Recruiting

Fermented Poi

Sponsor:

University of Hawaii

Code:

NCT07446205

Conditions

Gestational Diabetes Mellitus (GDM)

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fermented Poi

Study Details

Brief 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.

Conditions

Gestational Diabetes Mellitus (GDM)

Pregnancy

Study ID

NCT07446205

Start date

Jun 12, 2026

Status verified date

Apr, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Poi Intervention

Daily consumption of fermented poi for 4 weeks during the second trimester.

Interventions

Fermented Poi

Participants consume one pound of fermented poi daily for 28 days.

Primary outcome measure

  • Maternal microbial composition at the end of the intervention [ Time Frame: Baseline and 4 weeks ]

Central Contacts and Locations

Central contacts

Marie Kainoa Fialkowski Revilla

808-564-5915mariekf@hawaii.edu

Tomomi Otaki

totaki@cc.hawaii.edu

Locations

University of Hawai'i Cancer Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Marie Kainoa Fialkowski Revilla

808-564-5915mariekf@hawaii.edu

Hawaii Pacific Health

Recruiting

Honolulu, Hawaii, United States, 96826

Waimanalo Health Center

Recruiting

Waimanalo, Hawaii, United States, 96795

More Information

Sponsor

University of Hawaii

Last update posted

Jul 2, 2026

Last verified

Apr, 2026

Keywords

  • Gestational diabetes mellitus
  • Gestational Diabetes Mellitus (GDM)
  • Pregnancy
  • Maternal microbiome
  • Vaginal microbiome
  • Fermented foods
  • Poi
  • Dietary intervention
  • Nutrition education
  • Native Hawaiian and Pacific Islander (NHPI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2026-07-02.