The purpose of this study is to assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for gestational diabetes, and on child's weight and height at birth and 6 weeks of life.
Evidence from animal studies, human observational studies, and some randomized controlled trials has suggested that soy protein and isoflavones have beneficial effects on lipid and glucose metabolism. Additionally, soy isoflavones can diffuse across the placenta, enter fetal circulation and potentially reduce the susceptibility to cardiometabolic disorders in adulthood. Given the high prevalence of GDM and its serious health consequences for women and their children, and likely health benefits of soy protein and isoflavones on a panel of metabolic parameters, the role of maternal supplementation of soy protein and isoflavones for prevention of GDM and/or minimization of GDM severity in mothers and for improving health indicators in their offspring merits investigation. This study will provide new and essential information about the efficacy and feasibility of using soy-based whole foods to prevent and manage gestational diabetes development. This study will be a randomized, placebo-controlled trial. Forty pregnant women at high risk for gestational diabetes will be recruited from the obstetrics services at the Melrose Wakefield Hospital and Tufts Medical Center, and randomized to receive soy-based foods or minimize soy intake, from the 16th gestational week to birth. To measure participants' compliance with the treatment, the study will use three methods: (1) monthly telephone interview about adherence to the treatment; (2) daily soy food intake log; and (3) serum isoflavone concentrations. To evaluate the effects of soy supplementation on GDM, the study will collect blood samples to measure glucose, insulin, HbA1c, and lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol ). The study will also measure weight and body composition of participating pregnant women and the participants' respective children's weight, length and body composition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Women in the intervention group are asked to eat a combination of soy foods that contain about 25 grams of protein and 60-75 milligrams of isoflavones per day, from the 16th gestational week to birth. A registered dietitian will instruct them to incorporate the soy foods into their daily diet.
Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake.
Tufts Medical Center
Boston, Massachusetts, United States
Number of Participants With Adverse Events That Are Related to Treatment
The first aim of this study is to determine the safety of soy supplementation during pregnancy. This will be assessed by the number of participants who reported adverse events that are related to the study treatment.
Time frame: From enrollment through study completion, an average of 30 weeks or 210 days.
Effects of Soy Intake on Triglycerides (TG)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Triglycerides (TG) is one of the measurements of lipid metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Total Cholesterol (TC)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Total cholesterol (TC) is a measurement of lipid metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on High-density Lipoprotein Cholesterol (HDL-C)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. High-density lipoprotein cholesterol (HDL-C) is a measurement of lipid metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Free Fatty Acid (FFA)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Free fatty acid (FFA) is a measurement of lipid metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
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Effects of Soy Intake on Fasting Glucose
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Fasting glucose is a measurement of glucose metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Insulin
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Fasting insulin is a measurement of glucose metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Hemoglobin A1c (HbA1c)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. Hemoglobin A1c (HbA1c) is a measurement of glucose metabolism.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on C-reactive Protein (CRP)
The second aim of this study is to assess the effects of soy intake during pregnancy on glucose and lipid metabolism, and inflammation. C-reactive protein (CRP) is a measurement of inflammation.
Time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum