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| Name | Class |
|---|---|
| Naturex-Dbs | INDUSTRY |
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Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD or CVD risk factors and thus to our knowledge, it remains unknown as to whether the consumption of Concord Grape (poly)phenols can maintain vascular function in healthy individuals. The aim of this study is therefore to examine both acute and chronic effects of Concord Grape on cardiovascular health by investigating whether daily consumption of Concord Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial function, blood pressure and blood lipids, in young healthy men and women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsules regimen (1g) |
|
| Concord Grape Extract 1 | Active Comparator | 1 g Concord Grape Extract in 2 capsules |
|
| Concord Grape Extract 2 | Active Comparator | 500 mg Concord Grape Extract in 2 capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Identical formulation as the treatment consisting of colored maltodextrin using artificial colors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in flow mediated dilation (FMD) of the brachial artery | Determine changes in flow mediated dilation (FMD) of the brachial artery after 12 week consumption of 500 mg or 1 g of Concord grape extract vs. Placebo | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in flow mediated dilation (FMD) of the brachial artery | Determine changes in flow mediated dilation (FMD) of the brachial artery between 2 hours post consumption of 500 mg or 1 g of Concord grape extract vs. Placebo on day 0 and 2 h post consumption of 500 mg and 1 g Concard Grape extract vs. Placebo on day 84 | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in systolic and diastolic blood pressure (mmHg) | Determine changes in systolic and diastolic blood pressure (mmHg) at baseline and 2 hours post consumption of 500 mg and 1 g of Concord Grape extract on day 1 and day 84 | 12 weeks |
| Changes in heart rate (bpm) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | Waterloo | SE1 9NH | United Kingdom |
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| Concord Grape extract 1 | Dietary Supplement | 1 g Concord Grape extract in 2 capsules |
|
| Concord Grape extract 2 | Dietary Supplement | 500 mg Concord Grape extract in 2 capsules |
|
Determine changes in heart rate (bpm) at baseline and 2 hours post consumption of 500 mg and 1 g of Concord Grape extract on day 1 and day 84 |
| 12 weeks |
| Changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides) | Determine changes in blood lipids concentration (Total, HDL and LDL, cholesterol, triglycerides) after 84 days post consumption of 500 mg or 1 g Concord Grape extract vs. Placebo | 12 weeks |
| Percentage (%) of participants with any treatment-related adverse events | Determine safety and tolerability of 500 mg and 1 g of Concord Grape extract vs. Placebo (%) as per any treatment-related adverse events | 12 weeks |