The nitric oxide supplementation product, Neo40 Daily®, provides a dietary source of No2-. The product also allows for robust No2-reduction to NO from the extremely potent nitrite-reducing capacity of the polyphenols found in Hawthorne berry.(Bartsch et al., 1993) Neo40 Daily® is a unique product since it provides the dietary source of No2-, as well as the rate limiting No2- reduction activity.
Neo40 Daily® facilitates both endothelial dependent and independent NO production. The acute effects of Neo40 Daily® have been demonstrated in hypertensive patients.(Zand et al., 2011) Within 30 minutes following a single dose of the Neo40 Daily®, a significant reduction in systolic/diastolic BP and vascular compliance was observed, as well as, 4 hours following treatment, a significant improvement in endothelial function was seen. Furthermore, it has been used in longer term clinical trials to show elevated plasma levels of No3• and No2·, indicating an increase in systemically available NO, and lower levels of triglycerides in an older population with cardiovascular risk factors.(Zand et al., 2011) This pilot study also demonstrated a trend towards reduced BP and improved quality of life among its prehypertensive participates (Biswas et al., 2015). This current clinical trial aims to expand on this pilot study and examine the effect of NO supplementation on a pre- and mildly hypertensive populations with endothelial dysfunction as measured by EndoPAr® and asymmetric dimethyl L-arginine (ADMA). In a double blinded placebo controlled parallel arm study, we will further investigate the effect of Neo40 Daily® on 40 pre- and mildly hypertensive subjects with regards to changes in blood pressure, endothelial dysfunction and other markers of NO availability and CVD risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
42
Per Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg.
Hypertension Institute
Nashville, Tennessee, United States
The primary efficacy outcome is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP.
The primary efficacy outcome to be analyzed is the between-group changes from baseline (Day 0) to end of study (Day 30) in daytime mean systolic and diastolic BP readings using AHA guidelines.
Time frame: 30 days
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