Effect of Olive Oil Consumption on Cardiovascular Biomarkers

Study Overview
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Brief Summary
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The main aim of this study is to examine the effect of olive oil consumption on several cardiovascular risk markers between Caucasians and Asian ethnicity. The primary assessments: endothelial function's biomarkers: cell and vascular adhesion molecules (ICAMs and VCAMs) and nitric oxide (NO). The secondary assessments: Lipid profile.

Official Title
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Effect of Olive Oil Consumption on Cardiovascular Biomarkers in Asians and Caucasians: A Randomized, Crossover, Controlled Interventional Trial

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Dietary Supplement: Olive oil
* Dietary Supplement: Butter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Orient Asians (including Chinese, Japanese, Korean, and Malaysia Chinese) and Caucasians Age 18-70 years Self-reported in good general health Exclusion Criteria: Female Age older than 70 years or younger than 18 years Diagnosed and/or are taking medications for hypertension (>140/90mmHg) Diabetes High blood cholesterol Heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome) Allergy to olive oil or olive oil products Lactose intolerance Taking omega-3 supplements in fish oil and vitamins supplements in the last six months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, double-blind, placebo-controlled crossover trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive oil<br>Participants will receive 30ml/day of olive oil for two weeks | Dietary Supplement: Olive oil<br>* Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.<br>Dietary Supplement: Butter<br>* Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.<br>|
| Placebo Comparator: Butter<br>Participants will receive 30g/day of butter also for two weeks. | Dietary Supplement: Olive oil<br>* Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.<br>Dietary Supplement: Butter<br>* Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in ambulatory blood pressure |  | Baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma total cholesterol | Plasma total cholesterol vascular cell adhesion molecule 1 | Baseline and 2 weeks | 
| Changes in Intercellular Adhesion Molecule 1 | Plasma levels of Intercellular Adhesion Molecule 1 measured | Baseline and 2 weeks | 
| Changes in vascular cell adhesion molecule 1 | Plasma levels of vascular cell adhesion molecule 1 measured | Baseline and 2 weeks | 
| Changes in C-reactive protein | Plasma levels of CRP measured | Baseline and 2 weeks |