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| Name | Class |
|---|---|
| Welch's, Inc. | INDUSTRY |
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The study will compare Concord grape juice to a beverage that contains no grape flavonoids, but has a similar appearance and taste (placebo juice). A total of 60 overweight and obese participants over age 50 will be enrolled. Each participant will drink each beverage for 4 weeks with a 2-week rest period between two beverage consumption periods. The order of beverages (grape juice first or placebo juice first) will be randomized. The investigators will use ultrasound to measure brachial artery flow-mediated dilation, a measure of endothelial vasodilator function. The investigators will also collect blood samples to further assess the cardiovascular effects of grape juice.
The aim of the study is to determine whether Concord grape juice improves endothelial function in patients at risk who do not have cardiovascular disease and may provide information that would guide dietary recommendations. The results may also be used by the sponsor to substantiate claims and labeling of their product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active First | Other | Active Concord Grape Juice 12 oz per day Placebo Grape Juice 12 oz per day |
|
| Placebo First | Other | Placebo Grape Juice 12 oz per day Active Concord Grape Juice 12 oz per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Concord Grape Juice 12 oz per day | Other | Grape Juice 12 oz per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brachial artery flow mediated dilation | Endothelial function will be assessed as brachial artery flow-mediated dilation using vascular ultrasound | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nitroglycerin-mediated dilation | Non-endothelium-dependent dilation will be assessed by measuring the dilator response to sublingual nitroglycerin using vascular ultrasound | 4 weeks |
| Carotid-Femoral Pulse Wave Velocity |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting glucose and insulin | Fasting glucose and insulin | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Eberhardt, MD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo Grape Juice 12 oz per day | Other | Placebo Grape Juice 12 oz per day |
|
Central aortic stiffness will be assessed as carotid-femoral pulse wave velocity using applanation tonometry
| 4 weeks |
| Reactive hyperemia | We will use vascular ultrasound to determine maximal hyperemic flow velocity in the brachial artery induced by 4-minute cuff occlusion. | 4 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |