Sleep DeprivationNCT06075914
Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.
A study testing Ketogenic Intervention, Mediterranean Intervention and Ketone Ester in people with Sleep Deprivation and Nutritional Intervention, 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. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. 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, Nutritional Intervention
- What is being tested?
- Ketogenic Intervention, Mediterranean Intervention and Ketone Ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to Feb 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, 18-40 years old.
- BMI: 20-35 kg/m2
- Sleep at least 7h per night.
- Willing to participate in ~9-weeks of testing and provided food.
- Willing to adhere to all study procedures.
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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Jeff S Volek, PhD, 614-688-1701, volek.1@osu.edu
Madison L Kackley, PhD, 7408171622, kackley.19@osu.edu
About this study
Official title: Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention (STAK - Sleep + Feed)
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. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. Ketones are small molecules that appear in the blood when following a ketogenic diet or consuming ketone supplements. The goal of this project is to find out if diet and/or ketones can improve sleep deprivation detriments over 5 days of sleep restriction (-50% from habitual sleep).
Read the detailed description
We will conduct a double-blind, randomized and balanced 3-arm intervention (n = 20 x 3 conditions). Diet randomization will be determined by using an online randomization tool (www.randomizer.org). Participants (total n = 60-80) will be familiarized with all the physical performance tests to minimize learning effects and undergo baseline assessments. On the morning of Day 1 subjects will undergo Pre-Testing inclusive of a blood draw, physical, and cognitive performance. For that night, and the next 4 nights, all subjects will restrict their sleep by 50%. After Day 5, a six-week feeding period will begin according to the participant randomization: ketogenic diet (KD), mixed diet + placebo (MD+PL) or mixed diet + ketone ester (MD+KE). After a six-week feeding period, during which time participants return to their normal sleep and exercise habits, they will replicate the exact same 5-day sleep deprivation protocol before finishing all the study duties.
Test Day 1 \& 5: Participants will arrive at the testing lab between 6:00-9:00h, hydrated and after an overnight fast (<8h). Hydration/Surveys: Hydration will be measured non-invasively in a fasted urine sample via light refractometry. Well-being will be assessed using questionnaires. Blood Draws: After 10 minutes of rest, a trained phlebotomist will perform an intravenous blood draw from the antecubital fossa using a 21G butterfly needle. Total blood collected will be limited to two test tubes (total volume 2 x 10mL): EDTA plasma and serum. Supplement Ingestion: The first supplement dose (either KE or PL) will be consumed before commencing the cognitive testing battery. DXA: One, 7-minute whole-body scan will be conducted to assess lean-body mass and fat mass changes pre- to post-diet. This will occur on day 1 testing only during the first and second sleep deprivation protocol. Cognitive Tests: A series of computer and iPad-based cognitive tests will be administered to each participant to measure their attention, information processing, memory, function, inhibition, and social and emotional domains. VirTra: Participants will be tested on shooting competency using compressed gas weapons. Measures of reaction time, accuracy, precision, and spread will be recorded by a trained team member present in the room. Power/Strength: Whole body power and strength will be assessed using a 3 (trial) x 2 (L/R hand) manual handgrip testing, 3 (consecutive jump) x 3 (set) countermovement jump (CMJ) while on an electronic force plate, and lastly, a maximal isometric mid-thigh pull, also on the force plate. Participants will undergo testing in this order to minimize total body fatigue. All exercises will be demonstrated by a team physiologist. Response time: Upper body and lower body reaction time will be measured using the Quick Board. The Quick Board system is comprised of an iPad Quick Board application and a footpad with 5 sensors placed equidistant from each other, with two at the front of the footpad, two at the back of the footpad, and one in the middle of the footpad. Upper and lower body reaction time will be measured using hands and legs, respectively. After Day 1, participants will be instructed to restrict their sleep to 50% of their habitual sleeping duration. After testing on Day 5 (i.e. after 4 nights of consecutive sleep restriction) the participants will start the diet that they were assigned to and can resume regular sleeping habits ; after six weeks, they will return to the lab to begin their second sleep deprivation battery. During the study, participants will record daily morning fasting capillary ketone and glucose. Additionally, the Polar Watch/Chest Strap will measure activity and heart rate, and the Oura ring will measure sleep quality and architecture.
Test Days 2/3/4: Exercise habits will be assessed using a previously validated survey. We will then provide a structured workout program to follow on Days 2, 3, and 4. The program emphasizes strength, power, and hypertrophy. Using the provided Excel sheet, all the exercise repetitions and sets will be recorded during each training day. The Excel sheet will be returned to the study team on Day 5.
