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NCT Number: NCT07644806

Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction

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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Key information

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF) Cardiomyopathies Cardiovascular Diseases Heart Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extra-virgin olive oil

Other

At least 4 tablespoons of extra-virgin olive oil per day

Primary outcomes

  1. Change in 24-hour dietary recall monounsaturated fatty acids (MUFA)

    Time frame: At baseline, and 12-week

    Measured with validated 24-hour dietary recall (non-self administered)

  2. Change in dietary compliance (plasma monounsaturated fatty acids)

    Time frame: 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 outcomes

  1. 6-minute walk test distance

    Time frame: Baseline, 12-week

  2. Change in quality of life (Kansas City Cardiomyopathy Questionnaire)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Saiful Anuar Bin Singar, PhD

CONTACT

[email protected]

757-446-7149

Salvatore Carbone, PhD, RDN

CONTACT

[email protected]

757-446-7149

Sponsors and collaborators

Lead sponsor

Old Dominion University

Other

Registry information

Official study title

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

Acronym: OLEA-HF

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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