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Flavonoid Supplementation and Endothelial Function
This study has been completed.
Study NCT00331227   Information provided by Carolinas Healthcare System
First Received: May 26, 2006   Last Updated: March 14, 2007   History of Changes

May 26, 2006
March 14, 2007
May 2006
 
Change in endothelial function from baseline
Same as current
Complete list of historical versions of study NCT00331227 on ClinicalTrials.gov Archive Site
  • CRP
  • Lipid profile
  • Lp-PLA2
Same as current
 
Flavonoid Supplementation and Endothelial Function
Effect of Supplemental Flavonoids on Endothelial Function, Lipids, and Markers of Inflammation

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.

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.

Phase IV
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Healthy
Drug: Isotonix OPC-3 (flavonoid supplement)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
25
December 2006
 

Inclusion Criteria:

  • 18 yrs of age or older
  • no pregnant potential

Exclusion Criteria:

  • History of coronary artery disease
  • History of cerebrovascular disease
  • History of heart failure
  • Diabetes
  • Renal impairment
  • Uncontrolled hypertension
  • Untreated or clinically evident thyroid disease
  • Currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat
  • Pregnancy or breastfeeding
  • Tobacco use – Participants will be excluded with a history of smoking anytime in the past 6 months.
  • Inappropriate for participation in a study, if in the opinion of the investigator it is questionable whether the participant will be able to comply with all aspects of the protocol (e.g. inadequate cognitive skills, possible drug abuse or dependence, suspected psychiatric problems, etc.)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00331227
 
202021
Carolinas Healthcare System
 
Principal Investigator: Thomas Barringer, MD Carolinas Medical Center
Carolinas Healthcare System
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP