NCT06078683 · Ohio State University
Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
What this study 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).
View original scientific description
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).
Interventions
DIETARY_SUPPLEMENT
Ketone Ester Acute
Participants will undertake a controlled feeding intervention where they will consume 25g of C8 Ketone Diester with a meal, and images obtained before and after consumption. The supplement powder contains 12.5 g C8 Diester, sodium caseinate and soluble corn fiber, per serving. The powder contains 120 kcal, 0 g fat, 3 g carbohydrate, and 0 g protein. A standardized meal will be provided to subjects to consume with their allocated supplement during the MRI visits. This meal is formulated with whole foods (i.e. chicken, rice, and a fruit bar) as a mix of macronutrients (29% protein, 3% fat, and 68% carbohydrate - not including the supplements). The meal consists of \~700kcal of food and will be standardized between all visits and subjects.
DIETARY_SUPPLEMENT
Placebo Acute
Participants will undertake a controlled feeding intervention where they will drink two servings of the placebo with a meal, and images obtained before and after consumption. The placebo is flavor, energy, volume, and macronutrient matched will be given to patients as part of the placebo arm of the study. This placebo will not contain any BHB, which will be replaced with a similar caloric content of fat in the form of canola oil.
Primary outcome measures
Change in Cardiac MRI measures of cardiac function
Time frame: Baseline, 2 weeks
Participants undergo MRI scans, conducted by trained professionals. MRI imaging analyses will determine cardiac function. The images will be analyzed by trained imaging professionals to determine overall change in cardiac function.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 3, 2026 · Source of record for eligibility and locations