Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction (OLEA-HF)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF)
• Intervention / Treatment: Other: Extra-virgin olive oil

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Salvatore Carbone, PhD, RDN; Phone Number: 757-446-7149; Email: scarbone@odu.edu
• Study Contact Backup: Name: Saiful Anuar Bin Singar, PhD; Phone Number: 757-446-7149; Email: ssingar@odu.edu

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Strelitz Diabetes Center (Williams Hall)
      • Contact: Saiful Anuar Bin Singar, PhD; Phone Number: 757-446-7149; Email: ssingar@odu.edu
      • Contact: Salvatore Carbone, PhD, RDN; Phone Number: 7574467149; Email: scarbone@odu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extra-virgin olive oil	Other: Extra-virgin olive oil; At least 4 tablespoons of extra-virgin olive oil per day
No Intervention: Standard of care; Cardiac rehabilitation as part of standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test distance		Baseline, 12-week
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.	Baseline and 12-week

Collaborators and Investigators

• Sponsor: Old Dominion University
• Investigators: Principal Investigator: Salvatore Carbone, PhD, RDN, Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cardiomyopathy; Dietary fat quality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Cardiomyopathies
• Other Study ID Numbers: 26-01-FB-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No