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Soy Supplementation and Gestational Diabetes

NCT02806739 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    collaborator OTHER

  • Tufts University

    collaborator OTHER

  • Hallmark Health System

    collaborator OTHER

  • University of Massachusetts, Boston

    lead OTHER

Principal Investigators

  • Ling Shi, PhD · University of Massachusetts, Boston

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02806739 on ClinicalTrials.gov