Lactose-containing versus lactose-free milk for diabetes prevention in people with lactase non-persistence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

After a 2-week milk washout, participants with the LCT rs4988235 GG genotype and prediabetes are randomized 1:1 to lactose-containing or lactose-free milk for 12 weeks, with dose escalation of ½ cup, 1 cup, and 2 cups each for four weeks. Clinic visits before and after the intervention include lactose hydrogen breath tests and blood draws for fasting glucose, HbA1c, and metabolomics, while stool samples and continuous glucose monitoring are collected at home. The trial aims to test feasibility and tolerability and to measure changes in gut microbiome species, microbial functions, metabolites, and short-term glycemic outcomes. Randomization and controlled milk formulations are used to isolate the effect of lactose in a real-world consumption pattern.

Why it matters

Who can join: the full rules

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

Where it's running

• HCHS/SOL Bronx Field Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Brandilyn Peters-Samuelson, PhD — Albert Einstein College of Medicine
• Study coordinator: Brandilyn Peters-Samuelson, PhD
• Email: brandilyn.peterssamuelson@einsteinmed.edu
• Phone: 718-430-3281

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.