Sleep DeprivationSTAK-SleepNCT05519644
Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction
A study testing Sleep Deprivation, Heart Rate and Sleep Monitoring in people with Sleep Deprivation, run by Ohio State University at 1 site in United States.
Trial summary
Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep Deprivation, Heart Rate and Sleep Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to Sep 2026
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to comply with all study procedures including the following prior to Test Days: fasting (>10 h; water only), no alcohol (>24 h), no exercise (>24 h), no acute illness and controlled feeding before each Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
- Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
Who cannot join
- <18 or >40 years of age
- >35 body mass index (BMI).
- Diagnosed sleeping disorders (i.e., sleep apnea, insomnia).
- Gastrointestinal disorders or food allergies that would interfere with consuming the study supplements.
- Drink alcohol in excess of 3 drinks/day or 14 drinks/week
- Have any conditions or contraindications to blood draws.
Show all 11Show fewer
- Have been diagnosed with diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or use diabetic medications other than metformin
- Currently consume a low carbohydrate or ketogenic diet or have done so in the last 3 months
- Have experienced weight loss of >10% of your body weight within the last 6 months
- Are pregnant, lactating, or planning on becoming pregnant during the study
- Have any major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. The main purpose of these supplements is to raise your blood concentration of ketones, which are safe, small molecules that appear in the blood during fasting, when following a ketogenic diet, or consuming ketone supplements.
The main purpose of this study is to examine if ingesting a ketone ester supplement, twice daily, can improve cognitive and physical performance during short-term sleep restriction.
Read the detailed description
Only 1 in 3 U.S. Army Active Component Soldiers are estimated to get the target =7-hr of sleep on duty days, and ~14% have a sleep disorder. Insufficient sleep has profound effects on human performance that include deficits in working memory, creativity, innovative thinking, strategic planning, mood disturbances, lapses in attention and vigilance, and impaired physical performance. In a classic dose-response sleep study performed at Walter Reed Army Institute of Research, it was demonstrated that limiting sleep to 3-hr per night for 7-days resulted in a steady deterioration on a psychomotor vigilance task across the week of sleep restriction. Sleep restriction over 3-days has been shown to adversely affect marksmanship performance, including significantly longer time to make decisions, misidentifying friends versus foes, and believing performance did not change over time. Short-term sleep restriction is linked with impaired glucose metabolism and decreased whole body insulin sensitivity, and increases the risk of developing T2D. Military personnel have few good options to counteract physical and cognitive detriments attributed to insufficient sleep. Warfighters increasingly turn to caffeine and sugar-containing energy drinks to combat sleep loss and fatigue, especially during deployment. At best, these nutritional countermeasures provide a transient performance gain, and may trigger a 'rebound' hypoglycemia that exacerbates performance detriments that can increase the risk of obesity and related problems. Ketosis could improve tolerance to sleep restriction and sleep abnormalities through multiple mechanisms. We have reported that a 1-yr KD improved sleep quality and the proportion of people categorized as poor sleepers. Ketones are a preferred brain fuel that may enhance neurocognitive function. The ability to metabolize a lipid-derived substrate (ketones) capable of sustaining the brain's high energy demands during periods with limited access to carbohydrate was a central adaptation in human evolution, that is also associated with a remarkable protection from the adverse signs of hypoglycemia. At the low end of nutritional ketosis (0.5 mM), ~5% of whole brain energy metabolism is provided by ketones. At ketone concentrations of 1.5 mM (typical of KDs), ketones supply nearly 20%; at the higher end of nutritional ketosis 4-5 mM [achievable with ketone esters (KE)], half of the brain energy demands are met by ketones. Importantly in situations where brain glucose metabolism is impaired, uptake and utilization of ketones remain fully intact, suggesting a hierarchy of importance placed on ketones as the preferred fuel for human brains.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep Deprivation, Heart Rate, Sleep Monitoring, Diet, Exercise Performance
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep DeprivationOther
The sleeping protocol will be monitored by investigators and personnel with experience in sleep medicine. Participants will be required to reduce sleep by 50% of normal, for 4 consecutive nights, to observe potential deficits in physical and cognitive performance
Heart RateOther
HR will be assessed by wrist-based acceleration with cloud technology (Polar Unite™, Polar USA). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands of the cadets. Each participant will be fitted with the watch for acclimatization and then establish 3-day baseline patterns for 3 nights before the sleep loss protocol.
