Ketone and Diet Study for Sleep Restriction
This study is looking at whether specific diets or ketone supplements can help people cope with sleep deprivation. Researchers want to see if a Ketogenic Intervention (ready-to-eat Ketogenic Diet meals) or a Mediterranean Intervention (ready-to-eat Mediterranean Diet meals), along with a Ketone Ester supplement, can improve how people feel and perform after not getting enough sleep. You might be able to join if you are a healthy adult between 18 and 40 years old, have a BMI between 20-35 kg/m2, and usually sleep at least 7 hours a night. The study aims to enroll 60 participants. Success in this study would mean that these interventions help reduce the negative effects of sleep restriction on your sleep patterns, heart rate, and heart rate variability.
- Study design
- This is a double-blind, randomized study with three groups, aiming to include 60 participants. Participants will be randomly assigned to receive either a ketogenic diet, a mixed diet with a placebo, or a mixed diet with a ketone ester.
- What's involved
- You would participate in about 9 weeks of testing, which includes a 5-day period of restricted sleep, followed by a six-week feeding period, and then another 5-day sleep restriction period. This involves physical and cognitive tests, blood draws, and questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sleep, heart rate, and heart rate variability will be measured for up to approximately 9 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jeff S Volek, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Habitual SleepUp 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).
- PolysomnographyUp 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) MonitoringUp 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 - ANAMUp 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-CPTUp 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 TaskUp 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 PerformanceUp 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)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)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 MonitoringUp 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 MonitoringUp 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 DrawsUp 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).