Type 2 Diabetes (T2D) Clinical Trials

Find Type 2 Diabetes (T2D) Clinical Trials Near You

Milk for Diabetes Prevention

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

• Can speak and read English fluently

Locations
United States
New York
HCHS/SOL Bronx Field Center
RECRUITING
The Bronx
Contact Information
Primary
Brandilyn Peters-Samuelson, PhD
brandilyn.peterssamuelson@einsteinmed.edu
718-430-3281
Backup
Qibin Qi, PhD
qibin.qi@einsteinmed.edu
718-430-4203
Time Frame
Start Date: 2026-05-15
Estimated Completion Date: 2028-04
Participants
Target number of participants: 40
Treatments
Active_comparator: Lactose-Containing Milk
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
Active_comparator: Lactose-Free Milk
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
Sponsors
Collaborators: Azenta Life Sciences, Metabolic Solutions Inc., National Dairy Council, University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL)
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov