There is an emerging paradigm that certain foods promote nitric oxide (NO) production from the stepwise reduction of nitrate to nitrite to NO, providing an endothelium independent source of bioactive NO. We hypothesize that a unique formulation containing nitrate-rich beetroot along with Hawthorn berry shown to have a robust nitrite reductase activity would improve NO status in humans and modify cardiovascular risk factors. The trial was conducted at the Houston Institute for Clinical Research in Houston, Texas. Inclusion criteria for this double-blinded, placebo-controlled study were patients older than 40 years with 3 or more of the following cardiovascular risk factors: hypertension, obesity, hyperlipidemia, smoking, sedentary, family history of cardiovascular disease, and diabetes. Subjects were instructed to take either the NO dietary supplement called Neo40 Daily® or placebo twice daily on an empty stomach for 30 days. Patients taking the NO dietary supplement twice a day for 30 days led to a significant increase in both plasma nitrite (P < .01) and nitrate (P < .0001), indicating an increase in systemic NO availability. There was a statistically significant reduction in 72% of patients with elevated triglycerides (>150 mg/dL) after 30 days compared with their starting levels before taking the NO dietary supplement (168 ± 17 mg/dL vs 232 ± 19 mg/dL, P = .02). The strategy of formulating a combination of natural products and botanicals chosen specifically for their NO activity shows promise in restoring NO homeostasis in human subjects at risk for cardiovascular disease for use as a dietary supplement.
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