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

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

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

Study Overview

• Status: Unknown
• Conditions: Atherosclerosis
• Intervention / Treatment: Other: Vitaminized corn oil; Other: Olive oil

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • S. Orsola-Malpighi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: University of Bologna

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 25, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 25, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: ECLIPSE_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES