400 Participants Needed

Ketone Supplements for Ketosis

(STAK-VKM Trial)

Recruiting at 1 trial location
JV
ML
Overseen ByMadison L Kackley, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you maintain your medication habits throughout the study. If your medication use is unstable and might affect the trial outcomes, you may be excluded from participating.

What data supports the effectiveness of the treatment Ketone Supplements for Ketosis?

Research shows that ketone supplements, like the ones used in the trial, can safely increase blood ketone levels, which is a state known as ketosis. This state has been associated with potential benefits for physical and cognitive performance, making ketone supplements a practical way to achieve ketosis without dietary changes.12345

Is it safe for humans to consume ketone supplements?

Research shows that ketone supplements, like ketone esters and monoesters, are generally safe and well-tolerated in healthy adults. Some mild gastrointestinal effects, like nausea, may occur, especially at higher doses, but no significant changes in vital signs or lab tests were observed.13456

How is the ketone supplement treatment different from other treatments for ketosis?

The ketone supplement, specifically bis hexanoyl (R)-1,3-butanediol, is unique because it induces ketosis without requiring dietary changes, unlike traditional methods that rely on high-fat, low-carbohydrate diets. It is available in novel forms like powder and ready-to-drink beverages, which rapidly increase blood ketone levels, making it a convenient option for achieving nutritional ketosis.34578

What is the purpose of this trial?

This trial studies how different ages and overall health affect the body's response to a special drink. Participants will consume the drink, and researchers will measure how their bodies process it by checking blood and urine levels.

Research Team

JV

Jeff Volek, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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.

Inclusion Criteria

I am between 20 and 70 years old.
Participant has no health conditions that would prevent completion of the study requirements as judged by the Investigator based on health history
I understand the study and have signed consent forms.
See 1 more

Exclusion Criteria

You drink more than 3 drinks every day or more than 18 drinks each week.
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.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Testing

Participants undergo a series of tests including dietary assessment, body composition measurement, and a submaximal exercise test to determine eligibility and baseline metrics.

1 day
1 visit (in-person)

Test Day

Participants consume the C8 Ketone Diester Study Product and undergo blood and urine sampling to assess ketone metabolism and tolerability.

4-5 hours
1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and overall health status after the test day.

1-2 weeks

Treatment Details

Interventions

  • Beverage Tolerability Questionnaire (BTQ) and satiety visual analogue scale
  • Blood Draw
  • Ketone Supplement
  • Urine Analysis
Trial Overview 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: C8 Ketone SupplementExperimental Treatment4 Interventions
360mg/kg of supplement will be given on a singular testing day.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Buck Institute for Research on Aging

Collaborator

Trials
6
Recruited
1,200+

Findings from Research

The ketone monoester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate effectively elevates blood ketone levels in healthy volunteers, reaching maximum plasma concentrations of 3.30 mM for β-hydroxybutyrate within 1-2 hours after ingestion.
This ketone monoester was generally well-tolerated over a 5-day period, although some gastrointestinal side effects were noted at higher doses, indicating it is a safe alternative to traditional ketogenic diets for enhancing physical and cognitive performance.
Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects.Clarke, K., Tchabanenko, K., Pawlosky, R., et al.[2022]
Exogenous ketone drinks, such as ketone esters and ketone salts, effectively raise blood D-β-hydroxybutyrate (D-βHB) levels, with significant increases observed in a study of 15 participants, indicating a practical alternative to traditional ketogenic diets.
Both types of ketone drinks lowered blood glucose and triglyceride levels without causing adverse effects on blood electrolytes, suggesting they are safe and beneficial for metabolic health.
On the Metabolism of Exogenous Ketones in Humans.Stubbs, BJ., Cox, PJ., Evans, RD., et al.[2022]
Both powdered and ready-to-drink (RTD) formulations of the novel ketone ester BH-BD effectively induce ketosis in healthy adults, increasing blood beta-hydroxybutyrate (BHB) levels within approximately 15 minutes after consumption.
The study found that a higher dose of the powdered formulation (25g) resulted in significantly greater BHB concentrations compared to lower doses and the RTD version, but both formulations were equally effective in raising BHB levels without affecting blood glucose concentrations.
A Novel Powder Formulation of the Ketone Ester, Bis Hexanoyl (R)-1,3-Butanediol, Rapidly Increases Circulating ß-Hydroxybutyrate Concentrations in Healthy Adults.Nieman, KM., Anthony, JC., Stubbs, BJ.[2023]

References

Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. [2022]
On the Metabolism of Exogenous Ketones in Humans. [2022]
A Novel Powder Formulation of the Ketone Ester, Bis Hexanoyl (R)-1,3-Butanediol, Rapidly Increases Circulating ß-Hydroxybutyrate Concentrations in Healthy Adults. [2023]
Bis Hexanoyl (R)-1,3-Butanediol, a Novel Ketogenic Ester, Acutely Increases Circulating r- and s-ß-Hydroxybutyrate Concentrations in Healthy Adults. [2023]
Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. [2021]
Safety and tolerability of sustained exogenous ketosis using ketone monoester drinks for 28 days in healthy adults. [2020]
Dog model of therapeutic ketosis induced by oral administration of R,S-1,3-butanediol diacetoacetate. [2022]
Suppression of mitogenic response of bovine lymphocytes during experimental ketosis in calves. [2013]
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