Placebo - ControlNCT07051655
The Effects of Exogenous Ketones on Cognitive Function
A study testing Ketone Monoester (KE) in people with Placebo - Control and Ketone Monoester, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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.… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo - Control, Ketone Monoester
- What is being tested?
- Ketone Monoester (KE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eric Plaisance contact
United States1 site, 1 recruiting
- Recruiting
916 Building
Birmingham, Alabama, 35205
Sarah K Sweatt, PhD, 205-975-5398, sksweatt@uab.edu
William J Tyler, PhD, wjpt@uab.edu
About this study
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.
Read the 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.
- Conditions
- Placebo - Control, Ketone Monoester
- Being tested
- Ketone Monoester (KE), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester (KE)Dietary supplement
Also called ketone monoester (KME)
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Ketone Monoester (KE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Test Day 1 and Test Day 2
Secondary outcomes (12)
Senaptec Sensory Station - Visual Acuity
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station. This includes:
Visual Clarity Test - Measures the sharpness of vision using high-contrast letters; similar to a Snellen chart.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Visual perception
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Contrast Sensitivity - Assesses ability to detect subtle differences in luminance; important in low-light or low-contrast environments.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Stereopsis, spatial awareness
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Depth Perception - Measures the ability to judge the relative distance between objects using binocular vision.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Oculomotor control
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Near-Far Quickness - Assesses speed and accuracy in shifting focus between near and far objects; linked to accommodative and vergence flexibility.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Visual search
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Target Capture - tests speed and accuracy in identifying and responding to a target among distractors.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Visual working memory
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Perception Span - Evaluates ability to recall the location and identity of briefly presented visual stimuli.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Attention
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Go/No-Go - Assesses impulse control by requiring responses to specific stimuli while inhibiting others
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Processing Speed
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Reaction Time - Measures the speed of motor response to a visual stimulus; includes both simple and choice RT.
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Visual Tracking
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Multiple Object Tracking - Requires simultaneous tracking of multiple moving targets among distractors
Measured: Test Day 1 and Test Day 2
Senaptec Sensory Station - Visuomotor Integration
Participants will complete the full suite of visual and sensorimotor evaluations within the "Evaluation" tab of the Senaptec Sensory Station.
Eye-Hand Coordination - Measures the ability to synchronize visual input with precise hand movement.
Measured: Test Day 1 and Test Day 2
Driving Simulator Performance Metrics - Attention
Cognitive and functional performance will be assessed using a high-fidelity driving simulator.
- Lane-keeping variability
Driving simulator data will provide an ecologically valid, real-world proxy of cognitive-motor integration and decision-making under time pressure.
Measured: Test Day 1 and Test Day 2
Driving Simulator Performance Metrics - Reaction Time
Cognitive and functional performance will be assessed using a high-fidelity driving simulator. Participants will complete a standardized driving task
- Mean reaction time to unexpected events (e.g., pedestrian crossing)
- Braking accuracy and response latency
Driving simulator data will provide an ecologically valid, real-world proxy of cognitive-motor integration and decision-making under time pressure.
Measured: Test Day 1 and Test Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Dec 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placebo - ControlStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Sweatt, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051655
- Sponsor's protocol ID
- IRB-300013940
- Other IDs
- UAB
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exogenous Ketones on Cognitive Function
- ClinicalTrials.gov ID
- NCT07051655
- Acronym / sponsor ID
- IRB-300013940
- Conditions
- Placebo - Control, Ketone Monoester
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
| ketone monoester (KME) | Experimental | Dietary Supplement: Ketone Monoester (KE)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. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone Monoester (KE)Also: ketone monoester (KME)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 | ketone monoester (KME) |
| PlaceboParticipants 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. | Dietary supplement | Placebo |
Primary outcome
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Executive function
Time frame: Test Day 1 and Test Day 2
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.
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Attention
Time frame: Test Day 1 and Test Day 2
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.
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Processing Speed
Time frame: Test Day 1 and Test Day 2
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.
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Memory
Time frame: Test Day 1 and Test Day 2
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Plaisance contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Monoester (KE) in people with Placebo - Control and Ketone Monoester, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah K Sweatt, PhD (205-975-5398, sksweatt@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Toolbox Cognition Battery Composite Score and Domain-Specific Subtests - Executive function (time frame: Test Day 1 and Test Day 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.