Effect of a Nitric Oxide Supplementation Product on Endothelial Dysfunction and Prehypertensive Adults

NCT03895749 | Completed

• 1 other identifier: Neo40 ADMA
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Study Arms (2)

Neo40 Daily

ACTIVE COMPARATOR

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.

Dietary Supplement: NEO40 Daily

Placebo

PLACEBO COMPARATOR

Per Capsule: Beet Juice concentrate, Carmine, Croscarmellose Sodium, D-Mannitol, Magnesium Stearate, Orange flavour, Silicon dioxide, Stevia rebaudiana leaf, Xylitol.

Dietary Supplement: NEO40 Daily

Interventions

NEO40 Daily DIETARY_SUPPLEMENT

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.

Neo40 Daily; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hypertension Institute, Nashville: lead
• Neogenis Laboratories: collaborator

Study Sites (1)

Hypertension Institute

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Houston, MD

  Hypertension Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: placebo-controlled study material
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II, randomized,double-blind, placebo-controlled 2 arm parallel

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 29, 2019
• Study Start: April 5, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 18, 2018
• Last Updated: October 30, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)