Sleep MonitoringOther
Sleep will be assessed by wrist-based acceleration with cloud technology (Polar Unite™, Polar USA). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands of the cadets.Each participant will be fitted with the watch for acclimatization and then establish 3-day baseline patterns for 3 nights before the sleep loss protocol.
DietOther
Diet will be included and the same meals will be available for all subjects while controlling for caffeine. Participants will be given food during each intervention week.
Exercise PerformanceOther
Since weight training is now a crucial part of any warfighter's physical preparation, we will have subjects perform weight training workouts emphasizing all major muscle groups on Days 2, 3 and 4
Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep IndexBehavioural
These will be administered on Days 1 and 5 of each intervention trial to assess different behavioral outcomes.
Cognitive performanceOther
Automated Neuropsychological Assessment Metrics (ANAM), Cambridge Neuropsychological Test Automated Battery. (CANTAB),Gradual-onset Continuous Performance Task (GRAD-CPT),Face-Name Task will be used to assess cognitive function and performance.
Marksmanship PerformanceOther
Also called VirTra
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Multiple metrics of marksmanship (total number of shots fired/silhouette target presentation, percentage of targets successfully hit/min, the radial distance of a shot from the center on target, shot group tightness, and time from target presentation to trigger pull) will be collected during each visit.
Quick BoardOther
Also called Response Time
Upper body and lower body reaction tests will be assess using Quick Board Analysis on days 1 and 5 of the sleep restriction intervention.
Advanced Medical Technologies Inc, Jump TestOther
Also called Whole Body Power
Whole body power will be assessed with a repetitive jump test. Power (peak, average, curve functions) will be assessed using an AMTI force plate with Accupower 2.0 software (Advanced Mechanical Technology Inc, Watertown, MA).
CGM/CKMOther
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at ~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood DrawBiological
Blood samples will be collected according to the schedule in Figure 1.
Ketone SupplementDietary supplement
Participants will take a diester of hexanoic acid (a ketogenic medium chain fatty acid) and (R)-1,3 butanediol (C6 Di-ester) during one of the trial interventions
| Study group | Role | What they receive |
|---|---|---|
| Placebo First | Active comparator | Patients will be randomize to take the placebo for the first trial of the intervention, then after a 2 week washout, participants will perform the same intervention but with a ketone ester. Receives: Other: Sleep Deprivation; Other: Heart Rate; Other: Sleep Monitoring; Other: Diet; Other: Exercise Performance; Behavioral: Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index; Other: Cognitive performance; Other: Marksmanship Performance; Other: Quick Board; Other: Advanced Medical Technologies Inc, Jump Test; Other: CGM/CKM; Biological: Blood Draw; Dietary Supplement: Ketone Supplement |
| Ketone Ester First | Experimental | Patients will be randomize to take the ketone ester for the first trial of the intervention, then after a 2 week washout, participants will perform the same intervention but with a placebo Receives: Other: Sleep Deprivation; Other: Heart Rate; Other: Sleep Monitoring; Other: Diet; Other: Exercise Performance; Behavioral: Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index; Other: Cognitive performance; Other: Marksmanship Performance; Other: Quick Board; Other: Advanced Medical Technologies Inc, Jump Test; Other: CGM/CKM; Biological: Blood Draw; Dietary Supplement: Ketone Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated Neuropsychological Assessment Metrics (ANAM)
This cognitive battery is a library of computer-based tests of domains including attention, concentration, reaction time, memory, processing speed, decision-making, and executive function.
Measured: Up to ~ 4 weeks
Cambridge Neuropsychological Test Automated Battery. (CANTAB)
This iPad delivery assessment will include an Information Sampling Task to test impulsivity and decision making, response time (in msec), which provides a level of sensitivity not available with traditional paper and pencil tasks, processing speed, executive functioning, and spatial memory. We have also incorporated tasks which assess the ability to rapidly identify expressed facial emotions, which may index one's ability to accurately respond to overtly threatening or non-threatening stimuli
Measured: Up to ~ 4 Weeks
Gradual-onset Continuous Performance Task (GRAD-CPT
This test measures endogenous attentional control by using smooth (rather than abrupt) transitions between visual images. Scene stimuli are visually presented and smoothly transition from one scene to another. Subjects press a button when one type of scene is presented (e.g., city scene) and withhold the button press when another type of scene (e.g., mountain scene) is presented. It is a Go/No-Go test and assesses multiple metrics of executive function, including sustained attention, mind wandering, and response inhibition.
