Soy Supplementation and Gestational Diabetes

NCT02806739 | Completed Early Phase 1 DMC

• 1 other identifier: UL1TR000161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

Soy protein; isoflavones; gestational diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events That Are Related to Treatment

  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.

  From enrollment through study completion, an average of 30 weeks or 210 days.

Secondary Outcomes (8)

• 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 Total Cholesterol (TC)

  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 Free Fatty Acid (FFA)

  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

Study Arms (2)

Soy Group (Soy Protein + Isoflavones)

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.

Dietary Supplement: Soy Group (Soy Protein + Isoflavones)

Control Group (Minimize Soy Intake)

PLACEBO COMPARATOR

Control Group will avoid soy supplements and minimize intake of soy foods.

Dietary Supplement: Control Group (Minimize Soy Intake)

Interventions

Soy Group (Soy Protein + Isoflavones) DIETARY_SUPPLEMENT

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.

Soy Group (Soy Protein + Isoflavones)

Control Group (Minimize Soy Intake) DIETARY_SUPPLEMENT

Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake.

Control Group (Minimize Soy Intake)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Massachusetts, Boston: lead
• University of Massachusetts, Worcester: collaborator
• Tufts University: collaborator
• Hallmark Health System: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Soybean Proteins; Isoflavones; Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ling Shi, PhD

  University of Massachusetts, Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: June 21, 2016
• Study Start: January 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)