RecruitingNot ApplicableNCT06075914

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention (STAK - Sleep + Feed)


Sponsor

Ohio State University

Enrollment

60 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 40 Years

Inclusion Criteria5

  • 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 Criteria11

  • \<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)

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Interventions

OTHERKetogenic Intervention

Participants will receive ready-to-eat Ketogenic Diet meals.

OTHERMediterranean Intervention

Participants will receive ready-to-eat Mediterranean Diet meals.

DIETARY_SUPPLEMENTPlacebo

Participants will receive twice-daily placebo servings to be consumed once in the morning and once before sleep.

DIETARY_SUPPLEMENTKetone Ester

Participants will receive twice-daily ketone ester servings to be consumed once in the morning and once before sleep.


Locations(1)

The Ohio State University

Columbus, Ohio, United States

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NCT06075914


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