Flavonoid Supplementation and Endothelial Function

Alleen geregistreerde gebruikers kunnen artikelen vertalen

De link wordt op het klembord opgeslagen

ToestandVoltooid

Sleutelwoorden

Abstract

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.

Omschrijving

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.

Datums

Laatst geverifieerd:	02/28/2007
Eerste ingediend:	05/25/2006
Geschatte inschrijving ingediend:	05/25/2006
Eerst geplaatst:	05/28/2006
Laatste update ingediend:	03/13/2007
Laatste update geplaatst:	03/14/2007
Werkelijke startdatum van het onderzoek:	04/30/2006
Geschatte voltooiingsdatum van het onderzoek:	11/30/2006

Conditie of ziekte

Healthy

Interventie / behandeling

Drug: Isotonix OPC-3 (flavonoid supplement)

Fase

Fase 4

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie	18 Years Naar 18 Years
Geslachten die in aanmerking komen voor studie	All
Accepteert gezonde vrijwilligers	Ja
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.)

Resultaat

Primaire uitkomstmaten

1. Change in endothelial function from baseline [undefined]

Secundaire uitkomstmaten

1. CRP [undefined]

2. Lipid profile [undefined]

3. Lp-PLA2 [undefined]

Flavonoid Supplementation and Endothelial Function

Sleutelwoorden

proanthocyanidin b2

proanthocyanidin a1

proanthocyanidin b4

proanthocyanidin b1

proanthocyanidin a 2

proanthocyanidine

proanthocyanidin a 4

proanthocyanidin a 7

proanthocyanidin a 6

proanthocyanidin b3

proanthocyanidin b5

proanthocyanidin c1

inflammatie

ischemische hartklachten

flavonoid