Mahsa Jalili1, Homayoon Vahedi2, Hossein Poustchi3, Azita Hekmatdoost4. 1. Cell, Molecular Biology Group (CMBG), Department of Biology, Faculty of Natural Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. Electronic address: mahsa.jalili@ntnu.no. 2. Digestive Disease Research Center, Digestive Disease Research Institute (DDRI), Tehran, Iran. 3. Liver and Pancreatobiliary Research Group, Digestive Disease Research Institute (DDRI), Tehran, Iran. 4. National Nutrition and Food Technology Research Institute (NFTRI), Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences (SBMU), Tehran, Iran.
Abstract
BACKGROUND & AIMS:Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that is more prevalent in women. Vitamin D deficiency and hormonal disorders are also prevalent in Iranian women, and may influence the severity of clinical outcomes mediated by microinflammation, oxidative stress and intestinal permeability pathways. Our objective was to investigate the effects of co-administration of soy and vitamin D on some inflammatory, antioxidant and gut permeability markers in women with IBS. METHODS: In a randomized clinical trial, women (18-75 years of age) were randomly allocated into four groups to receive soy isoflavones (40 mg/day), cholecalciferol (50,000 IU/15 days), both soy isoflavones and cholecalciferol, or placebo for six weeks. The outcomes were plasma inflammatory markers, antioxidant status and fecal protease activity at week 0 and week 6. RESULTS: After the intervention, plasma inflammatory markers and fecal protease activity were reduced significantly in all treatment groups compared to the placebo group; however, there was no significant effect on antioxidant status. CONCLUSION: This study suggests combined supplementation of soy isoflavones and active vitamin D can improve some biochemical parameters regarding inflammation and intestinal permeability of IBS in women. TRIAL REGISTRATION: Clinical.Trials.govNCT02026518.
RCT Entities:
BACKGROUND & AIMS:Irritable bowel syndrome (IBS) is a common gastrointestinal disorder that is more prevalent in women. Vitamin Ddeficiency and hormonal disorders are also prevalent in Iranian women, and may influence the severity of clinical outcomes mediated by microinflammation, oxidative stress and intestinal permeability pathways. Our objective was to investigate the effects of co-administration of soy and vitamin D on some inflammatory, antioxidant and gut permeability markers in women with IBS. METHODS: In a randomized clinical trial, women (18-75 years of age) were randomly allocated into four groups to receive soy isoflavones (40 mg/day), cholecalciferol (50,000 IU/15 days), both soy isoflavones and cholecalciferol, or placebo for six weeks. The outcomes were plasma inflammatory markers, antioxidant status and fecal protease activity at week 0 and week 6. RESULTS: After the intervention, plasma inflammatory markers and fecal protease activity were reduced significantly in all treatment groups compared to the placebo group; however, there was no significant effect on antioxidant status. CONCLUSION: This study suggests combined supplementation of soy isoflavones and active vitamin D can improve some biochemical parameters regarding inflammation and intestinal permeability of IBS in women. TRIAL REGISTRATION: Clinical.Trials.govNCT02026518.