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RecruitingEARLY_Phase 1NCT07220122

Impact of Exogenous Ketones on Breathing in Healthy Volunteers

Trial Parameters

ConditionHealthy Volunteer
SponsorJohns Hopkins University
Study TypeINTERVENTIONAL
PhaseEARLY_Phase 1
Enrollment20
SexALL
Min Age18 Years
Max Age50 Years
Start Date2026-03-12
Completion2027-01-10
Interventions
1,3 butanediolPlacebo

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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).

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