Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331227
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2006-05-26
Brief Title:
Flavonoid Supplementation and Endothelial Function
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Effect of Supplemental Flavonoids on Endothelial Function Lipids and Markers of Inflammation
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
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:
None
Brief Summary:
Flavonoids are one of the many classes of natural chemicals found in a variety of foods People with the highest flavonoid blood levels have the lowest rates of coronary heart disease This is considered one of the reasons why high fruit and vegetable consumption is associated with lower rates of heart disease although it is not known if taking a flavonoid supplement provides the same protection as eating fruits and vegetables
The purpose of this study is to determine if a particular flavonoid supplement called Isotonix OPC-3 taken on a daily basis will improve the function of arterial vessels Arteries normally constrict after eating a high-fat meal This study will examine the potential of the OPC-3 to lessen this constriction response Approximately 25 people will be involved in this research project and participation will last for 10 weeks
The purpose of this study is to determine if a particular flavonoid supplement called Isotonix OPC-3 taken on a daily basis will improve the function of arterial vessels Arteries normally constrict after eating a high-fat meal This study will examine the potential of the OPC-3 to lessen this constriction response Approximately 25 people will be involved in this research project and participation will last for 10 weeks
Detailed Description:
We propose to use a supplement made by NutraMetrix called OPC-3 consisting of oligomeric proanthocyanidins derived from grape seed pine bark bilberry citrus and red wine extracts to determine effects on endothelial function lipoproteins and inflammation The primary outcome measure will be endothelial function as assessed by digital response to hyperemia using peripheral arterial tonometry measured both in the fasting state and after a single standardized high-fat meal when transient dysfunction is expected to occur Secondary outcome measures will be the lipid profile hs-CRP and Lp-PLA2 The recruitment population will be healthy volunteers The design will be a randomized placebo-controlled double-blind cross-over trial lasting 10 weeks
Study Oversight
Has Oversight DMC:
None
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?:
None