title: Effects of Synbiotics Supplementation in Lean Patients with Nonalcoholic Fatty Liver Disease: Study Protocol of a Pilot Randomized Double-blind Clinical Trial.
abstract: BACKGROUND
  Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no treatment option for patients with normal or low body mass index (BMI). The aim of this study is to evaluate the efficacy of synbiotics supplementation in NAFLD patients with normal or low BMI.
  
  
  METHODS
  In our randomized, double-blind, placebo-controlled clinical trial protocol, forty-two patients will be assigned to take either a synbiotic or a placebo capsule for 28 weeks. Both groups will undergo the standard treatment.
  
  
  BACKGROUND
  The study protocol has been approved by ethics committee of Shahid Beheshti University of Medical Sciences. At the beginning of the study, a written informed consent form will be signed and dated by subjects and investigators. The results will be published in due time.
authors.affiliation: Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Mofidi
authors.affiliation: Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Yari
authors.affiliation: Liver and Pancreatobiliary Diseases Research Group, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Poustchi
authors.affiliation: Liver and Pancreatobiliary Diseases Research Group, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Shahin
authors.initials: S
authors.lastname: Merat
authors.affiliation: Mehrad Hospital, Tehran, Iran.
authors.forename: Babak
authors.initials: B
authors.lastname: Nourinayyer
authors.affiliation: Digestive Oncology Reaserch Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Reza
authors.initials: R
authors.lastname: Malekzadeh
authors.affiliation: Department of Clinical Nutrition and Dietetics, Faculty of Nutrition and Food Technology, National Nutrition and Food Technology, Research Institute Shahid Beheshti University of Medical Science, Tehran, Iran.
authors.forename: Azita
authors.initials: A
authors.lastname: Hekmatdoost
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000178:diet therapy* / Q000503:physiopathology; D058616:Synbiotics / Q000008:administration & dosage*; D055815:Young Adult