Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

Launched by OHIO STATE UNIVERSITY · Aug 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether a special type of supplement called ketone esters can help improve thinking and physical performance when people are not getting enough sleep. Sleep deprivation, which is when you don’t get enough sleep, can happen often in military settings and can make it hard to concentrate and do daily tasks well. The researchers want to see if taking this supplement twice a day can make a difference during short periods of sleep restriction.

To be eligible for this study, participants should be between the ages of 18 and 40 and must be generally healthy without major health issues that could interfere with the study. They need to follow specific guidelines before the testing days, like fasting for over 10 hours and avoiding alcohol and exercise for a day before. Participants will be informed about the study procedures and will need to agree to participate by signing consent forms. If you or someone you know fits these criteria and is interested in helping to understand how to cope with sleep loss, this could be a valuable opportunity.

Gender

ALL

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)