Overview

This trial has been completed.

Condition gestational diabetes
Treatments soy group (soy protein + isoflavones), control group (minimize soy intake)
Phase phase 0
Sponsor University of Massachusetts, Boston
Collaborator University of Massachusetts, Worcester
Start date January 2013
End date September 2016
Trial size 40 participants
Trial identifier NCT02806739, UL1TR000161

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Intervention: Soy-based whole foods containing about 25 grams of soy protein and 60-75 mg isoflavones. Intervention group will consume soy foods containing about 25 grams of soy protein and 60-75 mg isoflavones per day, from 16th gestational week to birth. Examples of soy foods that contain 25 grams of soy protein and 60-75mg isoflavones include: 2 cups of soy milk, or 12 ounces tofu, or a half cup of soy nuts. Women in the Soy Group will be instructed by a registered dietitian how to incorporate the soy foods into their daily diet.
soy 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.
(Placebo Comparator)
Control Group will avoid soy supplements and minimize intake of soy foods.
control group (minimize soy intake)
Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake.

Primary Outcomes

Measure
Number of Participants With Adverse Events That Are Related to Treatment
time frame: From enrollment through study completion, an average of 30 weeks or 210 days.

Secondary Outcomes

Measure
Effects of Soy Intake on Triglycerides (TG)
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Total Cholesterol (TC)
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)
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Free Fatty Acid (FFA)
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Glucose
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Fasting Insulin
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on Hemoglobin A1c (HbA1c)
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Effects of Soy Intake on C-reactive Protein (CRP)
time frame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum

Eligibility Criteria

Female participants at least 18 years old.

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).

Additional Information

Official title 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)
Principal investigator Ling Shi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Massachusetts, Boston.