Ketone Supplements for Ketosis

(STAK-VKM Trial)

Recruiting at 1 trial location

Overseen By Madison L Kackley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Diabetes, Hypertension, Psychiatric, GI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how people with different metabolic health conditions, such as obesity or diabetes, process ketone supplements. The goal is to determine if these conditions affect the body's use of ketones, which serve as energy molecules. Participants will take a specific ketone supplement, known as Ketone Ester or DeltaG, to help researchers understand these differences better. Individuals who do not follow a low-carb diet and do not have uncontrolled health conditions like high blood pressure or diabetes might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on metabolic health and ketone processing.

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 prior data suggests that this ketone supplement is safe?

Research has shown that ketone supplements, such as the C8 ketone supplement, are generally safe for use. One study found that a type of ketone ester, including 1,3-butanediol, was considered safe by the FDA, indicating it is usually well-tolerated.

In studies with healthy adults, the supplement did not cause serious side effects. Most people tolerate ketone supplements well, though some might experience minor issues like an upset stomach. These supplements have also been safely used by older adults, showing they are not limited to athletes or younger individuals.

Overall, while current research suggests the ketone supplement is safe, individual responses can vary. Joining a clinical trial can help gather more information on how people of different ages and health conditions respond to these supplements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ketone supplements for inducing ketosis because they offer a unique approach compared to traditional methods like the ketogenic diet. While the ketogenic diet requires strict adherence to low-carbohydrate intake to trigger ketosis, ketone supplements can potentially induce this metabolic state more quickly and without dietary restrictions. The active ingredient, C8 ketone, is believed to efficiently raise ketone levels in the body, providing an alternative for those seeking the benefits of ketosis, such as improved energy and mental clarity, without the challenges of a restrictive diet.

What evidence suggests that ketone supplements might be effective for ketosis?

This trial will examine the effects of a C8 Ketone Supplement, administered to participants on a single testing day. Research has shown that ketone supplements can help the body enter ketosis, a state where it burns fat for energy instead of carbohydrates. Studies have found that these supplements raise levels of beta-hydroxybutyrate (BHB) in the blood, indicating ketosis. One study discovered that ketone supplements can help control blood sugar levels in people with type 2 diabetes. Additionally, they might improve physical performance by boosting endurance and strength. While more research is needed, these early findings suggest potential benefits, especially for those with metabolic health issues. ^{1 6 7 8 9}

Who Is on the Research Team?

Jeff Volek, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: C8 Ketone Supplement Experimental Treatment 4 Interventions

360mg/kg of supplement will be given on a singular testing day.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. Clarke, K., Tchabanenko, K., Pawlosky, R., et al.[2022]

In a study with conscious dogs, the ingestion of R,S-1,3-butanediol diacetoacetate induced ketosis, but the achieved level (0.8 mM) was lower than the levels (1-3 mM) seen in children on a ketogenic diet for epilepsy.

The study suggests that while the ketosis level in dogs was lower, humans might experience higher ketone body concentrations from the same doses of the ester, potentially making it a viable option for managing seizures in children with intractable epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dog model of therapeutic ketosis induced by oral administration of R,S-1,3-butanediol diacetoacetate. Puchowicz, MA., Smith, CL., Bomont, C., et al.[2022]

Inducing experimental ketosis in calves through a diet of 1,3 butanediol for 9 to 10 days significantly raised blood levels of beta-hydroxybutyrate, indicating successful ketosis.

The ketosis led to a significant suppression of lymphocyte function, which persisted for 2 weeks, and was associated with increased susceptibility to upper respiratory infections in the calves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suppression of mitogenic response of bovine lymphocytes during experimental ketosis in calves. Targowski, SP., Klucinski, W., Littledike, ET., et al.[2013]

A novel ketone di-ester, bis hexanoyl (R)-1,3-butanediol (BH-BD), effectively raises blood levels of beta-hydroxybutyrate (BHB) to 0.8-1.7 mM in healthy adults, indicating successful induction of ketosis without dietary changes.

The study showed that higher doses of BH-BD (25g) resulted in greater increases in BHB levels compared to lower doses (12.5g), while also decreasing plasma glucose and free fatty acids, suggesting potential metabolic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bis Hexanoyl (R)-1,3-Butanediol, a Novel Ketogenic Ester, Acutely Increases Circulating r- and s-ß-Hydroxybutyrate Concentrations in Healthy Adults. Crabtree, CD., Blade, T., Hyde, PN., et al.[2023]

A study involving 24 healthy adults showed that consuming a ketone monoester three times a day for 28 days safely elevated blood ketone levels without affecting body weight, blood glucose, cholesterol, or kidney function.

The only reported side effect was mild nausea in a small number of instances, indicating that the ketone monoester is well-tolerated for sustained use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of sustained exogenous ketosis using ketone monoester drinks for 28 days in healthy adults. Soto-Mota, A., Vansant, H., Evans, RD., et al.[2020]

In a 28-day study involving 59 healthy adults, the novel exogenous ketone diester bis-hexanoyl-(R)-1,3-butanediol (BH-BD) was found to be well-tolerated and safe, with no significant differences in tolerability scores compared to a placebo.

BH-BD effectively increased blood ketone levels one hour after consumption, indicating its potential for promoting nutritional ketosis without adverse effects on vital signs or laboratory measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. Chen, O., Blonquist, TM., Mah, E., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the Metabolism of Exogenous Ketones in Humans. Stubbs, BJ., Cox, PJ., Evans, RD., et al.[2022]

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Ketone Ester D‐β‐Hydroxybutyrate‐(R)‐1,3 Butanediol ...

This study demonstrates that ketone ester supplementation to induce mild ketosis in patients with type 2 diabetes mellitus could be ...

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Within these studies, 16 performance outcomes (8 subgroups for lower-body power and 8 subgroups for endurance performance outcomes) were identified (Table 1).

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frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1195702/full

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A study was undertaken to determine the acute effects of a beverage made with Avela™, (R)-1,3-butanediol, on blood beta-hydroxybutyrate ...

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ketone.com/blogs/blog/exogenous-ketones-ketoneaid-vs-hvmn-ketone-ester?srsltid=AfmBOoqU1RCUnfLdkDEpurfGA932lukILAcNyhGjgu0yth-PHzjzvyO0

KetoneAid vs. H.V.M.N. Ketone Ester

productized: D-Beta-hydroxybutyrate, R-1,3 butanediol monoester, a ketone ester that's FDA GRAS (“generally recognized as safe”). Now as the exogenous ketone ...

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pmc.ncbi.nlm.nih.gov/articles/PMC9734240/

Exogenous Ketone Supplements in Athletic Contexts

As well as glycerol, R,S-1,3-butanediol (BD) can be esterified to βHB or AcAc, with BD itself in turn elevating [βHB] given its action as a ketogenic precursor ...

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Targeting Aging With a Ketone Ester for Function in Frailty

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Ketone Ester Energy | No Sugar, No Caffeine (36 Count)

This is a ketogenic drink that includes 5 grams of Ketone (Mono)Ester (D-BHB bonded to R 1,3 Butanediol). This drink is more diluted than our Ke4 PRO drink ...