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

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ClinicalTrials.gov Identifier: NCT03486145
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Collaborators:
Karen L. Sweazea
Brendan Miller
Information provided by (Responsible Party):
Carol Johnston, Arizona State University

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).

Condition or disease Intervention/treatment Phase
High Blood Pressure Flow Mediated Dilation Dietary Supplement: fruit and vegetable juice supplement Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Both the study investigators and the participants were blinded regarding supplement assignments, and the identity of the "A" and "B" supplements were not revealed to study investigators until all data analyses were complete.
Primary Purpose: Prevention
Official Title: Nitrate-rich Fruit and Vegetable Supplement and Blood Pressure in Normotensive Healthy Young Males: a Randomized, Double-blinded, Placebo-controlled Trial
Actual Study Start Date : November 16, 2015
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 30, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486145


Locations
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United States, Arizona
Arizona State University
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
Arizona State University
Karen L. Sweazea
Brendan Miller

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carol Johnston, Professor and Associate Director, Arizona State University
ClinicalTrials.gov Identifier: NCT03486145     History of Changes
Other Study ID Numbers: AMPED1
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carol Johnston, Arizona State University:
beetroot juice
nitrates and nitrites
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases