Status:
RECRUITING
Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.
Lead Sponsor:
Ohio State University
Conditions:
Sleep Deprivation
Nutritional Intervention
Eligibility:
All Genders
18-40 years
Phase:
NA
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. Ketog...
Detailed Description
We will conduct a double-blind, randomized and balanced 3-arm intervention (n = 20 x 3 conditions). Diet randomization will be determined by using an online randomization tool (www.randomizer.org). Pa...
Eligibility Criteria
Inclusion
- 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
- \<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)
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06075914
Start Date
May 1 2023
End Date
December 1 2026
Last Update
May 14 2025
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210