Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction

NCT07644806 | Not Yet Recruiting

• 1 other identifier: 26-01-FB-0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Keywords

Cardiomyopathy; Dietary fat quality

Outcome Measures

Primary Outcomes (2)

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

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

  At baseline, and 12-week

• 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.

  At baseline and 12-week

Secondary Outcomes (2)

• 6-minute walk test distance

  Baseline, 12-week

• Change in quality of life (Kansas City Cardiomyopathy Questionnaire)

  Baseline and 12-week

Study Arms (2)

Extra-virgin olive oil

EXPERIMENTAL

Other: Extra-virgin olive oil

Standard of care

NO INTERVENTION

Cardiac rehabilitation as part of standard of care

Interventions

Extra-virgin olive oil OTHER

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

Extra-virgin olive oil

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Old Dominion University: lead

Study Sites (1)

Strelitz Diabetes Center (Williams Hall)

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Salvatore Carbone, PhD, RDN

  Macon & Joan Brock Virginia Health Sciences at Old Dominion University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvatore Carbone, PhD, RDN

CONTACT

757-446-7149; scarbone@odu.edu

Saiful Anuar Bin Singar, PhD

CONTACT

757-446-7149; ssingar@odu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Nutrition Program Director

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)