NCT07220122 Impact of Exogenous Ketones on Breathing in Healthy Volunteers
| NCT ID | NCT07220122 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-03-12 |
| Primary Completion | 2027-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-03-12 with a primary completion date of 2027-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Exogenous ketones (EK) are compounds that can increase the level of ketones in the body without needing to change what an individual eats. Although EK have been researched mainly in relation to energy and exercise, there haven't been many studies focusing specifically on how EKs affect breathing using well-established scientific methods. The investigators believe that EK may help improve breathing, which could be beneficial for situations like high altitudes, sleep apnea, and exercise. To explore how EK might influence breathing, the investigators are conducting a randomized, placebo-controlled crossover study with healthy volunteers.
Eligibility 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).
Contact & Investigator
Jonathan C Jun, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07220122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07220122 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07220122 currently recruiting?
Yes, NCT07220122 is actively recruiting participants. Contact the research team at mchaney7@jhmi.edu for enrollment information.
Where is the NCT07220122 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07220122 clinical trial?
NCT07220122 is sponsored by Johns Hopkins University. The principal investigator is Jonathan C Jun, MD at Johns Hopkins University. The trial plans to enroll 20 participants.