Recruiting

Kefir

Sponsor:

University of New Brunswick

Code:

NCT07682077

Conditions

Gestational Diabetes Mellitus (GDM)

Blood Glucose

Insulin Resistance, Diabetes

Gut Microbiome

Gut Metabolites

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Interventions

Kefir

Study Details

Brief 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

Study ID

NCT07682077

Start date

Jun 1, 2026

Status verified date

Sep, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant individual with a singleton pregnancy
  • 19 years and older of age
  • Gestational age 14,3 weeks or less at enrolment
  • Able and willing to attend four in-person study visits at the PEADS Laboratory: baseline, 18-20 weeks' gestation, 26-28 weeks' gestation, and 1 month postpartum
  • Willing and able to comply with study group assignment, including daily consumption of 250 mL of kefir if assigned to the intervention group
  • Willing to avoid kefir consumption until completion of the 26-28-week study visit if assigned to the control group
  • Willing to provide required biological and clinical samples, including stool samples and glucose/insulin data, according to the study protocol
  • No probiotic, prebiotic, synbiotic, or antibiotic use during the first trimester or at enrollment
  • Not currently consuming probiotic, prebiotic, synbiotic, or antiobiotic supplements
  • Willing to avoid probiotic, prebiotic, and synbiotic supplements until completion of the 26-28-week study visit.
  • Does not engage in regular moderate-to-vigorous physical activity
  • No recent or active infectious illness or significant gastrointestinal symptoms, including diarrhea or constipation in the first trimester of pregnancy.
  • No history of bariatric surgery
  • Able to communicate in English or French
  • Currently living in Fredericton, New Brunswick, and not planning to relocate before the 1-month postpartum visit

Exclusion Criteria:

  • Pre-existing metabolic disease affecting glucose regulation, including type 1 diabetes or type 2 diabetes
  • Current use or first trimester use of medications known to alter glucose metabolism, such as metformin or semaglutide
  • Gastrointestinal or inflammatory disease, including Crohn's disease, ulcerative colitis, celiac disease, or diagnosed irritable bowel syndrome
  • Allergy, intolerance, or other contraindication to dairy or components of kefir

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Daily Kefir Intake

Participants assigned to this group will consume 250 mL of kefir daily beginning at approximately 14 weeks' gestation through the routine GDM screening window at 26-28 weeks' gestation. Participants will otherwise continue their usual prenatal care and habitual diet.

no intervention: Control Group

Participants assigned to this group will continue their usual prenatal care and habitual diet beginning at approximately 14 weeks' gestation through the routine GDM screening window at 26-28 weeks' gestation. Participants will not consume the study kefir.

Interventions

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.

Primary outcome measure

  • Maternal Fasting Glucose Concentrations [ Time Frame: Baseline, 18-20 weeks' gestation, 26-28 weeks' gestation ]
  • Maternal hbA1c Concentrations [ Time Frame: Baseline, 18-20 weeks' gestation, 26-28 weeks' gestation ]
  • Maternal Fasting Insulin Concentrations [ Time Frame: 18-20 weeks' gestation, 26-28 weeks' gestation ]
  • Maternal Insulin Area Under the Curve [ Time Frame: 18-20 weeks' gestation, 26-28 weeks' gestation ]
  • Maternal Whole-Body Insulin Sensitivity [ Time Frame: 18-20 weeks' gestation, 26-28 weeks' gestation ]

Central Contacts and Locations

Central contacts

Maryam Kebbe, PhD, CLC, CMSS

15064516872maryam.kebbe@unb.ca

Locations

University Of New Brunswick

Recruiting

Fredericton, New Brunswick, Canada, E3B 5A3

Contacts

Maryam Kebbe, PhD, CLC, CMSS

15064516872maryam.kebbe@unb.ca

More Information

Sponsor

University of New Brunswick

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Keywords

  • Gestational diabetes mellitus
  • Pregnancy
  • Probiotics
  • Kefir
  • Gut microbiome
  • Gut metabolites
  • Glucose
  • Insulin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by University of New Brunswick on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.