50 Participants NeededMy employer runs this trial

Fermented Poi for Gestational Diabetes

Recruiting at 2 trial locations
MK
TO
Overseen ByTomomi Otaki
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Hawaii
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether eating fermented poi daily can reduce the risk of gestational diabetes and improve gut health in pregnant women. Researchers aim to determine if this traditional Hawaiian food can positively impact the maternal microbiome and overall pregnancy outcomes. Pregnant women between 10 and 24 weeks along, with no pre-existing health conditions, and residing on the windward side of O'ahu may qualify for this study. Participants will receive poi and nutrition education via text messages for four weeks. As an unphased trial, this study provides a unique opportunity to explore the benefits of a traditional diet on pregnancy health.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that fermented poi is safe for pregnant women?

Research has shown that fermented poi, a traditional Hawaiian food, might be safe and easy to digest. One study suggested that poi is gentle on the stomach and less likely to cause allergies. Another study highlighted that the fermentation process in poi reduces harmful bacteria, potentially making it safer to eat. While these findings are encouraging, they come from small studies, and larger studies are needed to confirm them. For those considering joining the trial, this information suggests that fermented poi may be a safe choice, but discussing any concerns with a doctor is always best.12345

Why are researchers excited about this trial?

Unlike the standard treatments for gestational diabetes, which often include insulin therapy and dietary modifications, fermented poi offers a unique approach. Fermented poi is a traditional Hawaiian food made from taro root, and it's packed with probiotics that may help regulate blood sugar levels naturally. Researchers are excited because this treatment could provide a dietary option with fewer side effects, potentially improving gut health while managing blood sugar levels. This natural intervention could pave the way for more holistic management of gestational diabetes.

What evidence suggests that fermented poi might be an effective treatment for gestational diabetes?

Research has shown that eating fermented foods can improve how the body handles sugar, such as lowering fasting blood sugar levels and enhancing insulin function. Some studies suggest that probiotics, the beneficial bacteria in certain foods, might help control blood sugar in people with gestational diabetes. Fermented poi, a naturally cultured food, is believed to support gut health, which is important during pregnancy. Although specific research on fermented poi for gestational diabetes is limited, its probiotic benefits could help maintain healthier blood sugar levels. In this trial, participants will consume fermented poi daily for four weeks during the second trimester, offering a promising option for managing or reducing the risk of gestational diabetes.25678

Who Is on the Research Team?

MK

Marie Kainoa Fialkowski Revilla

Principal Investigator

University of Hawaii

Are You a Good Fit for This Trial?

This trial is for pregnant women at least 18 years old, between about 10 and 24 weeks into pregnancy, who live on the windward side of O'ahu, can read and write in English, own a smartphone, have no pre-existing health conditions, and are able to complete study activities.

Inclusion Criteria

Be able to read and write in English
Live on the windward side of O'ahu
I am able to participate in all study activities.
See 4 more

Exclusion Criteria

Not able to read and write in English
Have pre-existing health conditions
Less than 10 weeks pregnant or already in third trimester
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Washout

Participants avoid poi and other fermented foods/beverages as specified in the protocol

1 week

Treatment

Participants consume one pound of fermented poi daily for 28 consecutive days, with culturally tailored nutrition education delivered via secure text messaging

4 weeks
Enrollment, baseline, mid-point, end of intervention visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments in the third trimester

Long-term follow-up in third trimester

What Are the Treatments Tested in This Trial?

Interventions

  • Fermented Poi

Trial Overview

The study tests if eating one pound of fermented poi daily for four weeks—along with nutrition education by text—can improve gut bacteria and lower gestational diabetes risk during pregnancy. Results will be compared to similar women not receiving poi.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Poi InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Hawaii

Lead Sponsor

Trials
122
Recruited
55,200+

Citations

(PDF) A non-dairy probiotic's (poi) influence on changing ...

Measurable outcomes included pre- and post-treatment microbiological fecal culture analyses. We found no significant differences in total bacterial counts ...

Impact of Natural Fermentation on Mineral Composition ... - PMC

Results: RS and NRS significantly increased in fermented poi, while mineral composition remained unaffected. Untargeted global metabolomic ...

Poi for Mama: a Pilot to Improve Maternal Microbiome and ...

This investigator-initiated, non-randomized pilot study evaluates the effect of daily consumption of fermented poi on the maternal microbiome and ...

The effect of probiotics on gestational diabetes mellitus - PMC

This analysis indicated that probiotics improved glycemic indices in GDM patients. The results revealed that probiotics reduce serum FBS, FBI, ...

Poi-Based, Low-Allergenic, Cultured Foods for the ...

It is proposed that hypoallergenic, easy to digest, naturally cultured poi, addresses the problem of how probiotics and nutrition is delivered to patients.

Poi for Mama: a Pilot to Improve Maternal Microbiome and ...

This study aims to inform the feasibility and design of a larger culturally grounded dietary intervention for gestational diabetes prevention.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40988566/

Probiotics and dietary fibre fermented milk ...

PFM reduced GDM risk by 55% compared with SC (OR = 0.45, 95% CI: 0.25-0.83). At the time of the oral glucose tolerance test (OGTT), median ...

Prenatal exposure to dietary levels of glyphosate disrupts ...

These results suggest that prenatal glyphosate exposure is associated with generation and dose-dependent shifts in host-microbe-metabolite ...