Actively Recruiting

Phase Not Applicable
Age: 19Years - 55Years
All Genders
Healthy Volunteers
ID07051655

The Effects of Exogenous Ketones on Cognitive Function

Led by University of Alabama at Birmingham · Updated on 2026-01-07

45

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the acute effects of exogenous ketone monoester (KME) supplementation on cognitive function in adults aged 19 to 55 years. The study involves three groups: obese sedentary individuals, lean sedentary individuals, and lean individuals who are regular athletes. The study aims to assess how KME versus placebo affects cognitive, sensorimotor, and functional outcomes, and to compare cognitive performance across these groups. Participants will attend two test days separated by 3 to 7 days. On one day, they will consume a single dose of placebo, and on the other day, a single dose of KME, both dosed at 357 mg per kg of body weight. Thirty minutes after consumption on each test day, participants will complete cognitive assessments using the NIH Toolbox Cognition Battery, sensorimotor tests with the Senaptec Sensory Station, and driving performance evaluations via a driving simulator. During the study, participants will undergo testing on both days to measure cognitive functions like executive function, attention, processing speed, and memory. Sensorimotor abilities such as visual acuity, perception, oculomotor control, and visuomotor integration will also be assessed. Driving simulation tests will evaluate attention and reaction times. The study monitors these outcomes to understand the effects of KME supplementation, with participation lasting across the two test days separated by a few days.

CONDITIONS

Brief Title

The Effects of Exogenous Ketones on Cognitive Function

Who Can Participate

Age: 19Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 to 55 years
  • Body mass index (BMI) between 30 and 40 for obese group or 18 to 25 for lean and athlete groups
  • Sedentary status with less than 2 hours per week of structured physical activity for obese and lean groups
  • Active athlete status with at least 5 days per week of structured physical activity for athlete group
Not Eligible

You will not qualify if you...

  • Diagnosed neurological conditions such as Parkinson's disease, multiple sclerosis, schizophrenia, muscular dystrophy, stroke, or 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 2 weeks

Participants undergo two test days separated by 3 to 7 days. On each test day, participants arrive fasted and consume a single dose of ketone monoester or placebo. Thirty minutes after consumption, cognitive, sensorimotor, and driving performance assessments are completed.

2 visits (in-person) separated by 3 to 7 days

Trial Site Locations

Total: 1 location

1

916 Building

Birmingham, Alabama, United States, 35205

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Research Team

S

Sarah K Sweatt, PhD

E

Eric Plaisance

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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