Clinical trial NCT03486145: Effect of Nitrate-rich Fruit and Vegetable Supplement on Blood Pressure
Official title: Nitrate-rich Fruit and Vegetable Supplement and Blood Pressure in Normotensive Healthy Young Males: a Randomized, Double-blinded, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Flow Mediated Dilation
Keywords: beetroot juice
nitrates and nitrites
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Karen L. Sweazea
name: Brendan Miller
First posted: 2018-04-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma nitrates and nitrites
timeFrame: Two week change in concentration (week 2 - baseline)
measure: Flow-mediated dilation
timeFrame: Two week change in dilation (week 2 - baseline)
measure: Blood pressure
timeFrame: Two week change in blood pressure (week 2 - baseline)
Secondary outcomes:
measure: Effect of athletic status on endothelial function
timeFrame: Two week change in flow mediated dilation (week 2 - baseline) by athletic status
measure: Effect of athletic status on blood pressure
timeFrame: Two week change in blood pressure (week 2 - baseline) by athletic status
Other outcomes:
measure: FMD and mood
timeFrame: Two week change in FMD and mood
measure: FMD and sleep quality
timeFrame: Two week change in FMD and sleep quality
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
citation: Sweazea KL, Johnston CS, Miller B, Gumpricht E. Nitrate-Rich Fruit and Vegetable Supplement Reduces Blood Pressure in Normotensive Healthy Young Males without Significantly Altering Flow-Mediated Vasodilation: A Randomized, Double-Blinded, Controlled Trial. J Nutr Metab. 2018 Sep 16;2018:1729653. doi: 10.1155/2018/1729653. eCollection 2018.