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IRCT2013022411763N5 IRCT 2013-08-06 Vice Chancellor for Research, Isfahan University of Medical Sciences probiotics and prediabetes Effect of probiotic supplementation on glycemic, inflammatory indices, blood lipids and body composition in prediabetic patients 2012-12-01 anticipated 60 Complete https://irct.ir/trial/11918 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A prediabetes. Intervention 1: Probiotic Familact, 500 miligrams capsules, once a day (with lunch), for 60 days. Intervention 2: Placebo.
public Sepideh.Mahboobi
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1792 2110 sepidmahboobi@gmail.com Isfahan University Of Medical Sciences scientific Dr. Gholamreza Askari
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 1792 2110 askari@mui.ac.ir Isfahan University Of Medical Sciences Iran (Islamic Republic of) all prediabetic patients at the age range of 25 to 65 years old with fsting plasma glucose between 100 and 125 mg/dl and glucose tolerance test between 140 to 200 mg/dl are included in the study, study subjects must have an stesdy state of glycemic and lipid control and drug usage. patients with chronic hepatic, renal, heart and acute inflammatory diseases are not included in the study. patients who have allergic responses to probiotics or those who want to give up following the study or those who have not taken their probiotics will be excluded from the study. 25 years 65 years Both E-11 Non-insulin-dependent diabetes mellitus Treatment - Drugs Placebo Probiotic Familact, 500 miligrams capsules, once a day (with lunch), for 60 days. Placebo Fasting blood glucose. Timepoint: the first day of the study and the last day of 8th week. Method of measurement: Colorimetry. Glycated hemoglobin(HbA1C). Timepoint: the first day of the study and the last day of 8th week. Method of measurement: Ion exchange chromatography. Total serum cholestrol. Timepoint: the first day of the study and the last day of 8th week. Method of measurement: Enzymatic assay with autoanalyser. Serum triglycerides. Timepoint: the first day of the study and the last day of 8th week. Method of measurement: Enzymatic assay with autoanalyser. Serum low density lipoprotein. Timepoint: the first day of the study and the last day of 8th week. Method of measurement: Enzymatic assay with autoanalyser. Serum High density lipoprotein. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Enzymatic assay with autoanalyser. Erythrocyte sedimentation rate. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Instrumental analaysis method. High sensitive C- Reactive Protein. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Turbidimetric Method. Height. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Stadiometer. Body compisition. Timepoint: the first day of the study and the last day of 8th week. Method of measurement: BIA method. Blood pressure. Timepoint: The first day of the study and the last day of 8th week. Method of measurement: Presure indicator. Research Deputy of Isfahan University of Medical Sciences Vice Chancellor for Research, Isfahan University of Medical Sciences Research Deputy of Isfahan University of Medical Sciences Approved 2010-09-23 Isfahan Regional Bioethics Committee Isfahan University of Medical Sciences, Hezarjarib St., Isfahan Isfahan Iran (Islamic Republic of)