Olive Oil and Cardiovascular Health

NCT01983943 | Withdrawn

• 1 other identifier: 13-001080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Hydroxytyrosol

EXPERIMENTAL

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.; Behavioral: Nutrition counseling; Device: Endopat

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo; Behavioral: Nutrition counseling; Device: Endopat

Interventions

Hydroxytyrosol, the active ingredient in olive oil. DIETARY_SUPPLEMENT

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

Hydroxytyrosol

Placebo DIETARY_SUPPLEMENT

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

Placebo

Nutrition counseling BEHAVIORAL

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

Hydroxytyrosol; Placebo

Endopat 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.

Hydroxytyrosol; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

3,4-dihydroxyphenylethanol; Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Amir Lerman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Invasive Cardiologist, Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)