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Dietary Supplement
Ketone Supplements for Ketosis (STAK-VKM Trial)
N/A
Recruiting
Led By Jeff 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
Ages 20 - 70 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 hours
Awards & highlights
STAK-VKM Trial Summary
This trial will study how age, metabolic health, and obesity affect the body's response to ketone esters, which are used to treat people of different ages.
Who is the study for?
This trial is for individuals aged 20-70 who can fast, avoid alcohol and exercise before testing, and maintain consistent diet and medication habits. They must not have health issues that could affect study participation or interpretation of results as determined by the Investigator.Check my eligibility
What is being tested?
The study examines how different people metabolize a ketone supplement across various ages and metabolic health statuses. It involves questionnaires on beverage tolerability, blood draws to measure ketones, urine analysis, and monitoring satiety levels.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include reactions to the ingredients in the ketone supplements such as soy or milk protein allergies. Participants with known sensitivities to these components are excluded from the trial.
STAK-VKM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 20 and 70 years old.
STAK-VKM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Capillary d-BHB
Secondary outcome measures
Beverage tolerability questionnaire (BTQ)
Capillary glucose concentrations
Insulin
+2 moreSTAK-VKM Trial Design
1Treatment groups
Experimental Treatment
Group I: C8 Ketone SupplementExperimental Treatment4 Interventions
360mg/kg of supplement will be given on a singular testing day.
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?
Buck Institute for Research on AgingOTHER
2 Previous Clinical Trials
70 Total Patients Enrolled
Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,220 Total Patients Enrolled
2 Trials studying Ketosis
45 Patients Enrolled for Ketosis
Jeff Volek, PhDPrincipal InvestigatorOhio State University
3 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You drink more than 3 drinks every day or more than 18 drinks each week.I am between 20 and 70 years old.I have a significant digestive condition that could affect the study's results.My health allows me to fully participate in and understand this study.I am not regularly taking any medication or supplement that could interfere with the trial.You use tobacco.I follow a low-carb diet or have used ketone supplements recently.I understand the study and have signed consent forms.I have a serious health condition like high blood pressure or diabetes that isn't under control.You use cannabis.You have given blood in the last 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: C8 Ketone Supplement
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the current enrollment process include adults aged 18 and above?
"As indicated by the requirements for participation, would-be participants must be aged 20 or above and no older than 70."
Answered by AI
What is the estimated enrollment for this experiment?
"Affirmative, the evidence on clinicaltrials.gov demonstrates that this medical trial is presently recruiting participants. It was initially advertised on June 20th 2022 and has been modified since then. A total of 400 patients are required to be enrolled at one site for it to begin."
Answered by AI
Am I eligible to register for this clinical trial?
"In order to join this medical research, applicants must have ketosis and range in age from 20 to 70. This trial intends to recruit a total of 400 participants."
Answered by AI
Are there any openings to join this clinical test at the moment?
"The particulars on clinicaltrials.gov affirm that, as of 6/20/2023, this trial is looking for patients to participate. This entry was initially posted and most recently updated on the same date."
Answered by AI
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