Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/31/2019 |
| Start Date: | April 5, 2017 |
| End Date: | April 18, 2018 |
A Double-Blind, Placebo-Controlled Parallel Study to Investigate the Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults
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.
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.
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.
Inclusion Criteria:
- Subjects with seated resting systolic blood pressures between 130-160 mmHg and
diastolic between 85 and 100 mm Hg (inclusive) at screening visit
- Subjects with an elevated ADMA
- Agreement to maintain current level of physical activity and diet throughout the study
- Agrees to comply with study procedures including willingness to fast at least 12 hours
before blood samples, abstain from alcohol two days prior to blood sampling and blood
pressure measurement, abstain from coffee at least 14 hours before blood pressure
Exclusion Criteria:
- Females who are pregnant, breastfeeding or planning to become pregnant during the
course of the study.
- Seated office systolic blood pressure ou side of the target range (systolic BP<130 mm
Hg or >160 mmHg) or diastolic BP< 85 or 100 mm Hg at screening visit
- The use of natural health products for th treatment of hypertension within 2 weeks of
screening
- Significant cardiac history defined as a h story of myocardial infarction (Ml);
coronary angioplasty or bypass graft(s); Valvular isease or repair; unstable angina
pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive
heart failure; or coronary artery disease (CAD)
- Type I diabetes
- Unstable medical conditions that in the opinion of the Principle Investigator preclude
the subject from participating in the study
- Alcohol or drug abuse within the last 6 months
- Clinically significant abnormal laboratory results at screening
- Participation in a clinical research trial wi hin 30 days prior to randomization
- Allergy or sensitivity to study supplemen ingredients
- Individuals who are cognitively impaired nd/or who are unable to give informed consent
- Any other condition which in the lnvestig tor's opinion may adversely affect the
subject's ability to complete the study or its meas res or which may pose significant
risk to the subject.
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