Comparison of Microbiome Changes in Healthy Adults Following Ketone Ester Consumption

Study acronym: BREAK
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 30 days later Sep 30, 2026 → Oct 30, 2026
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Record History

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  1. Primary and study completion pushed from Sep 30, 2026 to Oct 30, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
  2. Start date changed from estimate of Oct 10, 2025 to Nov 21, 2025v5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026
    • Start date: Sep 21, 2025 to Oct 10, 2025
    • Eligibility criteria expanded, about 51 words
    • Site details revised
  4. Start date: May 24, 2025 to Sep 21, 2025v3
  5. Primary and study completion dates: Aug 31, 2025 to Sep 30, 2025
    • Start date: May 1, 2025 to May 24, 2025
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints: details revised at 1 of 1 entry
    v2
  6. Study First Submitted
  • 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.
The goal of this observational study is to learn if a ketone ester can improve the content of the gut microbiome. The main questions it aims to answer are: * Does a ketone ester reduce age-related signatures in the gut microbiome? * What changes occur in the gut microbiome after consuming a ketone ester? Participants will: * Take a ketone ester every day for seven (7) days * Collect and ship stool samples within seven (7) days before, during, and within seven (7) days after the study period * Measure their ketone levels with a urine strip every day after having the drink * Answer questions about their typical diet on a normal day * Record their symptoms, if any arise
Trial Details
NCT Number NCT06954675
Lead Sponsor University of California, San Francisco
Conditions
(from sponsor)		 Microbiome Analysis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov