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Study identifier: NCT07224074 Synced from ClinicalTrials.gov · July 29, 2026
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Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)

Condition: Healthy Participants · Sleep  ·  Sponsor: Johns Hopkins University

PhasePhase 1
Planned participants20
Who can joinAll sexes, 18 Years to 50 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Mariah V Potocki, Bachelors of Science  ·  410-550-2233  ·  mchaney7@jhmi.edu

Athena Mavronis, Associates of Science  ·  410-550-4588  ·  amavron1@jh.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Johns Hopkins BayviewBaltimore, Maryland, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07224074