12 weeks. Method of measurement: Serum insulin*FBS/405.;QUICKI. Timepoint: At baseline, after 12 weeks. Method of measurement: Calculation.;Fasting Glucose. Timepoint: At baseline, after 12 weeks. Method of measurement: GOD/POD.;TG. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;Cholestrol. Timepoint: At baseline, after 12 weeks. Method of measurement: Enzymatic colorimetric assay.;LDL. Timepoint: At baseline, after 12 weeks. Method of measurement: Calculation.;Blood pressure. Timepoint: At baseline, after 12 weeks. Method of measurement: sphygmomanometer.Body mass index. Timepoint: At baseline, after 12 weeks. Method of measurement: calculation.;WHR. Timepoint: At baseline, after 12 weeks. Method of measurement: calculation.;Percentage body fat. Timepoint: At baseline, after 12 weeks. Method of measurement: BIA.
Sponsor/Collaborators: Vice-chancellor for research, Iran University of Medical Sciences
Gender: All
Age: 20 years60 years
Phases: Phase 2
Enrollment: 105
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
Start Date: 14/12/2014
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/2083