What is the mechanism of action of this treatment?

Ketone esters (KE) are ingested to elevate blood levels of beta-hydroxybutyrate (BHB), a key ketone body. BHB is broken down into acetoacetate, which enters the Krebs cycle to produce ATP, providing an alternative energy source when glucose is scarce. This is particularly important for ketosis patients, as it helps manage energy levels and metabolic health, especially in conditions like diabetes and obesity where ketone metabolism may be compromised.

What side effects are associated with this type of intervention?

Common treatments for inducing ketosis, such as ketone esters (KE), can have several side effects. These may include gastrointestinal discomfort, such as nausea, diarrhea, and abdominal pain, due to the body's adjustment to increased ketone levels. Additionally, there can be a risk of electrolyte imbalances, dehydration, and hypoglycemia, especially if the diet is not well-balanced. Long-term use of KE might also affect liver function and lipid profiles. It is important to monitor these side effects and consult with a healthcare provider to manage them effectively.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved drugs for the treatment of ketosis that focus on ketone esters or the breakdown and oxidation of beta-hydroxybutyrate (BHB). Research is ongoing to understand how ketone esters affect metabolism, particularly in conditions like obesity and diabetes, but no specific treatments have been approved yet.

What other types of research exist?

Promising novel alternatives to ketone esters for ketosis patients include hydroxycarbazole derivatives, which have shown potential as PPAR alpha/gamma dual agonists and antioxidants. Compounds 10a and 16, in particular, have demonstrated activity in animal studies and may offer benefits in modulating ketone metabolism and providing antioxidant effects.

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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

Must not have

Participant follows a low-carbohydrate diet (<30% energy from carbohydrate) or have used exogenous ketone supplements within 4-months of study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 hours

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 20 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I follow a low-carb diet or have used ketone supplements recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Capillary d-BHB

Secondary study objectives

Beverage tolerability questionnaire (BTQ)

Capillary glucose concentrations

Insulin

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2014

Completed Phase 4

~2350

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ketone esters (KE) are ingested to elevate blood levels of beta-hydroxybutyrate (BHB), a key ketone body. BHB is broken down into acetoacetate, which enters the Krebs cycle to produce ATP, providing an alternative energy source when glucose is scarce. This is particularly important for ketosis patients, as it helps manage energy levels and metabolic health, especially in conditions like diabetes and obesity where ketone metabolism may be compromised.