RecruitingNot Applicable

Milk for Diabetes Prevention

United States40 participantsStarted 2026-05-15

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastrointestinal symptoms

Timeframe: Daily From Screening visit to Week 12

Change in Expired Breath Hydrogen

Timeframe: From Baseline to Week 12

Change in gut microbiome features - Relative Abundance of Species

Timeframe: From Baseline to Week 12

Change in gut microbiome features - Functional Pathway Relative Abundance

Timeframe: From Baseline to Week 12

Change in gut microbiome features - Metabolomics

Timeframe: From Baseline to Week 12

Change in glycemic outcomes - Fasting glucose

Timeframe: From Baseline to Week 12

Change in glycemic outcomes - Hemoglobin A1c (HbA1c)

Timeframe: From Baseline to Week 12

Trial details

NCT IDNCT06513026

SponsorAlbert Einstein College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Brandilyn Peters-Samuelson, PhD

718-430-3281 brandilyn.peterssamuelson@einsteinmed.edu

View on ClinicalTrials.gov More Lactose Intolerance trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Gastrointestinal symptoms

Timeframe: Daily From Screening visit to Week 12

Change in Expired Breath Hydrogen

Timeframe: From Baseline to Week 12

Change in gut microbiome features - Relative Abundance of Species

Timeframe: From Baseline to Week 12

Change in gut microbiome features - Functional Pathway Relative Abundance

Timeframe: From Baseline to Week 12

Change in gut microbiome features - Metabolomics

Timeframe: From Baseline to Week 12

Change in glycemic outcomes - Fasting glucose

Timeframe: From Baseline to Week 12

Change in glycemic outcomes - Hemoglobin A1c (HbA1c)

Timeframe: From Baseline to Week 12