Olive Oil and Cardiovascular Health
NCT01983943 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2015-06-03
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
Interventions
- DIETARY_SUPPLEMENT
-
Hydroxytyrosol, the active ingredient in olive oil.
A 40mg capsule will be taken once daily for 6 months.
- DIETARY_SUPPLEMENT
-
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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Amir Lerman, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- United States
Study Locations
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