Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorOld Dominion University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Co-morbidity expected to limit survival (e.g., terminal illness).
End-stage renal disease.
Unstable fluid overload.
Current pregnancy (self-disclose).
Trial design
Design model
Parallel
Treatments tested in this trial
Extra-virgin olive oil
Other interventionAt least 4 tablespoons of extra-virgin olive oil per day
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Extra-virgin olive oilExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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-week2
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-weekSecondary outcomes
1
6-minute walk test distance
Time frame
Baseline, 12-week2
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-weekSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: