About this trial
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.
Eligibility criteria
Qualifiers
LNP genotype (LCT gene rs4988235, GG genotype)
History of pre-diabetes, defined as fasting blood glucose 100-125 mg/dL and/or hemoglobin A1c (HbA1c) 5.7-6.4% and have not been diagnosed with diabetes nor take diabetes medication (pre-diabetes determined at most recent study visit [for HCHS/SOL participant] or most recent medical chart or self-report [for other participant])
Drink ≤1 cup milk/day
Basic computer or smartphone skills
Disqualifiers
Diabetes diagnosis
Taking anti-diabetes medication
Cancer, cardiovascular disease (CVD), or life-threatening illness
Known milk allergy
Trial design
Treatments tested in this trial
- Lactose-Containing Milk
- Lactose-Free Milk
Treatment groups
Sponsors and collaborators
Albert Einstein College of Medicine
Lead sponsor
National Dairy Council
Collaborator
University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL)
Collaborator
Azenta Life Sciences
Collaborator
Metabolic Solutions Inc.
Collaborator