Open Label Clinical Trial of Vascanox® HP on Nitric Oxide and Blood Pressure

NCT05928676 | Completed

• 1 other identifier: 022-CalroyHS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Conversion of dietary nitrates to nitric oxide (NO) is a non-canonical pathway that plays an important role in NO biology, particulalry under pathological conditions. Nitrate supplementation has been shown to help control mild hypertension. Recent studies have suggested that another gaseous transmitter, hydrogen sulfide, also influences NO biosynthesis and metabolism. This open-label clinical trial will evalute the effect of Vascanox® HP, a proprietary formulation that combines dietary sources of nitric oxide and hydrogen sulfide, on nitric oxide bioavailability and on blood pressure in subjects experiencing elevated blood pressure. Participants will supplement with Vascanox® HP for four weeks. Blood pressure will be measured at baseline, two weeks, and fours weeks. Salivary nitric oxide will be assessed prior to and two, six, and 24 hours after dosing on the first day of the study and prior to and two hours after dosing at subsequent study visits. Participants will also self-monitor their saliva nitric oxide levels and blood pressure daily for 4 weeks. Changes in study outcomes over time will be evaluated via analysis of variance (ANOVA) and paired t-tests.

Conditions

Hypertension; Elevated Blood Pressure

Keywords

hypertension; elevated blood pressure; nitric oxide; S-allylcysteine; dietary nitrate; Vascanox HP

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Change in blood pressure in millimeters of mercury (mmHg) assessed in the branchial artery

  Assessed at baseline, at 2 weeks, and at the 4 week conclusion of study

Secondary Outcomes (1)

• Salivary nitric oxide

  Salivary nitric oxide assessed prior to and two hours after dosing at baseline, 2 weeks, and at the 4 week conclusion of the study. Salivary nitric oxide will be additionally assessed at 6 and 24 hours after dosing on the first day of the study only.

Study Arms (1)

Vascanox® HP

EXPERIMENTAL

Dietary Supplement: Vascanox® HP

Interventions

Vascanox® HP DIETARY_SUPPLEMENT

Vascanox® HP is a proprietary formulation that combines dietary sources of nitric oxide and hydrogen sulfide aimed at increasing the levels and duration of nitric oxide biosynthesis. Vascanox® HP contains an advanced blend of berry extracts in addition to beet root powder, black garlic, vitamin C, and minerals known to influence nitric oxide biosynthesis and metabolism. Because of the particular combination of ingredients, Vascanox® HP is expected to affect both canonical and non-canonical pathways of nitric oxide production and to augment nitric oxide reservoir in the body leading to an increased and prolonged nitric oxide bioavailability.

Vascanox® HP

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild hypertension defined as brachial artery blood pressure greater than or equal to 130 mm Hg systolic and less than or equal to 140 mm Hg systolic or greater than or equal to 85 mm Hg diastolic or less than 90 mm Hg diastolic while taking or not taking antihypertensive drugs.
• Not currently taking nitric oxide supplements, and not consuming nitric oxide supplements for 14 days prior to screening.
• Ability to give written informed consent.
• Ability to adhere to study protocol directives and procedures.

You may not qualify if:

• Initiated or had a dose change of an antihypertensive agent less than 6 months prior to the enrollment date.
• A positive nitric oxide saliva test strip (result \>2) on the day of Screening.
• A positive nitric oxide saliva test strip (result \>2) on the day of Baseline/Visit 1.
• A high saliva NO3 test strip result (result \>2) but a low NO test strip result.
• Current use of antibiotics.
• Chronic steroid use \>15 mg daily.
• Previous myocardial infarction less than 2 years of enrollment date.
• Unstable angina.
• Previous stroke or transient ischemic attack (TIA) less than 2 years of enrollment date.
• Uncompensated congestive heart failure (CHF).
• Previous percutaneous transluminal coronary angioplasty (PTCA) or stent less than 2 years of enrollment date.
• Previous coronary arterial bypass graft (CABG) less than 2 years of enrollment date.
• Known or previous cancer less than 5 years of enrollment date.
• Type 1 diabetes mellitus.
• Prescribed dosing with insulin, injectable or inhaled.

Sponsors & Collaborators

• Calroy Health Sciences: lead

Study Sites (1)

The Hypertension Institute

Nashville, Tennessee, 37205, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Houston, M.D.

  The Hypertension Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 3, 2023
• Study Start: June 24, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-06

Locations

US (1)