What side effects are associated with this type of intervention?

Treatments for ketosis, such as BHB Monoester, which directly deliver beta-hydroxybutyrate (BHB), can have several side effects. Commonly reported side effects include gastrointestinal discomfort, such as nausea and diarrhea, due to the body's adaptation to elevated ketone levels. There may also be metabolic disturbances, including changes in acid-base balance, which can lead to symptoms like fatigue and dizziness. While these treatments are generally well-tolerated, individual responses can vary, and long-term effects are still being studied.

What prior FDA approvals exist?

There are currently no specific FDA-approved treatments for ketosis that involve the direct delivery of beta-hydroxybutyrate (BHB) or similar compounds. Research is ongoing to understand the metabolic and signaling effects of different ketone bodies, including BHB Monoester, but these treatments are still under investigation and have not yet received FDA approval.

What other types of research exist?

Promising alternatives to BHB Monoester for ketosis patients include AcAc Diester, C8 Ketone Diester, and 1,3-Butanediol (BDO). These compounds elevate ketone levels through different mechanisms and may offer distinct metabolic and signaling benefits.

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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

Must not have

Participant has a clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study beverage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~ 4 weeks

Summary

This trial tests different types of ketone supplements and a precursor to see how they affect metabolism. The study involves participants who meet specific health and dietary criteria. These supplements increase ketone levels in the blood, offering an alternative energy source to glucose.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am male.

Select...

I am between 20 and 30 years old.

Exclusion Criteria

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

Select...

I have a serious stomach or intestine condition that could affect the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~ 4 weeks

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

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

Primary study objectives

Ketones

Secondary study objectives

AcAc, R-BHB and S-BHB changes across trials

Acid-Base Balance

Alanine Change

+13 more

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

2014

Completed Phase 4

~2350

0 / 3Eligibility 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

The most common treatments for ketosis, such as BHB Monoester, work by directly delivering beta-hydroxybutyrate (BHB) into the bloodstream. BHB serves as an alternative energy source to glucose, which is particularly beneficial during periods of low carbohydrate intake or fasting. This direct delivery of BHB can help maintain energy levels, support cognitive function, and reduce inflammation. Additionally, BHB has signaling functions that can influence gene expression and metabolic pathways, promoting a state of ketosis more efficiently. For patients, this means improved metabolic flexibility, better management of energy levels, and potential therapeutic benefits for conditions like epilepsy, neurodegenerative diseases, and metabolic disorders.

Hepatic gluconeogenic and ketogenic interrelationships in the lactating cow.BDK inhibition acts as a catabolic switch to mimic fasting and improve metabolism in mice.