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The OLEA-HF study aims to explore whether daily supplementation of extra-virgin olive oil (EVOO) for 12 weeks during participation in a cardiac rehabilitation program (standard of care) is feasible in patients with heart failure with reduced ejection fraction (HFrEF). The investigators will also determine the effects of EVOO on functional capacity and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extra-virgin olive oil | Experimental |
| |
| Standard of care | No Intervention | Cardiac rehabilitation as part of standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-virgin olive oil | Other | At least 4 tablespoons of extra-virgin olive oil per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour dietary recall monounsaturated fatty acids (MUFA) | Measured with validated 24-hour dietary recall (non-self administered) | At baseline, and 12-week |
| Change in dietary compliance (plasma monounsaturated fatty acids) | Measured by changes in biomarkers of monounsaturated fatty acids (MUFA) consumption. Plasma concentrations of MUFA reflect the consumption of a diet rich in MUFA fatty acids, such as oleic acid found in extra-virgin olive oil, making them reliable biomarkers of dietary adherence. | At baseline and 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk test distance | Baseline, 12-week | |
| Change in quality of life (Kansas City Cardiomyopathy Questionnaire) | The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered instrument used to evaluate the quality of life of patients with heart failure. The score ranges from 0 to 100. Higher scores indicate fewer symptoms and a better clinical outcome (better quality of life). Change is calculated by subtracting the baseline score from the 12-week score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salvatore Carbone, PhD, RDN | Contact | 757-446-7149 | scarbone@odu.edu | |
| Saiful Anuar Bin Singar, PhD | Contact | 757-446-7149 | ssingar@odu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Salvatore Carbone, PhD, RDN | Macon & Joan Brock Virginia Health Sciences at Old Dominion University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strelitz Diabetes Center (Williams Hall) | Norfolk | Virginia | 23510 | United States |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline and 12-week |