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NCT02806739 · ClinicalTrials.gov registry record · Early Phase 1

Soy Supplementation and Gestational Diabetes

A Early Phase 1 study of Gestational Diabetes, sponsored by University of Massachusetts, Boston.

Completed
Registry status
Early Phase 1
Development phase
40
Enrollment target
1
Study location

NCT02806739: Completed Early Phase 1 study of Gestational Diabetes, sponsored by University of Massachusetts, Boston.

NCT02806739 is a Early Phase 1 study of Gestational Diabetes that has completed, run by University of Massachusetts, Boston. The registered enrollment target is 40 participants, below the 321-participant average among 41 other Gestational Diabetes trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02806739, a Early Phase 1 study of Gestational Diabetes, has completed, sponsored by University of Massachusetts, Boston.

COMPLETED
Registry status
Early Phase 1
Development phase
40 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Soy Group (Soy Protein + Isoflavones)
  • DIETARY_SUPPLEMENT Control Group (Minimize Soy Intake)

Study Locations (1)

Massachusetts

  • Tufts Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2013-01
Est. Completion 2016-09
Phase Early Phase 1

What the finished NCT02806739 record still lists

NCT02806739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 321-participant average among 41 other Gestational Diabetes trials with a reported enrollment target (88% lower).

The record links to 1 condition, with Gestational Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Soy Group (Soy Protein + Isoflavones) is the first listed.

NCT02806739 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02806739 about?

NCT02806739 is a clinical study titled "Soy Supplementation and Gestational Diabetes". 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 ...

What is the current status of trial NCT02806739?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2013-01. Estimated completion is 2016-09.

What conditions does trial NCT02806739 study?

This clinical trial studies the following conditions: Gestational Diabetes.

What interventions are being tested in trial NCT02806739?

The interventions under investigation include: Soy Group (Soy Protein + Isoflavones) (DIETARY_SUPPLEMENT), Control Group (Minimize Soy Intake) (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02806739?

This trial is sponsored by University of Massachusetts, Boston, which has 18 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02806739 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Gestational Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02806739's enrollment target sits among peer trials

40 28th of 41 higher than 9 of 41 other Gestational Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gestational Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02806739, the US trial registry maintained by the National Library of Medicine. NCT02806739 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.