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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Ketone Monoester (KE)
Dietary supplementParticipants 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.
Placebo
Dietary supplementParticipants 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.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: ketone monoester (KME)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Executive function
Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Dimensional Change Card Sort Test - Measures executive function and cognitive flexibility by assessing the ability to switch between mental rules.
Time frame
Test Day 1 and Test Day 22
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Attention
Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Flanker Inhibitory Control and Attention Test - Evaluates attention and the ability to inhibit responses to distracting information.
Time frame
Test Day 1 and Test Day 23
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Processing Speed
Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Oral Symbol Digit Substitution Test - Assesses processing speed by requiring participants to match symbols and digits under time pressure.
Time frame
Test Day 1 and Test Day 24
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Memory
Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Picture Sequence Memory Test - Tests episodic memory by having participants recall sequences of illustrated scenes in the correct order.
Time frame
Test Day 1 and Test Day 2Secondary outcomes
1
Senaptec Sensory Station - Visual Acuity
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station. This includes: Visual Clarity Test - Measures the sharpness of vision using high-contrast letters; similar to a Snellen chart.
Time frame
Test Day 1 and Test Day 22
Senaptec Sensory Station - Visual perception
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station. Contrast Sensitivity - Assesses ability to detect subtle differences in luminance; important in low-light or low-contrast environments.
Time frame
Test Day 1 and Test Day 23
Senaptec Sensory Station - Stereopsis, spatial awareness
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station. Depth Perception - Measures the ability to judge the relative distance between objects using binocular vision.
Time frame
Test Day 1 and Test Day 24
Senaptec Sensory Station - Oculomotor control
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station. Near-Far Quickness - Assesses speed and accuracy in shifting focus between near and far objects; linked to accommodative and vergence flexibility.
Time frame
Test Day 1 and Test Day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov