Recruiting

KME

Sponsor:

University of Alabama at Birmingham

Code:

NCT07051655

Conditions

Placebo - Control

Ketone Monoester

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

Ketone Monoester (KE)

Placebo

Study Details

Brief 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.

Conditions

Placebo - Control

Ketone Monoester

Study ID

NCT07051655

Start date

Dec 1, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participants will undergo two test days (Test Day 1 and Test Day 2) 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.

experimental: ketone monoester (KME)

Participants will undergo two test days separated by 3-7 days. On one test day, participants will consume a single dose of ketone monoester (KME) (357 mg/kg of body weight). Thirty minutes after consuming the KME, cognitive assessments will be completed including NIH Toolbox cognitive assessments, Senaptec Sensory Station, and driving simulation.

Interventions

Ketone Monoester (KE)

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.

Placebo

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.

Primary outcome measure

  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Executive function [ Time Frame: Test Day 1 and Test Day 2 ]
  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Attention [ Time Frame: Test Day 1 and Test Day 2 ]
  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Processing Speed [ Time Frame: Test Day 1 and Test Day 2 ]
  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Memory [ Time Frame: Test Day 1 and Test Day 2 ]

Central Contacts and Locations

Central contacts

Sarah K Sweatt, PhD

205-975-5398sksweatt@uab.edu

Eric Plaisance

plaisep@uab.edu

Locations

916 Building

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Sarah K Sweatt, PhD

205-975-5398sksweatt@uab.edu

William J Tyler, PhD

wjpt@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-13.