Olive Oil and Cardiovascular Health

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Hydroxytyrosol on Vascular Health

Conditions
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Cardiovascular Disease, Endothelial Function

Intervention / Treatment
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* Dietary Supplement: Hydroxytyrosol, the active ingredient in olive oil.
* Dietary Supplement: Placebo
* Behavioral: Nutrition counseling
* Device: Endopat


Participation Criteria
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Eligibility Criteria
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Subjects will be included if they have all of the following Age ≥ 18 years old Have known diagnosis of coronary artery disease Demonstrated endothelial dysfunction (reactive hyperemia - EndoPAT score < 2.0) at time of screening Patient exclusion criteria: Patients will be excluded if they have one or more of the following: Hypertension (at Screening): any patient with systolic blood pressure (SBP) ≥ 170 mmHg or diastolic blood pressure ≥ 110 mmHg, or hypotension (SBP < 100 mmHg) Uncontrolled Diabetes Mellitus Experienced an acute coronary syndrome within 3 months PCI or revascularization for an acute coronary syndrome within 3 months Second (II) or third (III) degree heart block without a pacemaker and/or concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia Congestive heart failure NYHA class III and IV Unstable serum creatinine (>2.0) 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 Any concurrent life threatening condition with a life expectancy less than 2 years History or evidence of drug or alcohol abuse within the last 12 months 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 History of noncompliance to medical regimens or unwillingness to comply with the study protocol History of malignancy other than basal cell skin cancer within the past five years 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 Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety Persons directly involved in the execution of this protocol Pregnant or nursing (lactating) women 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydroxytyrosol<br>Hydroxytyrosol, the major polyphenol in olive oil, 40mg will be taken once per day for 6 months. | Dietary Supplement: Hydroxytyrosol, the active ingredient in olive oil.<br>* A 40mg capsule will be taken once daily for 6 months.<br>Behavioral: Nutrition counseling<br>* Nutrition counseling on eating a healthy diet will be offered once at baseline.<br>Device: Endopat<br>* An endopat test will be administered twice, once and baseline and once after 6 months of supplementation, to test endothelial function. This is a non-invasive test that takes about 15 minutes.<br>|
| Placebo Comparator: Placebo<br>Placebo 40mg will be taken once per day for 6 months. | Dietary Supplement: Placebo<br>* A 40mg placebo will be taken once per day for 6 months.<br>Behavioral: Nutrition counseling<br>* Nutrition counseling on eating a healthy diet will be offered once at baseline.<br>Device: Endopat<br>* An endopat test will be administered twice, once and baseline and once after 6 months of supplementation, to test endothelial function. This is a non-invasive test that takes about 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | In order to address these hypotheses, our specific aims are to investigate the effect of administration of six months of hydroxytyrosol in individuals with multiple cardiovascular risk factors and with known coronary artery disease, on: Improvement of endothelial function as determined by peripheral endothelial function testing and circulating EPCs. | 6 months | 
| Surrogate markers | In order to address these hypotheses, our specific aims are to investigate the effect of administration of six months of hydroxytyrosol in individuals with multiple cardiovascular risk factors and with known coronary artery disease, on: Improvement and normalization of surrogate markers of CVD such as leukocytes, glucose, lipids, renal function, and high-sensitivity C-reactive protein (hs-CRP). | 6 months |