NCT06513026Recruiting
Milk for Diabetes Prevention
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 15 May 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Albert Einstein College of Medicine
- Diseases
- Type 2 diabetes
- NCT number
- NCT06513026
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 15 May 2026 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes diagnosis
- Taking anti-diabetes medication
- Cancer, cardiovascular disease (CVD), or life-threatening illness
- Known milk allergy
- History of GI surgery
Lab values
- Taking medication that must be taken separate from calcium or dairy products
Other
- Has severe GI symptoms after drinking milk
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HCHS/SOL Bronx Field Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.