An interventional study of Extra-virgin olive oil in Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Old Dominion University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Old Dominion University · Not applicable, Interventional, and Treatment
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.
553 studies on the registry are indexed under Cardiomyopathies; 152 are open to participants now.
This study's planned enrollment of 40 is below the median of 51 across 266 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Old Dominion University is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Extra-virgin olive oil
Cardiac rehabilitation as part of standard of care
At least 4 tablespoons of extra-virgin olive oil per day
Change in 24-hour dietary recall monounsaturated fatty acids (MUFA)
Measured with validated 24-hour dietary recall (non-self administered)
Time frame: 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.
Time frame: At baseline and 12-week
6-minute walk test distance
Time frame: 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.
Time frame: Baseline and 12-week
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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