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Clinical Trials/NCT07644806
NCT07644806Not yet recruitingNot Applicable

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

Old Dominion University1 site in 1 country40 target enrollmentStarted: July 1, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
40
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Salvatore Carbone

Associate Professor and Nutrition Program Director

Old Dominion University

Study Sites (1)

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