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RECRUITING
NCT07051655
NA

The Effects of Exogenous Ketones on Cognitive Function

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

19 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-12-01

Completion Date

2026-04

Last Updated

2026-01-07

Healthy Volunteers

Yes

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.

Locations (1)

916 Building

Birmingham, Alabama, United States