Who is eligible for clinical trial NCT05519644?

Participants must meet protocol criteria for Sleep Deprivation. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05519644 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-28

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction (NCT05519644)

🔵 Active, Not Recruiting Observational / Diagnostic 💊 Investigational Drug / Biologic Sponsor: Ohio State University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).

Location: The Ohio State University — Columbus, Ohio

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

The Ohio State University — Columbus, Ohio

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