High Blood Pressure Clinical Trial
Official title:
Nitrate-rich Fruit and Vegetable Supplement and Blood Pressure in Normotensive Healthy Young Males: a Randomized, Double-blinded, Placebo-controlled Trial
Verified date | March 2018 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is hypothesized that the daily supplementation of a nitrate-rich, two-ounce fruit and vegetable energy supplement (Isagenix International LLC) by healthy young adults with a would increase circulating nitrates and improve cardiovascular parameters compared to a nitrate-deficient placebo (prune juice).
Status | Completed |
Enrollment | 57 |
Est. completion date | March 30, 2016 |
Est. primary completion date | March 30, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: • healthy men aged 18-40y Exclusion Criteria: - hypo- or hypertension (blood pressure < 100/65 or >140/90 - cigarette use within past year - food allergies - specific medication use (nitroglycerin, beta-blockers, calcium channel blockers), - unwillingness to drink juice concentrates and follow study restrictions. |
Country | Name | City | State |
---|---|---|---|
United States | Arizona State University | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | Brendan Miller, Karen L. Sweazea |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | FMD and mood | The association of FMD with mood | Two week change in FMD and mood | |
Other | FMD and sleep quality | The association of FMD with sleep quality | Two week change in FMD and sleep quality | |
Primary | Plasma nitrates and nitrites | The primary objective of this study was to examine the short-term effects of a novel, two-ounce nitrate-rich fruit and vegetable supplement (FVS) (AMPED NOx, Isagenix International LLC) on plasma nitrates and nitrites in healthy young men. | Two week change in concentration (week 2 - baseline) | |
Primary | Flow-mediated dilation | The primary objective of this study was to examine the short-term effects of a novel, two-ounce nitrate-rich fruit and vegetable supplement (FVS) (AMPED NOx, Isagenix International LLC) on endothelial function in healthy young men. | Two week change in dilation (week 2 - baseline) | |
Primary | Blood pressure | The primary objective of this study was to examine the short-term effects of a novel, two-ounce nitrate-rich fruit and vegetable supplement (FVS) (AMPED NOx, Isagenix International LLC) on blood pressure in healthy young men. | Two week change in blood pressure (week 2 - baseline) | |
Secondary | Effect of athletic status on endothelial function | To explore whether athletic status modified the flow mediated dilation response to the supplement athletes | Two week change in flow mediated dilation (week 2 - baseline) by athletic status | |
Secondary | Effect of athletic status on blood pressure | To explore whether athletic status modified the blood pressure response to supplementation | Two week change in blood pressure (week 2 - baseline) by athletic status |
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