Clinical Trial

Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk

Recruiting
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Summary
This investigator-initiated, non-randomized pilot study evaluates the effect of daily consumption of fermented poi on the maternal microbiome and gestational diabetes risk during pregnancy. Fifty pregnant participants between approximately 12 and 24 weeks of gestation will receive one pound of poi daily for four weeks, accompanied by culturally tailored nutrition education delivered via secure text messaging. Changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes will be assessed and compared with matched controls derived from an existing cohort. This study aims to inform the feasibility and design of a larger culturally grounded dietary intervention for gestational diabetes prevention.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-24
Trial Details
NCT Number NCT07446205
Lead Sponsor University of Hawaii
Conditions Gestational Diabetes Mellitus (GDM), Pregnancy
Enrollment 50 participants
Start Date 2026-06-12
Primary Completion 2027-01-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-02