RecruitingNot Applicable

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

United States60 participantsStarted 2023-05-01

Plain-language 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. 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).

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * Willing to adhere to all study procedures. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Habitual Sleep

Timeframe: Up to ~9-weeks

Polysomnography

Timeframe: Up to ~9-weeks

Heart Rate + Variability (HRV) Monitoring

Timeframe: Up to ~9-weeks

Neuropsychological Outcome 1 - ANAM

Timeframe: Up to ~9-weeks

Neuropsychological Outcome 2 - GRAD-CPT

Timeframe: Up to ~9-weeks

Neuropsychological Outcome 3 - Face-Name Task

Timeframe: Up to ~9-weeks

Shooting Performance

Timeframe: Up to ~9-weeks

Neuromuscular Monitoring (Agility)

Timeframe: Up to ~9-weeks

Trial details

NCT IDNCT06075914

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Jeff S Volek, PhD, RD

6146881701 volek.1@osu.edu

View on ClinicalTrials.gov More Sleep Deprivation trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Habitual Sleep

Timeframe: Up to ~9-weeks

Polysomnography

Timeframe: Up to ~9-weeks

Heart Rate + Variability (HRV) Monitoring

Timeframe: Up to ~9-weeks

Neuropsychological Outcome 1 - ANAM

Timeframe: Up to ~9-weeks

Neuropsychological Outcome 2 - GRAD-CPT

Timeframe: Up to ~9-weeks

Neuropsychological Outcome 3 - Face-Name Task

Timeframe: Up to ~9-weeks

Shooting Performance

Timeframe: Up to ~9-weeks

Neuromuscular Monitoring (Agility)

Timeframe: Up to ~9-weeks