ClinConnect ClinConnect Logo
Search / Trial NCT06075914

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

Launched by OHIO STATE UNIVERSITY · Oct 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Ketogenic Diet Mediterranean Diet Ketone Esters Placebo

ClinConnect Summary

This clinical trial is looking at how diet and a special type of supplement called ketones can help people who are dealing with sleep deprivation, which is common in military settings. Sleep deprivation can make it hard to focus, reduce work efficiency, and increase mistakes in daily tasks. The researchers want to see if following a specific diet or taking ketone supplements can improve these problems over a period of five days when participants are allowed to sleep only half of their usual amount.

To participate in this trial, you need to be between 18 and 40 years old, healthy, and sleep at least 7 hours a night. You will also need to be willing to follow the study's procedures and participate for about 9 weeks, during which you will be provided with food. However, if you have certain health conditions, like sleep disorders or gastrointestinal issues, or if you consume a low-carb diet, you may not be eligible. Participants can expect to be involved in various tests and will have their health monitored throughout the study. This trial is currently recruiting participants of all genders.

Gender

ALL

Eligibility criteria

  • 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)

About Ohio State University

The Ohio State University (OSU) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a commitment to improving patient care and outcomes, OSU leverages its extensive resources, interdisciplinary collaboration, and expertise in diverse medical fields. The university fosters an environment of rigorous scientific inquiry, ensuring that clinical trials are conducted with the highest ethical standards and adherence to regulatory guidelines. Through its Clinical Trials Office, OSU aims to translate groundbreaking research into practical applications, benefiting both local and global communities.

Locations

Columbus, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Jeff S Volek, PhD

Principal Investigator

Ohio State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported