Recruiting

EVOO

Sponsor:

Old Dominion University

Code:

NCT07644806

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Extra-virgin olive oil

Study Details

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.

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Study ID

NCT07644806

Start date

Jul 1, 2026

Status verified date

Oct, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Extra-virgin olive oil

no intervention: Standard of care

Cardiac rehabilitation as part of standard of care

Interventions

Extra-virgin olive oil

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Salvatore Carbone, PhD, RDN

757-446-7149scarbone@odu.edu

Saiful Anuar Bin Singar, PhD

757-446-7149ssingar@odu.edu

Locations

Strelitz Diabetes Center (Williams Hall)

Recruiting

Norfolk, Virginia, United States, 23510

Contacts

Salvatore Carbone, PhD, RDN

7574467149scarbone@odu.edu

Saiful Anuar Bin Singar, PhD

757-446-7149ssingar@odu.edu

More Information

Sponsor

Old Dominion University

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Cardiomyopathy
  • Dietary fat quality

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by Old Dominion University on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.