Gestational Diabetes
Conditions
Keywords
Soy protein, isoflavones, gestational diabetes
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSoy Group (Soy Protein + Isoflavones)
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.
DIETARY_SUPPLEMENTControl Group (Minimize Soy Intake)
Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake.
Sponsors
University of Massachusetts, Worcester
Tufts University
Hallmark Health System
University of Massachusetts, Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>=18 years * ≤ 18 weeks of pregnancy * Singleton pregnancy * Have at least one of the risk factors for GDM, including overweight (BMI ≥ 25 kg/m2) before this pregnancy, first-degree relative with type-2 diabetes mellitus (T2DM), abnormal glucose tolerance/GDM in previous pregnancy, and/or history of macrosomia (birth weight ≥ 4,000 gram) in previous pregnancy * Being able and willing to give written informed consent.
Exclusion criteria
* Allergic to soy or milk products * Current smoker * Preexisting diabetes outside of pregnancy or other heath conditions that could affect glucose levels * Chronic or serious medical conditions such as hypertension, heart disease, stroke, chronic renal or hepatic disease, or malignant disease (by self-report and medical record review) * Use of medications that could interfere with insulin secretion or insulin sensitivity * Weight loss during this pregnancy more than 10% of pre-pregnancy body weight * Current severe nausea and/or vomiting (by self-report).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events That Are Related to Treatment | From enrollment through study completion, an average of 30 weeks or 210 days. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of Soy Intake on Total Cholesterol (TC) | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on High-density Lipoprotein Cholesterol (HDL-C) | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on Free Fatty Acid (FFA) | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on Triglycerides (TG) | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on Fasting Insulin | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on Hemoglobin A1c (HbA1c) | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on C-reactive Protein (CRP) | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
| Effects of Soy Intake on Fasting Glucose | Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum | 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. |
Countries
United States
Outcome results
None listed