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NCT06513026 · ClinicalTrials.gov registry record · NA
Milk for Diabetes Prevention
A NA study, sponsored by Albert Einstein College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT06513026: Recruiting NA study, sponsored by Albert Einstein College of Medicine.
NCT06513026 is a NA study that is actively recruiting participants, run by Albert Einstein College of Medicine. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06513026, a NA study, is actively recruiting participants, sponsored by Albert Einstein College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Gastrointestinal symptoms, specifically abdominal pain, bloating, flatulence, and diarrhea, will be recorded daily from screening visit through 12 weeks of milk intervention. The occurrence and severity of these four adverse events will be summarized and reported by study arm. Average frequencies of none-mild vs. moderate-severe symptoms will be compared between treatment groups by week of study, as well as for specific time intervals corresponding to milk doses (weeks 1-4, 5-8, 9-12).
Interventions
- DIETARY_SUPPLEMENT Lactose-Containing Milk
- DIETARY_SUPPLEMENT Lactose-Free Milk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-05-15 |
| Est. Completion | 2028-04 |
| Phase | NA |
What NCT06513026 shows while recruiting
NCT06513026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Lactose-Containing Milk is the first listed.
NCT06513026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06513026 about?
NCT06513026 is a clinical study titled "Milk for Diabetes Prevention". 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 c...
What is the current status of trial NCT06513026?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-05-15. Estimated completion is 2028-04.
What interventions are being tested in trial NCT06513026?
The interventions under investigation include: Lactose-Containing Milk (DIETARY_SUPPLEMENT), Lactose-Free Milk (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06513026?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06513026's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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