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

University of Bologna

Status: Unknown

Conditions: Atherosclerosis

Treatments: Other: Vitaminized corn oil; Other: Olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03005535

ECLIPSE_2016

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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65 participants in 2 patient groups, including a placebo group

Vitaminized corn oil

Active Comparator group

Description:

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

Treatment:

Other: Vitaminized corn oil

Olive oil

Placebo Comparator group

Description:

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

Treatment:

Other: Olive oil