Measured: Up to ~4 weeks
Face-Name Task
We will implement a face-name relational memory task, known to activate the hippocampus (along with prefrontal and parietal cortices) in humans using face-name pairs presented for 3-sec with an interval of 750-msec. Participants will judge which name was previously presented with the face. After a 15-min delay, participants will complete an associative face-name recognition task to assess episodic memory performance.
Measured: Up to ~4 weeks
Total number of shots fired
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Total number of shots fired, a metric of marksmanship, will be collected during each visit, to assess reaction time and accuracy.
Measured: Up to ~4 weeks
Percentage of targets successfully hit per minute
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Percentage of targets successfully hit/min, a metric of marksmanship, will be collected during each visit to assess accuracy.
Measured: Up to ~4 weeks
Radial distance of a shot from the center on target
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. The radial distance of a shot from the center on target, a metric of marksmanship, will be collected during each visit to assess shot accuracy.
Measured: Up to ~4 weeks
Shot Group Tightness
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Shot group tightness, a metric of marksmanship, will be collected during each visit to assess multi-shot accuracy.
Measured: Up to ~4 weeks
Time from target presentation to trigger pull
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Time from target presentation to trigger pull, a metric of marksmanship , will be collected during each visit to assess reaction time.
Measured: Up to ~4 weeks
Power Outcome (QuickBoard)
Upper body and lower body reaction tests will be assess using Quick Board Analysis on days 1 and 5 of the sleep restriction intervention.
Measured: Up to ~4 weeks
Secondary outcomes (9)
CGM/CKM
Diurnal concentrations of ketones and glucose via a continuous monitor. The ketone sensor in this CKM device is similar to the FreeStyle Libre continuous glucose monitoring (CGM). The sensor adheres to the back of the arm where it continuously samples interstitial fluid for quantification of BHB concentration. The sensor is worn for a period of 2-wk, two sensors will be used to cover all test days in this study (4 weeks including 2 week washout)
Measured: Up to ~ 4 weeks
Heart Rate
HR will be assessed by wrist-based acceleration with cloud technology (Polar Unite™, Polar USA). This will allow for assessment of changes in HR.
Measured: Up to ~ 4 weeks
Short Form- McGill Pain Questionnaire
The Short Form McGill pain questionnaire (SF-MPQ) will be used to assess pain in individuals. Clinically important change (CIC): mean improvement in total scores >5 on the 0-45 SF-MPQ scale. Minimum detectable change (MDC) for total, sensory, affective, average, and current pain: 5.2cm, 4.5cm, 2.8cm, 1.4cm, and 1.4cm, respectively. The SF-MPQ will be examined around the sleep restriction/exercise intervention on Days 1 and 5 to assess pain change.
Measured: Up to ~ 4 weeks
Profile of Mood States- Short Form
Shortened Profile of Mood States- Short Form (POMS-SF) measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. For each word and statement, they must circle the number on a Likert scale from 0= Not at all to 4=Extremely for how often they have felt those feelings today and over the past week. The POMS-SF will be examined around the sleep restriction/exercise intervention on Days 1 and 5 to assess mood.
Measured: Up to ~ 4 weeks
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. PSQI will be examined around the sleep restriction/exercise intervention on Days 1 and 5 to assess sleep quality.
Measured: Up to ~ 4 weeks
Insulin
Differences in blood hormones insulin after supplementation will be analyzed using commercially available ELISA assay kits (Cayman Chemical, USA).
Measured: Up to ~ 4 weeks
Ghrelin
Differences in blood hormones insulin after supplementation will be analyzed using commercially available ELISA assay kits (Cayman Chemical, USA).
Measured: Up to ~ 4 weeks
CRP
Differences in blood proteins after supplementation will be analyzed using commercially available ELISA assay kits (Cayman Chemical, USA).
Measured: Up to ~ 4 weeks
Brain Derived Neurotropic Factor
Differences in neurotrophins after supplementation will be analyzed using commercially available ELISA assay kits (Cayman Chemical, USA).
