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

NCT ID: NCT03005535

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitaminized corn oil

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

Group Type ACTIVE_COMPARATOR

Vitaminized corn oil

Intervention Type OTHER

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

Olive oil

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

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type OTHER

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

Interventions

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Vitaminized corn oil

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

Intervention Type OTHER

Olive oil

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Responsible Party

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Claudio Borghi

Chief Internal Medicine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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S. Orsola-Malpighi University Hospital

Bologna, BO, Italy

Site Status

Countries

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Italy

Other Identifiers

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ECLIPSE_2016

Identifier Type: -

Identifier Source: org_study_id