Milk for Diabetes Prevention Comparing Lactose-Containing and Lactose-Free Milk Effects on Gut Microbiome and Glycemic Outcomes in Adults with Lactase Non-Persistence and Pre-Diabetes

What this Trial Is About

Researchers are studying adults with lactase non-persistence (LNP), a genetic condition that causes lactose intolerance due to low lactase enzyme levels. This trial aims to evaluate the effects of drinking lactose-containing versus lactose-free milk on gut bacteria and blood sugar control in people with pre-diabetes who normally consume at least one cup of milk daily. The study is based on findings suggesting milk intake may reduce type 2 diabetes risk in LNP individuals by altering gut microbiota and related metabolites. The study begins with a 2-week milk washout period, after which participants are randomly assigned to drink either lactose-containing (1% or 2%) or lactose-free (1% or 2%) milk for 12 weeks. Milk intake increases in stages: half a cup daily for weeks 1-4, one cup daily for weeks 5-8, then two cups daily for weeks 9-12. After the main study period, participants continue drinking two cups daily for an additional two weeks. Participants will have visits before and after the 12-week milk intervention, with tests including lactose challenge hydrogen breath tests and blood draws for glucose, hemoglobin A1c, and metabolomics. Stool samples and continuous glucose monitoring data will be collected at home. The study will assess changes in gastrointestinal symptoms, gut microbiome characteristics, and various measures of blood sugar control throughout the 12 to 14 weeks of participation.

Milk for Diabetes Prevention