Heart Failure With Reduced Ejection Fraction (HFrEF)
Conditions
Keywords
Cardiomyopathy, Dietary fat quality
Brief summary
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.
Interventions
At least 4 tablespoons of extra-virgin olive oil per day
Sponsors
Old Dominion University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with HFrEF with left ventricular ejection fraction ≤35 %. * Referred to and enrolled in the standard cardiac rehabilitation program at Sentara Cardiac Rehabilitation Center, but has not yet initiated/started cardiac rehabilitation (i.e., has not attended the first cardiac rehab session). * Able and willing to comply with study procedures and provide informed consent.
Exclusion criteria
* Co-morbidity expected to limit survival (e.g., terminal illness). * End-stage renal disease. * Unstable fluid overload. * Current pregnancy (self-disclose). * Habitual use of EVOO greater than 4 tablespoons per day. * Known allergy or sensitivity to olive oil or its components. * Unwillingness or inability to incorporate EVOO or dietary recommendations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour dietary recall monounsaturated fatty acids (MUFA) | At baseline, and 12-week | Measured with validated 24-hour dietary recall (non-self administered) |
| Change in dietary compliance (plasma monounsaturated fatty acids) | At baseline and 12-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-minute walk test distance | Baseline, 12-week | — |
| Change in quality of life (Kansas City Cardiomyopathy Questionnaire) | Baseline and 12-week | 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. |
Countries
United States
Contacts
CONTACTSalvatore Carbone, PhD, RDN
CONTACTSaiful Anuar Bin Singar, PhD
PRINCIPAL_INVESTIGATORSalvatore Carbone, PhD, RDN
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Outcome results
None listed