A Pilot Study of Soy Protein and Isoflavone Supplementation for Improved Glucose Metabolism and Lipid Profiles in Pregnant Women at High Risk for Gestational Diabetes Mellitus (GDM)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events That Are Related to Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Number of Participants With Adverse Events That Are Related to Treatment
时间窗: 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.
次要结局
- Effects of Soy Intake on Triglycerides (TG)(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on Free Fatty Acid (FFA)(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on Fasting Insulin(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on Total Cholesterol (TC)(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on Hemoglobin A1c (HbA1c)(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on C-reactive Protein (CRP)(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on High-density Lipoprotein Cholesterol (HDL-C)(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)
- Effects of Soy Intake on Fasting Glucose(Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum)