Ketone supplement effects on sleep and breathing in healthy adults

Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-EFFECTS)

This study will test whether taking a ketone supplement (Ketone-IQ) before bed changes sleep quality, breathing, and blood ketone levels in healthy adults aged 18–50.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07224074 on ClinicalTrials.gov

What this trial studies

In an open-label Phase 1 study, 20 healthy volunteers (10 men, 10 women) will take two different doses of Ketone-IQ (20 g and 40 g) on separate nights with a 1–2 day washout. Dosing occurs at home 30 minutes before sleep and participants will measure capillary beta-hydroxybutyrate (BHB) before ingestion, at 1, 3, and 5 hours after ingestion, and on awakening. Sleep will be recorded at home using a headband EEG (Sleep Profiler) and questionnaires will capture sleep quality, palatability, and GI side effects. The study excludes people with diagnosed sleep disorders, certain respiratory or metabolic conditions, low-carbohydrate/ketogenic diets, pregnancy/breastfeeding, or specific medications.

Who should consider this trial

Good fit: Ideal participants are healthy adults 18–50 years old with a BMI of 18–30 kg/m2 who do not have diagnosed sleep disorders, are not on low-carbohydrate or ketogenic diets, and are not pregnant or breastfeeding.

Not a fit: People with diagnosed sleep disorders, chronic respiratory disease, diabetes or chronic kidney disease, those on SGLT2 inhibitors or certain medications, those regularly consuming exogenous ketones or on low-carb diets, and pregnant or breastfeeding individuals are unlikely to qualify or benefit from this phase 1 exploration.

Why it matters

Potential benefit: If successful, this could identify a simple, non-diet supplement approach to modify sleep quality or sleep architecture in healthy adults.

How similar studies have performed: Preclinical data and a few small human studies suggest ketones can alter sleep stages (e.g., promoting slow-wave sleep or preventing exercise-related REM loss), but systematic human data on exogenous ketones and sleep architecture are limited.

Eligibility criteria

Inclusion Criteria:

* Adults aged 18-50 years old with a BMI of 18 - 30 kg/m\^2

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 (10), daily opioid use.
* K-BREATHE: no history of claustrophobia or panic disorder
* Frequent alcohol intake (more than 1 drink per day on average, or \> 10 drinks per week).

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Bayview — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Jonathan Jun, MD — Johns Hopkins University
• Study coordinator: Mariah V Potocki, Bachelors of Science

Conditions Healthy Participants; Sleep; Healthy; Ketones