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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Fermented Poi
  Participants consume one pound of fermented poi daily for 28 days.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• University of Hawai'i Cancer Center — Honolulu
• Hawaii Pacific Health — Honolulu
• Waimanalo Health Center — Waimanalo

Публикации

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

Идентификаторы

NCT: NCT07446205 · REVILLA-2025-3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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