Six-Week Feeding Intervention: All food items will be provided to the participants. Food will arrive in cold, vacuum sealed containers that are microwave-safe and ready-to-eat. Each item is labeled in accordance with USDA rules and regulations. Participants will be responsible for picking food up from the testing center on a weekly basis. Depending on calorie needs, some participants may receive more food than just pre-packaged breakfast, lunch, and dinner to cover their total daily energy requirements.
- Conditions
- Sleep Deprivation, Nutritional Intervention
- Being tested
- Ketogenic Intervention, Mediterranean Intervention, Placebo, Ketone Ester
- Keywords
- Ketogenic Diet, Mediterranean Diet, Ketone Esters, Placebo
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic InterventionOther
Participants will receive ready-to-eat Ketogenic Diet meals.
Mediterranean InterventionOther
Participants will receive ready-to-eat Mediterranean Diet meals.
PlaceboDietary supplement
Participants will receive twice-daily placebo servings to be consumed once in the morning and once before sleep.
Ketone EsterDietary supplement
Participants will receive twice-daily ketone ester servings to be consumed once in the morning and once before sleep.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet Arm | Experimental | The goal of the KD is to have participants achieve consistent blood BHB ≥0.5 mM; preferably in the range of >1 to 3 mM. We will measure ketones daily via finger stick to provide individual feedback and provide a quantitative measure of compliance. The KD will consist of approximately 50 g carbohydrate and 1.5 g/kg reference weight protein. These may be adjusted based on daily BHB readings. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods. A wide range of foods will be incorporated including non-starchy vegetables, fruits (berries, olives, tomatoes, lemons/limes), meats (beef, chicken, pork, fish, lamb), nuts and seeds, oils (olive, canola, coconut), cheese, butter, cream, eggs, and fatty fish (salmon, sardines). Nutritional ketosis is associated with natriuresis that will lead to sodium and fluid loss if the extra sodium excreted is not compensated, thus slightly higher sodium and potassium intakes will be required. Receives: Other: Ketogenic Intervention |
| Mediterranean Diet + Placebo | Placebo comparator | The MD+PL arm will be modeled after a Mediterranean style eating pattern. It will contain the same amount of protein as the KD, but with slight variations in protein sources, including limiting red meat to 1x/wk. The diet will provide unprocessed, higher-fiber foods with emphasis on vegetables, fruits, nuts and seeds, legumes, tubers, whole grains, and fish and seafood. Poultry, eggs, cheese, and yogurt will be included in moderate amounts. Use of olive oil and other monounsaturated fat sources (e.g., avocados and olives) will be encouraged while keeping added sugars to a minimum and avoiding highly processed foods (refined grains, fruit juice, processed meats). Saturated fat will be <10% of energy. We will include adequate omega-3 fats (e.g., salmon). No alcohol will be included in both diets, but we will track consumption. This group will also consume two daily doses of placebo. Receives: Other: Mediterranean Intervention; Dietary Supplement: Placebo |
| Mediterranean Diet + Ketone Ester | Active comparator | The MD+KE arm will consume the exact same diet as the MD+PL group with the exception they will consume two daily doses of KE instead of the placebo. Receives: Other: Mediterranean Intervention; Dietary Supplement: Ketone Ester |
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual Sleep
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. Habitual sleep will be measured using a validated Pittsburgh Sleep Index questionnaire (average time in bed in the past 30-days).
Measured: Up to ~9-weeks
Polysomnography
Sleep parameters (timing, duration, and quality of sleep) will be assessed by a continuous ring-finger wearable (Oura Ring™, USA). Specific sleep monitoring variables are polysomnography sleep stages (light sleep, rapid eye-movement sleep, deep sleep, sleep latency, total sleep duration).
Measured: Up to ~9-weeks
Heart Rate + Variability (HRV) Monitoring
Heart rate and heart rate variability will be assessed during sleep deprivation by wrist-based acceleration and bluetooth pairing with a chest heart rate sensor (Polar Unite™, Polar USA).
Measured: Up to ~9-weeks
Neuropsychological Outcome 1 - ANAM
The first cognitive assessment will be done via 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 ~9-weeks
Neuropsychological Outcome 2 - GRAD-CPT
The second cognitive assessment will be Gradual-onset Continuous Performance Task (GRAD-CPT). 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 that assesses multiple metrics of executive function, including sustained attention, mind wandering, and response inhibition.
Measured: Up to ~9-weeks
Neuropsychological Outcome 3 - Face-Name Task
The third task is the Face-Name Task. 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 ~9-weeks
Shooting Performance
Ohio State University is one of the few centers in the world equipped with a Virtual Training (VirTra) small arms indoor training simulator. 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.
