RecruitingPhase 1NCT07224074

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

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


Sponsor

Johns Hopkins University

Enrollment

20 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Ketones are molecules generated by the body during the metabolism of fat. Exogenous ketones (EK) are substances that can raise the level of ketones in the circulation without changing diet. In this research study, the investigators are testing the tolerability, sleep effects, and dose effects of a commercially available EK product called Ketone-IQ. The investigators will administer Ketone-IQ open-label to healthy volunteers (n=20, 10 men, 10 women) before sleep in the participant's home setting and collect information about subjective sleep and GI symptoms, as well as objective data about beta-hydroxybutyrate (BHB) levels and sleep architecture using a headband-EEG device (Sleep Profiler). Participants will measure capillary BHB levels before ingestion and at 1, 3, and 5 hours post-ingestion, as well as upon awakening. Questionnaires will be used to gather feedback on the palatability of EK, GI side effects, and sleep quality. Higher scores indicate better sleep quality. Two doses (20 g and 40 g) of Ketone-IQ will be tested each for two nights, with one night used to measure BHB levels and a separate night to allow for uninterrupted sleep.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking a drinkable ketone supplement affects sleep quality and breathing patterns in healthy adults. Ketones are molecules the body produces during fasting or low-carb diets, and researchers want to know if consuming them externally changes how the body breathes during sleep. **You may be eligible if...** - You are a healthy adult between 18 and 50 years old - Your BMI is between 18 and 30 - You do not have any known sleep disorders (such as sleep apnea, insomnia, or narcolepsy) - You are not currently on a ketogenic, very low-carb, or intermittent fasting diet - You do not drink more than 1 alcoholic drink per day on average **You may NOT be eligible if...** - You have a diagnosed sleep disorder or a high-risk sleep apnea score (STOP-BANG of 5 or higher) - You have uncontrolled asthma, COPD, or another active lung condition - You have chronic kidney disease or diabetes (Type 1 or Type 2) - You are pregnant or breastfeeding - You take acetazolamide or SGLT2 inhibitor medications - You use supplemental oxygen or opioids daily Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTKETONE-IQ 20 grams (g)

Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 20g will be ingested (open-label) before bedtime.

DIETARY_SUPPLEMENTKETONE-IQ 40 grams (g)

Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 40g will be ingested (open-label) before bedtime.


Locations(1)

Johns Hopkins Bayview

Baltimore, Maryland, United States

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NCT07224074


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