RECRUITING

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. The main purpose of these supplements is to raise your blood concentration of ketones, which are safe, small molecules that appear in the blood during fasting, when following a ketogenic diet, or consuming ketone supplements. The main purpose of this study is to examine if ingesting a ketone ester supplement, twice daily, can improve cognitive and physical performance during short-term sleep restriction.

Official Title

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

Quick Facts

Study Start:2023-06-20
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05519644

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is willing and able to comply with all study procedures including the following prior to Test Days: fasting (\>10 h; water only), no alcohol (\>24 h), no exercise (\>24 h), no acute illness and controlled feeding before each Test Day, maintain diet, exercise, medication, and supplement habits throughout the study.
  2. * Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history.
  3. * Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Investigator.
  1. * \<18 or \>40 years of age
  2. * \>35 body mass index (BMI).
  3. * Diagnosed sleeping disorders (i.e., sleep apnea, insomnia).
  4. * Gastrointestinal disorders or food allergies that would interfere with consuming the study supplements.
  5. * Drink alcohol in excess of 3 drinks/day or 14 drinks/week
  6. * Have any conditions or contraindications to blood draws.
  7. * Have been diagnosed with diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or use diabetic medications other than metformin
  8. * Currently consume a low carbohydrate or ketogenic diet or have done so in the last 3 months
  9. * Have experienced weight loss of \>10% of your body weight within the last 6 months
  10. * Are pregnant, lactating, or planning on becoming pregnant during the study
  11. * Have any major psychiatric disorders (e.g., schizophrenia, bipolar disorder)

Contacts and Locations

Study Contact

Jeff S Volek, PhD
CONTACT
6146881701
volek.1@osu.edu
Madison L Kackley, PhD
CONTACT
7408171622
kackley.19@osu.edu

Principal Investigator

Jeff S Volek, PhD
PRINCIPAL_INVESTIGATOR
Ohio State University

Study Locations (Sites)

The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Ohio State University

  • Jeff S Volek, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2026-08

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep Deprivation