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Milk for Diabetes Prevention

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoint(s) modified
    • Start date changed from estimate of Apr 2026 to May 15, 2026
    v8
  2. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Start date: Feb 2026 to Apr 2026
    • Primary and study completion dates: Feb 2028 to Apr 2028
    • Site details revised
    • Collaborators: 2 to 4
  3. Start date: Oct 2025 to Feb 2026v6 Show 5 more changesShow less
    • Primary and study completion dates: Oct 2027 to Feb 2028
    • Eligibility criteria expanded, about 27 words
    • Study description expanded, about 6 words
    • Site contact updated
    • Collaborators: 1 to 2
  4. Start date: Aug 2025 to Oct 2025
    • Primary and study completion dates: Aug 2027 to Oct 2027
    v5
  5. Start date: May 2025 to Aug 2025
    • Primary and study completion dates: May 2027 to Aug 2027
    • Eligibility criteria shortened, about 5 words
    • Collaborators expanded, about 3 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jan 2025 to May 2025
    • Primary and study completion dates: Jan 2027 to May 2027
    v3
  2. Start date: Aug 2024 to Jan 2025
    • Primary and study completion dates: Aug 2026 to Jan 2027
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06513026
Lead Sponsor Albert Einstein College of Medicine
Collaborators: National Dairy Council, University of Minnesota (UM) Advanced Research and Diagnostic Laboratory (ARDL), Azenta Life Sciences, Metabolic Solutions Inc.
Conditions
(from sponsor)		 Lactose Intolerance, Lactose Intolerant, Lactase Persistence, Pre-Diabetes, Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2, Glucose Intolerance, Lactose Intolerance
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov