The Effects of Exogenous Ketones on Cognitive Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-55
SponsorUniversity of Alabama at Birmingham

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ketone Monoester (KE)
  • Placebo

Treatment groups

45 Participants
are divided into 2 treatment groups