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| Name | Class |
|---|---|
| University of Parma | OTHER |
| Activ'inside | INDUSTRY |
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Endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. It is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Finding dietary/dietary supplement-oriented approaches to improving endothelial function is of public health interest.
A randomized double-blind placebo controlled 4-way crossover study will be conducted to determine if acute consumption of a proprietary polyphenol extract (156 mg / 222 mg / 333 mg) will have a dose dependent response on endothelium-dependent flow-mediated dilation (ED-FMD) in fasting conditions, in comparison to a placebo (maltodextrin) in male smokers (20 - 45 years; n=20).FMD and blood pressure will be assessed at 0 & 2 hour timepoints following consumption of a single dose of polyphenol extract, accompanying blood samples will be collected to assess a range of endpoints including nitric oxide metabolites, angiotensin and polyphenols metabolites. Endothelium-independent vasodilation will also be measured 2 hours post consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyphenol extract low dose | Experimental | 156mg single dose |
|
| Polyphenol extract medium dose | Experimental | 222mg single dose |
|
| Polyphenol extract high dose | Experimental | 333mg single dose |
|
| Placebo | Placebo Comparator | Maltodextrin single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyphenol extract | Dietary Supplement | Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation | Acute change in endothelium-dependent flow-mediated dilation | Change over 2 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelium-independent vasodilation | Acute change in endothelium-independent vasodilation in response to Glyceryl trinitrate (GTN) drug | Change after 2 hours post dose |
| Systolic blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Measured in serum | Visit 1, 0 hour only |
| Glucose | Measured in plasma | Visit 1, 0 hour only |
Inclusion Criteria:
Exclusion Criteria:
Polyphenols have a gender effect, a single sex population was chosen to increase homogeneity of test population and therefore likelihood of observing an FMD response. Males were selected.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christopher Gill | Contact | +442870123181 | c.gill@ulster.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Intervention Studies Unit, Ulster University | Recruiting | Coleraine | Co.Londonderry | BT52 1SA | United Kingdom |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059808 | Polyphenols |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Double-blind placebo controlled dose-response crossover study
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Double-blinded
| Placebo | Dietary Supplement | Maltodextrin |
|
Measured by brachial cuff
| Change over 2 hours post dose |
| Diastolic blood pressure | Measured by brachial cuff | Change over 2 hours post dose |
| Tolerance and acceptability of extract | Safety parameter. Measured on a 3-point likert scale (a lower value being a better outcome: 1, totally acceptable - 3, not at all acceptable) | Immediately after each intervention |
| Height | Measured in metres | Visit 1, 0 hour only |
| Weight | Measured in kg | 0 hour, at each time-point |
| Angiotensin-converting enzyme (ACE) | Exploratory outcome | Change over 2 hours |
| Circulating polyphenol metabolites | Exploratory outcome. Measured in plasma | Change over 2 hours |
| Endothelin1 | Exploratory outcome. Measured in serum | Change over 2 hours |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |