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| Name | Class |
|---|---|
| California Strawberry Commission | OTHER |
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Cardiovascular disease (CVD) is the leading cause of death in the US. Statistics show that approximately 91% of individuals with CVD have vascular dysfunction. Hypertension is a major modifiable risk factor for CVD and approximately 60% of adults in the US are pre-hypertensive and hypertensive. In addition, the prevalence of hypertension is associated with aging in both genders; however, the increase in blood pressure (BP) in women after menopause exceeds that of men.
The development of effective and safe strategies to improve vascular function is of significance as it can have a great impact on quality of life, productivity and economic burden for the affected populations. One such alternative would be to introduce into the diet food sources that are rich in naturally occurring bioactive compounds. Thus, the long-term goal of the investigators is to provide feasible and effective dietary ways for postmenopausal women to improve their vascular function and quality of life.
Strawberries are a rich source of bioactive compounds and its total antioxidant content ranks third among all fruits and vegetables. Hence, the purpose of this study is to bring forth evidence that incorporation of strawberries into the diet will reduce blood pressure and improve cardiovascular function in pre- and stage 1-hypertensive postmenopausal women.
Sixty eligible postmenopausal women between the ages of 45 and 65 and a seated BP of ≥ 130/85 mm Hg but ≤ 160/100 mmHg at the screening visit will be randomly assigned to one of three groups:
The investigators hypothesize that regular consumption of strawberry will improve cardiovascular function, decrease BP and blood markers of oxidative stress as well as inflammation. Investigators also expect the findings of this study to provide a foundation for further studies to examine the effects of long-term incorporation of strawberry into the diet and the integrity of cardiovascular system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Freeze-dried placebo powder - two doses of 25 g/day for 8 weeks |
|
| 25 g of Freeze-dried Strawberry Powder | Active Comparator | Freeze-dried strawberry and placebo powder - one dose of 25 g/day of each for 8 weeks |
|
| 50 g of Freeze-dried Strawberry Powder | Experimental | Freeze-dried strawberry powder - two doses of 25 g/day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25 g of Freeze-dried Strawberry Powder | Dietary Supplement | Participants will be given one packet of 25 g of freeze-dried strawberry powder and one packet of 25 g of placebo powder and asked to consume one packet in the morning and one at night. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Stiffness | By assessing pulse wave velocity and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia). | 8 weeks |
| Endothelial function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bahram H Arjmandi, PhD, RD | Florida State University | Principal Investigator |
| Arturo Figueroa, PhD | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29099521 | Derived | Feresin RG, Johnson SA, Pourafshar S, Campbell JC, Jaime SJ, Navaei N, Elam ML, Akhavan NS, Alvarez-Alvarado S, Tenenbaum G, Brummel-Smith K, Salazar G, Figueroa A, Arjmandi BH. Impact of daily strawberry consumption on blood pressure and arterial stiffness in pre- and stage 1-hypertensive postmenopausal women: a randomized controlled trial. Food Funct. 2017 Nov 15;8(11):4139-4149. doi: 10.1039/c7fo01183k. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| 50 g of Freeze-dried Strawberry Powder | Dietary Supplement | Participants will be given two packets of 25 g of freeze-dried strawberry powder and asked to consume one packet in the morning and one at night. |
|
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| Placebo Powder | Dietary Supplement | Participants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night. |
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By assessing blood biomarkers of vascular function (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
| 8 weeks |
| Oxidative Stress | By assessing blood biomarkers of oxidative stress (superoxide dismutase, nitrate/nitrite, 8-isoprostane, malondialdehyde , and oxidized low density lipoprotein). | 8 weeks |
| Inflammation | By assessing blood biomarkers of inflammation (tumor necrosis factor-α and C-reactive protein). | 8 weeks |