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Flavonoid Supplementation and Endothelial Function

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ClinicalTrials.gov Identifier: NCT00331227
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : March 15, 2007
Sponsor:
Information provided by:
Atrium Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Drug: Isotonix OPC-3 (flavonoid supplement) Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Supplemental Flavonoids on Endothelial Function, Lipids, and Markers of Inflammation
Study Start Date : May 2006
Study Completion Date : December 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in endothelial function from baseline

Secondary Outcome Measures :
  1. CRP
  2. Lipid profile
  3. Lp-PLA2

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331227


Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Thomas Barringer, MD Carolinas Medical Center
More Information
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ClinicalTrials.gov Identifier: NCT00331227    
Other Study ID Numbers: 202021
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: March 15, 2007
Last Verified: March 2007
Keywords provided by Atrium Health:
flavonoids
food supplements
endothelial function
no conditions allowed, healthy volunteers only