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| Name | Class |
|---|---|
| CIC Inserm 1405, University Hospital Clermont-Ferrand, France | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRP 300 mg | Experimental | 300 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols. |
|
| SBRP 600 mg | Experimental | 600 mg standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols. |
|
| Placebo | Placebo Comparator | Colored maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memophenol 300 mg | Dietary Supplement | 300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in endothelium-dependent flow-mediated dilation (ED-FMD) | ED-FMD : maximal change in the diameter of the brachial artery induced by increased flow, expressed in percentage (%) of the basal diameter. | Between Baseline (Before product intake) and 2 hours after product intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change in endothelium-independent vasodilation (EIVD) | 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 . | Between Baseline (Before product intake) and 2 hours after product intake |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle Pickering | CIC Inserm 1405, University Hospital Clermont-Ferrand, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Inserm 1405, University Hospital Clermont-Ferrand, | Clermont-Ferrand | 63003 | France |
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| Memophenol 600 mg | Dietary Supplement | 600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols. |
|
| Placebo | Dietary Supplement | Colored maltodextrin |
|
| Change in diastolic blood pressure |
Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated. |
| Between Baseline (Before product intake) and 2 hours after product intake |
| Change in systolic blood pressure | Blood pressure will be measured 3 times separated by 3-minute intervals. The average of the 3 measurements will be calculated. | Between Baseline (Before product intake) and 2 hours after product intake |