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NCT07446205 · ClinicalTrials.gov registry record · NA
Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
A NA study, sponsored by University of Hawaii.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT07446205: Recruiting NA study, sponsored by University of Hawaii.
NCT07446205 is a NA study that is actively recruiting participants, run by University of Hawaii. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07446205, a NA study, is actively recruiting participants, sponsored by University of Hawaii.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Primary Outcome
Assessment of changes in maternal microbial composition, including the relative abundance of beneficial species such as Lactobacilli crispatus, by the end of the 4-week poi intervention.
Interventions
- OTHER Fermented Poi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-06-12 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
What NCT07446205 shows while recruiting
NCT07446205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Fermented Poi is the first listed.
NCT07446205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07446205 about?
NCT07446205 is a clinical study titled "Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk". 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 d...
What is the current status of trial NCT07446205?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2026-06-12. Estimated completion is 2027-01-31.
What interventions are being tested in trial NCT07446205?
The interventions under investigation include: Fermented Poi (OTHER).
Who is sponsoring clinical trial NCT07446205?
This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07446205's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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