Clinical trial
Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction
Name
2022H0169
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. 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.
Trial arms
Trial start
2023-06-20
Estimated PCD
2026-08-01
Trial end
2026-08-01
Status
Recruiting
Treatment
Sleep Deprivation
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
Arms:
Ketone Ester First, Placebo First
Heart Rate
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.
Arms:
Ketone Ester First, Placebo First
Sleep Monitoring
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.
Arms:
Ketone Ester First, Placebo First
Diet
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.
Arms:
Ketone Ester First, Placebo First
Exercise Performance
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
Arms:
Ketone Ester First, Placebo First
Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index
These will be administered on Days 1 and 5 of each intervention trial to assess different behavioral outcomes.
Arms:
Ketone Ester First, Placebo First
Cognitive performance
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.
Arms:
Ketone Ester First, Placebo First
Marksmanship Performance
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.
Arms:
Ketone Ester First, Placebo First
Other names:
VirTra
Quick Board
Upper body and lower body reaction tests will be assess using Quick Board Analysis on days 1 and 5 of the sleep restriction intervention.
Arms:
Ketone Ester First, Placebo First
Other names:
Response Time
Advanced Medical Technologies Inc, Jump Test
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).
Arms:
Ketone Ester First, Placebo First
Other names:
Whole Body Power
CGM/CKM
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.
Arms:
Ketone Ester First, Placebo First
Blood Draw
Blood samples will be collected according to the schedule in Figure 1.
Arms:
Ketone Ester First, Placebo First
Ketone 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
Arms:
Ketone Ester First, Placebo First
Size
60
Primary endpoint
Automated Neuropsychological Assessment Metrics (ANAM)
Up to ~ 4 weeks
Cambridge Neuropsychological Test Automated Battery. (CANTAB)
Up to ~ 4 Weeks
Gradual-onset Continuous Performance Task (GRAD-CPT
Up to ~4 weeks
Face-Name Task
Up to ~4 weeks
Total number of shots fired
Up to ~4 weeks
Percentage of targets successfully hit per minute
Up to ~4 weeks
Radial distance of a shot from the center on target
Up to ~4 weeks
Shot Group Tightness
Up to ~4 weeks
Time from target presentation to trigger pull
Up to ~4 weeks
Power Outcome (QuickBoard)
Up to ~4 weeks
Eligibility criteria
Inclusion Criteria:
* 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.
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)
Protocol
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Updated at
2023-07-10
1 organization
Organization
Ohio State University