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NCT06078683Recruiting

Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function

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

Source: ClinicalTrials.gov · Last updated 3 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
26 Sept 2023
Start date
6 Jun 2023
Primary completion date
31 Aug 2027
Lead sponsor
Ohio State University
NCT number
NCT06078683

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 6 Jun 2023 to the primary completion date, 31 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Other metallic implants/aneurysm clips that are contraindicated in MRI
  • Prior diagnosis of oxygen dependent pulmonary disease
  • 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
  • Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months.
  • Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study.
  • The subject cannot currently be on a low-carb diet plan. 30-day washout would be required.

Other illness

  • Known allergy or sensitivity to Gadolinium based contrast agents
  • Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device
  • Type I diabetes
  • History of diabetic ketoacidosis
  • 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)
  • 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.
  • Allergy to test article ingredients, or lactose intolerance

Lab values

  • History of severe kidney disease with eGFR\<30 ml/kg/1.73m2
  • 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

Other

  • Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial
  • Claustrophobia
  • Body Mass Index (BMI) \< 25
  • Unable or unwilling to follow guidelines of assigned supplement group.
  • Refusal to consent

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Ross Heart Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.