Using ketone supplements to improve performance during sleep deprivation

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

This study tests if taking ketone supplements can help people perform better mentally and physically when they haven't had enough sleep, especially for military personnel.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT05519644 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of ketone ester supplements on cognitive and physical performance in individuals experiencing short-term sleep restriction. Participants will ingest the supplement twice daily while undergoing controlled conditions that limit sleep. The research aims to determine if these supplements can mitigate the negative impacts of sleep deprivation, which is particularly relevant for military personnel who often face inadequate sleep. The study will monitor various performance metrics to assess the efficacy of the intervention.

Who should consider this trial

Good fit: Ideal candidates are military personnel aged 18 to 40 who are willing to comply with study protocols and do not have sleep disorders or other health conditions that could interfere with the study.

Not a fit: Patients over 40 years of age, those with diagnosed sleep disorders, or individuals with gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this could enhance cognitive and physical performance in individuals suffering from sleep deprivation.

How similar studies have performed: While there is some evidence supporting the use of ketone supplements in enhancing performance, this specific approach in the context of sleep deprivation is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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.

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)

Where this trial is running

Columbus, Ohio

• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Jeff S Volek, PhD — Ohio State University
• Study coordinator: Jeff S Volek, PhD

Conditions Sleep Deprivation