Measured: Up to ~9-weeks
Neuromuscular Monitoring (Agility)
We will be collecting agility measures (upper/lower body) using the QuickBoard. This 5-sensor bluetooth board is designed to capture upper- and lower-body contact reaction time and precision to randomized light prompts on an iPad. Participants will undergo 3 series of upper-lower body prompts, 20s each, with 60s rest in-between sets (1:3 work:rest ratio).
Measured: Up to ~9-weeks
Neuromuscular Monitoring (Strength)
Strength performance will be monitored by using hand-grip strength, countermovement jump power, and isometric mid-thigh pull. All exercises will be performed in sets of 3.
Measured: Up to ~9-weeks
Continuous Intestitial Fluid Monitoring
Continuous quantification of interstitial fluid glucose and beta-hydroxybutyrate (BHB) will be monitored using sensor-based devices developed and manufactured by Abbott Biowearables. Values are recorded non-invasively and automatically every 15-minutes. The wear period for a sensor is 14-days and thus we will have participants apply new sensors a week before beginning the second sleep deprivation trial. Sensors will be placed on the non-dominant arm (mid-triceps region) during each experimental phase.
Measured: Up to ~9-weeks
Daily Ketone/Glucose Monitoring
Daily fasting glucose/ketones will be assessed using capillary finger stick lancing. A small drop of blood will be obtained once daily, while fasting, using enzymatic strips fitted for a handheld analyzer (KetoMojo). All the data will be stored in the device's internal memory.
Measured: Up to ~9-weeks
Venous Blood Draws
Fasting venous blood will be collected at Day 1 and Day 5 of the sleep restriction protocol, then again after the 6-week feeding period to measure metabolites and hormones in serum and plasma (i.e., cholesterol, testosterone, growth-hormone, insulin, melatonin, epinephrine/norepinephrine).
Measured: Up to ~9-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 May 2023
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Model description
- Double-blind, random allocation, balanced 3-arm study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff S Volek, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075914
- Sponsor's protocol ID
- 2022H0308
- Other IDs
- CDMRP-PR212399-D
- Status last verified
- May 2026
- First submitted
- 27 Jul 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 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 With Nutritional Intervention (STAK - Sleep + Feed)
- ClinicalTrials.gov ID
- NCT06075914
- Acronym / sponsor ID
- 2022H0308
- Conditions
- Sleep Deprivation, Nutritional Intervention
- Keywords
- Ketogenic Diet, Mediterranean Diet, Ketone Esters, Placebo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Oct 2023 (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. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. Ketones are small molecules that appear in the blood when following a ketogenic diet or consuming ketone supplements. The goal of this project is to find out if diet and/or ketones can improve sleep deprivation detriments over 5 days of sleep restriction (-50% from habitual sleep).
Detailed description
We will conduct a double-blind, randomized and balanced 3-arm intervention (n = 20 x 3 conditions). Diet randomization will be determined by using an online randomization tool (www.randomizer.org). Participants (total n = 60-80) will be familiarized with all the physical performance tests to minimize learning effects and undergo baseline assessments. On the morning of Day 1 subjects will undergo Pre-Testing inclusive of a blood draw, physical, and cognitive performance. For that night, and the next 4 nights, all subjects will restrict their sleep by 50%. After Day 5, a six-week feeding period will begin according to the participant randomization: ketogenic diet (KD), mixed diet + placebo (MD+PL) or mixed diet + ketone ester (MD+KE). After a six-week feeding period, during which time participants return to their normal sleep and exercise habits, they will replicate the exact same 5-day sleep deprivation protocol before finishing all the study duties.
