Fermented Poi for Gestational Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Marie Kainoa Fialkowski Revilla
Principal Investigator
University of Hawaii
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dietary Washout
Participants avoid poi and other fermented foods/beverages as specified in the protocol
Treatment
Participants consume one pound of fermented poi daily for 28 consecutive days, with culturally tailored nutrition education delivered via secure text messaging
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments in the third trimester
What Are the Treatments Tested in This Trial?
Interventions
- Fermented Poi
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Daily consumption of fermented poi for 4 weeks during the second trimester.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Hawaii
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.