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

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vitaminized corn oil
Olive oil
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • S. Orsola-Malpighi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitaminized corn oil

Olive oil

Arm Description

Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)

Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)

Outcomes

Primary Outcome Measures

Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
12 hour fasting lipid profile change from the baseline to the end of the intervention period
PCSK9 levels change from the baseline to the end of the intervention period

Secondary Outcome Measures

Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period
Blood pressure change from the baseline to the end of the intervention period
Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period

Full Information

First Posted
December 5, 2016
Last Updated
December 25, 2016
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT03005535
Brief Title
Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function
Acronym
ECLIPSE
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitaminized corn oil
Arm Type
Active Comparator
Arm Description
Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)
Arm Title
Olive oil
Arm Type
Placebo Comparator
Arm Description
Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)
Intervention Type
Other
Intervention Name(s)
Vitaminized corn oil
Intervention Description
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
Intervention Type
Other
Intervention Name(s)
Olive oil
Intervention Description
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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 Outcome Measure Information:
Title
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)
Title
Blood pressure change from the baseline to the end of the intervention period
Time Frame
6 months
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
S. Orsola-Malpighi University Hospital
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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