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Ketone Ester + Nutritional Intervention for Sleep Deprivation

Q: Is eligibility for this research limited to seniors or are younger individuals able to participate?

According to the prerequisites for this clinical trial, only those between 18 and 40 years old are eligible.

Q: Does my profile fit the criteria necessary to join this research endeavor?

This medical trial seeks 60 patients aged 18 to 40 who suffer from <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a> deprivation. Qualified candidates will receive access to the <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> treatment being trialled.

Q: Are participants able to join the experiment at this time?

As indicated on clinicaltrials.gov, this trial is still actively recruiting patients. It was first posted to the website on May 1st 2023 and has since been modified as recently as October 4th 2023.

Q: How many volunteers have enrolled in this clinical experiment?

Affirmative. Per the clinicaltrials.gov website, this medical trial is actively recruiting participants since its original posting on May 1st 2023 and most recent update on October 4th 2023. It has capacity to intake 60 patients from one site location.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~9-weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am healthy and between 18 to 40 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 / 1Eligibility criteria met

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Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,560 Total Patients Enrolled

1 Trials studying Sleep Deprivation

60 Patients Enrolled for Sleep Deprivation

Jeff S Volek, PhDPrincipal InvestigatorOhio State University

2 Previous Clinical Trials

75 Total Patients Enrolled

1 Trials studying Sleep Deprivation

60 Patients Enrolled for Sleep Deprivation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this research limited to seniors or are younger individuals able to participate?

"According to the prerequisites for this clinical trial, only those between 18 and 40 years old are eligible."

Answered by AI

Does my profile fit the criteria necessary to join this research endeavor?

"This medical trial seeks 60 patients aged 18 to 40 who suffer from sleep deprivation. Qualified candidates will receive access to the experimental treatment being trialled."

Answered by AI

Are participants able to join the experiment at this time?

"As indicated on clinicaltrials.gov, this trial is still actively recruiting patients. It was first posted to the website on May 1st 2023 and has since been modified as recently as October 4th 2023."

Answered by AI

How many volunteers have enrolled in this clinical experiment?

"Affirmative. Per the clinicaltrials.gov website, this medical trial is actively recruiting participants since its original posting on May 1st 2023 and most recent update on October 4th 2023. It has capacity to intake 60 patients from one site location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

2023. "Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075914.

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