Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:05 AM
Study NCT ID:
NCT07446205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-04', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diet quality score (Food Frequency Questionnaire)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Change in diet quality score as measured by the Food Frequency Questionnaire, comparing participants who completed the poi intervention with matched controls.'}, {'measure': 'Gestational weight gain', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Change in maternal weight (kg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Change in systolic and diastolic blood pressure (mmHg) from baseline to post-intervention, comparing participants who received the poi intervention with matched controls'}, {'measure': 'Gestational diabetes mellitus (GDM) diagnosis', 'timeFrame': 'By post-intervention (no later than 27 weeks gestation)', 'description': 'Proportion of participants with a Gestational diabetes mellitus (GDM) diagnosis (yes/no) by post-intervention, comparing participants who received the poi intervention with matched controls'}, {'measure': 'Acceptability score (Theoretical Framework of Acceptability [TFA] questionnaire)', 'timeFrame': '4 weeks', 'description': 'Acceptability score as measured by the Theoretical Framework of Acceptability (TFA) questionnaire (e.g., mean score), assessed at post-intervention.'}], 'primaryOutcomes': [{'measure': 'Maternal microbial composition at the end of the intervention', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Maternal microbial composition and its association with the bacterial taxonomic profile of fermented poi', 'timeFrame': '4 weeks', 'description': 'Identification of whether maternal microbial composition is associated with the bacterial taxonomic profile of the fermented poi provided during the study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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)'], 'conditions': ['Gestational Diabetes Mellitus (GDM)', 'Pregnancy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "PMID: 15712767 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"}, {'type': 'BACKGROUND', 'citation': 'PMID: 34328109 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.'}, {'type': 'BACKGROUND', 'citation': 'PMID: 28930173 Baião DDS, de Freitas CS, Gomes LP, da Silva D, Correa ACNTF, Pereira PR, Del Aguila EM, 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.'}, {'type': 'BACKGROUND', 'citation': 'PMID: 28118127 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.'}, {'type': 'BACKGROUND', 'citation': 'PMID: 37563289 Jenkins DJ, Woolston BM, Hood-Pishchany MI, Pelayo P, Konopaski AN, Peters MQ, 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.'}, {'type': 'BACKGROUND', 'citation': 'PMID: 37764061 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.'}, {'type': 'BACKGROUND', 'citation': 'Cho JJ, Yamakawa RA, Hollyer J. Hawaiian Kalo, Past and Future. Sustain Agric Univ Hawaii Manoa CTAHR. Published online 2007.'}, {'type': 'BACKGROUND', 'citation': "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"}, {'type': 'BACKGROUND', 'citation': '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;81(3):58-70.'}, {'type': 'BACKGROUND', 'citation': 'Institute of Medicine and National Research Council. Weight Gain During Pregnancy: Reexamining the Guidelines. (Rasmussen KM, Yaktine AL, eds.). National Academies Press (US); 2009. Accessed February 25, 2025. http://www.ncbi.nlm.nih.gov/books/NBK32813'}, {'pmid': '38435884', 'type': 'BACKGROUND', 'citation': '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': '30843102', 'type': 'BACKGROUND', 'citation': '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': '32725280', 'type': 'BACKGROUND', 'citation': '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': '37664380', 'type': 'BACKGROUND', 'citation': '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': '28637892', 'type': 'BACKGROUND', 'citation': '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': '38078586', 'type': 'BACKGROUND', 'citation': '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': '38812661', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants 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.\n\nStudy 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be at least 10 weeks into their pregnancy\n* have no pre-existing health conditions\n* Be able to read and write in English\n* be at least18 years of age\n* Own a smartphone\n* Live on the windward side of O'ahu\n* Be able to complete study activities\n\nExclusion Criteria:\n\n* Less than 10 weeks pregnant or already in third trimester\n* Have pre-existing health conditions\n* Not able to read and write in English\n* Under 18 years of age\n* Do not own a smartphone\n* Do not live on the windward side of O'ahu\n* Unable to complete study activities"}, 'identificationModule': {'nctId': 'NCT07446205', 'briefTitle': 'Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk', 'orgStudyIdInfo': {'id': 'REVILLA-2025-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Poi Intervention', 'description': 'Daily consumption of fermented poi for 4 weeks during the second trimester.', 'interventionNames': ['Other: Fermented Poi']}], 'interventions': [{'name': 'Fermented Poi', 'type': 'OTHER', 'description': 'Participants consume one pound of fermented poi daily for 28 days.', 'armGroupLabels': ['Poi Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'contacts': [{'name': 'Marie Kainoa Fialkowski Revilla', 'role': 'CONTACT', 'email': 'mariekf@hawaii.edu', 'phone': '808-564-5915'}], 'facility': "University of Hawai'i Cancer Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96826', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Pacific Health', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96795', 'city': 'Waimanalo', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Waimanalo Health Center', 'geoPoint': {'lat': 21.34614, 'lon': -157.7238}}], 'centralContacts': [{'name': 'Marie Kainoa Fialkowski Revilla', 'role': 'CONTACT', 'email': 'mariekf@hawaii.edu', 'phone': '808-564-5915'}, {'name': 'Tomomi Otaki', 'role': 'CONTACT', 'email': 'totaki@cc.hawaii.edu'}], 'overallOfficials': [{'name': 'Marie Kainoa Fialkowski Revilla', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hawaii'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}