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Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction

Olive Oil Supplementation to Enhance Exercise Tolerance in Cardiac Rehabilitation in Patients With Heart Failure With Reduced Ejection Fraction: The OLEA-HF Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The OLEA-HF study tests whether people with heart failure and a weak heart pump can take extra-virgin olive oil daily for 12 weeks during a standard heart rehab program. It also looks at how the oil affects their ability to do physical activities and their quality of life.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have heart failure in which the heart’s main pumping chamber pumps out 35% or less of its blood with each beat.
  • Have been referred to and enrolled in heart rehab at Sentara Cardiac Rehabilitation Center, but have not attended the first session.
  • Can and will follow study steps and give informed consent, meaning you understand the study and agree to join.

Who can't join

  • Have another illness expected to shorten your life, such as a terminal illness.
  • Have end-stage kidney disease, meaning your kidneys have stopped working or barely work.
  • Have an unstable buildup of extra fluid in your body.
  • Are currently pregnant, based on what you report.
  • Usually use more than 4 tablespoons of extra-virgin olive oil per day.
  • Have a known allergy or sensitivity to olive oil or anything in it.
  • Cannot or will not add extra-virgin olive oil to your diet or follow the diet advice.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

VA