Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT03005535
Status:
UNKNOWN
Last Update Posted:
2016-12-29
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function
Sponsor:
University of Bologna
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECLIPSE
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: