Pilot testing daily fermented poi to improve the maternal microbiome and lower gestational diabetes risk
Official title: Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
Run by University of Hawaii · NCT07446205 · Data updated 2026-11-12
This pilot will test whether eating one pound of fermented poi daily for four weeks can change the maternal microbiome and lower gestational diabetes risk for pregnant people in mid-pregnancy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | University of Hawaii Academic / other |
| Locations | 3 sites (Honolulu, Hawaii and 2 other locations) |
| Status | Recruiting |
| Started | June 12, 2026 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07446205 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant people at least 10 weeks into pregnancy but not yet in the third trimester (roughly early-to-mid second trimester), age 18 or older, with no major pre-existing health conditions, who live on the windward side of Oʻahu, can read and write English, own a smartphone, and can complete study activities.
✕Probably not a fit
People with pre-existing health conditions (including pregestational diabetes), those already in the third trimester, or those unable or unwilling to eat poi, use a smartphone, or attend local visits are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This non-randomized pilot will enroll 50 pregnant participants in the second trimester to consume one pound of fermented poi daily for 28 days while receiving culturally tailored nutrition education via secure text messaging. Participants will complete baseline, mid-point, end-of-intervention, and third-trimester follow-up visits with collection of self-collected vaginal swabs and optional oral and rectal swabs, plus anthropometrics, blood pressure, dietary records, and questionnaires. Outcomes will include changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes compared with matched controls from an existing cohort. The study is designed to test feasibility and generate data to inform a larger, culturally grounded dietary intervention for gestational diabetes prevention.
Why it matters
Potential benefit: If successful, this could provide a simple, culturally grounded dietary option to improve maternal microbiome health and reduce risk factors for gestational diabetes.
How similar studies have gone: Prior research on fermented foods and probiotics shows some microbiome and metabolic effects but pregnancy-specific evidence is limited and mixed, making this culturally specific poi intervention largely novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be at least 10 weeks into their pregnancy * have no pre-existing health conditions * Be able to read and write in English * be at least18 years of age * Own a smartphone * Live on the windward side of O'ahu * Be able to complete study activities Exclusion Criteria: * Less than 10 weeks pregnant or already in third trimester * Have pre-existing health conditions * Not able to read and write in English * Under 18 years of age * Do not own a smartphone * Do not live on the windward side of O'ahu * Unable to complete study activities
Where it's running
-
University of Hawai'i Cancer Center
Honolulu, Hawaii, United States Recruiting -
Hawaii Pacific Health
Honolulu, Hawaii, United States Recruiting -
Waimanalo Health Center
Waimanalo, Hawaii, United States Recruiting
Study contacts
- Principal investigator: Marie Kainoa Fialkowski Revilla — University of Hawaii
- Study coordinator: Marie Kainoa Fialkowski Revilla
- Email: mariekf@hawaii.edu
- Phone: 808-564-5915
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.