Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)

Study acronym: K-SLEEP
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Jan 1, 2028 to Sep 3, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 1, 2026 to Dec 18, 2025
    • Site details revised
    v2
  3. Minor 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.
Ketones are molecules generated by the body during the metabolism of fat. Exogenous ketones (EK) are substances that can raise the level of ketones in the circulation without changing diet. In this research study, the investigators are testing the tolerability, sleep effects, and dose effects of a commercially available EK product called Ketone-IQ. The investigators will administer Ketone-IQ open-label to healthy volunteers (n=20, 10 men, 10 women) before sleep in the participant's home setting and collect information about subjective sleep and GI symptoms, as well as objective data about beta-hydroxybutyrate (BHB) levels and sleep architecture using a headband-EEG device (Sleep Profiler). Participants will measure capillary BHB levels before ingestion and at 1, 3, and 5 hours post-ingestion, as well as upon awakening. Questionnaires will be used to gather feedback on the palatability of EK, GI side effects, and sleep quality. Higher scores indicate better sleep quality. Two doses (20 g and 40 g) of Ketone-IQ will be tested each for two nights, with one night used to measure BHB levels and a separate night to allow for uninterrupted sleep.
Trial Details
NCT Number NCT07224074
Lead Sponsor Johns Hopkins University
Collaborators: HVMN Inc, KETONE-IQ
Conditions
(from sponsor)
Healthy Participants, Sleep
Related terms Ketosis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov