Ignite Creation Date:
2024-05-05 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00553774
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2007-11-02
Brief Title:
Effect of Cocoa Flavanols on Vascular Function
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients Interaction Between Endothelial Progenitor Cells Reactivity of Micro- and Macrocirculation
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Cocoa
Brief Summary:
Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease CAD CAD patients also show impaired function and number of endothelial progenitor cells EPCs adult stem cells which circulate in adult blood and contribute to endothelial repair Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa Yet the mechanism is not known It is also not known whether flavanol-rich cocoa provides an additive positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification Therefore the researchers propose to perform an investigator-initiated randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy An improvement of endothelial function as measured by flow-mediated dilation FMD will be the primary endpoint of this study The researchers propose to also measure determinants of FMD such as microvascular response inflammatory markers metabolites of nitric oxide as well as the number and function of EPCs in the blood Importantly detailed food questionnaires and plasma flavanolsmetabolites will help to further support a causal link between flavanol-intake and improved vascular function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None