Type 2 DiabetesNCT06078683
Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
A study testing Ketone Ester Acute in people with Type 2 Diabetes and Ketone Body Metabolism, run by Ohio State University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Ketone Body Metabolism, Ketones, Metabolism
- What is being tested?
- Ketone Ester Acute
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christopher Crabtree, MS contact
United States1 site, 1 recruiting
- Recruiting
The Ross Heart Hospital
Columbus, Ohio, 43210
Debbie Scandling, 614-688-5623, debbie.scandling@osumc.edu
Orlando Simonetti, Ph.D.
About this study
Official title: Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With Diabetes
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).
Read the detailed description
This study is a single center, randomized controlled study of up to 30 subjects with diabetes. The study is designed to compare the acute effects of KE versus an energy and volume matched placebo on cardiac function and blood flow following a meal. Eligible subjects will have a known diagnosis of type 2 diabetes and will be selected from a larger population at the Ohio State University Wexner Medical Center. Enrolled subjects will be stratified by sex to ensure equal proportions of men and women in each group (KE and placebo) and then randomly assigned (1:1) to a group, before washing out and crossing over to the other group (KE or Placebo). The order of treatment will be randomized such that half the cohort starts first with KE, and the other half with Placebo.
CMR will be performed on the days of supplement ingestion. CPET may be performed prior to starting the first intervention. Following a 2-wk washout period, each patient will replicate the acute CMR visit with the opposing treatment (KE or Placebo).
CMR will be used to evaluate cardiac function, myocardial blood flow, and cardiac and vascular function. CMR will provide insightful data on the magnitude, timeline, and functional impact of nutritional ketosis on cardiovascular function and myocardial blood flow in patients diagnosed with T2D.
- Conditions
- Type 2 Diabetes, Ketone Body Metabolism, Ketones, Metabolism
- Being tested
- Ketone Ester Acute, Placebo Acute
- Medical subject headings
- Diabetes Mellitus, Type 2, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Ester AcuteDietary supplement
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.
Placebo AcuteDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Keto Ester Acute | Experimental | This arm will provide a Ketone Ester supplement + a meal for consumption. Receives: Dietary Supplement: Ketone Ester Acute |
| Placebo Acute | Placebo comparator | This arm will provide a Placebo beverage + a meal for consumption. Receives: Dietary Supplement: Placebo Acute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiac MRI measures of cardiac function
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.
Measured: Baseline, 2 weeks
Secondary outcomes (5)
Change in Quality of Life Questionnaire
Participants will complete a quality of life questionnaire several times throughout the study. The questions are divided into three areas: Dyspnea, Fatigue and Emotional Function. The scores for each are added up and divided by the number of questions. A 7-point scale is used for areas where 1 is the best and 7 is the worst.
Measured: Baseline, 2 weeks
Metabolic Panel
Changes in metabolic blood panel will be assessed at lab visits.
Measured: Baseline, 2 weeks
Lipid Panel
Changes in lipid blood panel will be assessed at lab visits.
Measured: Baseline, 2 weeks
B-natriuretic peptide (BNP)
Changes in BNP (pg/mL) will be assessed at lab visits.
Measured: Baseline, 2 weeks
Change in Cardiac function after acute ingestion of KE or placebo
Cardiovascular performance and function will be investigated using CMR at rest, both before and immediately after consumption of KE or placebo.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start6 Jun 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuchi Han, Ohio State University
- Investigators
- Yuchi Han, MD, MMSc, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078683
- Sponsor's protocol ID
- 2022H0376
- Other IDs
- CDMRP-PR212399-F
- Status last verified
- Mar 2026
- First submitted
- 26 Sep 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No