Effect of Nitrate-rich Fruit and Vegetable Supplement on Blood Pressure
- Conditions
- Flow Mediated DilationHigh Blood Pressure
- Interventions
- Dietary Supplement: fruit and vegetable juice supplementDietary Supplement: Placebo
- Registration Number
- NCT03486145
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
• healthy men aged 18-40y
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FVS (fruit and vegetable juice supplement) 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. PRU (prune juice) Placebo 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.
- Primary Outcome Measures
Name Time Method Blood pressure 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.
Plasma nitrates and nitrites 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.
Flow-mediated dilation 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.
- Secondary Outcome Measures
Name Time Method Effect of athletic status on blood pressure Two week change in blood pressure (week 2 - baseline) by athletic status To explore whether athletic status modified the blood pressure response to supplementation
Effect of athletic status on endothelial function 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
Trial Locations
- Locations (1)
Arizona State University
🇺🇸Phoenix, Arizona, United States