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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR212399-F | Other Grant/Funding Number | Departent of Defense |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keto Ester Acute | Experimental | This arm will provide a Ketone Ester supplement + a meal for consumption. |
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| Placebo Acute | Placebo Comparator | This arm will provide a Placebo beverage + a meal for consumption. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Ester Acute | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fat storage | Participants undergo MRI scans, conducted by trained professionals. MRI imaging analyses will determine fat storage. | Baseline, 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debbie Scandling, BS | Contact | 614-688-5623 | debbie.scandling@osumc.edu | |
| Christopher Crabtree, MS | Contact | crabtree.223@osu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yuchi Han, MD, MMSc | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ross Heart Hospital | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized, double-blinded, placebo-controlled, crossover study
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| Placebo Acute | Dietary 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. |
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| Metabolic Panel | Changes in metabolic blood panel will be assessed at lab visits. | Baseline, 2 weeks |
| Lipid Panel | Changes in lipid blood panel will be assessed at lab visits. | Baseline, 2 weeks |
| B-natriuretic peptide (BNP) | Changes in BNP (pg/mL) will be assessed at lab visits. | 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. | Baseline, 2 weeks |
| D004700 | Endocrine System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |