Status:
NOT_YET_RECRUITING
Milk for Diabetes Prevention
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Dairy Council
University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL)
Conditions:
Lactose Intolerance
Lactose Intolerant
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 l...
Detailed Description
The trial will feature a 2-week milk washout period, followed by 1:1 randomization to lactose-containing (1% or 2%) or lactose-free (1% or 2%) milk for 12 weeks (4 weeks each of ½ cup, 1 cup, and 2 cu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Diabetes diagnosis
- Taking anti-diabetes medication
- Cancer, cardiovascular disease (CVD), or life-threatening illness
- Known milk allergy
- Has severe GI symptoms after drinking milk
- History of GI surgery
- Had a double mastectomy
- Smoking
- More than 1 alcoholic beverage/day
- Pregnant or breastfeeding
- Colonoscopy in last 2 weeks
- Antibiotics in last 3 months
- Taking probiotics or fiber supplements (if taking, must be able to stop taking during study)
- Taking laxatives, stool softeners, anti-diarrheal (if taking, must be able to stop taking during study)
- Taking lactase pills (if taking, must be able to stop taking)
- Participating in extreme dieting program
- Planning extended travel that would prevent participation in study
- Taking medication that must be taken separate from calcium or dairy products
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06513026
Start Date
February 1 2026
End Date
February 1 2028
Last Update
December 18 2025
Active Locations (1)
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1
HCHS/SOL Bronx Field Center
The Bronx, New York, United States, 10458