Flavonoid Supplementation and Endothelial Function

Wake Forest University (WFU)

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Isotonix OPC-3 (flavonoid supplement)

Study type

Interventional

Funder types

Other

Identifiers

NCT00331227

202021

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.)