RECRUITING

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

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. 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).

Official Title

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention (STAK - Sleep + Feed)

Quick Facts

Study Start:2023-05-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06075914

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. * Healthy, 18-40 years old.
  2. * BMI: 20-35 kg/m2
  3. * Sleep at least 7h per night.
  4. * Willing to participate in \~9-weeks of testing and provided food.
  5. * Willing to adhere to all study procedures.
  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, RD
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 Date2023-05-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Ketogenic Diet
  • Mediterranean Diet
  • Ketone Esters
  • Placebo

Additional Relevant MeSH Terms

  • Sleep Deprivation
  • Nutritional Intervention