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The Effects of Exogenous Ketones on Cognitive Function

NCT07051655 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051655 on ClinicalTrials.gov