Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Description

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

Conditions

Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes, Metabolic Syndrome

Study Overview

Study Details

Study overview

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

Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Condition
Heart Failure With Preserved Ejection Fraction
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ross Heart Hospital, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
  • 2. Known allergy or sensitivity to Gadolinium based contrast agents
  • 3. Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
  • 4. Other metallic implants/aneurysm clips that are contraindicated in MRI
  • 5. Claustrophobia
  • 6. History of severe kidney disease with estimated glomerular filtration rate (eGFR) \<30 ml/kg/1.73m2
  • 7. Type I diabetes
  • 8. History of diabetic ketoacidosis
  • 9. Prescription use of sodium-glucose cotransporter-2 inhibitors (SGLT2i)
  • 10. Prior diagnosis of oxygen dependent pulmonary disease
  • 11. Body Mass Index (BMI) \< 25
  • 12. Recent acute myocardial infarction or acute coronary syndrome (30 days)
  • 13. Recent (within 30 days) or planned (within 30 days) cardiac revascularization.
  • 14. History of un-revascularized left main coronary artery disease, severe un- revascularized triple vessel disease, coronary artery bypass graft surgery \< 30 days.
  • 15. Left ventricular ejection fraction \< 50%
  • 16. Uncontrolled systemic systolic/diastolic blood pressure (SBP/DBP) hypertension (SBP \>180 or DBP \>110 mmHg)
  • 17. Severe stenotic or regurgitant valvular heart disease, expected to lead to surgery during the trial period.
  • 18. Persistent atrial fibrillation.
  • 19. History of uncontrolled or untreated ventricular arrhythmias
  • 20. Cardiovascular diseases or treatments that increase the unpredictability of the subject's clinical course, independent of heart failure
  • 21. Heart transplant or listing for heart transplant.
  • 22. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
  • 23. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents or mechanical support within 1 week of screening and during the screening period prior to randomization
  • 24. Hemoglobin of \<9 g/dL at screening
  • 25. Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening
  • 26. Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
  • 27. Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.
  • 28. Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \<10 ng/mL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a)
  • 29. Presence of any disease other than heart failure that results in a life expectancy of \<1 year (in the opinion of the investigator)
  • 30. History or recurrent severe hypokalemia, potassium \< 3.0 mg/dL.
  • 31. Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study.
  • 32. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfil the trial requirements or complete the trial
  • 33. Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol.
  • 34. Unable or unwilling to follow guidelines of assigned supplement group.
  • 35. Allergy to test article ingredients, or lactose intolerance
  • 36. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.
  • 37. Patient must have stable weight over the past 3 months (± 5% total body weight). If no weight was recorded in the past 3 months, will have 1 month lead in time for wash out.
  • 38. Refusal to consent

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Yuchi Han, MD, MMSc, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

2026-08-31