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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07644806
- Acronym / sponsor ID
- OLEA-HF / 26-01-FB-0005
- Keywords
- Cardiomyopathy, Dietary fat quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra-virgin olive oil | Experimental | Other: Extra-virgin olive oil |
| Standard of care | No intervention | –Cardiac rehabilitation as part of standard of care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra-virgin olive oilAt least 4 tablespoons of extra-virgin olive oil per day | Other | Extra-virgin olive oil |
Primary outcome
Change in 24-hour dietary recall monounsaturated fatty acids (MUFA)
Time frame: At baseline, and 12-week
Measured with validated 24-hour dietary recall (non-self administered)
Change in dietary compliance (plasma monounsaturated fatty acids)
Time frame: At baseline and 12-week
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.
2 secondary outcomes
6-minute walk test distance
Time frame: Baseline, 12-week
Change in quality of life (Kansas City Cardiomyopathy Questionnaire)
Time frame: Baseline and 12-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Reduced Ejection Fraction (HFrEF)
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Recruiting
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
HFrEF - Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
HFrEF Polypill in Sri Lanka RCT
Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
Pharmacological Optimization in Prevention in Heart Failure: A Sex-gap?
Heart Failure, Acute Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salvatore Carbone, PhD, RDN principal investigator
Macon & Joan Brock Virginia Health Sciences at Old Dominion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Carbone, PhD, RDN (757-446-7149, scarbone@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour dietary recall monounsaturated fatty acids (MUFA) (time frame: At baseline, and 12-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.