Clinical trial NCT03005535: Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function
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
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period
timeFrame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
measure: 12 hour fasting lipid profile change from the baseline to the end of the intervention period
timeFrame: At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks)
measure: PCSK9 levels change from the baseline to the end of the intervention period
timeFrame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
Secondary outcomes:
measure: Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period
timeFrame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
measure: Blood pressure change from the baseline to the end of the intervention period
timeFrame: 6 months
measure: Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period
timeFrame: At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
state: BO
Study officials:
References: