Recruiting
Phase 1

Ketone-IQ

Sponsor:

Johns Hopkins University

Code:

NCT07224074

Conditions

Healthy Participants

Sleep

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

KETONE-IQ 20 grams (g)

KETONE-IQ 40 grams (g)

Study Details

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.

Conditions

Healthy Participants

Sleep

Study ID

NCT07224074

Start date

Dec 18, 2025

Status verified date

Jan, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

KETONE-IQ 20 grams (g)

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: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 40g will be ingested (open-label) before bedtime.

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 and Locations

Central contacts

Mariah V Potocki, Bachelors of Science

410-550-2233mchaney7@jhmi.edu

Athena Mavronis, Associates of Science

410-550-4588amavron1@jh.edu

Locations

Johns Hopkins Bayview

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Mariah V Potocki, Bachelors of Science

410-550-2233mchaney7@jhmi.edu

Athena Mavronis, Associates of Science

410-550-4588amavron1@jh.edu

Principal Investigator:

Jonathan Jun, Doctor

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 14, 2026

Last verified

Jan, 2026

Keywords

  • Sleep
  • Healthy
  • Ketones

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-14.