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Ketone Supplement for Sleep Deprivation (STAK-Sleep Trial)

N/A

Recruiting

Led By Jeff S Volek, PhD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~4 weeks

Awards & highlights

STAK-Sleep Trial Summary

This trial is testing whether a twice-daily ketone ester supplement can help improve performance during short-term sleep restriction in military personnel.

Who is the study for?

This trial is for healthy adults aged 18-40, with a BMI of ≤35, who can follow study procedures like fasting and controlled feeding. It's not for those with psychiatric disorders, recent significant weight loss, sleep or gastrointestinal disorders, heavy alcohol use, metabolic diseases (except metformin users), current/recent ketogenic dieters, or pregnant/lactating women.Check my eligibility

What is being tested?

The study tests if a ketone ester supplement taken twice daily can boost cognitive and physical performance when sleep is restricted. Participants will undergo various assessments including sleep monitoring, heart rate tracking, diet control and performance tests while experiencing short-term sleep deprivation.See study design

What are the potential side effects?

Potential side effects from the ketone supplements may include digestive discomfort or allergic reactions. Since this involves dietary intervention rather than medication, severe side effects are less likely but individual responses to supplements vary.

STAK-Sleep Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~4 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

Automated Neuropsychological Assessment Metrics (ANAM)

Cambridge Neuropsychological Test Automated Battery. (CANTAB)

Face-Name Task

+7 more

Secondary outcome measures

Brain Derived Neurotropic Factor

CGM/CKM

CRP

+6 more

STAK-Sleep Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketone Ester FirstExperimental Treatment13 Interventions

Patients will be randomize to take the ketone ester for the first trial of the intervention, then after a 2 week washout, participants will perform the same intervention but with a placebo

Group II: Placebo FirstActive Control13 Interventions

Patients will be randomize to take the placebo for the first trial of the intervention, then after a 2 week washout, participants will perform the same intervention but with a ketone ester.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Draw

2006

Completed Phase 4

~2400

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,107 Total Patients Enrolled

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,683 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

Media Library

Diet Clinical Trial Eligibility Overview. Trial Name: NCT05519644 — N/A

Sleep Deprivation Research Study Groups: Placebo First, Ketone Ester First

Sleep Deprivation Clinical Trial 2023: Diet Highlights & Side Effects. Trial Name: NCT05519644 — N/A

Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519644 — N/A

Frequently Asked Questions

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

Are there still opportunities to join this experiment?

"The clinical trial in question is currently not seeking participants, per the information provided on clinicaltrials.gov. This medical research was first posted November 1st 2022 and most recently updated August 24th of that same year. Although this study has ended its recruitment period, there are presently 40 other trials welcoming patients."

Answered by AI

What criteria must potential participants meet to be considered for this research program?

"This trial is seeking 60 volunteers with sleep debt who are aged between 18 and 40. Before being accepted, applicants must demonstrate their commitment to the study by adhering to specific pre-test requirements such as fasting for 10 hours or more, abstaining from alcohol and exercise for 24 hours prior to testing days, not having any acute illnesses and maintaining a controlled feeding regimen before each test day throughout the duration of the study. Furthermore they must have no health conditions that would impede them completing all activities associated with this clinical trial; should be aware of what's expected of them in terms of procedures related to it; and provide informed consent authorising access"

Answered by AI

What objectives is this research attempting to accomplish?

"This clinical research will be conducted over a span of four weeks to measure the Automated Neuropsychological Assessment Metrics (ANAM). As secondary objectives, participants must assess their mood using the abbreviated Profile of Mood States- Short Form (POMS-SF) and answer questions regarding Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment on a Likert scale. Additionally Brain Derived Neurotropic Factor differences after supplementation shall be tested with ELISA assay kits while heart rate variability is monitored via wrist-"

Answered by AI