The Effects of Exogenous Ketones on Cognitive Function
University of Alabama at Birmingham
45 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the acute effects of exogenous ketone monoester (KME) supplementation on cognitive function in three groups of adults aged 19-55 years: (1) obese, sedentary individuals; (2) lean, sedentary individuals; and (3) lean individuals who engage in regular physical activity (e.g., collegiate or amateur athletes). The main questions it aims to answer are to: * Assess the effects of acute KME supplementation versus placebo on cognitive, sensorimotor, and functional outcomes within groups. * Compare cognitive performance across the three groups. The primary outcome is cognitive performance assessed using the NIH Toolbox Cognition Battery. Secondary Outcomes include sensorimotor performance, measured using the Senaptec Sensory System, and driving performance, assessed with a driving simulator.
Eligibility
Inclusion Criteria4
- Age 19-55 years
- BMI 30-40 (obese group) or 18-25 (lean and athlete groups)
- Sedentary status (<2 hrs/week of structured physical activity) for obese and lean groups
- Active athlete status (≥5 days/week of structured activity) for athlete group
Exclusion Criteria5
- Diagnosed neurological conditions (e.g., Parkinson's disease, multiple sclerosis, schizophrenia, muscular dystrophy, stroke, cerebral palsy)
- History of seizures
- Use of medications for diabetes, mood disorders, or attention disorders
- Pregnant or breastfeeding
- Current or recent use (within 1 month) of exogenous ketone supplements or adherence to a ketogenic diet
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Interventions
Participants will undergo two test days separated by 3-7 days. On both test days, participants will arrive fasted and consume a single dose of ketone monoester or placebo (357 mg/kg of body weight) in random order. Drinks will be prepared by non-study personnel and matched in taste, texture, and appearance to maintain blinding. Thirty minutes after consuming the ketone monoester or placebo, cognitive assessments will be completed including NIH Toolbox cognitive assessments, Senaptec Sensory Station, and driving simulation.
Participants will undergo two test days separated by 3-7 days. On one test day, participants will consume a single dose of placebo (357 mg/kg of body weight). Thirty minutes after consuming the placebo, cognitive assessments will be completed including NIH Toolbox cognitive assessments, Senaptec Sensory Station, and driving simulation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07051655