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

Atherosclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03005535
• Other study ID #: ECLIPSE_2016
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 5, 2016
• Last updated: December 25, 2016
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: December 2016
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 65
• Est. completion date: November 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Other:
• Vitaminized corn oil
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
• Olive oil
Oil consumption at the two main meals, lunch and dinner (15gx2 per day)

Locations

Country	Name	City	State
Italy	S. Orsola-Malpighi University Hospital	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	Blood pressure change from the baseline to the end of the intervention period		6 months	No
Secondary	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)	No