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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07224074
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Participants
  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • KETONE-IQ 20 grams (g) — DIETARY_SUPPLEMENT
    Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 20g will be ingested (open-label) before bedtime.
  • KETONE-IQ 40 grams (g) — DIETARY_SUPPLEMENT
    Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 40g will be ingested (open-label) before bedtime.

Study Details

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.

Key Dates

Start date
Dec 18, 2025
Status verified
Jan 2026
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: K-SLEEP
    Healthy Participants will ingest (1) Ketone IQ 20 g or (2) Ketone IQ 40 g before bedtime and undergo objective and subjective sleep assessments.

Primary Outcome Measure

Beta hydroxybutyrate (BHB) maximal concentration (Cmax) [ Time Frame: 1, 3, 5 hours, and final awakening (Night 2); and 1, 3, 5 hours, and final awakening (Night 5) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins BayviewBaltimoreMaryland21224
Mariah V Potocki, Bachelors of Science
[email protected]
410-550-2233
Athena Mavronis, Associates of Science
[email protected]
410-550-4588
Jonathan Jun, Doctor (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Bayview· Baltimore, MD

Related Studies