Olive Oil and Cardiovascular Health

NCT ID: NCT01983943

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-07-31

Brief Summary

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).

Conditions

Cardiovascular Disease; Endothelial Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Hydroxytyrosol

Hydroxytyrosol, the major polyphenol in olive oil, 40mg will be taken once per day for 6 months.

Group Type: EXPERIMENTAL

Hydroxytyrosol, the active ingredient in olive oil.

Intervention Type: DIETARY_SUPPLEMENT

A 40mg capsule will be taken once daily for 6 months.

Nutrition counseling

Intervention Type: BEHAVIORAL

Nutrition counseling on eating a healthy diet will be offered once at baseline.

Endopat

Intervention Type: DEVICE

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

Placebo 40mg will be taken once per day for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

A 40mg placebo will be taken once per day for 6 months.

Nutrition counseling

Intervention Type: BEHAVIORAL

Nutrition counseling on eating a healthy diet will be offered once at baseline.

Endopat

Intervention Type: DEVICE

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.

Interventions

Hydroxytyrosol, the active ingredient in olive oil.

A 40mg capsule will be taken once daily for 6 months.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

A 40mg placebo will be taken once per day for 6 months.

Intervention Type: DIETARY_SUPPLEMENT

Nutrition counseling

Nutrition counseling on eating a healthy diet will be offered once at baseline.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Amir Lerman

Invasive Cardiologist, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

13-001080

Identifier Type: -

Identifier Source: org_study_id