Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

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. 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.

Conditions

• Sleep Deprivation

Interventions

OTHER

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

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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

BEHAVIORAL

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.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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).

OTHER

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.

BIOLOGICAL

Blood Draw

Blood samples will be collected according to the schedule in Figure 1.

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Jeff S Volek, PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations