NCT06075914 · Ohio State University
Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.
What this study is about
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.
View original scientific description
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).
Interventions
OTHER
Ketogenic Intervention
Participants will receive ready-to-eat Ketogenic Diet meals.
OTHER
Mediterranean Intervention
Participants will receive ready-to-eat Mediterranean Diet meals.
DIETARY_SUPPLEMENT
Placebo
Participants will receive twice-daily placebo servings to be consumed once in the morning and once before sleep.
DIETARY_SUPPLEMENT
Ketone Ester
Participants will receive twice-daily ketone ester servings to be consumed once in the morning and once before sleep.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- \<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.
- 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)
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations