Diabetes, Insulin, Gut, Enteric Supplementation Trial

Starting soon · Not applicable

Conditions studied: Gestational Diabetes Mellitus (GDM), Blood Glucose, Insulin Resistance, Diabetes, Gut Microbiome, Gut Metabolites

In brief

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.

Key facts

Study ID: NCT07682077
Run by: University of New Brunswick
People needed: 60
Starts: 2026-06-01
Expected to finish: 2029-06-01
Last updated by the study team: 2026-07-02

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Full record on ClinicalTrials.gov

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