Effects of a ketone ester beverage on heart function and exercise tolerance

Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With Diabetes

This study is testing if a special drink made from ketones can improve heart function and exercise ability in people with heart failure, type 2 diabetes, or metabolic syndrome.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06078683 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of a ketone ester (KE) beverage on heart function and exercise performance in individuals with heart failure with preserved ejection fraction (HFpEF), type 2 diabetes, or metabolic syndrome. It is a single-center, randomized controlled trial involving up to 30 participants who will be assigned to receive either the KE or a placebo beverage for six weeks, followed by a washout period and crossover to the alternate beverage. The primary outcome will be assessed through cardiopulmonary exercise testing (CPET) to measure maximal exercise performance, alongside daily monitoring of health markers. Participants will continue their standard heart failure and diabetes treatments throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with heart failure, type 2 diabetes, or metabolic syndrome who have stable medical therapy.

Not a fit: Patients with severe heart failure (NYHA class IV) or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve exercise tolerance and cardiac function in patients with heart failure and related metabolic conditions.

How similar studies have performed: While the use of ketone esters in metabolic conditions is an emerging area, similar studies have shown promising results in improving metabolic health, though this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old
2. Type II Diabetes Mellitus
3. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)
4. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization
5. Body Mass Index (BMI) ≥ 25
6. Ability to participate in exercise treadmill testing (only if CPET is performed)
7. Ability to sign written consent

Exclusion 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 eGFR\<30 ml/kg/1.73m2
7. Type I diabetes
8. History of diabetic ketoacidosis
9. Prior diagnosis of oxygen dependent pulmonary disease
10. Body Mass Index (BMI) \< 25
11. 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
12. 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
13. Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.
14. 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)
15. Presence of any disease other than diabetes that results in a life expectancy of \<1 year (in the opinion of the investigator)
16. Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study.
17. 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
18. Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol.
19. Unable or unwilling to follow guidelines of assigned supplement group.
20. Allergy to test article ingredients, or lactose intolerance
21. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.
22. Refusal to consent

Where this trial is running

Columbus, Ohio

• The Ross Heart Hospital — Columbus, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Yuchi Han, MD, MMSc — Ohio State University
• Study coordinator: Debbie Scandling, BS

Conditions Type 2 Diabetes; Ketone Body Metabolism; Ketones, Metabolism