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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
Must not have
Have experienced weight loss of >10% of your body weight within the last 6 months
Diagnosed sleeping disorders (i.e., sleep apnea, insomnia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~4 weeks
Awards & highlights

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lost more than 10% of my body weight in the last 6 months.
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I have been diagnosed with a sleeping disorder.
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I have diabetes or a metabolic condition, or I take diabetic medication other than metformin.
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I am either younger than 18 or older than 40 years old.

Timeline

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

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

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
290,544 Total Patients Enrolled
Ohio State UniversityLead Sponsor
844 Previous Clinical Trials
639,449 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
~39 spots leftby Aug 2026
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