HealthyNCT07010666
BHB and Cognition During Exercise-Heat Stress
A study testing Beta-Hydroxybutyrate, Carbohydrate and Caffeine in people with Healthy, run by University of South Carolina at 1 site in United States.
Trial summary
The study investigates how consuming a ketone ester (BHB) along with caffeine impacts cognitive performance under heat stress, similar to what military personnel experience in hot environments. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Beta-Hydroxybutyrate, Carbohydrate and Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 12 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male and female participants who are between 18 and 35 years of age (inclusive).
- Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit.
- Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
- Exercise regularly as per physical activity guidelines for Americans3 [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period.
- Can maintain their exercise status at the beginning of the study throughout the study period.
- Can achieve a peak oxygen consumption at screening that is at least 55 ml/kg/min.
- Have normal or acceptable to the investigator vital signs (BP and HR) at screening.
- Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Female participants who are lactating, pregnant or planning to become pregnant during the study.
- Carry a diagnosis of diabetes.
- Weigh less than or equal to 80 pounds at any visits.
- Answer "yes" to any of the questions asked on the screening questionnaire.
- Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible.
Show all 17Show fewer
- Consume more than two standard alcoholic drinks per day.
- Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study.
- Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume.
- Smoking tobacco products.
- Have a history of alcohol or substance abuse in the 12 months prior to the screening visit.
- Are cognitively impaired and/or unable to give informed consent.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
- Have a current or previous diagnosis with SARS-CoV-2 in the three months prior to screening.
- Have had major surgery three months prior to screening or have a planned major surgery during the course of the study.
- Have received or use test product(s) in another research study in the 28 days prior to baseline visit, or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study.
- Have any other active or unstable medical conditions or use medications, supplements, or therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina Sport Science Lab
Columbia, South Carolina, 29208
About this study
Official title: Beta-Hydroxybutyrate Ingestion and Cognition During Exercise-Heat Stress
The study investigates how consuming a ketone ester (BHB) along with caffeine impacts cognitive performance under heat stress, similar to what military personnel experience in hot environments. The extreme heat can impair brain function, affecting decision-making and performance, which is critical for Special Operations Forces (SOF). BHB provides an alternative energy source for the brain, potentially improving brain blood flow and cognition, particularly during "stressful" situations. By comparing ketone and carbohydrate intake with caffeine, this study aims to find better ways to maintain mental sharpness during stressful conditions. The results could help enhance the safety and effectiveness of military operations.
Read the detailed description
This study aims to examine the effects of ingestion of 25g of BHB ketone ester and 4 mg/kg of caffeine on cognitive performance during exercise-heat induced hyperthermia when compared to carbohydrate combined with the same dosage of caffeine. This will be the first study to investigate the effects of ketone ester ingestion on cognition during exercise-heat induced hyperthermia in endurance-trained adults. Further, this study has the potential to impact the safety and mission success of SOF by improving cognitive performance when making critical decisions in a physiologically compromised state.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-HydroxybutyrateDietary supplement
25 grams of BHB
CarbohydrateDietary supplement
25 grams of carbohydrate
CaffeineDietary supplement
4 mg/kg of caffeine
| Study group | Role | What they receive |
|---|---|---|
| Ketone Supplementation | Experimental | Participants received 25g of BHB ketone ester and 4 mg/kg of caffeine. Receives: Dietary Supplement: Beta-Hydroxybutyrate; Dietary Supplement: Caffeine |
| Control | Active comparator | Participants received 25g of carbohydrate and 4 mg/kg of caffeine. Receives: Dietary Supplement: Carbohydrate; Dietary Supplement: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Inhibitory Control by reaction time (Go/No go)
To determine if the intervention has an impact on inhibitory control by measuring reaction time to Go targets (hits).
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Changes in Inhibitory Control by reaction time by errors (Go/No go)
To determine if the intervention has an impact on inhibitory control by measuring errors of commission representing incorrect responses to the target NoGo (false alarm).
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Changes in Attention (Go/No go)
To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Changes in Object Hit and Avoid (OHA) task: Total accuracy, Target accuracy, and Non-target accuracy
To determine the effects of the intervention on rapid response execution and inhibition during complex continuous task performance, changes in total accuracy, target accuracy, and non-target accuracy in response to the intervention will be assessed.
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Changes in 1-Back Task
The determine the effects of the intervention on working memory capacity.
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Changes in 2-Back Task
The determine the effects of the intervention on working memory capacity.
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Changes in Hopkins Verbal Learning Task
The determine the effects of the intervention on verbal learning and memory
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Secondary outcomes (4)
Heart Rate
Changes in heart rate across the visit
Measured: Heart rate monitors will be outfitted at baseline (at the beginning of experimental visits) and heart will be measured continuously throughout experimental visit days (approximately 2 hours per day). Maximum and average heart rates will be recorded.
Core Body Temperature
Changes in core body temperature across the visit
Measured: rectal thermometers outfitted at baseline (at the beginning of experimental visits) and core temperature will be measured continuously throughout experimental visit days (approximately 2 hours per day). Maximum and average temperature will be recorded.
