NCT07224074 Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
| NCT ID | NCT07224074 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-12-18 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18-50 years old with a BMI of 18 - 30 kg/m\^2 Exclusion Criteria: * No concomitant sleep disorder (e.g. sleep apnea, insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia). If there is no known diagnosis of sleep apnea, a STOP-BANG score of 5 or higher is an exclusion. * No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled Chronic Obstructive Pulmonary Disease (COPD), pneumonia, interstitial lung disease. * No known history of chronic renal disease or diabetes (type 1 or type 2). * No use of supplemental oxygen. * Cannot be on a low carbohydrate (\<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones * Cannot be pregnancy or breastfeeding * Cannot be on medications: acetazolamide or Sodium-glucose cotransporter-2 (SGLT2) inhibitor (10), daily opioid use. * K-BREATHE: no history of claustrophobia or panic disorder * Frequent alcohol intake (more than 1 drink per day on average, or \> 10 drinks per week).
Contact & Investigator
Jonathan Jun, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07224074 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07224074 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07224074 currently recruiting?
Yes, NCT07224074 is actively recruiting participants. Contact the research team at mchaney7@jhmi.edu for enrollment information.
Where is the NCT07224074 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07224074 clinical trial?
NCT07224074 is sponsored by Johns Hopkins University. The principal investigator is Jonathan Jun, MD at Johns Hopkins University. The trial plans to enroll 20 participants.