Diabetes, Insulin, Gut, Enteric Supplementation Trial (DIGEST)

Pregnancy is characterized by progressive metabolic and hormonal changes, including increasing insulin resistance, particularly in the second trimester. At the same time, the maternal gut microbiome undergoes substantial shifts across gestation and may contribute to glucose metabolism, insulin resistance, and inflammation. Dietary strategies that can favorably influence the gut microbiome and metabolic health during pregnancy may represent a promising approach to reduce GDM risk. Kefir, a fermented dairy beverage containing a complex consortium of beneficial bacteria and yeasts, has shown potential for improving glycemic control and modulating the gut microbiome in non-pregnant populations, but its preventive role for GDM has not been well established.

The primary aims of this study are to determine whether daily kefir consumption initiated in mid-pregnancy can improve maternal glucose and insulin regulation. Secondary aims will examine whether kefir consumption reduces the incidence of GDM, beneficially modulates maternal gut microbiome and metabolite profiles, and alters postpartum health measures such as breastmilk composition and infant anthropometrics.

This randomized controlled trial in the PEADS Lab at the University of New Brunswick will assign pregnant participants to either a daily kefir intervention group or a control group receiving usual prenatal care. Participants in the intervention group will consume 250 mL of kefir daily beginning at approximately 14 weeks' gestation and continuing until the routine GDM screening window at 26-28 weeks' gestation. Those in the control group will continue with their usual care and habitual diet, but will be asked not to consume kefir for the duration of the study. Participants will attend study visits across pregnancy and postpartum, during which researchers will collect dietary recalls, anthropometric and body composition measurements, blood pressure, and stool and breastmilk samples. Fasted clinical bloodwork will be used to assess glucose and insulin-related outcomes, including screening for GDM.

The primary outcomes are between-group differences in maternal glycemic and insulinemic measures. Secondary outcomes include the incidence of GDM, changes in gut microbial diversity, composition, and metabolites such as short-chain fatty acid concentrations, maternal body composition, breastmilk composition, and infant anthropometrics. Assessments will occur at baseline (~14 weeks gestation), at the GDM screening windows (18-20 weeks for high-risk and 26-28 weeks for low-risk), and one month postpartum.

Pregnancy represents a critical opportunity for early prevention of metabolic complications that can affect lifelong maternal and child health. This study is the first to evaluate kefir as a practical, food-based intervention for GDM prevention, while also exploring the role of the gut microbiome as a potential modifiable mechanism. By integrating clinical, dietary, and microbiome data, this trial will help generate evidence to support accessible nutrition strategies that may improve pregnancy outcomes and inform future maternal health recommendations.