| NCT ID | NCT06513026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Einstein College of Medicine |
| Condition | Lactose Intolerance |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-05-15 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Brandilyn Peters-Samuelson, PhD
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine
Frequently Asked Questions
Who can join the NCT06513026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Lactose Intolerance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513026 currently recruiting?
Yes, NCT06513026 is actively recruiting participants. Contact the research team at brandilyn.peterssamuelson@einsteinmed.edu for enrollment information.
Where is the NCT06513026 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06513026 clinical trial?
NCT06513026 is sponsored by Albert Einstein College of Medicine. The principal investigator is Brandilyn Peters-Samuelson, PhD at Albert Einstein College of Medicine. The trial plans to enroll 40 participants.