Measured: Up to ~4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start20 Jun 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind, placebo-controlled, two-period cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Volek, Ohio State University
- Investigators
- Jeff S Volek, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519644
- Sponsor's protocol ID
- 2022H0169
- Other IDs
- CDMRP-PR212399-C
- Acronym
- STAK-Sleep
- Status last verified
- May 2026
- First submitted
- 18 Aug 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buga A, Stoner JT, Sapper TN, Crabtree CD, Decker DD, Robinson BT, Kackley ML, McClure T, Chebbi A, Stalter H, Dawson L, Whiteman A, Spencer M, Lane L, Hayes SM, Mindel J, Kraemer WJ, Volek JS. Supplementation With Ketogenic Precursors Enhances Virtual Reality Shooting Performance During Sleep Restriction: A Randomized, Placebo-Controlled, Crossover Trial. Mil Med. 2026 Sep 17:usag429. doi: 10.1093/milmed/usag429. Online ahead of print.
PubMed 42753265
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction
- ClinicalTrials.gov ID
- NCT05519644
- Acronym / sponsor ID
- STAK-Sleep / 2022H0169
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Aug 2022 (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.
Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. The main purpose of these supplements is to raise your blood concentration of ketones, which are safe, small molecules that appear in the blood during fasting, when following a ketogenic diet, or consuming ketone supplements.
The main purpose of this study is to examine if ingesting a ketone ester supplement, twice daily, can improve cognitive and physical performance during short-term sleep restriction.
Detailed description
Only 1 in 3 U.S. Army Active Component Soldiers are estimated to get the target =7-hr of sleep on duty days, and ~14% have a sleep disorder. Insufficient sleep has profound effects on human performance that include deficits in working memory, creativity, innovative thinking, strategic planning, mood disturbances, lapses in attention and vigilance, and impaired physical performance. In a classic dose-response sleep study performed at Walter Reed Army Institute of Research, it was demonstrated that limiting sleep to 3-hr per night for 7-days resulted in a steady deterioration on a psychomotor vigilance task across the week of sleep restriction. Sleep restriction over 3-days has been shown to adversely affect marksmanship performance, including significantly longer time to make decisions, misidentifying friends versus foes, and believing performance did not change over time. Short-term sleep restriction is linked with impaired glucose metabolism and decreased whole body insulin sensitivity, and increases the risk of developing T2D. Military personnel have few good options to counteract physical and cognitive detriments attributed to insufficient sleep. Warfighters increasingly turn to caffeine and sugar-containing energy drinks to combat sleep loss and fatigue, especially during deployment. At best, these nutritional countermeasures provide a transient performance gain, and may trigger a 'rebound' hypoglycemia that exacerbates performance detriments that can increase the risk of obesity and related problems. Ketosis could improve tolerance to sleep restriction and sleep abnormalities through multiple mechanisms. We have reported that a 1-yr KD improved sleep quality and the proportion of people categorized as poor sleepers. Ketones are a preferred brain fuel that may enhance neurocognitive function. The ability to metabolize a lipid-derived substrate (ketones) capable of sustaining the brain's high energy demands during periods with limited access to carbohydrate was a central adaptation in human evolution, that is also associated with a remarkable protection from the adverse signs of hypoglycemia. At the low end of nutritional ketosis (0.5 mM), ~5% of whole brain energy metabolism is provided by ketones. At ketone concentrations of 1.5 mM (typical of KDs), ketones supply nearly 20%; at the higher end of nutritional ketosis 4-5 mM [achievable with ketone esters (KE)], half of the brain energy demands are met by ketones. Importantly in situations where brain glucose metabolism is impaired, uptake and utilization of ketones remain fully intact, suggesting a hierarchy of importance placed on ketones as the preferred fuel for human brains.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A double-blind, placebo-controlled, two-period cross-over study
| Arm | Type | Receives |
|---|---|---|
| Placebo First | Active comparator | Other: Sleep Deprivation, Other: Heart Rate, Other: Sleep Monitoring, Other: Diet, Other: Exercise Performance, Behavioral: Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index, Other: Cognitive performance, Other: Marksmanship Performance, Other: Quick Board, Other: Advanced Medical Technologies Inc, Jump Test, Other: CGM/CKM, Biological: Blood Draw, Dietary Supplement: Ketone SupplementPatients will be randomize to take the placebo for the first trial of the intervention, then after a 2 week washout, participants will perform the same intervention but with a ketone ester. |
| Ketone Ester First | Experimental | Other: Sleep Deprivation, Other: Heart Rate, Other: Sleep Monitoring, Other: Diet, Other: Exercise Performance, Behavioral: Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index, Other: Cognitive performance, Other: Marksmanship Performance, Other: Quick Board, Other: Advanced Medical Technologies Inc, Jump Test, Other: CGM/CKM, Biological: Blood Draw, Dietary Supplement: Ketone SupplementPatients will be randomize to take the ketone ester for the first trial of the intervention, then after a 2 week washout, participants will perform the same intervention but with a placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant is willing and able to comply with all study procedures including the following prior to Test Days: fasting (>10 h; water only), no alcohol (>24 h), no exercise (>24 h), no acute illness and controlled feeding before each Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
- Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
- Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
Key exclusion criteria (11 listed)
- <18 or >40 years of age
- >35 body mass index (BMI).
