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Recruiting NCT07051655

The Effects of Exogenous Ketones on Cognitive Function

No phase Interventional Placebo - Control Ketone Monoester

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketone Monoester (KE), Placebo.
Who it may be relevant to
Registry conditions: Placebo - Control, Ketone Monoester. Basic parameters: 19 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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).

Exogenous ketones are considered a functional food, providing potential health benefits beyond basic nutrition. Specifically, KME has been shown to elevate circulating β-hydroxybutyrate (βHB), an alternative brain fuel that may enhance cognitive performance. Prior studies have demonstrated that KME improves cognition in individuals with Alzheimer's disease and mild cognitive impairment; however, its effects in otherwise healthy, sedentary individuals-particularly those with obesity-or in physically active individuals remain unknown.

Emerging evidence suggests that individuals with obesity may exhibit early cognitive deficits, especially in executive function and processing speed, which could increase their risk of accelerated cognitive decline with aging. These deficits may be partially attributed to impaired cerebral glucose metabolism. Since ketones serve as an efficient alternative energy substrate for the brain, ketone supplementation may help compensate for these metabolic deficits and enhance cognitive performance.

This study aims to compare cognitive performance across the three groups and assess the effects of acute KME supplementation versus placebo on cognitive, sensorimotor, and functional outcomes. 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.

This three-group design allows for the investigation of differential responses to ketone supplementation across a spectrum of metabolic health and physical conditioning. By using sensitive, multimodal assessment tools, this study will help determine whether exogenous ketones confer cognitive and functional benefits broadly, or whether these effects are most pronounced in metabolically impaired populations.

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 Stat
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Senaptec Sensory Station - Visual Acuity [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Visual perception [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Stereopsis, spatial awareness [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Oculomotor control [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Visual search [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Visual working memory [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Attention [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Processing Speed [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Visual Tracking [Time frame: Test Day 1 and Test Day 2]
  • Senaptec Sensory Station - Visuomotor Integration [Time frame: Test Day 1 and Test Day 2]
  • Driving Simulator Performance Metrics - Attention [Time frame: Test Day 1 and Test Day 2]
  • Driving Simulator Performance Metrics - Reaction Time [Time frame: Test Day 1 and Test Day 2]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • 916 Building — Birmingham

Identifiers

NCT: NCT07051655 · IRB-300013940 · UAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