Olive Oil and Cardiovascular Health

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 13-001080
    NCT ID: NCT01983943
    Sponsor Protocol Number: 13-001080

About this study

The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Patients will be included if they have all of the following

  1. Age ≥ 18 years old
  2. Have known diagnosis of coronary artery disease
  3. Demonstrated endothelial dysfunction (reactive hyperemia - EndoPAT score < 2.0) at time of screening

Exclusion criteria:

Patients will be excluded if they have one or more of the following:

  1. Hypertension (at Screening): any patient with systolic blood pressure (SBP) ≥ 170 mmHg or diastolic blood pressure ≥ 110 mmHg, or hypotension (SBP < 100 mmHg)
  2. Uncontrolled Diabetes Mellitus
  3. Experienced an acute coronary syndrome within 3 months
  4. PCI or revascularization for an acute coronary syndrome within 3 months
  5. Second (II) or third (III) degree heart block without a pacemaker and/or concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia
  6. Congestive heart failure NYHA class III and IV
  7. Unstable serum creatinine (>2.0)
  8. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the olive oil including, but not limited to, any of the following:

    • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
    • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
    • Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt
  9. Any concurrent life threatening condition with a life expectancy less than 2 years
  10. History or evidence of drug or alcohol abuse within the last 12 months
  11. History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
  12. History of noncompliance to medical regimens or unwillingness to comply with the study protocol
  13. History of malignancy other than basal cell skin cancer within the past five years
  14. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
  15. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  16. Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety
  17. Persons directly involved in the execution of this protocol
  18. Pregnant or nursing (lactating) women
  19. Women of child-bearing potential unless postmenopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Amir Lerman, M.D.

Closed for enrollment

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CLS-20154146

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