Recruiting

Ketone with Nutritional Intervention

Sponsor:

Ohio State University

Code:

NCT06075914

Conditions

Sleep Deprivation

Nutritional Intervention

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Ketogenic Intervention

Mediterranean Intervention

Placebo

Ketone Ester

Study Details

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. 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).

Conditions

Sleep Deprivation

Nutritional Intervention

Study ID

NCT06075914

Start date

May 1, 2023

Status verified date

May, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketogenic Diet Arm

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.

placebo comparator: Mediterranean Diet + Placebo

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.

active comparator: Mediterranean Diet + Ketone Ester

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.

Interventions

Ketogenic Intervention

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

Mediterranean Intervention

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

Placebo

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

Ketone Ester

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

Primary outcome measure

  • Habitual Sleep [ Time Frame: Up to ~9-weeks ]
  • Polysomnography [ Time Frame: Up to ~9-weeks ]
  • Heart Rate + Variability (HRV) Monitoring [ Time Frame: Up to ~9-weeks ]
  • Neuropsychological Outcome 1 - ANAM [ Time Frame: Up to ~9-weeks ]
  • Neuropsychological Outcome 2 - GRAD-CPT [ Time Frame: Up to ~9-weeks ]
  • Neuropsychological Outcome 3 - Face-Name Task [ Time Frame: Up to ~9-weeks ]
  • Shooting Performance [ Time Frame: Up to ~9-weeks ]
  • Neuromuscular Monitoring (Agility) [ Time Frame: Up to ~9-weeks ]
  • Neuromuscular Monitoring (Strength) [ Time Frame: Up to ~9-weeks ]
  • Continuous Intestitial Fluid Monitoring [ Time Frame: Up to ~9-weeks ]
  • Daily Ketone/Glucose Monitoring [ Time Frame: Up to ~9-weeks ]
  • Venous Blood Draws [ Time Frame: Up to ~9-weeks ]

Central Contacts and Locations

Central contacts

Jeff S Volek, PhD, RD

6146881701volek.1@osu.edu

Madison L Kackley, PhD

7408171622kackley.19@osu.edu

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jeff S Volek, PhD

614-688-1701volek.1@osu.edu

Madison L Kackley, PhD

7408171622kackley.19@osu.edu

More Information

Sponsor

Ohio State University

Last update posted

Jun 24, 2026

Last verified

May, 2026

Keywords

  • Ketogenic Diet
  • Mediterranean Diet
  • Ketone Esters
  • Placebo

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-06-24.