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

University of Bologna65 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atherosclerosis

Interventions

Vitaminized corn oilOTHER

Oil consumption at the two main meals, lunch and dinner (15gx2 per day)

Olive oilOTHER

Oil consumption at the two main meals, lunch and dinner (15gx2 per day)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, Italy

Outcomes

Primary Outcomes

Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period

Time frame: 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

Time frame: 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

Time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)

Secondary Outcomes

Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period

Time frame: 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

Time frame: 6 months

Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period

Time frame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)

Data from ClinicalTrials.gov

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