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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
No Placebo-Only Group
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.
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.
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:Select...
I have lost more than 10% of my body weight in the last 6 months.
Select...
I have been diagnosed with a sleeping disorder.
Select...
I have diabetes or a metabolic condition, or I take diabetic medication other than metformin.
Select...
I am either younger than 18 or older than 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Automated Neuropsychological Assessment Metrics (ANAM)
Cambridge Neuropsychological Test Automated Battery. (CANTAB)
Face-Name Task
+7 moreSecondary study objectives
Brain Derived Neurotropic Factor
CGM/CKM
CRP
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2014
Completed Phase 4
~2350
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
342 Previous Clinical Trials
293,147 Total Patients Enrolled
Ohio State UniversityLead Sponsor
871 Previous Clinical Trials
655,672 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You drink more than 3 drinks a day or 14 drinks a week.I have been diagnosed with a sleeping disorder.I have diabetes or a metabolic condition, or I take diabetic medication other than metformin.I have lost more than 10% of my body weight in the last 6 months.You are currently following a low-carb or ketogenic diet, or have done so in the past 3 months.I am either younger than 18 or older than 40 years old.Your BMI is over 35.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo First
- Group 2: Ketone Ester First
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.