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.
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Gastrointestinal symptoms
Timeframe: Daily From Screening visit to Week 12
Change in Expired Breath Hydrogen
Timeframe: From Baseline to Week 12
Change in gut microbiome features - Relative Abundance of Species
Timeframe: From Baseline to Week 12
Change in gut microbiome features - Functional Pathway Relative Abundance
Timeframe: From Baseline to Week 12
Change in gut microbiome features - Metabolomics
Timeframe: From Baseline to Week 12
Change in glycemic outcomes - Fasting glucose
Timeframe: From Baseline to Week 12
Change in glycemic outcomes - Hemoglobin A1c (HbA1c)
Timeframe: From Baseline to Week 12
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) mean glucose
Timeframe: From Screening visit to Week 14 visit
Brandilyn Peters-Samuelson, PhD
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) glycemic variability
Timeframe: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time above range
Timeframe: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time in range
Timeframe: From Screening visit to Week 14 visit
Change in glycemic outcomes - Continuous Glucose Monitoring (CGM) time below range
Timeframe: From Screening visit to Week 14 visit