Impact of Exogenous Ketones on Breathing in Healthy Volunteers

NCT07220122 | Recruiting Early Phase 1

• 1 other identifier: IRB00517978-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

ketones breathing exogenous

Outcome Measures

Primary Outcomes (1)

• Hypercapnic Ventilatory Response (HCVR)

  Minute ventilation (L/min) while breathing 7% Carbon Dioxide (CO2). Measured once during each visit.

  During each visit, one measurement at baseline, repeated again 2.5 hours after ingesting Ketone-IQ or Placebo

Secondary Outcomes (1)

• Ketone Level

  During each visit measured 4 times (baseline, 1 hour, 2.5 hours post-ingestion)

Study Arms (2)

Ketones first

EXPERIMENTAL

Visit 1: ketones, Visit 2: Placebo

Dietary Supplement: 1,3 butanediol; Dietary Supplement: Placebo

Placebo first

EXPERIMENTAL

Visit 1: Placebo, Visit 2: ketones

Dietary Supplement: 1,3 butanediol; Dietary Supplement: Placebo

Interventions

1,3 butanediol DIETARY_SUPPLEMENT

40 mg Ketone-IQ beverage

Ketones first; Placebo first

Placebo DIETARY_SUPPLEMENT

Placebo (taste matched)

Ketones first; Placebo first

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI of 18 - 30 kg/m2

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Interventions

1,3-butylene glycol

Study Officials

• Jonathan C Jun, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariah Potocki

CONTACT

410-550-2233; mchaney7@jhmi.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blind placebo controlled randomized crossover design.

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 23, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 10, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 3 years following study completion.
• Access Criteria: Researchers requesting access must contact the PI for permission.

Locations

US (1)