CIC Inserm 1405, University Hospital Clermont-Ferrand,
Clermont-Ferrand, 63003, France
NCT Number: NCT04697589
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, that's 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.
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Notify Me20 year–45 year
Male
Interventional
Not applicable
Clermont-Ferrand, 63003, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Exclusion criteria
Volunteers whose fasting blood sample at V0 will reveal a pathological level of glycaemia (> 1,26 g/L) and/ or a dyslipidemia (example : triacylglycerol > 1,75 g/L) will be excluded.
300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
Colored maltodextrin
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
ED-FMD : maximal change in the diameter of the brachial artery induced by increased flow, expressed in percentage (%) of the basal diameter.
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
EIVD : Baseline diameter of the brachial artery will be assessed, and the increase in diameter of the brachial artery after application of glyceryl trinitrate will be measured .
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.
Time frame: Between Baseline (Before product intake) and 2 hours after product intake
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated.
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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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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