- Diagnosed sleeping disorders (i.e., sleep apnea, insomnia).
- Gastrointestinal disorders or food allergies that would interfere with consuming the study supplements.
- Drink alcohol in excess of 3 drinks/day or 14 drinks/week
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 |
|---|---|---|
| Sleep DeprivationThe sleeping protocol will be monitored by investigators and personnel with experience in sleep medicine. Participants will be required to reduce sleep by 50% of normal, for 4 consecutive nights, to observe potential deficits in physical and cognitive performance | Other | Ketone Ester First, Placebo First |
| Heart RateHR will be assessed by wrist-based acceleration with cloud technology (Polar Unite™, Polar USA). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands of the cadets. Each participant will be fitted with the watch for acclimatization and then establish 3-day baseline patterns for 3 nights before the sleep loss protocol. | Other | Ketone Ester First, Placebo First |
| Sleep MonitoringSleep will be assessed by wrist-based acceleration with cloud technology (Polar Unite™, Polar USA). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands of the cadets.Each participant will be fitted with the watch for acclimatization and then establish 3-day baseline patterns for 3 nights before the sleep loss protocol. | Other | Ketone Ester First, Placebo First |
| DietDiet will be included and the same meals will be available for all subjects while controlling for caffeine. Participants will be given food during each intervention week. | Other | Ketone Ester First, Placebo First |
| Exercise PerformanceSince weight training is now a crucial part of any warfighter's physical preparation, we will have subjects perform weight training workouts emphasizing all major muscle groups on Days 2, 3 and 4 | Other | Ketone Ester First, Placebo First |
| Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep IndexThese will be administered on Days 1 and 5 of each intervention trial to assess different behavioral outcomes. | Behavioural | Ketone Ester First, Placebo First |
| Cognitive performanceAutomated Neuropsychological Assessment Metrics (ANAM), Cambridge Neuropsychological Test Automated Battery. (CANTAB),Gradual-onset Continuous Performance Task (GRAD-CPT),Face-Name Task will be used to assess cognitive function and performance. | Other | Ketone Ester First, Placebo First |
| Marksmanship PerformanceAlso: VirTraThe Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Multiple metrics of marksmanship (total number of shots fired/silhouette target presentation, percentage of targets successfully hit/min, the radial distance of a shot from the center on target, shot group tightness, and time from target presentation to trigger pull) will be collected during each visit. | Other | Ketone Ester First, Placebo First |
| Quick BoardAlso: Response TimeUpper body and lower body reaction tests will be assess using Quick Board Analysis on days 1 and 5 of the sleep restriction intervention. | Other | Ketone Ester First, Placebo First |
| Advanced Medical Technologies Inc, Jump TestAlso: Whole Body PowerWhole body power will be assessed with a repetitive jump test. Power (peak, average, curve functions) will be assessed using an AMTI force plate with Accupower 2.0 software (Advanced Mechanical Technology Inc, Watertown, MA). | Other | Ketone Ester First, Placebo First |
| CGM/CKMContinuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at ~2- week intervals during the study. The sensor will be removed at the end of the final test day. | Other | Ketone Ester First, Placebo First |
| Blood DrawBlood samples will be collected according to the schedule in Figure 1. | Biological | Ketone Ester First, Placebo First |
| Ketone SupplementParticipants will take a diester of hexanoic acid (a ketogenic medium chain fatty acid) and (R)-1,3 butanediol (C6 Di-ester) during one of the trial interventions | Dietary supplement | Ketone Ester First, Placebo First |
Primary outcome
Automated Neuropsychological Assessment Metrics (ANAM)
Time frame: Up to ~ 4 weeks
This cognitive battery is a library of computer-based tests of domains including attention, concentration, reaction time, memory, processing speed, decision-making, and executive function.
