Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorOhio State University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
<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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ketogenic Intervention
Other interventionParticipants will receive ready-to-eat Ketogenic Diet meals.
Mediterranean Intervention
Other interventionParticipants will receive ready-to-eat Mediterranean Diet meals.
Placebo
Dietary supplementParticipants will receive twice-daily placebo servings to be consumed once in the morning and once before sleep.
Ketone Ester
Dietary supplementParticipants will receive twice-daily ketone ester servings to be consumed once in the morning and once before sleep.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Ketogenic Diet ArmExperimental treatment 1 intervention
Group B: Mediterranean Diet + PlaceboPlacebo comparator 2 interventions
Group C: Mediterranean Diet + Ketone EsterActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to ~9-weeks2
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).
Time frame
Up to ~9-weeks3
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).
Time frame
Up to ~9-weeks4
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.
Time frame
Up to ~9-weeksSponsors and contacts
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Source ClinicalTrials.gov