Flavonoid Supplementation and Endothelial Function

NCT00331227 | Completed Phase 4

• 1 other identifier: 202021
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in endothelial function from baseline

Secondary Outcomes (3)

• CRP

• Lipid profile

• Lp-PLA2

Interventions

Isotonix OPC-3 (flavonoid supplement) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs of age or older
• no pregnant potential

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Officials

• Thomas Barringer, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2006
• First Posted: May 29, 2006
• Study Start: May 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 25, 2022

Record last verified: 2007-03