Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06078683

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Led by Ohio State University · Updated on 2026-04-03

30

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone esters).

CONDITIONS

Official Title

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and 80 years or younger
  • Diagnosis of type 2 diabetes mellitus
  • Stable medical treatment for at least 1 month with no planned changes between testing sessions
  • Dose of oral diuretics stable for 1 week before randomization
  • Body mass index (BMI) of 25 or higher
  • Ability to participate in exercise treadmill testing if performed
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Women who are pregnant, currently breastfeeding, or planning to become pregnant during the study
  • Known allergy or sensitivity to gadolinium-based contrast agents
  • Presence of implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy device, or left ventricular assist device
  • Other metallic implants or aneurysm clips that prevent safe MRI
  • Claustrophobia
  • History of severe kidney disease with eGFR below 30 ml/kg/1.73m2
  • Diagnosis of type 1 diabetes
  • History of diabetic ketoacidosis
  • Prior diagnosis of oxygen-dependent lung disease
  • Body mass index (BMI) less than 25
  • Major surgery within 90 days before or planned within 90 days after screening
  • Acute or chronic liver disease with elevated liver enzymes more than three times the upper limit of normal
  • Gastrointestinal surgery or disorder interfering with supplement consumption; prior bariatric surgery allowed if weight stable for 3 months
  • Active or suspected cancer or cancer history within 2 years except certain low-risk skin, cervical, or prostate cancers
  • Any disease other than diabetes with life expectancy under 1 year
  • Current or recent participation in another investigational drug or device study within 30 days
  • Chronic alcohol or drug abuse or other conditions impairing study adherence
  • Any clinical condition that risks participant safety or compliance
  • Unable or unwilling to follow supplement group guidelines
  • Allergy to study supplement ingredients or lactose intolerance
  • Currently on a low-carbohydrate diet without a 30-day washout
  • Refusal to provide consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Ross Heart Hospital

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

D

Debbie Scandling, BS

CONTACT

C

Christopher Crabtree, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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