Clinical trial NCT02806739: Soy Supplementation and Gestational Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gestational Diabetes
Keywords: Soy protein
isoflavones
gestational diabetes
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Tufts University
name: Hallmark Health System
First posted: 2016-06-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Adverse Events That Are Related to Treatment
timeFrame: From enrollment through study completion, an average of 30 weeks or 210 days.
Secondary outcomes:
measure: Effects of Soy Intake on Triglycerides (TG)
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on Total Cholesterol (TC)
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on Free Fatty Acid (FFA)
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on Fasting Glucose
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on Fasting Insulin
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on Hemoglobin A1c (HbA1c)
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
measure: Effects of Soy Intake on C-reactive Protein (CRP)
timeFrame: Baseline (14 weeks of pregnancy), 28 weeks of pregnancy, and 6 week postpartum
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Boston
name: Ling Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: