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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:

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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 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

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 more

Secondary study objectives

Brain Derived Neurotropic Factor

CGM/CKM

CRP

+6 more

Awards & 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

0 / 4Eligibility criteria met