NCT07224074 (K-SLEEP) is a Phase 1 clinical trial of KETONE-IQ 20 grams (g) in Healthy Participants, sponsored by Johns Hopkins University.

Who is sponsoring NCT07224074?

NCT07224074 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT07224074?

Interventions in NCT07224074: KETONE-IQ 20 grams (g), KETONE-IQ 40 grams (g).

What condition does NCT07224074 study?

NCT07224074 studies Healthy Participants, Sleep.

Is NCT07224074 still recruiting?

NCT07224074 is currently recruiting now. Last updated 14 January 2026.

Last reviewed 2026-01-14 · How we verify

NCT07224074: K-SLEEP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1 Last updated 14 January 2026

What this trial tests

Phase 1 trial testing KETONE-IQ 20 grams (g) in Healthy Participants in 20 participants. Currently enrolling.

Timeline

18 December 2025

Primary endpoint
1 January 2028

1 January 2028

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	18 December 2025
Primary completion	1 January 2028
Estimated completion	1 January 2028
Sites	1 location across United States

Drugs / interventions tested

KETONE-IQ 20 grams (g)
KETONE-IQ 40 grams (g)

Conditions studied

Healthy Participants — all drugs for Healthy Participants →
Sleep — all drugs for Sleep →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 50, any sex, with Healthy Participants or Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Other Johns Hopkins University trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07224074 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 14 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07224074.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing