Olive Oil and Cardiovascular Health

Effects of Hydroxytyrosol on Vascular Health

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).

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Disease; Endothelial Function
• Intervention / Treatment: Dietary supplement: Hydroxytyrosol, the active ingredient in olive oil.; Behavioral: Nutrition counseling; Device: Endopat; Dietary supplement: Placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Subjects 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

Patient 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxytyrosol; 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.; A 40mg capsule will be taken once daily for 6 months.; Behavioral: Nutrition counseling; Nutrition counseling on eating a healthy diet will be offered once at baseline.; Device: Endopat; 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.
Placebo Comparator: Placebo; Placebo 40mg will be taken once per day for 6 months.	Behavioral: Nutrition counseling; Nutrition counseling on eating a healthy diet will be offered once at baseline.; Device: Endopat; 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.; Dietary supplement: Placebo; A 40mg placebo will be taken once per day for 6 months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; 3,4-dihydroxyphenylethanol
• Other Study ID Numbers: 13-001080