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