Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function

Study Overview
=================
Brief Summary
-----------------
This will be a randomized clinical trial carried out on subjects with suboptimal control of cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9

Detailed Description
-----------------
In order to assess the mid term effects of vitaminized corn oil on endothelial function and on early markers of functional damage of the arterial wall, moderately hypercholesterolemic subjects will be supplemented for 8 weeks with 30 g/day of both a vitaminized corn oil (plus B6 and E vitamins) or olive oil. The two intervention periods will be spaced by a 4 week washout period.

Official Title
-----------------
Randomised Clinical Trial to Assess the Medium-term Effect of 30 g/Day of a Vitaminised Corn Oil or Olive Oil, on Lipid Parameters, Vascular Risk Markers Blood Pressure and Endothelial Function, in Moderately Hypercholesterolemic Subjects

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Other: Vitaminized corn oil
* Other: Olive oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total cholesterol between 200 and 280 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL Triglycerides lower than 200 mg/dL Cardiovascular risk at 10 years lower than 10% Informed consent Exclusion Criteria: Secundary prevention for cardiovascular diseases BMI higher than 30 Assumption of lipid lowering drug or supplement Alcohol abuse Alterations in thyroid, liver or kidney functions, muscle diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitaminized corn oil<br>Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal) | Other: Vitaminized corn oil<br>* Oil consumption at the two main meals, lunch and dinner (15gx2 per day)<br>|
| Placebo Comparator: Olive oil<br>Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal) | Other: Olive oil<br>* Oil consumption at the two main meals, lunch and dinner (15gx2 per day)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period |  | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) | 
| 12 hour fasting lipid profile change from the baseline to the end of the intervention period |  | At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks) | 
| PCSK9 levels change from the baseline to the end of the intervention period |  | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period |  | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) | 
| Blood pressure change from the baseline to the end of the intervention period |  | 6 months | 
| Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period |  | At the beginning and after 8 weeks of both intervention periods (up to 24 weeks) |