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Diabetes, Insulin, Gut, Enteric Supplementation Trial

RecruitingNAAges 19 Years - anyFemaleUniversity of New Brunswick
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In plain words

What the trial is, and whether it could suit you

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 r

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Kefir
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Where

1 site
University Of New Brunswick
Fredericton, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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