Test Day 1 \& 5: Participants will arrive at the testing lab between 6:00-9:00h, hydrated and after an overnight fast (<8h). Hydration/Surveys: Hydration will be measured non-invasively in a fasted urine sample via light refractometry. Well-being will be assessed using questionnaires. Blood Draws: After 10 minutes of rest, a trained phlebotomist will perform an intravenous blood draw from the antecubital fossa using a 21G butterfly needle. Total blood collected will be limited to two test tubes (total volume 2 x 10mL): EDTA plasma and serum. Supplement Ingestion: The first supplement dose (either KE or PL) will be consumed before commencing the cognitive testing battery. DXA: One, 7-minute whole-body scan will be conducted to assess lean-body mass and fat mass changes pre- to post-diet. This will occur on day 1 testing only during the first and second sleep deprivation protocol. Cognitive Tests: A series of computer and iPad-based cognitive tests will be administered to each participant to measure their attention, information processing, memory, function, inhibition, and social and emotional domains. VirTra: Participants will be tested on shooting competency using compressed gas weapons. Measures of reaction time, accuracy, precision, and spread will be recorded by a trained team member present in the room. Power/Strength: Whole body power and strength will be assessed using a 3 (trial) x 2 (L/R hand) manual handgrip testing, 3 (consecutive jump) x 3 (set) countermovement jump (CMJ) while on an electronic force plate, and lastly, a maximal isometric mid-thigh pull, also on the force plate. Participants will undergo testing in this order to minimize total body fatigue. All exercises will be demonstrated by a team physiologist. Response time: Upper body and lower body reaction time will be measured using the Quick Board. The Quick Board system is comprised of an iPad Quick Board application and a footpad with 5 sensors placed equidistant from each other, with two at the front of the footpad, two at the back of the footpad, and one in the middle of the footpad. Upper and lower body reaction time will be measured using hands and legs, respectively. After Day 1, participants will be instructed to restrict their sleep to 50% of their habitual sleeping duration. After testing on Day 5 (i.e. after 4 nights of consecutive sleep restriction) the participants will start the diet that they were assigned to and can resume regular sleeping habits ; after six weeks, they will return to the lab to begin their second sleep deprivation battery. During the study, participants will record daily morning fasting capillary ketone and glucose. Additionally, the Polar Watch/Chest Strap will measure activity and heart rate, and the Oura ring will measure sleep quality and architecture.
Test Days 2/3/4: Exercise habits will be assessed using a previously validated survey. We will then provide a structured workout program to follow on Days 2, 3, and 4. The program emphasizes strength, power, and hypertrophy. Using the provided Excel sheet, all the exercise repetitions and sets will be recorded during each training day. The Excel sheet will be returned to the study team on Day 5.
Six-Week Feeding Intervention: All food items will be provided to the participants. Food will arrive in cold, vacuum sealed containers that are microwave-safe and ready-to-eat. Each item is labeled in accordance with USDA rules and regulations. Participants will be responsible for picking food up from the testing center on a weekly basis. Depending on calorie needs, some participants may receive more food than just pre-packaged breakfast, lunch, and dinner to cover their total daily energy requirements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, random allocation, balanced 3-arm study.
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet Arm | Experimental | Other: Ketogenic InterventionThe goal of the KD is to have participants achieve consistent blood BHB ≥0.5 mM; preferably in the range of >1 to 3 mM. We will measure ketones daily via finger stick to provide individual feedback and provide a quantitative measure of compliance. The KD will consist of approximately 50 g carbohydrate and 1.5 g/kg reference weight protein. These may be adjusted based on daily BHB readings. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods. A wide range of foods will be incorporated including non-starchy vegetables, fruits (berries, olives, tomatoes, lemons/limes), meats (beef, chicken, pork, fish, lamb), nuts and seeds, oils (olive, canola, coconut), cheese, butter, cream, eggs, and fatty fish (salmon, sardines). Nutritional ketosis is associated with natriuresis that will lead to sodium and fluid loss if the extra sodium excreted is not compensated, thus slightly higher sodium and potassium intakes will be required. |
| Mediterranean Diet + Placebo | Placebo comparator | Other: Mediterranean Intervention, Dietary Supplement: PlaceboThe MD+PL arm will be modeled after a Mediterranean style eating pattern. It will contain the same amount of protein as the KD, but with slight variations in protein sources, including limiting red meat to 1x/wk. The diet will provide unprocessed, higher-fiber foods with emphasis on vegetables, fruits, nuts and seeds, legumes, tubers, whole grains, and fish and seafood. Poultry, eggs, cheese, and yogurt will be included in moderate amounts. Use of olive oil and other monounsaturated fat sources (e.g., avocados and olives) will be encouraged while keeping added sugars to a minimum and avoiding highly processed foods (refined grains, fruit juice, processed meats). Saturated fat will be <10% of energy. We will include adequate omega-3 fats (e.g., salmon). No alcohol will be included in both diets, but we will track consumption. This group will also consume two daily doses of placebo. |
| Mediterranean Diet + Ketone Ester | Active comparator | Other: Mediterranean Intervention, Dietary Supplement: Ketone EsterThe MD+KE arm will consume the exact same diet as the MD+PL group with the exception they will consume two daily doses of KE instead of the placebo. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, 18-40 years old.
- BMI: 20-35 kg/m2
- Sleep at least 7h per night.
- Willing to participate in ~9-weeks of testing and provided food.
- Willing to adhere to all study procedures.
