Exogenous ketones and breathing in healthy adults
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers
This will test if a single dose of an exogenous ketone drink changes breathing in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07220122 on ClinicalTrials.gov |
What this trial studies
This is a randomized, single-blind, placebo-controlled crossover study in healthy volunteers comparing a 40 g dose of 1,3-butanediol (Ketone IQ) to a taste-matched placebo. Participants complete two in-person visits separated by a 48-hour to 14-day washout, with blood beta-hydroxybutyrate (BHB) measured at baseline, 1 hour, and 2.5 hours after ingestion. Hypercapnic ventilatory response (HCVR) testing is performed with timing guided by BHB levels to see if ketone exposure alters breathing. The design allows within-subject comparison of breathing responses after ketone versus placebo dosing.
Who should consider this trial
Good fit: Healthy adults with BMI 18–30 kg/m2 who are not pregnant or breastfeeding, not on low-carbohydrate or ketogenic diets, and without sleep, respiratory, renal, or diabetic disorders.
Not a fit: People with diagnosed sleep apnea or other chronic respiratory diseases, diabetes or chronic kidney disease, those on excluded medications (such as SGLT2 inhibitors or acetazolamide), pregnant or breastfeeding individuals, and those already following ketogenic diets are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could provide a short-term way to improve ventilatory responses during situations like high altitude, exercise, or sleep-disordered breathing.
How similar studies have performed: Exogenous ketones and 1,3-butanediol have been used in prior human metabolic and exercise studies, but well-controlled evidence specifically showing improved breathing is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI of 18 - 30 kg/m2 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, daily opioid use. * No history of claustrophobia or panic disorder * No frequent alcohol intake (more than 1 drink per day on average, or \> 10 drinks per week).
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan C Jun, MD — Johns Hopkins University
- Study coordinator: Mariah Potocki
- Email: mchaney7@jhmi.edu
- Phone: 410-550-2233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.