An interventional study of Fermented Poi in Gestational Diabetes Mellitus (GDM) and Pregnancy, sponsored by University of Hawaii. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by University of Hawaii · Not applicable, Interventional, and Prevention
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.
This investigator-initiated, non-randomized pilot study evaluates whether daily consumption of fermented poi during pregnancy can improve maternal microbiome composition and reduce risk factors related to gestational diabetes mellitus (GDM). The intervention will be implemented during the second trimester. After a brief dietary washout period (avoiding poi and other fermented foods/beverages as specified in the protocol), eligible participants will receive fermented poi from a single source meeting food safety standards and will be instructed to consume one pound per day for 28 consecutive days. Participants will also receive culturally tailored nutrition education delivered via secure text messaging throughout the intervention period.
Participants will complete study assessments at enrollment, baseline, mid-point, end of intervention, long term follow-up in third trimester. Maternal microbiome outcomes will be assessed using self-collected vaginal swabs (with optional self-collection of oral and rectal swabs, if applicable). Samples will be labeled with a study identification code and returned to the study team using approved procedures. Study staff will collect anthropometrics and blood pressure at scheduled visits. Participants will complete questionnaires related to pregnancy characteristics, psychosocial and cultural factors, and intervention acceptability and feasibility. Dietary intake will also be assessed using a mobile food record and questionnaire-based measures during the study period. With participant authorization, information on GDM diagnosis and labor and delivery outcomes will be obtained from the participant's health care provider.
Study outcomes will be compared with matched controls derived from an existing cohort with similar characteristics and no or low poi consumption. Findings from this pilot study will inform feasibility, procedures, and effect-size estimates to support the design of a larger culturally grounded dietary intervention for GDM prevention.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 50 is below the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →University of Hawaii is the lead sponsor of 97 studies on the registry; 21 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Daily consumption of fermented poi for 4 weeks during the second trimester.
Other: Fermented Poi
Participants consume one pound of fermented poi daily for 28 days.
Maternal microbial composition at the end of the intervention
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.
Time frame: Baseline and 4 weeks
Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi
Identification of whether maternal microbial composition is associated with the bacterial taxonomic profile of the fermented poi provided during the study.
Time frame: 4 weeks
Diet quality score (Food Frequency Questionnaire)
Change in diet quality score as measured by the Food Frequency Questionnaire, comparing participants who completed the poi intervention with matched controls.
Time frame: Baseline and 4 weeks
Gestational weight gain
Change in maternal weight (kg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls
Time frame: Baseline and 4 weeks
Blood pressure
Change in systolic and diastolic blood pressure (mmHg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls
Time frame: Baseline and 4 weeks
Gestational diabetes mellitus (GDM) diagnosis
Proportion of participants with a Gestational diabetes mellitus (GDM) diagnosis (yes/no) by post-intervention, comparing participants who received the poi intervention with matched controls
Time frame: By post-intervention (no later than 27 weeks gestation)
Acceptability score (Theoretical Framework of Acceptability [TFA] questionnaire)
Acceptability score as measured by the Theoretical Framework of Acceptability (TFA) questionnaire (e.g., mean score), assessed at post-intervention.
Time frame: 4 weeks
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 7 months after the start.
Of 307 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 7 months is below that.
Counting every sponsor, half of 310 studies reached it within 28 months; a quarter within 13 and three quarters within 48.
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University of Hawaii