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| Name | Class |
|---|---|
| Wild Blueberry Association of North America | OTHER |
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Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Aging is the primary risk factor for CVD, in large part due to adverse modifications to the arteries. These modifications include vascular endothelial dysfunction and arterial stiffness. Vascular endothelial dysfunction is an initiating step in atherosclerosis, and is primarily caused by reduced nitric oxide (NO) bioavailability secondary to excessive superoxide-driven oxidative stress and inflammation. Endothelial dysfunction leads to arterial stiffness and the development of hypertension (HTN) which further increases CVD. Greater than 2/3 of the US population has elevated blood pressure or stage 1-HTN. As such, interventions that improve vascular endothelial dysfunction by increasing NO bioavailability and mitigating excessive oxidative stress and inflammation are needed. Blueberries are rich in bioactive compounds including flavonoids, phenolic acids, and pterostilbene. These compounds and their metabolites have been shown to attenuate oxidative stress and inflammation. The primary goal of this study is to assess the efficacy of blueberries to improve reduce blood pressure and improve vascular endothelial dysfunction and arterial stiffness in middle-aged/older men with elevated blood pressure or stage 1-HTN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry | Experimental | 22 g blueberry powder per day |
|
| Control | Placebo Comparator | 22 g placebo control powder per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry Powder | Dietary Supplement | 22 g/day wild blueberry powder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive hyperemia index | Endothelial function assessed as reactive hyperemia index using peripheral arterial tonometry (EndoPat) | Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Augmentation index | Arterial stiffness assessed as augmentation index using an automated blood pressure monitor (SphygmoCor) | Baseline to 12 Weeks |
| Pulse wave velocity | Arterial stiffness assessed as carotid-femoral pulse wave velocity using an automated blood pressure monitor (SphygmoCor) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food and Nutrition Clinical Research Laboratory | Fort Collins | Colorado | 80523-1571 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25578927 | Background | Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
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| Placebo Powder |
| Dietary Supplement |
22 g/day placebo powder |
|
| Baseline to 12 Weeks |
| Endothelial cell protein expression | Protein expression will be assessed as an exploratory analysis for markers of nitric oxide bioavailability, inflammation, and/or oxidative stress will be measured by quantitative immunofluorescence in biopsied venous endothelial cells | Baseline to 12 Weeks |
| Hemoglobin A1c | Blood hemoglobin A1C will be measured | Baseline to 12 Weeks |
| Lipid profile | Blood lipid profiles will be measured | Baseline to 12 Weeks |
| Nitric oxide metabolites | Blood nitrate/nitrite will be measured | Baseline to 12 Weeks |
| ICAM-1 | Blood ICAM-1 will be measured | Baseline to 12 Weeks |
| VCAM-1 | Blood VCAM-1 will be measured | Baseline to 12 Weeks |
| Blood pressure | Brachial and Aortic blood pressure (systolic blood pressure, diastolic blood pressure, pulse pressure, aortic pressure) assessed using an automated blood pressure monitor (SphygmoCor) | Baseline to 12 Weeks |
| Gut microbiota | Determine the effects on stool sample microbial populations | Baseline to 12 Weeks |
| Plasma blueberry polyphenol metabolites | Targeted analysis of plasma metabolites by GC-MS and LC-MS | Baseline to 12 Weeks |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |