RecruitingNot ApplicableNCT06513026

Milk for Diabetes Prevention

Sponsor

Albert Einstein College of Medicine

Enrollment

40 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Lactose intolerance Diabetes Mellitus, Type 2 Pre-diabetes Lactose Intolerant Lactase Persistence

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria18

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

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Interventions

DIETARY_SUPPLEMENTLactose-Containing Milk

Participants will be asked to drink regular milk (1% or 2%) for 12 weeks as follows: * Weeks 1-4: ½ cup milk per day * Weeks 5-8: 1 cup milk per day * Weeks 9-12: 2 cups milk per day Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.

DIETARY_SUPPLEMENTLactose-Free Milk

Participants will be asked to drink 1% or 2% lactose-free milk for 12 weeks as follows: * Weeks 1-4: ½ cup milk per day * Weeks 5-8: 1 cup milk per day * Weeks 9-12: 2 cups milk per day Participants will continue drinking 2 cups milk/day for 2 weeks after the 12-week follow-up visit.