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

NCT ID: NCT03486145

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-16
• Study Completion Date: 2016-03-30

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).

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.

Conditions

High Blood Pressure; Flow Mediated Dilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

fruit and vegetable juice supplement

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karen L. Sweazea

UNKNOWN

Sponsor Role: collaborator

Brendan Miller

UNKNOWN

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Carol Johnston

Professor and Associate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30305961 (View on PubMed)

Other Identifiers

AMPED1

Identifier Type: -

Identifier Source: org_study_id