RECRUITING

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Conditions

Heart Failure With Preserved Ejection Fraction Type 2 Diabetes Metabolic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-06-06

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06078683

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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

Contacts and Locations

Study Contact

Debbie Scandling, BS

CONTACT

614-688-5623

debbie.scandling@osumc.edu

Christopher Crabtree, MS

CONTACT

crabtree.223@osu.edu

Principal Investigator

Yuchi Han, MD, MMSc

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

The Ross Heart Hospital

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-06

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-06-06

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure With Preserved Ejection Fraction
Type 2 Diabetes
Metabolic Syndrome