title: Soy Isoflavones Supplementation for Patients with Irritable Bowel Syndrome: A Randomized Double Blind Clinical Trial.
abstract: BACKGROUND Irritable bowel syndrome (IBS) is one of the common gastrointestinal disorders with unknown etiology. In experimental models, it is proposed that soy isoflavones may suppress the clinical and psychological symptoms of IBS by alteration of gut barrier tight junctions. METHODS We conducted this study to evaluate the effects of soy isoflavones on IBS symptoms and patients' quality of life. In a randomized double blind placebo-controlled clinical trial, 67 patients with IBS were allocated to consume either soy isoflavones capsules or a placebo for 6 weeks. The primary outcome was a significant reduction in symptoms severity score and the secondary outcome was a significant improvement in quality of life. RESULTS 45 participants completed the study. There was no significant changes in mean differences of symptoms severity score between the two groups; however soy isoflavone supplementation could significantly improve the quality of life scores (p=0.009). CONCLUSION Soy isoflavones supplementation could improve the quality of life in patients with IBS; however it did not suppress the symptoms severity in 6 weeks. Further research with a longer duration is needed to determine the sustained clinical efficacy. This study was registered at clinicaltrials.gov as NCT02026518.
authors.affiliation: National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Mahsa
authors.initials: M
authors.lastname: Jalili
authors.affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Homayoon
authors.initials: H
authors.lastname: Vahedi
authors.affiliation: Department of Epidemiology and Biostatistics, School of Public Health, Clinical Trial Center, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Leila
authors.initials: L
authors.lastname: Janani
authors.affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Hossein
authors.initials: H
authors.lastname: Poustchi
authors.affiliation: Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Reza
authors.initials: R
authors.lastname: Malekzadeh
authors.affiliation: National Nutrition and Food Technology Research Institute, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Azita
authors.initials: A
authors.lastname: Hekmatdoost
keywords: Irritable Bowel Syndrome; Soy Isoflavone; quality of life; randomized clinical trial