Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078683
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-09-26
Brief Title:
Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Effects of Acute and Chronic Ketone Ester Consumption on Exercise Tolerance and Cardiac Function in Subjects With the Metabolic Phenotype of Heart Failure With Preserved Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to evaluate how a ketone ester KE beverage affects heart function and health in people with heart failure compared to a placebo beverage a beverage made with standard food ingredients that do not contain ketone esters
Detailed Description:
This study is a single center randomized controlled study of up to 30 subjects with metabolic heart failure with preserved ejection fraction HFpEF phenotype The study is designed to compare the effects of KE versus an energy and volume matched placebo on maximal exercise performance measured by CPET Eligible subjects will have a known diagnosis of HF or type 2 diabetes or metabolic syndrome or obesity and will be selected from a larger population being followed in the Heart Failure Clinic 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 11 to a group before washing out and crossing over to the other group KE or Placebo Subjects will follow the intervention of twice daily consumption of the KE or placebo for a period of 6 weeks followed by a 4 week washout All subjects will then crossover to the other group KE or placebo for another 6 weeks of intervention Primary data will be collected at baseline and at the end of the 6-week intervention for both groups In addition subjects will undergo daily monitoring of blood markers blood pressure heart rate and overall health All subjects will continue standard HF and diabetes therapies with adjustment in medications as needed
Cardiopulmonary exercise testing CPET also known as Maximal oxygen consumption testing VO2 will be used to assess exercise performance and Cardiac Magnetic Resonance Imaging CMR 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 in patients diagnosed with HFpEF
Cardiopulmonary exercise testing CPET also known as Maximal oxygen consumption testing VO2 will be used to assess exercise performance and Cardiac Magnetic Resonance Imaging CMR 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 in patients diagnosed with HFpEF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDMRP-PR212399-F | OTHER_GRANT | Departent of Defense | None |