Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes, Ketone Body Metabolism, Ketones, Metabolism

In brief

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).

Key facts

Study ID

NCT06078683

Run by

Ohio State University

People needed

30

Starts

2023-06-06

Expected to finish

2027-08-31

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
• Known allergy or sensitivity to Gadolinium based contrast agents
• Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
• Other metallic implants/aneurysm clips that are contraindicated in MRI
• Claustrophobia
• History of severe kidney disease with eGFR<30 ml/kg/1.73m2
• Type I diabetes
• History of diabetic ketoacidosis
• Prior diagnosis of oxygen dependent pulmonary disease
• Body Mass Index (BMI) < 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
• 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
• Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.
• 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)
• Presence of any disease other than diabetes that results in a life expectancy of <1 year (in the opinion of the investigator)
• Current enrolment in another investigational device or drug study or completion within <30 days of a trial of another investigational device or drug study.
• 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
• Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol.
• Unable or unwilling to follow guidelines of assigned supplement group.
• Allergy to test article ingredients, or lactose intolerance
• The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.
• Refusal to consent

Where it is running

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

Full record on ClinicalTrials.gov

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