Improving resilience to sleep deprivation with diet and ketones
Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention (STAK - Sleep + Feed)
This study is testing if a ketogenic diet or ketone supplements can help healthy adults handle the negative effects of not getting enough sleep.
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 | NCT06075914 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a ketogenic diet or ketone supplementation can mitigate the negative effects of sleep deprivation in healthy adults aged 18-40. Participants will undergo a 5-day sleep restriction followed by a 6-week dietary intervention involving either a ketogenic diet, a mixed diet with placebo, or a mixed diet with ketone esters. The study employs a double-blind, randomized design to ensure unbiased results, with assessments of physical and cognitive performance before and after the intervention. The goal is to determine if dietary changes can enhance resilience against the cognitive and physical impairments caused by lack of sleep.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-40 with a BMI between 20-35 who can commit to the study's duration and procedures.
Not a fit: Patients with diagnosed sleep disorders, metabolic dysfunctions, or those currently on a ketogenic diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies to help individuals cope with the adverse effects of sleep deprivation.
How similar studies have performed: While the approach of using dietary interventions to address sleep deprivation is promising, it remains relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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)
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, RD
- Email: volek.1@osu.edu
- Phone: 6146881701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.