- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895749
Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults
October 29, 2019 updated by: Hypertension Institute, Nashville
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.
Study Overview
Detailed Description
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
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37205
- Hypertension Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Neo40 Daily
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.
|
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.
|
Placebo Comparator: Placebo
Per Capsule: Beet Juice concentrate, Carmine, Croscarmellose Sodium, D-Mannitol, Magnesium Stearate, Orange flavour, Silicon dioxide, Stevia rebaudiana leaf, Xylitol.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 30 days
|
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.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2017
Primary Completion (Actual)
February 1, 2018
Study Completion (Actual)
April 18, 2018
Study Registration Dates
First Submitted
March 15, 2019
First Submitted That Met QC Criteria
March 27, 2019
First Posted (Actual)
March 29, 2019
Study Record Updates
Last Update Posted (Actual)
October 30, 2019
Last Update Submitted That Met QC Criteria
October 29, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neo40 ADMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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