Gestational Diabetes Mellitus (GDM)NCT07446205
Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
A study testing Fermented Poi in people with Gestational Diabetes Mellitus (GDM) and Pregnancy, run by University of Hawaii at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Pregnancy
- What is being tested?
- Fermented Poi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Jun 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tomomi Otaki contact
United States3 sites, 3 recruiting
- Recruiting
University of Hawai'i Cancer Center
Honolulu, Hawaii, 96813
Marie Kainoa Fialkowski Revilla, 808-564-5915, mariekf@hawaii.edu
- Recruiting
Hawaii Pacific Health
Honolulu, Hawaii, 96826
- Recruiting
Waimanalo Health Center
Waimanalo, Hawaii, 96795
About this study
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.
Read the detailed description
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.
- Conditions
- Gestational Diabetes Mellitus (GDM), Pregnancy
- Being tested
- Fermented Poi
- 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)
- Medical subject headings
- Diabetes, Gestational, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented PoiOther
Participants consume one pound of fermented poi daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Poi Intervention | Experimental | Daily consumption of fermented poi for 4 weeks during the second trimester. Receives: Other: Fermented Poi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start12 Jun 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Kainoa Fialkowski Revilla, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446205
- Sponsor's protocol ID
- REVILLA-2025-3
- Status last verified
- Apr 2026
- First submitted
- 4 Feb 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15712767Shahriari 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.
PubMed 34328109Baiao 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.
PubMed 28930173Lagisetty 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.
PubMed 28118127Jenkins 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.
PubMed 37563289Dias 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.
PubMed 37764061Cho 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
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.
PubMed 35261986Institute 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/
PubMed 20669500Slouha 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.
PubMed 38435884Kramer 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.
PubMed 30843102Auvinen 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.
PubMed 32725280Ikoh 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.
PubMed 37664380Sonne 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.
PubMed 28637892
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
- ClinicalTrials.gov ID
- NCT07446205
- Acronym / sponsor ID
- REVILLA-2025-3
- Conditions
- Gestational Diabetes Mellitus (GDM), Pregnancy
- Keywords
- Gestational diabetes mellitus, Gestational Diabetes Mellitus (GDM), Pregnancy, Maternal microbiome, Vaginal microbiome, Fermented foods, Poi, Dietary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poi Intervention | Experimental | Other: Fermented PoiDaily consumption of fermented poi for 4 weeks during the second trimester. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented PoiParticipants consume one pound of fermented poi daily for 28 days. | Other | Poi Intervention |
Primary outcome
Maternal microbial composition at the end of the intervention
Time frame: Baseline and 4 weeks
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.
1 secondary outcome
Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 15712767Brown 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.
- Background: PubMed 34328109Shahriari 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.
- Background: PubMed 28930173Baiao 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.
- Background: PubMed 28118127Lagisetty 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.
- Background: PubMed 37563289Jenkins 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.
- Background: PubMed 37764061Dias 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.
- BackgroundCho JJ, Yamakawa RA, Hollyer J. Hawaiian Kalo, Past and Future. Sustain Agric Univ Hawaii Manoa CTAHR. Published online 2007.
- BackgroundMiller 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: PubMed 35261986Kawamura 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.
- Background: PubMed 20669500Institute 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/
- Background: PubMed 38435884Slouha 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.
- Background: PubMed 30843102Kramer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomomi Otaki contact
Marie Kainoa Fialkowski Revilla principal investigator
University of Hawaii
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Poi in people with Gestational Diabetes Mellitus (GDM) and Pregnancy, run by University of Hawaii at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Kainoa Fialkowski Revilla (808-564-5915, mariekf@hawaii.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal microbial composition at the end of the intervention (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07446205, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.