The Effects of Exogenous Ketones on Cognitive Function

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07051655
Status
Recruiting
Apply to this trial

Conditions

  • Ketone Monoester
  • Placebo - Control

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Ketone Monoester (KE) — DIETARY_SUPPLEMENT
    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 — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
916 BuildingBirminghamAlabama35205
Sarah K Sweatt, PhD
[email protected]
205-975-5398
William J Tyler, PhD
[email protected]

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916 Building· Birmingham, AL

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