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

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

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).

Study Overview

• Status: Completed
• Conditions: High Blood Pressure; Flow Mediated Dilation
• Intervention / Treatment: Dietary supplement: fruit and vegetable juice supplement; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FVS (fruit and vegetable juice supplement); The supplement contained ≈ 260-280 mg or 4 mmoles nitrate per two-ounce serving along with ≈ 51 mg total polyphenols. The FVS contains 7880 mg of a proprietary blend of beet root extract (Beta vulgaris), celery stem and leaf extract (Apium graveolens), red spinach leaf extract (Amaranthus dubius), stevia leaf extract (Stevia rebaudiana), and a fruit and vegetable extract blend (green tea leaf, red grape, white grape, bilberry, carrot, grapefruit, papaya, pineapple, strawberry, apple, apricot, cherry, orange, broccoli, green cabbage leaf, onion, garlic, black current, asparagus, tomato, olive and cucumber). Virtually all of the nitrates in FVS derive from the beet, celery, and red spinach extracts.	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_COMPARATOR: PRU (prune juice); The placebo supplement was prune juice (Sunsweet brand 100% prune juice) (PRU). Prune juice was selected based on its very similar caloric and sugar content, its high antioxidant and phenolic profile, but low nitrate content. The prune juice contained <0.6 mg nitrates and 133 mg total polyphenols per two-ounce serving.	Dietary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
FMD and mood	The association of FMD with mood	Two week change in FMD and mood
FMD and sleep quality	The association of FMD with sleep quality	Two week change in FMD and sleep quality

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Karen L. Sweazea; Brendan Miller

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2015
• Primary Completion (ACTUAL): March 30, 2016
• Study Completion (ACTUAL): March 30, 2016

Study Registration Dates

• First Submitted: June 8, 2017
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (ACTUAL): April 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: beetroot juice; nitrates and nitrites
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: AMPED1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No