Status:
NOT_YET_RECRUITING
Impact of Exogenous Ketones on Breathing in Healthy Volunteers
Lead Sponsor:
Johns Hopkins University
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
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 energ...
Detailed Description
Healthy volunteers will undergo daytime hypercapnic ventilatory response (HCVR) testing before and after ingesting 40g of exogenous ketones or placebo. Circulating ketone levels (beta-hydroxybutyrate)...
Eligibility Criteria
Inclusion
- BMI of 18 - 30 kg/m2
Exclusion
- 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).
Key Trial Info
Start Date :
January 10 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07220122
Start Date
January 10 2026
End Date
February 10 2027
Last Update
October 24 2025
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224