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Ketone Ester + Nutritional Intervention for Sleep Deprivation

N/A

Recruiting

Led By Jeff S Volek, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy, 18-40 years old

Be between 18 and 65 years old

Must not have

<18 or >40 years of age

Diagnosed sleeping disorders (i.e., sleep apnea, insomnia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~9-weeks

Summary

This trial will examine if ketogenic diet/supplements can improve effects of sleep deprivation in military personnel over 5 days of restricted sleep.

Who is the study for?

This trial is for healthy adults aged 18-40 with a BMI of 20-35, who sleep at least 7 hours nightly and are willing to undergo about 9 weeks of testing with provided food. Excluded are those with sleeping or major psychiatric disorders, certain dietary habits or conditions, recent significant weight loss, pregnancy, excessive alcohol consumption, or metabolic/endocrine dysfunctions.

What is being tested?

The study investigates if diets (Mediterranean or Ketogenic) or ketone supplements can mitigate the negative effects of sleep deprivation over five days where participants get half their usual amount of sleep. Participants will receive either a ketone ester supplement, Mediterranean diet intervention, ketogenic diet intervention, or placebo.

What are the potential side effects?

Potential side effects may include digestive discomfort due to dietary changes and possible reactions to the ketone ester such as nausea or bad taste. The full range of side effects from the interventions is not detailed but could vary based on individual tolerance to diet alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy and between 18 to 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am either younger than 18 or older than 40 years old.

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I have been diagnosed with a sleeping disorder.

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I have lost more than 10% of my body weight in the last 6 months.

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I have diabetes or a metabolic condition, or I take diabetic medication other than metformin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~9-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~9-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~9-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Continuous Intestitial Fluid Monitoring

Daily Ketone/Glucose Monitoring

Habitual Sleep

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Ketogenic Diet ArmExperimental Treatment1 Intervention

The goal of the KD is to have participants achieve consistent blood BHB ≥0.5 mM; preferably in the range of \>1 to 3 mM. We will measure ketones daily via finger stick to provide individual feedback and provide a quantitative measure of compliance. The KD will consist of approximately 50 g carbohydrate and 1.5 g/kg reference weight protein. These may be adjusted based on daily BHB readings. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods. A wide range of foods will be incorporated including non-starchy vegetables, fruits (berries, olives, tomatoes, lemons/limes), meats (beef, chicken, pork, fish, lamb), nuts and seeds, oils (olive, canola, coconut), cheese, butter, cream, eggs, and fatty fish (salmon, sardines). Nutritional ketosis is associated with natriuresis that will lead to sodium and fluid loss if the extra sodium excreted is not compensated, thus slightly higher sodium and potassium intakes will be required.

Group II: Mediterranean Diet + Ketone EsterActive Control2 Interventions

The MD+KE arm will consume the exact same diet as the MD+PL group with the exception they will consume two daily doses of KE instead of the placebo.

Group III: Mediterranean Diet + PlaceboPlacebo Group2 Interventions

The MD+PL arm will be modeled after a Mediterranean style eating pattern. It will contain the same amount of protein as the KD, but with slight variations in protein sources, including limiting red meat to 1x/wk. The diet will provide unprocessed, higher-fiber foods with emphasis on vegetables, fruits, nuts and seeds, legumes, tubers, whole grains, and fish and seafood. Poultry, eggs, cheese, and yogurt will be included in moderate amounts. Use of olive oil and other monounsaturated fat sources (e.g., avocados and olives) will be encouraged while keeping added sugars to a minimum and avoiding highly processed foods (refined grains, fruit juice, processed meats). Saturated fat will be \<10% of energy. We will include adequate omega-3 fats (e.g., salmon). No alcohol will be included in both diets, but we will track consumption. This group will also consume two daily doses of placebo.

0 / 5Eligibility criteria met