Recruiting
Early Phase 1

Exogenous Ketones

Sponsor:

Johns Hopkins University

Code:

NCT07220122

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

1,3 butanediol

Placebo

Study Details

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.

Conditions

Healthy Volunteer

Study ID

NCT07220122

Start date

Mar 12, 2026

Status verified date

Mar, 2026

Completion date

Feb 10, 2027

Anticipated

Primary completion date

Jan 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketones first

Visit 1: ketones, Visit 2: Placebo

experimental: Placebo first

Visit 1: Placebo, Visit 2: ketones

Interventions

1,3 butanediol

40 mg Ketone-IQ beverage

Placebo

Placebo (taste matched)

Primary outcome measure

  • Hypercapnic Ventilatory Response (HCVR) [ Time Frame: During each visit, one measurement at baseline, repeated again 2.5 hours after ingesting Ketone-IQ or Placebo ]

Central Contacts and Locations

Central contacts

Mariah Potocki

410-550-2233mchaney7@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Jonathan C Jun

410-550-0115jjun2@jhmi.edu

MD

jjun2@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • ketones breathing exogenous

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 2026-03-31.