Blood Ketone Levels
Changes in blood ketone levels across the visit
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Blood Glucose Levels
Changes in blood glucose levels across the visit
Measured: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start29 Jan 2025
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn M. Arent, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010666
- Sponsor's protocol ID
- Pro00139698
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Hydroxybutyrate Ingestion and Cognition During Exercise-Heat Stress
- ClinicalTrials.gov ID
- NCT07010666
- Acronym / sponsor ID
- Pro00139698
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 8 Jun 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 study investigates how consuming a ketone ester (BHB) along with caffeine impacts cognitive performance under heat stress, similar to what military personnel experience in hot environments. The extreme heat can impair brain function, affecting decision-making and performance, which is critical for Special Operations Forces (SOF). BHB provides an alternative energy source for the brain, potentially improving brain blood flow and cognition, particularly during "stressful" situations. By comparing ketone and carbohydrate intake with caffeine, this study aims to find better ways to maintain mental sharpness during stressful conditions. The results could help enhance the safety and effectiveness of military operations.
Detailed description
This study aims to examine the effects of ingestion of 25g of BHB ketone ester and 4 mg/kg of caffeine on cognitive performance during exercise-heat induced hyperthermia when compared to carbohydrate combined with the same dosage of caffeine. This will be the first study to investigate the effects of ketone ester ingestion on cognition during exercise-heat induced hyperthermia in endurance-trained adults. Further, this study has the potential to impact the safety and mission success of SOF by improving cognitive performance when making critical decisions in a physiologically compromised state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone Supplementation | Experimental | Dietary Supplement: Beta-Hydroxybutyrate, Dietary Supplement: CaffeineParticipants received 25g of BHB ketone ester and 4 mg/kg of caffeine. |
| Control | Active comparator | Dietary Supplement: Carbohydrate, Dietary Supplement: CaffeineParticipants received 25g of carbohydrate and 4 mg/kg of caffeine. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult male and female participants who are between 18 and 35 years of age (inclusive).
- Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit.
- Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
- Exercise regularly as per physical activity guidelines for Americans3 [structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)] and willing to maintain the same level of physical activity throughout the study period.
- Can maintain their exercise status at the beginning of the study throughout the study period.
Key exclusion criteria (17 listed)
- Female participants who are lactating, pregnant or planning to become pregnant during the study.
- Carry a diagnosis of diabetes.
- Weigh less than or equal to 80 pounds at any visits.
- Answer "yes" to any of the questions asked on the screening questionnaire.
- Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
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 |
|---|---|---|
| Beta-Hydroxybutyrate25 grams of BHB | Dietary supplement | Ketone Supplementation |
| Carbohydrate25 grams of carbohydrate | Dietary supplement | Control |
| Caffeine4 mg/kg of caffeine | Dietary supplement | Control, Ketone Supplementation |
Primary outcome
Changes in Inhibitory Control by reaction time (Go/No go)
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
To determine if the intervention has an impact on inhibitory control by measuring reaction time to Go targets (hits).
Changes in Inhibitory Control by reaction time by errors (Go/No go)
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
To determine if the intervention has an impact on inhibitory control by measuring errors of commission representing incorrect responses to the target NoGo (false alarm).
Changes in Attention (Go/No go)
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
To determine if the device has an impact on attention by measuring errors of omission to the target Go (misses).
Changes in Object Hit and Avoid (OHA) task: Total accuracy, Target accuracy, and Non-target accuracy
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
To determine the effects of the intervention on rapid response execution and inhibition during complex continuous task performance, changes in total accuracy, target accuracy, and non-target accuracy in response to the intervention will be assessed.
Changes in 1-Back Task
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
The determine the effects of the intervention on working memory capacity.
Changes in 2-Back Task
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
The determine the effects of the intervention on working memory capacity.
Changes in Hopkins Verbal Learning Task
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
The determine the effects of the intervention on verbal learning and memory
4 secondary outcomes
Heart Rate
Time frame: Heart rate monitors will be outfitted at baseline (at the beginning of experimental visits) and heart will be measured continuously throughout experimental visit days (approximately 2 hours per day). Maximum and average heart rates will be recorded.
Core Body Temperature
Time frame: rectal thermometers outfitted at baseline (at the beginning of experimental visits) and core temperature will be measured continuously throughout experimental visit days (approximately 2 hours per day). Maximum and average temperature will be recorded.
Blood Ketone Levels
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Blood Glucose Levels
Time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-Hydroxybutyrate, Carbohydrate and Caffeine in people with Healthy, run by University of South Carolina 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 8 Jun 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Inhibitory Control by reaction time (Go/No go) (time frame: On the experimental visit days: At Baseline (0 minutes prior to the exercise protocol), 45 minutes after baseline (exercise protocol midpoint), 90 minutes after baseline (end of the exercise protocol).). The study lists 7 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 8 Jun 2025.