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Diabetes, Insulin, Gut, Enteric Supplementation Trial

NCT07682077 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-02

No results posted yet for this study

Summary

Pregnancy is a critical window for metabolic health, and early changes in blood sugar regulation can increase the risk of gestational diabetes mellitus (GDM), which affects both maternal and infant health. At the same time, the maternal gut microbiome changes throughout pregnancy and may play a role in glucose metabolism and insulin resistance. Kefir, a fermented milk drink containing beneficial bacteria and yeasts, may be a simple dietary strategy to support metabolic health during pregnancy, but its role in preventing GDM has not been well studied.

This study will test whether drinking kefir daily from mid-pregnancy until routine GDM screening can improve glucose and insulin regulation, reduce the incidence of GDM, and modulate the maternal gut microbiome and metabolites, among other outcomes.

Pregnant individuals will be randomly assigned to either a kefir group or a control group receiving usual prenatal care. Researchers will collect blood glucose and insulin measures, dietary information, stool samples, and body composition data across pregnancy and postpartum to evaluate metabolic and microbiome-related changes.

As one of the first studies to examine kefir as an early pregnancy intervention for GDM prevention, this study will help clarify whether a practical, food-based approach can improve maternal metabolic health. The findings may support future nutrition strategies aimed at reducing GDM risk and improving pregnancy outcomes.

Conditions

  • Gestational Diabetes Mellitus (GDM)
  • Blood Glucose
  • Insulin Resistance, Diabetes
  • Gut Microbiome
  • Gut Metabolites

Interventions

DIETARY_SUPPLEMENT

Kefir

Kefir is a fermented dairy beverage containing a complex host of live bacteria and yeasts. In this study, participants assigned to the intervention group will consume 250 mL of kefir daily from approximately 14 weeks' gestation until the routine GDM screening window at 26-28 weeks' gestation. Participants will otherwise continue their usual prenatal care and habitual diet.

Sponsors & Collaborators

  • University of New Brunswick

    lead OTHER

Principal Investigators

  • Maryam Kebbe, PhD, CLC · University of New Brunswick

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2029-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07682077 on ClinicalTrials.gov