Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes

Objective: The aim of this study is to determine the effects of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes. Study design: parallel single-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with preeclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either soy-protein (intervention group: n=30) or the standard diet (control group: n=30). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (September 5, 2014-Februray 4, 2015). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH). Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.

Kashan University of Medical Sciences