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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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High Blood Pressure, Flow Mediated Dilation

Intervention / Treatment
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* Dietary Supplement: fruit and vegetable juice supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FVS (fruit and vegetable juice supplement)<br>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<br>* 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.<br>|
| Placebo Comparator: PRU (prune juice)<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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beetroot juice, nitrates and nitrites