Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
40 participants
INTERVENTIONAL
2013-01-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Soy Group (Soy Protein + Isoflavones)
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.
Control Group (Minimize Soy Intake)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≤ 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
* 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).
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Massachusetts, Worcester
OTHER
Tufts University
OTHER
Hallmark Health System
OTHER
University of Massachusetts, Boston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ling Shi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Boston
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tufts Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.