title: The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial.
abstract: The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has emerged as a new candidate that may be linked to metabolic diseases. We hypothesize that selective modulation of the intestinal microbiota by probiotic or synbiotic supplementation may improve metabolic dysfunction and prevent diabetes in prediabetics. In this study, a synthesis and study of synbiotics will be carried out for the first time in Iran.
  
  
  
  In a randomized triple-blind controlled clinical trial, 120 adults with impaired glucose tolerance based on the inclusion criteria will be selected by a simple random sampling method and will be randomly allocated to 6 months of 6 g/d probiotic, synbiotic or placebo. The fecal abundance of bacteria, blood pressure, height, weight, and waist and hip circumferences will be measured at baseline and following treatment. Also, plasma lipid profiles, HbA1C, fasting plasma glucose, and insulin levels, will be measured and insulin resistance (HOMA-IR) and beta-cell function (HOMA-B) will be calculated at baseline and will be repeated at months 3, 6, 12, and 18. The data will be compared within and between groups using statistical methods.
  
  
  
  The results of this trial could contribute to the evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in prevention and management of metabolic syndrome in prediabetes.
  
  
  
  Iranian Registry of Clinical Trials: IRCT201511032321N2 . Registered on 27 February 2016.
authors.affiliation: Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Nazila
authors.initials: N
authors.lastname: Kassaian
authors.affiliation: Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Ashraf
authors.initials: A
authors.lastname: Aminorroaya
authors.affiliation: Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. awat_feiz@hlth.mui.ac.ir.|Biostatistics and Epidemiology Department, School of Health, Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. awat_feiz@hlth.mui.ac.ir.
authors.forename: Awat
authors.identifier: 0000-0002-9724-2983
authors.initials: A
authors.lastname: Feizi
authors.affiliation: Microbiology Departments, Science Faculty, Islamic Azad University (IAU), Arak Branch, Arak, Iran.
authors.forename: Parvaneh
authors.initials: P
authors.lastname: Jafari
authors.affiliation: Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Masoud
authors.initials: M
authors.lastname: Amini
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000209:etiology / Q000382:microbiology / Q000517:prevention & control*; D004734:Energy Metabolism; D005243:Feces / Q000382:microbiology; D005260:Female; D000069196:Gastrointestinal Microbiome; D041981:Gastrointestinal Tract / Q000382:microbiology*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000097:blood; D007492:Iran; D008055:Lipids / Q000097:blood; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000150:complications / Q000382:microbiology / Q000628:therapy*; D008875:Middle Aged; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D058616:Synbiotics / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin; D008055:Lipids; C517652:hemoglobin A1c protein, human
keywords: Impaired glucose tolerance; Metabolic syndrome; Microbiome; Probiotic; Synbiotic