Trial Summary
What is the purpose of 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
This trial is for adults with lactase non-persistence (genetic lactose intolerance) and pre-diabetes. Participants should be those who can still consume at least one cup of milk daily despite their intolerance.Inclusion Criteria
Basic computer or smartphone skills
I speak English or Spanish.
Drink ≤1 cup milk/day
+3 more
Exclusion Criteria
Not pregnant or breastfeeding
I haven't taken antibiotics in the last 3 months.
I do not have cancer, heart disease, or any life-threatening illness.
+12 more
Participant Groups
The study aims to compare the effects of drinking lactose-containing milk versus lactose-free milk on gut health and blood sugar control in people with genetic lactose intolerance and pre-diabetes.
2Treatment groups
Active Control
Group I: Lactose-Containing MilkActive Control1 Intervention
Participants will be randomized to lactose-containing milk in strata of age (\<60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio
Group II: Lactose-Free MilkActive Control1 Intervention
Participants will be randomized to lactose-free milk in strata of age (\<60, ≥60) and sex (female, male). Within each age and sex stratum, 10 participants will be randomized into two intervention groups in a 1:1 ratio
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
HCHS/SOL Bronx Field CenterBronx, NY
Loading ...
Who Is Running the Clinical Trial?
Albert Einstein College of MedicineLead Sponsor