Milk for Diabetes Prevention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAlbert Einstein College of Medicine

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

40 Participants
are divided into 2 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