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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486145
• Other study ID #: AMPED1
• Status: Completed
• Phase: N/A
• First received: June 8, 2017
• Last updated: March 27, 2018
• Start date: November 16, 2015
• Est. completion date: March 30, 2016

Study information

• Verified date: March 2018
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Flow Mediated Dilation
• High Blood Pressure
• Hypertension

Intervention

Dietary Supplement:
• fruit 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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Brendan Miller, Karen L. Sweazea

Country where clinical trial is conducted

United States, 

Outcome

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