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

Not Applicable

• Conditions: Atherosclerosis
• Interventions: Other: Vitaminized corn oil; Other: Olive oil

• Registration Number: NCT03005535
• Lead Sponsor: University of Bologna

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.

Study Timeline

• Study Start: 2016-10
• Status Verified: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-25
• Last Update Submitted: 2016-12-25
• Study First Posted: 2016-12-29
• Last Update Posted: 2016-12-29
• Primary Completion: 2017-02
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitaminized corn oil	Vitaminized corn oil	Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)
Olive oil	Olive oil	Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

S. Orsola-Malpighi University Hospital; 🇮🇹 Bologna, BO, Italy