Heart Failure With Reduced Ejection Fraction (HFrEF)OLEA-HFNCT07644806
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
A study testing Extra-virgin olive oil in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Old Dominion University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- Extra-virgin olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Strelitz Diabetes Center (Williams Hall)
Norfolk, Virginia, 23510
Salvatore Carbone, PhD, RDN, 7574467149, scarbone@odu.edu
Saiful Anuar Bin Singar, PhD, 757-446-7149, ssingar@odu.edu
About this study
Official title: 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.
- Being tested
- Extra-virgin olive oil
- Keywords
- Cardiomyopathy, Dietary fat quality
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-virgin olive oilOther
At least 4 tablespoons of extra-virgin olive oil per day
| Study group | Role | What they receive |
|---|---|---|
| Extra-virgin olive oil | Experimental | Not described Receives: Other: Extra-virgin olive oil |
| Standard of care | No intervention | Cardiac rehabilitation as part of standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour dietary recall monounsaturated fatty acids (MUFA)
Measured with validated 24-hour dietary recall (non-self administered)
Measured: 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.
Measured: At baseline and 12-week
Secondary outcomes (2)
6-minute walk test distance
Measured: 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.
Measured: Baseline and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Carbone, Old Dominion University
- Investigators
- Salvatore Carbone, PhD, RDN, Principal investigator, Macon & Joan Brock Virginia Health Sciences at Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644806
- Sponsor's protocol ID
- 26-01-FB-0005
- Acronym
- OLEA-HF
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No