Olive Oil and Cardiovascular Health

Cardiovascular Disease Clinical Trial

Official title:

Effects of Hydroxytyrosol on Vascular Health

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01983943
• Other study ID #: 13-001080
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2013
• Last updated: June 1, 2015
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Endothelial Function

Intervention

Dietary Supplement:
• Hydroxytyrosol, the active ingredient in olive oil.
A 40mg capsule will be taken once daily for 6 months.
• Placebo
A 40mg placebo 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No