Exogenous ketone monoester effects on thinking, sensorimotor skills, and driving
The Effects of Exogenous Ketones on Cognitive Function
NA · University of Alabama at Birmingham · NCT07051655
This test will try a single dose of a ketone monoester supplement versus a placebo to see if it improves thinking, sensorimotor skills, and driving performance in adults 19–55 who are obese and sedentary, lean and sedentary, or lean and regularly active.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07051655 on ClinicalTrials.gov |
What this trial studies
Adults aged 19–55 in three groups (obese sedentary, lean sedentary, and lean active) receive either an acute dose of ketone monoester or a placebo and then complete cognitive, sensorimotor, and driving assessments. Cognitive performance is measured with the NIH Toolbox Cognition Battery, sensorimotor function with the Senaptec Sensory System, and driving ability with a driving simulator. The study compares within-group effects of ketone versus placebo and compares baseline cognitive performance across the three groups. Exclusion criteria include neurological diagnoses, seizure history, certain medications, pregnancy/breastfeeding, recent ketone use, or adherence to a ketogenic diet.
Who should consider this trial
Good fit: Ideal candidates are adults 19–55 with BMI 30–40 for the obese group or BMI 18–25 for the lean and athlete groups who meet the activity criteria (sedentary <2 hrs/week or athlete ≥5 days/week) and who are not pregnant and do not have excluded neurological conditions or disallowed medications.
Not a fit: People with diagnosed neurological disorders, a history of seizures, current use of diabetes/mood/attention medications, pregnant or breastfeeding individuals, or those currently using exogenous ketones or following a ketogenic diet are unlikely to be eligible or to benefit from this acute-supplement test.
Why it matters
Potential benefit: If successful, a ketone monoester supplement could provide a safe, short-term boost to cognitive and sensorimotor performance, particularly for people with obesity who may have impaired cerebral glucose metabolism.
How similar studies have performed: Prior studies have shown cognitive benefits of ketone monoesters in Alzheimer's disease and mild cognitive impairment, but applying acute ketone supplementation to otherwise healthy obese or athletic adults is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Birmingham, Alabama
- 916 Building — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Sarah K Sweatt, PhD
- Email: sksweatt@uab.edu
- Phone: 205-975-5398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Placebo - Control, Ketone Monoester