Flavonoid Supplementation and Endothelial Function
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 02/28/2007 |
| Primero enviado: | 05/25/2006 |
| Inscripción estimada enviada: | 05/25/2006 |
| Publicado por primera vez: | 05/28/2006 |
| Última actualización enviada: | 03/13/2007 |
| Última actualización publicada: | 03/14/2007 |
| Fecha de inicio real del estudio: | 04/30/2006 |
| Fecha estimada de finalización del estudio: | 11/30/2006 |
Condición o enfermedad
Intervención / tratamiento
Drug: Isotonix OPC-3 (flavonoid supplement)
Fase
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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.) |
Salir
Medidas de resultado primarias
1. Change in endothelial function from baseline [undefined]
Medidas de resultado secundarias
1. CRP [undefined]
2. Lipid profile [undefined]
3. Lp-PLA2 [undefined]
