Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697589
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2021-01-05
Brief Title:
Acute Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects
Sponsor:
Activinside
Organization:
Activinside
Study Overview
Official Title:
Acute Dose-response Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects Randomized Cross-over Double-blind Clinical Study
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients Finding safe and effective product able to improve endothelial function is of public health interest
Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function in particular endothelium-dependent flow-mediated dilation ED-FMD after a single dose Grape is also a main source of flavanol monomers thats why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake
The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols SBRP on ED-FMD in fasting conditions in comparison to a placebo in healthy adults This blend is made of two botanical extracts a grape extract and a blueberry extract In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product appropriate biological parameters and circulating metabolites will be assayed
Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function in particular endothelium-dependent flow-mediated dilation ED-FMD after a single dose Grape is also a main source of flavanol monomers thats why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake
The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols SBRP on ED-FMD in fasting conditions in comparison to a placebo in healthy adults This blend is made of two botanical extracts a grape extract and a blueberry extract In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product appropriate biological parameters and circulating metabolites will be assayed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None