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 |
|---|---|---|
| Ketogenic InterventionParticipants will receive ready-to-eat Ketogenic Diet meals. | Other | Ketogenic Diet Arm |
| Mediterranean InterventionParticipants will receive ready-to-eat Mediterranean Diet meals. | Other | Mediterranean Diet + Ketone Ester, Mediterranean Diet + Placebo |
| PlaceboParticipants will receive twice-daily placebo servings to be consumed once in the morning and once before sleep. | Dietary supplement | Mediterranean Diet + Placebo |
| Ketone EsterParticipants will receive twice-daily ketone ester servings to be consumed once in the morning and once before sleep. | Dietary supplement | Mediterranean Diet + Ketone Ester |
Primary outcome
Habitual Sleep
Time frame: Up to ~9-weeks
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. Habitual sleep will be measured using a validated Pittsburgh Sleep Index questionnaire (average time in bed in the past 30-days).
Polysomnography
Time frame: Up to ~9-weeks
Sleep parameters (timing, duration, and quality of sleep) will be assessed by a continuous ring-finger wearable (Oura Ring™, USA). Specific sleep monitoring variables are polysomnography sleep stages (light sleep, rapid eye-movement sleep, deep sleep, sleep latency, total sleep duration).
Heart Rate + Variability (HRV) Monitoring
Time frame: Up to ~9-weeks
Heart rate and heart rate variability will be assessed during sleep deprivation by wrist-based acceleration and bluetooth pairing with a chest heart rate sensor (Polar Unite™, Polar USA).
Neuropsychological Outcome 1 - ANAM
Time frame: Up to ~9-weeks
The first cognitive assessment will be done via 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.
Neuropsychological Outcome 2 - GRAD-CPT
Time frame: Up to ~9-weeks
The second cognitive assessment will be Gradual-onset Continuous Performance Task (GRAD-CPT). 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 that assesses multiple metrics of executive function, including sustained attention, mind wandering, and response inhibition.
Neuropsychological Outcome 3 - Face-Name Task
Time frame: Up to ~9-weeks
The third task is the Face-Name Task. 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.
Shooting Performance
Time frame: Up to ~9-weeks
Ohio State University is one of the few centers in the world equipped with a Virtual Training (VirTra) small arms indoor training simulator. 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.
Neuromuscular Monitoring (Agility)
Time frame: Up to ~9-weeks
We will be collecting agility measures (upper/lower body) using the QuickBoard. This 5-sensor bluetooth board is designed to capture upper- and lower-body contact reaction time and precision to randomized light prompts on an iPad. Participants will undergo 3 series of upper-lower body prompts, 20s each, with 60s rest in-between sets (1:3 work:rest ratio).
Neuromuscular Monitoring (Strength)
Time frame: Up to ~9-weeks
Strength performance will be monitored by using hand-grip strength, countermovement jump power, and isometric mid-thigh pull. All exercises will be performed in sets of 3.
Continuous Intestitial Fluid Monitoring
Time frame: Up to ~9-weeks
Continuous quantification of interstitial fluid glucose and beta-hydroxybutyrate (BHB) will be monitored using sensor-based devices developed and manufactured by Abbott Biowearables. Values are recorded non-invasively and automatically every 15-minutes. The wear period for a sensor is 14-days and thus we will have participants apply new sensors a week before beginning the second sleep deprivation trial. Sensors will be placed on the non-dominant arm (mid-triceps region) during each experimental phase.
Daily Ketone/Glucose Monitoring
Time frame: Up to ~9-weeks
Daily fasting glucose/ketones will be assessed using capillary finger stick lancing. A small drop of blood will be obtained once daily, while fasting, using enzymatic strips fitted for a handheld analyzer (KetoMojo). All the data will be stored in the device's internal memory.
Venous Blood Draws
Time frame: Up to ~9-weeks
Fasting venous blood will be collected at Day 1 and Day 5 of the sleep restriction protocol, then again after the 6-week feeding period to measure metabolites and hormones in serum and plasma (i.e., cholesterol, testosterone, growth-hormone, insulin, melatonin, epinephrine/norepinephrine).
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 24 Jun 2026.
- OSU Office of Responsible Research PracticesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
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 Ketogenic Intervention, Mediterranean Intervention and Ketone Ester in people with Sleep Deprivation and Nutritional Intervention, 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 5 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: looking for participants now, as of the sponsor's last update on 24 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. 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 Jeff S Volek, PhD, RD (6146881701, volek.1@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habitual Sleep (time frame: Up to ~9-weeks). The study lists 12 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 24 Jun 2026.