Olive Oil and Cardiovascular Health

Not Applicable

Withdrawn

• Conditions: Cardiovascular Disease; Endothelial Function
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Hydroxytyrosol, the active ingredient in olive oil.; Behavioral: Nutrition counseling; Device: Endopat

• Registration Number: NCT01983943
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Nutrition counseling	Placebo 40mg will be taken once per day for 6 months.
Placebo	Placebo	Placebo 40mg will be taken once per day for 6 months.
Hydroxytyrosol	Hydroxytyrosol, the active ingredient in olive oil.	Hydroxytyrosol, the major polyphenol in olive oil, 40mg will be taken once per day for 6 months.
Hydroxytyrosol	Nutrition counseling	Hydroxytyrosol, the major polyphenol in olive oil, 40mg will be taken once per day for 6 months.
Hydroxytyrosol	Endopat	Hydroxytyrosol, the major polyphenol in olive oil, 40mg will be taken once per day for 6 months.
Placebo	Endopat	Placebo 40mg will be taken once per day for 6 months.

Primary Outcome Measures

Name	Time	Method
Surrogate markers	6 months	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).
Endothelial function	6 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States