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Ketone Supplement

Ketone Supplementation for Enhancing Ketosis (STAK: OK'd Trial)

N/A
Recruiting
Led By Jeff S Volek, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male
Aged 20 - 30 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~ 4 weeks
Awards & highlights

STAK: OK'd Trial Summary

This trial will compare the effects of four different compounds on metabolism, including the ketone body BHB.

Who is the study for?
This trial is for healthy males aged 20-30, with a BMI of 18-29 kg/m^2 who don't smoke or use cannabis, haven't used ketone supplements or followed a low-carb diet recently, and aren't taking part in other studies. They must be able to fast and avoid alcohol before test days.Check my eligibility
What is being tested?
The study compares the effects of different Ketone Ester (KE) compounds and Butanediol (BDO), which are believed to affect metabolism differently. It's a full crossover study where participants will try all KE types at two serving sizes to see how they impact ketones, glucose, and acid-base balance.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to the study beverages' ingredients. Since this involves fasting and controlled feeding, participants might also experience hunger or fatigue.

STAK: OK'd Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am male.
Select...
I am between 20 and 30 years old.

STAK: OK'd Trial 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
Ketones
Secondary outcome measures
AcAc, R-BHB and S-BHB changes across trials
Acid-Base Balance
Alanine Change
+13 more

STAK: OK'd Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: C8 Ketone Di-ester 360mg/kgExperimental Treatment7 Interventions
Group II: C8 Ketone Di-ester 180mg/kgExperimental Treatment7 Interventions
Group III: BHB mono-ester 360mg/kgExperimental Treatment7 Interventions
Group IV: BHB Mono-ester 180mg/kgExperimental Treatment7 Interventions
Group V: AcAc Di-ester 360mg/kgExperimental Treatment7 Interventions
Group VI: AcAc Di-ester 180mg/kgExperimental Treatment7 Interventions
Group VII: (R)-1,3 butanediol 360mg/kgExperimental Treatment7 Interventions
Group VIII: (R)-1,3 butanediol 180mg/kgExperimental Treatment7 Interventions
Group IX: ControlPlacebo Group8 Interventions
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 UniversityLead Sponsor
829 Previous Clinical Trials
505,728 Total Patients Enrolled
2 Trials studying Ketosis
430 Patients Enrolled for Ketosis
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,152 Total Patients Enrolled
Jeff S Volek, PhDPrincipal InvestigatorOhio State University
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

AcAc Diester (Ketone Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05501366 — N/A
Ketosis Research Study Groups: (R)-1,3 butanediol 360mg/kg, BHB Mono-ester 180mg/kg, BHB mono-ester 360mg/kg, C8 Ketone Di-ester 360mg/kg, AcAc Di-ester 180mg/kg, AcAc Di-ester 360mg/kg, Control, (R)-1,3 butanediol 180mg/kg, C8 Ketone Di-ester 180mg/kg
Ketosis Clinical Trial 2023: AcAc Diester Highlights & Side Effects. Trial Name: NCT05501366 — N/A
AcAc Diester (Ketone Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501366 — 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 any opportunities to join this experiment?

"Data hosted on clinicaltrials.gov attests to the fact that this particular medical study is no longer searching for patients, with its last edition taking place on August 11th 2022. Nevertheless, there are 24 other trials actively looking for participants at present."

Answered by AI

Am I eligible to participate in this experiment?

"This clinical trial entails enlisting 15 individuals with ketosis who are between 20 and 30 years old. Notably, prerequisites for applicants include: being male; having a BMI of 18 to 29 kilograms per meter squared; voluntary ability and willingness to comply with the protocols such as fasting (>10 hours) without food or alcohol (>24 hours), no exercise (> 24 hours); lack of acute illness and controlled feeding before test days; absence of any health conditions that would impede completion of study requirements determined by investigator based on medical history; thorough understanding of procedures required in this research study with signed informed consent form authorizing release if relevant protected health information."

Answered by AI

Does this medical experiment accept patients of all ages, or is there an upper limit to participation?

"The requirements to be part of this clinical trial specify that participants must between 20 and 30 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies
Jeff Volek 2023. "Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05501366.
~10 spots leftby Sep 2026
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