Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With Diabetes
Ohio State University
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).
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…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 80 years old 2. Type II Diabetes Mellitus 3. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions) 4. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization 5. Body Mass Index (BMI) ≥ 25 6. Ability to participate in exercise treadmill testing (only if CPET is performed) 7. Ability to sign written consent Exclusion Criteria: 1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the…
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.
Location
- The Ross Heart HospitalColumbus, Ohio