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This study evaluates effects of different doses of phenolic acids on healthy volunteers.
It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| 43.3 mg hydrolyzed green coffee extract | Experimental | hydrolyzed green coffee extract as interventions |
|
| 86.6 mg hydrolyzed green coffee extract | Experimental | hydrolyzed green coffee extract as interventions |
|
| 173 mg hydrolyzed green coffee extract | Experimental | hydrolyzed green coffee extract as interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 43.3 mg hydrolyzed green coffee extract | Other | Reconstituted in water and given to subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by oral administration of phenolic acid in improving endothelial function | Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline. | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(Area Under Curve) of the concentration/time curve | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids | 6 hours |
| Tmax | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids |
| Measure | Description | Time Frame |
|---|---|---|
| Blood concentrations in plasma. | Blood concentrations in plasma. | 6 hours |
| To investigate safety of investigational products: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Tan | Société des Produits Nestlé (SPN) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Western Australia | Crawley | Perth | 6009 | Australia |
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| ID | Term |
|---|---|
| C017616 | phenolic acid |
| C008315 | maltodextrin |
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| 86.6 mg hydrolyzed green coffee extract | Other | Reconstituted in water and given to subjects |
|
|
| 173 mg hydrolyzed green coffee extract | Other | Reconstituted in water and given to subjects |
|
|
| Placebo | Other | Reconstituted in water and given to subjects |
|
|
| 6 hours |
| Elimination half-life | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids | 6 hours |
| through study completion, an average of 1 year. |