Skip to main content
OpenTrials
Completed

NCT Number: NCT03486145

Effect of Nitrate-rich Fruit and Vegetable Supplement on Blood Pressure

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

High Blood Pressure Cardiovascular Diseases Flow Mediated Dilation Hypertension Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fruit and vegetable juice supplement

Dietary 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.

Placebo

Dietary 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.

Primary outcomes

  1. Plasma nitrates and nitrites

    Time frame: 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.

  2. Flow-mediated dilation

    Time frame: 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.

  3. Blood pressure

    Time frame: 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 outcomes

  1. Effect of athletic status on endothelial function

    Time frame: 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

  2. Effect of athletic status on blood pressure

    Time frame: Two week change in blood pressure (week 2 - baseline) by athletic status

    To explore whether athletic status modified the blood pressure response to supplementation

Other outcomes

  1. FMD and mood

    Time frame: Two week change in FMD and mood

    The association of FMD with mood

  2. FMD and sleep quality

    Time frame: Two week change in FMD and sleep quality

    The association of FMD with sleep quality

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Brendan Miller
  • Karen L. Sweazea

Registry information

Official study title

Nitrate-rich Fruit and Vegetable Supplement and Blood Pressure in Normotensive Healthy Young Males: a Randomized, Double-blinded, Placebo-controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2018
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.