Cambridge Neuropsychological Test Automated Battery. (CANTAB)
Time frame: Up to ~ 4 Weeks
This iPad delivery assessment will include an Information Sampling Task to test impulsivity and decision making, response time (in msec), which provides a level of sensitivity not available with traditional paper and pencil tasks, processing speed, executive functioning, and spatial memory. We have also incorporated tasks which assess the ability to rapidly identify expressed facial emotions, which may index one's ability to accurately respond to overtly threatening or non-threatening stimuli
Gradual-onset Continuous Performance Task (GRAD-CPT
Time frame: Up to ~4 weeks
This test measures endogenous attentional control by using smooth (rather than abrupt) transitions between visual images. Scene stimuli are visually presented and smoothly transition from one scene to another. Subjects press a button when one type of scene is presented (e.g., city scene) and withhold the button press when another type of scene (e.g., mountain scene) is presented. It is a Go/No-Go test and assesses multiple metrics of executive function, including sustained attention, mind wandering, and response inhibition.
Face-Name Task
Time frame: Up to ~4 weeks
We will implement a face-name relational memory task, known to activate the hippocampus (along with prefrontal and parietal cortices) in humans using face-name pairs presented for 3-sec with an interval of 750-msec. Participants will judge which name was previously presented with the face. After a 15-min delay, participants will complete an associative face-name recognition task to assess episodic memory performance.
Total number of shots fired
Time frame: Up to ~4 weeks
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Total number of shots fired, a metric of marksmanship, will be collected during each visit, to assess reaction time and accuracy.
Percentage of targets successfully hit per minute
Time frame: Up to ~4 weeks
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Percentage of targets successfully hit/min, a metric of marksmanship, will be collected during each visit to assess accuracy.
Radial distance of a shot from the center on target
Time frame: Up to ~4 weeks
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. The radial distance of a shot from the center on target, a metric of marksmanship, will be collected during each visit to assess shot accuracy.
Shot Group Tightness
Time frame: Up to ~4 weeks
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Shot group tightness, a metric of marksmanship, will be collected during each visit to assess multi-shot accuracy.
Time from target presentation to trigger pull
Time frame: Up to ~4 weeks
The Virtual Training Simulator (VirTra V-100) system (VirTra Corporate HQ, Tempe, AZ) is used by both military and law enforcement agencies to provide training. The V-100 and associated compatible weapons are equipped with recoil kits for unsurpassed live-fire simulation, at distances up to 2,000-m, authoring capabilities for the creation of customized scenarios on 4 individual firing lanes. Time from target presentation to trigger pull, a metric of marksmanship , will be collected during each visit to assess reaction time.
Power Outcome (QuickBoard)
Time frame: Up to ~4 weeks
Upper body and lower body reaction tests will be assess using Quick Board Analysis on days 1 and 5 of the sleep restriction intervention.
9 secondary outcomes
CGM/CKM
Time frame: Up to ~ 4 weeks
Heart Rate
Time frame: Up to ~ 4 weeks
Short Form- McGill Pain Questionnaire
Time frame: Up to ~ 4 weeks
Profile of Mood States- Short Form
Time frame: Up to ~ 4 weeks
Pittsburgh Sleep Quality Index
Time frame: Up to ~ 4 weeks
Insulin
Time frame: Up to ~ 4 weeks
Ghrelin
Time frame: Up to ~ 4 weeks
CRP
Time frame: Up to ~ 4 weeks
Brain Derived Neurotropic Factor
Time frame: Up to ~4 weeks
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 1 Jun 2026.
- Derived from this study: PubMed 42753265Buga A, Stoner JT, Sapper TN, Crabtree CD, Decker DD, Robinson BT, Kackley ML, McClure T, Chebbi A, Stalter H, Dawson L, Whiteman A, Spencer M, Lane L, Hayes SM, Mindel J, Kraemer WJ, Volek JS. Supplementation With Ketogenic Precursors Enhances Virtual Reality Shooting Performance During Sleep Restriction: A Randomized, Placebo-Controlled, Crossover Trial. Mil Med. 2026 Sep 17:usag429. doi: 10.1093/milmed/usag429. Online ahead of print.
- OSU Office of Responsible Research PracticesLink provided by the sponsor.
Related trials for Sleep Deprivation
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
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.
Jeff S Volek, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Deprivation, Heart Rate and Sleep Monitoring in people with Sleep Deprivation, run by Ohio State University 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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 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. 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?
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?
Automated Neuropsychological Assessment Metrics (ANAM) (time frame: Up to ~ 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05519644, which also lists 1 linked publication.
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 1 Jun 2026.