NCT07051655

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

June 3, 2025

Last Update Submit

January 6, 2026

Conditions

Placebo - ControlKetone Monoester

Outcome Measures

Primary Outcomes (4)

  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Executive function

    Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Dimensional Change Card Sort Test - Measures executive function and cognitive flexibility by assessing the ability to switch between mental rules.

    Test Day 1 and Test Day 2

  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Attention

    Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Flanker Inhibitory Control and Attention Test - Evaluates attention and the ability to inhibit responses to distracting information.

    Test Day 1 and Test Day 2

  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Processing Speed

    Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Oral Symbol Digit Substitution Test - Assesses processing speed by requiring participants to match symbols and digits under time pressure.

    Test Day 1 and Test Day 2

  • NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Memory

    Cognitive function will be assessed using the NIH Toolbox Cognition Battery, administered on an iPad. \- Picture Sequence Memory Test - Tests episodic memory by having participants recall sequences of illustrated scenes in the correct order.

    Test Day 1 and Test Day 2

Secondary Outcomes (12)

  • Senaptec Sensory Station - Visual Acuity

    Test Day 1 and Test Day 2

  • Senaptec Sensory Station - Visual perception

    Test Day 1 and Test Day 2

  • Senaptec Sensory Station - Stereopsis, spatial awareness

    Test Day 1 and Test Day 2

  • Senaptec Sensory Station - Oculomotor control

    Test Day 1 and Test Day 2

  • Senaptec Sensory Station - Visual search

    Test Day 1 and Test Day 2

  • +7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

ketone monoester (KME)

EXPERIMENTAL

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.

Dietary Supplement: Ketone Monoester (KE)

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.

Also known as: ketone monoester (KME)
ketone monoester (KME)
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

916 Building

Birmingham, Alabama, 35205, United States

RECRUITING

Central Study Contacts

Sarah K Sweatt, PhD

CONTACT

205-975-5398sksweatt@uab.edu

Eric Plaisance

CONTACT

plaisep@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2025

First Posted

July 4, 2025

Study Start

December 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)