Milk for Diabetes Prevention

Individuals with lactase non-persistence (LNP; determined by a functional variant in the LCT gene \[rs4988235, GG genotype\]) are susceptible to lactose intolerance in adulthood due to deficiency of lactase, the enzyme which digests milk lactose sugars. However, many LNP individuals still drink ≥1 cup of milk daily. Recent analysis in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) found that consumption of 1 serving (cup) of milk/day was associated with \~30% lower risk of type 2 diabetes among LNP individuals, but not among individuals with lactase persistence (LP). This beneficial effect might be partially explained by favorable alterations in gut microbiota and related metabolites associated with higher milk consumption among LNP individuals. Based on these observational study findings, the investigator team proposes to conduct a randomized, controlled trial of lactose-containing vs. lactose-free milk in LNP individuals with pre-diabetes, to comprehensively investigate the effects of milk intake on the gut microbiome and glycemic outcomes.

NCT Number	NCT06513026
Lead Sponsor	Albert Einstein College of Medicine Collaborators: National Dairy Council, University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL), Azenta Life Sciences, Metabolic Solutions Inc.
Conditions	Lactose Intolerance, Lactose Intolerant, Lactase Persistence, Pre-Diabetes, Diabetes Mellitus, Type 2
Enrollment	40 participants
Start Date	2026-05-15
Primary Completion	2028-04 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-05-26