Recommended Diet for Gestational Diabetes

Phase-Based Progress Estimates
Long Island University, New York, NYGestational Diabetes+1 MoreRecommended Diet - Behavioral
18 - 45
What conditions do you have?

Study Summary

This trial is investigating the effects of diet on the microbiome of pregnant women and their connection to developing gestational diabetes mellitus.

Eligible Conditions
  • Gestational Diabetes
  • Pregnancy Complications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to approximately GA Week 37; up to approximately 12 weeks post birth

GA Week 24-28
Number of Participants at GA Week 24 Without an OGTT
Week 37
Gestational age at Delivery
Gestational age at First GDM
Gestational age at First Preeclampsia
Number of Participants With OGTT Oral Glucose Intolerance Test
Number of Participants With Preterm Birth
Number of Participants With live Birth
Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy
Week 37
Global Clinical Outcome (GCO) Rank Score (GCO Rank)

Trial Safety

Trial Design

4 Treatment Groups

ArmD_Post-diagnosis Gestational Diabetes Control
1 of 4
ArmC_Non- Pregnant Control
1 of 4
ArmA_Random Diet Control
1 of 4
ArmB_Recommended Diet Experimental
1 of 4

Active Control

Experimental Treatment

65 Total Participants · 4 Treatment Groups

Primary Treatment: Recommended Diet · No Placebo Group · Phase 1

ArmB_Recommended Diet Experimental
Experimental Group · 1 Intervention: Recommended Diet · Intervention Types: Behavioral
ArmD_Post-diagnosis Gestational Diabetes ControlNoIntervention Group · 1 Intervention: ArmD_Post-diagnosis Gestational Diabetes Control · Intervention Types:
ArmC_Non- Pregnant ControlNoIntervention Group · 1 Intervention: ArmC_Non- Pregnant Control · Intervention Types:
ArmA_Random Diet ControlNoIntervention Group · 1 Intervention: ArmA_Random Diet Control · Intervention Types:

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately ga week 37; up to approximately 12 weeks post birth

Who is running the clinical trial?

Long Island UniversityLead Sponsor
8 Previous Clinical Trials
504 Total Patients Enrolled
Xuebin Yin, MDPrincipal InvestigatorBROOKLYN INNOSEQ INC.
Joseph Morin, PhDStudy ChairLong Island University
Jeanmaire Molina, PhDPrincipal InvestigatorLong Island University

Eligibility Criteria

Age 18 - 45 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

How many individuals are enrolled in this investigation?

"Affirmative, the information on confirms that this medical trial is recruiting participants. This experiment was first posted on February 11th 2022 and its most recent update occurred two weeks later. The study seeks to enroll 65 individuals at a single site." - Anonymous Online Contributor

Unverified Answer

Are applicants aged 25 or older being considered for this experiment?

"Qualified participants must be between the age of 18 and 45 to partake in this research study." - Anonymous Online Contributor

Unverified Answer

Has Recommended Diet been endorsed by the FDA?

"Since the evidence is still limited, Recommended Diet has been given a safety rating of 1 on our internal scale. This score reflects that this trial is in its earliest stages and lacks substantial data regarding efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Are participants currently being sought for this clinical trial?

"The details on show that the recruitment process for this study is still active, commencing February 11th 2022 and revised February 23rd 2022." - Anonymous Online Contributor

Unverified Answer

Who qualifies for this medical research experiment?

"This medical trial is looking to enrol 65 individuals, aged 18-45 who have experienced adverse birth outcomes. Furthermore, potential participants need to meet the following criteria: female patients between 18-45 years old; Groups A/B/D must be verified pregnant through a blood test (medical documentation); Subgroups A1 and B1 are expecting mothers in their initial trimester of pregnancy; Subgroups A2 and B2 encompass expectant women during their second stage of gestation; Subgroups A3 and B3 include those that are carrying a child in their final semester of pregnancy; Group D comprises females whose OGTT scores were below par after" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.