RecruitingNot ApplicableNCT06078683

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

Sponsor

Ohio State University

Enrollment

30 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Ketone Body Metabolism Ketones, Metabolism

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether drinking a ketone ester supplement improves exercise capacity and heart function in people with Type 2 diabetes who are overweight. Ketones are an alternative fuel source the body can use for energy. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with Type 2 diabetes - Your treatment has been stable for at least 1 month - Your BMI is 25 or above (overweight or obese) - You are able to participate in an exercise test **You may NOT be eligible if...** - You have Type 1 diabetes - Your medical treatment has changed very recently - You are unable to exercise safely - You do not meet other medical criteria assessed by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTKetone 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_SUPPLEMENTPlacebo 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.