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NCT07224074 · ClinicalTrials.gov registry record · Phase 1
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
A Phase 1 study of Sleep and Healthy Participants, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT07224074: Recruiting Phase 1 study of Sleep and Healthy Participants, sponsored by Johns Hopkins University.
NCT07224074 is a Phase 1 study of Sleep and Healthy Participants that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 20 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07224074, a Phase 1 study of Sleep and Healthy Participants, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Participants will measure their capillary BHB levels at home at 4 time points after ingestion (1, 3, 5 hours, and final awakening). The investigators will derive the maximal BHB concentration (mmol) of these timepoints. Measured on two occasions: Night 2 (Ketone IQ 20 g) and Night 5 (Ketone IQ 40 g).
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT KETONE-IQ 20 grams (g)
- DIETARY_SUPPLEMENT KETONE-IQ 40 grams (g)
Study Locations (1)
Maryland
- Johns Hopkins Bayview - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-12-18 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What NCT07224074 shows while recruiting
NCT07224074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which KETONE-IQ 20 grams (g) is the first listed.
NCT07224074 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07224074 about?
NCT07224074 is a clinical study titled "Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)". 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 c...
What is the current status of trial NCT07224074?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-12-18. Estimated completion is 2028-01-01.
What conditions does trial NCT07224074 study?
This clinical trial studies the following conditions: Sleep, Healthy Participants.
What interventions are being tested in trial NCT07224074?
The interventions under investigation include: KETONE-IQ 20 grams (g) (DIETARY_SUPPLEMENT), KETONE-IQ 40 grams (g) (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07224074?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07224074 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07224074's enrollment target sits among peer trials
20 134th of 151 higher than 12 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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