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

NCT03486145 | Completed

• 1 other identifier: AMPED1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

High Blood Pressure; Flow Mediated Dilation

Keywords

beetroot juice; nitrates and nitrites

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Effect of athletic status on endothelial function

  Two week change in flow mediated dilation (week 2 - baseline) by athletic status

• Effect of athletic status on blood pressure

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

Other Outcomes (2)

• FMD and mood

  Two week change in FMD and mood

• FMD and sleep quality

  Two week change in FMD and sleep quality

Study Arms (2)

FVS (fruit and vegetable juice supplement)

EXPERIMENTAL

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

PRU (prune juice)

PLACEBO COMPARATOR

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

Interventions

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.

FVS (fruit and vegetable juice 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.

PRU (prune juice)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy men aged 18-40y

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• Karen L. Sweazea: collaborator
• Brendan Miller: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• 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.

  PMID: 30305961 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Fruit

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Director

Model Details: 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).

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: April 3, 2018
• Study Start: November 16, 2015
• Primary Completion: March 30, 2016
• Study Completion: March 30, 2016
• Last Updated: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)