Actively Recruiting
Milk for Diabetes Prevention
Led by Albert Einstein College of Medicine · Updated on 2026-04-17
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
N
National Dairy Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Milk for Diabetes Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- LNP genotype (LCT gene rs4988235, GG genotype)
- History of pre-diabetes with fasting blood glucose 100-125 mg/dL and/or hemoglobin A1c 5.7-6.4%, without diabetes diagnosis or diabetes medication use
- Drinks at least 1 cup of milk per day
- Basic computer or smartphone skills
- Able to speak and read English fluently
You will not qualify if you...
- Diagnosis of diabetes
- Taking anti-diabetes medication
- Cancer, cardiovascular disease, or life-threatening illness
- Known milk allergy
- Severe gastrointestinal symptoms after drinking milk
- History of gastrointestinal surgery
- Had a double mastectomy
- Smoking
- Consuming more than 1 alcoholic beverage per day
- Pregnant or breastfeeding
- Colonoscopy within the last 2 weeks
- Antibiotic use within the last 3 months
- Taking probiotics or fiber supplements (unless able to stop during study)
- Taking laxatives, stool softeners, or anti-diarrheal medications (unless able to stop during study)
- Taking lactase pills (unless able to stop during study)
- Participating in extreme dieting program
- Planning extended travel preventing study participation
- Taking medication that must be taken separately from calcium or dairy products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
HCHS/SOL Bronx Field Center
The Bronx, New York, United States, 10458
Actively Recruiting
Research Team
B
Brandilyn Peters-Samuelson, PhD
CONTACT
Q
Qibin Qi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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