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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
57
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.
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.
Arizona State University
Phoenix, Arizona, United States
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.
Time frame: Two week change in concentration (week 2 - baseline)
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.
Time frame: Two week change in dilation (week 2 - baseline)
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.
Time frame: Two week change in blood pressure (week 2 - baseline)
Effect of athletic status on endothelial function
To explore whether athletic status modified the flow mediated dilation response to the supplement athletes
Time frame: Two week change in flow mediated dilation (week 2 - baseline) by athletic status
Effect of athletic status on blood pressure
To explore whether athletic status modified the blood pressure response to supplementation
Time frame: Two week change in blood pressure (week 2 - baseline) by athletic status
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