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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07224074
The ClinicalTrials.gov registry entry for NCT07224074 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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