NCT06075914 Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.
| NCT ID | NCT06075914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Sleep Deprivation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-05-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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)
Contact & Investigator
Jeff S Volek, PhD
PRINCIPAL INVESTIGATOR
Ohio State University
Frequently Asked Questions
Who can join the NCT06075914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Sleep Deprivation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06075914 currently recruiting?
Yes, NCT06075914 is actively recruiting participants. Contact the research team at volek.1@osu.edu for enrollment information.
Where is the NCT06075914 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06075914 clinical trial?
NCT06075914 is sponsored by Ohio State University. The principal investigator is Jeff S Volek, PhD at Ohio State University. The trial plans to enroll 60 participants.