Impact of Exogenous Ketones on Breathing in Healthy Volunteers

Study acronym: K-BREATHE
StatusCompleted
PhaseEarly Phase 1
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Jan 10, 2027 to Sep 3, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 6 words
    • Site details revised
  2. Recruitment opened
    • Start date changed from estimate of Feb 15, 2026 to Mar 12, 2026
    • Site details revised
    v4
  3. Start date: Jan 10, 2026 to Feb 15, 2026v3
  4. Secondary endpoints: details revised at 1 of 1 entryv2
  5. 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.
Exogenous ketones (EK) are compounds that can increase the level of ketones in the body without needing to change what an individual eats. Although EK have been researched mainly in relation to energy and exercise, there haven't been many studies focusing specifically on how EKs affect breathing using well-established scientific methods. The investigators believe that EK may help improve breathing, which could be beneficial for situations like high altitudes, sleep apnea, and exercise. To explore how EK might influence breathing, the investigators are conducting a randomized, placebo-controlled crossover study with healthy volunteers.
Trial Details
NCT Number NCT07220122
Lead Sponsor Johns Hopkins University
Conditions
(from sponsor)		 Healthy Volunteer
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov