Flow Mediated Dilation, High Blood Pressure
Conditions
Keywords
beetroot juice, nitrates and nitrites
Brief summary
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).
Detailed description
Endothelial cells of the peripheral vasculature are key sources of vasoactive factors regulating healthy blood pressure. One of the primary vasodilatory factors released from these cells is nitric oxide (NO). Production of NO is stimulated both through enzymatic-dependent mechanisms via NO synthase, as well as from dietary intake of nitrate-containing foods or supplements that increase NO bioavailability. This study examined whether the daily consumption of a nitrate-rich, two-ounce fruit and vegetable energy supplement (Isagenix International LLC) would increase circulating nitrates and improve cardiovascular parameters compared to a nitrate-deficient placebo (prune juice). Healthy male adults aged 18-40y (n=45) were recruited to participate in this longitudinal double-blind, placebo-controlled, randomized clinical trial. Subjects maintained their typical diet and physical activity patterns during the study. Anthropometric and cardiovascular (blood pressure and flow-mediated dilation (FMD)) parameters, along with plasma nitrates and nitrites were measured at baseline and after one and two weeks of supplementation. Subjects also completed questionnaires on sleep quality and mood. It is hypothesized that the nitrate-rich FVS supplement will provide a good source of dietary nitrates and effectively reduced blood pressure in normotensive, healthy young males.
Interventions
DIETARY_SUPPLEMENTfruit and vegetable juice supplement
FVS was provided by Isagenix International LLC in identically sealed bottles labeled labeled B. Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement.
DIETARY_SUPPLEMENTPlacebo
PRU was provided by Isagenix International LLC in identically sealed bottles labeled labeled A. Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement.
Sponsors
Karen L. Sweazea
Brendan Miller
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Both the study investigators and the participants were blinded regarding supplement assignments, and the identity of the A and B supplements were not revealed to study investigators until all data analyses were complete.
Intervention model description
Participants were stratified by age, height, weight, BMI, blood pressure and athletic status and randomly assigned to consume daily either the fruit and vegetable rich juice supplement (B) or prune juice (A; control treatment).
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated dilation | Two week change in dilation (week 2 - baseline) | 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. |
| Plasma nitrates and nitrites | Two week change in concentration (week 2 - baseline) | 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. |
| Blood pressure | Two week change in blood pressure (week 2 - baseline) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of athletic status on blood pressure | Two week change in blood pressure (week 2 - baseline) by athletic status | To explore whether athletic status modified the blood pressure response to supplementation |
| Effect of athletic status on endothelial function | Two week change in flow mediated dilation (week 2 - baseline) by athletic status | To explore whether athletic status modified the flow mediated dilation response to the supplement athletes |
Other
| Measure | Time frame | Description |
|---|---|---|
| FMD and mood | Two week change in FMD and mood | The association of FMD with mood |
| FMD and sleep quality | Two week change in FMD and sleep quality | The association of FMD with sleep quality |
Countries
United States
Outcome results
None listed