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Recommended Diet for Gestational Diabetes

Phase 1
Recruiting
Led By Jeanmaire Molina, PhD
Research Sponsored by Long Island University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women between the age of 18-45 Groups A and B have to be confirmed pregnant by blood test (confirmed by medical records) Subgroups A1 and B1 are pregnant women in their first trimester Subgroups A2 and B2 are pregnant women in their second trimester Subgroups A3 and B3 are pregnant women in their third trimester
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately ga week 37; up to approximately 12 weeks post birth
Awards & highlights

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately ga week 37; up to approximately 12 weeks post birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately ga week 37; up to approximately 12 weeks post birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Gestational Diabetes Mellitus (GDM) Week 8 to post-delivery throughout their entire pregnancy
Secondary outcome measures
Gestational age at Delivery
Gestational age at First GDM
Gestational age at First Preeclampsia
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: ArmB_Recommended Diet ExperimentalExperimental Treatment1 Intervention
This group is composed of pregnant women divided into 3 subgroups, one of each trimester. This arm will be required to provide 2 fecal samples. One at the start of recruitment, and one at the end of a 4-week period. Their diet will be altered and they will received pre-selected food items to consume during this period. The Recommended Diet is designed by a Registered Dietician to provide caloric and nutritional intake
Group II: ArmD_Post-diagnosis Gestational Diabetes ControlActive Control1 Intervention
This group is composed of pregnant women diagnosed with GDM in their current pregnancy through Oral Glucose Tolerance Test. This arm will be required to provide 1 fecal sample. It will be used as comparison of the microbiome of GDM women.
Group III: ArmC_Non- Pregnant ControlActive Control1 Intervention
This group is composed of non-pregnant women. This arm will be required to provide 1 fecal sample. It will be used as a baseline for comparison of the microbiome
Group IV: ArmA_Random Diet ControlActive Control1 Intervention
This group is composed of pregnant women divided into 3 subgroups, one of each trimester. This arm will be required to provide 2 fecal samples. One at the start of recruitment, and one at the end of a 4-week period where they log the food items they consume. Their diet will not be altered as they are required to log their regular diet.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Long Island UniversityLead Sponsor
8 Previous Clinical Trials
504 Total Patients Enrolled
BROOKLYN INNOSEQ INC.UNKNOWN
Joseph Morin, PhDStudy ChairLong Island University
~19 spots leftby May 2025
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