Milk for Diabetes Prevention

Conditions studied

Lactose Intolerance, Lactose Intolerant, Lactase Persistence, Pre-Diabetes, Diabetes Mellitus, Type 2

About this study

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.

Interventions

• Dietary Supplement: Lactose-Containing Milk — Participants will be asked to drink regular milk (1% or 2%) for 12 weeks as follows: * Weeks 1-4: ½ cup milk per day * Weeks 5-8: 1 cup milk per day * Weeks 9-12: 2 cups milk per day Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.
• Dietary Supplement: Lactose-Free Milk — Participants will be asked to drink 1% or 2% lactose-free milk for 12 weeks as follows: * Weeks 1-4: ½ cup milk per day * Weeks 5-8: 1 cup milk per day * Weeks 9-12: 2 cups milk per day Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.

Primary outcomes

• Gastrointestinal symptoms (Daily From Screening visit to Week 12)
• Change in Expired Breath Hydrogen (From Baseline to Week 12)
• Change in gut microbiome features - Relative Abundance of Species (From Baseline to Week 12)
• Change in gut microbiome features - Functional Pathway Relative Abundance (From Baseline to Week 12)
• Change in gut microbiome features - Metabolomics (From Baseline to Week 12)
• Change in glycemic outcomes - Fasting glucose (From Baseline to Week 12)
• Change in glycemic outcomes - Hemoglobin A1c (HbA1c) (From Baseline to Week 12)
• Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) mean glucose (From Screening visit to Week 14 visit)

Eligibility information

Study locations

• HCHS/SOL Bronx Field Center, The Bronx, New York 10458 United States