Flavonoid Supplementation and Endothelial Function - Full Text View

Sponsored by:	Carolinas Healthcare System
Information provided by:	Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT00331227

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Isotonix OPC-3 (flavonoid supplement)	Phase IV

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Supplemental Flavonoids on Endothelial Function, Lipids, and Markers of Inflammation

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:

Change in endothelial function from baseline

Secondary Outcome Measures:

CRP
Lipid profile
Lp-PLA2

Estimated Enrollment:	25
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331227

Sponsors and Collaborators

Carolinas Healthcare System

Investigators

Principal Investigator:

Thomas Barringer, MD

Carolinas Medical Center

More Information

Study ID Numbers:	202021
Study First Received:	May 26, 2006
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00331227
Health Authority:	United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:

flavonoids
food supplements
endothelial function
no conditions allowed, healthy volunteers only

Study placed in the following topic categories:

Healthy
Inflammation

ClinicalTrials.gov processed this record on January 15, 2009