Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extra-virgin olive oil.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction (HFrEF). Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Olive Oil Supplementation to Enhance Exercise Tolerance in Cardiac Rehabilitation in Patients With Heart Failure With Reduced Ejection Fraction: The OLEA-HF Study
Overview
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
- Other Extra-virgin olive oil
At least 4 tablespoons of extra-virgin olive oil per day
Primary outcome measures
- Change in 24-hour dietary recall monounsaturated fatty acids (MUFA) [Time frame: At baseline, and 12-week]
- Change in dietary compliance (plasma monounsaturated fatty acids) [Time frame: At baseline and 12-week]
Secondary outcome measures (2)
- 6-minute walk test distance [Time frame: Baseline, 12-week]
- Change in quality of life (Kansas City Cardiomyopathy Questionnaire) [Time frame: Baseline and 12-week]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Strelitz Diabetes Center (Williams Hall) — Norfolk
Identifiers
NCT: NCT07644806 · 26-01-FB-0005