Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk

NCT07446205 | Recruiting DMC

• 1 other identifier: REVILLA-2025-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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

Pregnancy; Gestational Diabetes Mellitus (GDM)

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 4 weeks

Secondary Outcomes (1)

• Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi

  4 weeks

Other Outcomes (5)

• Diet quality score (Food Frequency Questionnaire)

  Baseline and 4 weeks

• Gestational weight gain

  Baseline and 4 weeks

• Blood pressure

  Baseline and 4 weeks

Study Arms (1)

Poi Intervention

EXPERIMENTAL

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

Other: Fermented Poi

Interventions

Fermented Poi OTHER

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

Poi Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (3)

University of Hawai'i Cancer Center

Honolulu, Hawaii, 96813, United States

RECRUITING

Hawaii Pacific Health

Honolulu, Hawaii, 96826, United States

RECRUITING

Waimanalo Health Center

Waimanalo, Hawaii, 96795, United States

RECRUITING

Related Publications (17)

• Brown AC, Shovic A, Ibrahim SA, Holck P, Huang A. A non-dairy probiotic's (poi) influence on changing the gastrointestinal tract's microflora environment. Altern Ther Health Med. 2005 Jan-Feb;11(1):58-64.

  PMID: 15712767 BACKGROUND

• Shahriari A, Karimi E, Shahriari M, Aslani N, Khooshideh M, Arab A. The effect of probiotic supplementation on the risk of gestational diabetes mellitus among high-risk pregnant women: A parallel double-blind, randomized, placebo-controlled clinical trial. Biomed Pharmacother. 2021 Sep;141:111915. doi: 10.1016/j.biopha.2021.111915. Epub 2021 Jul 10.

  PMID: 34328109 BACKGROUND

• Baiao DDS, de Freitas CS, Gomes LP, da Silva D, Correa ACNTF, Pereira PR, Aguila EMD, Paschoalin VMF. Polyphenols from Root, Tubercles and Grains Cropped in Brazil: Chemical and Nutritional Characterization and Their Effects on Human Health and Diseases. Nutrients. 2017 Sep 20;9(9):1044. doi: 10.3390/nu9091044.

  PMID: 28930173 BACKGROUND

• Lagisetty PA, Priyadarshini S, Terrell S, Hamati M, Landgraf J, Chopra V, Heisler M. Culturally Targeted Strategies for Diabetes Prevention in Minority Population. Diabetes Educ. 2017 Feb;43(1):54-77. doi: 10.1177/0145721716683811.

  PMID: 28118127 BACKGROUND

• Jenkins DJ, Woolston BM, Hood-Pishchany MI, Pelayo P, Konopaski AN, Quinn Peters M, France MT, Ravel J, Mitchell CM, Rakoff-Nahoum S, Whidbey C, Balskus EP. Bacterial amylases enable glycogen degradation by the vaginal microbiome. Nat Microbiol. 2023 Sep;8(9):1641-1652. doi: 10.1038/s41564-023-01447-2. Epub 2023 Aug 10.

  PMID: 37563289 BACKGROUND

• Dias S, Pheiffer C, Adam S. The Maternal Microbiome and Gestational Diabetes Mellitus: Cause and Effect. Microorganisms. 2023 Aug 31;11(9):2217. doi: 10.3390/microorganisms11092217.

  PMID: 37764061 BACKGROUND

• Cho JJ, Yamakawa RA, Hollyer J. Hawaiian Kalo, Past and Future. Sustain Agric Univ Hawaii Manoa CTAHR. Published online 2007.

  BACKGROUND

• Miller DE. Glycemic Index of Taro Corm and Poi. M.S. University of Hawai'i at Manoa; 2002. Accessed February 25, 2025. https://www.proquest.com/docview/2572554294/abstract/AEE2EEA85A341C8PQ

  BACKGROUND

• Kawamura MY, Mau MK, Soon R, Yamasato K. A Scoping Review on Gestational Diabetes in Hawai'i: A "Window of Opportunity" to Address Intergenerational Risk for Type 2 Diabetes Mellitus. Hawaii J Health Soc Welf. 2022 Mar;81(3):58-70.

  PMID: 35261986 BACKGROUND

• Institute of Medicine (US) and National Research Council (US) Committee to Reexamine IOM Pregnancy Weight Guidelines; Rasmussen KM, Yaktine AL, editors. Weight Gain During Pregnancy: Reexamining the Guidelines. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32813/

  PMID: 20669500 BACKGROUND

• Slouha E, Gates KM, Al-Geizi H, Baah E, Clunes LA, Kollias TF. The Relationship Between Gestational Diabetes and the Risk of Cancer: A Systematic Review. Cureus. 2024 Jan 31;16(1):e53328. doi: 10.7759/cureus.53328. eCollection 2024 Jan.

  PMID: 38435884 BACKGROUND

• Kramer CK, Campbell S, Retnakaran R. Gestational diabetes and the risk of cardiovascular disease in women: a systematic review and meta-analysis. Diabetologia. 2019 Jun;62(6):905-914. doi: 10.1007/s00125-019-4840-2. Epub 2019 Mar 7.

  PMID: 30843102 BACKGROUND

• Auvinen AM, Luiro K, Jokelainen J, Jarvela I, Knip M, Auvinen J, Tapanainen JS. Type 1 and type 2 diabetes after gestational diabetes: a 23 year cohort study. Diabetologia. 2020 Oct;63(10):2123-2128. doi: 10.1007/s00125-020-05215-3. Epub 2020 Jul 29.

  PMID: 32725280 BACKGROUND

• Ikoh Rph CL, Tang Tinong R. The Incidence and Management of Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus. Cureus. 2023 Aug 31;15(8):e44468. doi: 10.7759/cureus.44468. eCollection 2023 Aug.

  PMID: 37664380 BACKGROUND

• Sonne DP, Hemmingsen B. Comment on American Diabetes Association. Standards of Medical Care in Diabetes-2017. Diabetes Care 2017;40(Suppl. 1):S1-S135. Diabetes Care. 2017 Jul;40(7):e92-e93. doi: 10.2337/dc17-0299. No abstract available.

  PMID: 28637892 BACKGROUND

• American Diabetes Association Professional Practice Committee. 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S111-S125. doi: 10.2337/dc24-S006.

  PMID: 38078586 BACKGROUND

• Calvo MJ, Parra H, Santeliz R, Bautista J, Luzardo E, Villasmil N, Martinez MS, Chacin M, Cano C, Checa-Ros A, D'Marco L, Bermudez V, De Sanctis JB. The Placental Role in Gestational Diabetes Mellitus: A Molecular Perspective. touchREV Endocrinol. 2024 Apr;20(1):10-18. doi: 10.17925/EE.2024.20.1.5. Epub 2024 Mar 14.

  PMID: 38812661 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Gonadal Disorders

Study Officials

• Marie Kainoa Fialkowski Revilla

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Kainoa Fialkowski Revilla

CONTACT

808-564-5915; mariekf@hawaii.edu

Tomomi Otaki

CONTACT

totaki@cc.hawaii.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: March 3, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)