Diet for Sleep Debt

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University, Columbus, OH
Sleep Debt
Diet - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 9 Secondary · Reporting Duration: Up to ~4 weeks

Week 4
Cambridge Neuropsychological Test Automated Battery. (CANTAB)
Week 4
Automated Neuropsychological Assessment Metrics (ANAM)
CGM/CKM
CRP
Ghrelin
Heart Rate
Insulin
Pittsburgh Sleep Quality Index
Profile of Mood States- Short Form
Short Form- McGill Pain Questionnaire
Up to ~4 weeks
Brain Derived Neurotropic Factor
Face-Name Task
Gradual-onset Continuous Performance Task (GRAD-CPT
Percentage of targets successfully hit per minute
Power Outcome (QuickBoard)
Radial distance of a shot from the center on target
Shot Group Tightness
Time from target presentation to trigger pull
Total number of shots fired

Trial Safety

Trial Design

2 Treatment Groups

Placebo First
1 of 2
Ketone Ester First
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Diet · No Placebo Group · N/A

Ketone Ester FirstExperimental Group · 13 Interventions: Diet, Sleep Deprivation, Heart Rate, Sleep Monitoring, Exercise Performance, Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index, Advanced Medical Technologies Inc, Jump Test, Blood Draw, CGM/CKM, Cognitive performance, Ketone Supplement, Marksmanship Performance, Quick Board · Intervention Types: Other, Other, Other, Other, Other, Behavioral, Other, Biological, Other, Other, DietarySupplement, Other, Other
Placebo FirstActiveComparator Group · 13 Interventions: Diet, Sleep Deprivation, Heart Rate, Sleep Monitoring, Exercise Performance, Surveys, McGill Pain Questionnaire, Shortened Profile of Mood States, Pittsburg Sleep Index, Advanced Medical Technologies Inc, Jump Test, Blood Draw, CGM/CKM, Cognitive performance, Ketone Supplement, Marksmanship Performance, Quick Board · Intervention Types: Other, Other, Other, Other, Other, Behavioral, Other, Biological, Other, Other, DietarySupplement, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2006
Completed Phase 2
~1480

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~4 weeks
Closest Location: The Ohio State University · Columbus, OH
Photo of oh the ohio state university 1Photo of oh the ohio state university 2Photo of oh the ohio state university 3
2011First Recorded Clinical Trial
0 TrialsResearching Sleep Debt
340 CompletedClinical Trials

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
281 Previous Clinical Trials
285,758 Total Patients Enrolled
Jeff S Volek, PhDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
15 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are not currently under the care of a physician or other health care provider.
You understand the study procedures and authorizes the release of protected health information to the Investigator.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.