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

• ClinicalTrials.gov Identifier: NCT05928676
• Recruitment Status: Completed
• First Posted: July 3, 2023
• Last Update Posted: August 2, 2023
• Sponsor: Calroy Health Sciences
• Information provided by (Responsible Party): Calroy Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Elevated Blood Pressure	Dietary Supplement: Vascanox® HP	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effects of S-allylcysteine-rich Garlic Extract and Dietary Inorganic Nitrate Formula (Vascanox® HP) on Blood Pressure and Nitric Oxide Levels: an Open-label Clinical Trial Among Hypertensive Adults
• Actual Study Start Date: June 24, 2023
• Actual Primary Completion Date: July 31, 2023
• Actual Study Completion Date: July 31, 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: Vascanox® HP

Dietary Supplement: Vascanox® HP; 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.

Outcome Measures

Primary Outcome Measures :

1. Blood pressure [ Time Frame: Assessed at baseline, at 2 weeks, and at the 4 week conclusion of study ]
   Change in blood pressure in millimeters of mercury (mmHg) assessed in the branchial artery

Secondary Outcome Measures :

1. Salivary nitric oxide [ Time Frame: 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. ]
   Salivary levels of nitric oxide assessed using commercially available FDA registered strips. Nitric oxide test strips measure nitrite, which is used as an established surrogate marker for nitric oxide.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Pregnant females.
• Females of child bearing age not on an accepted contraception control method.
• Allergy/sensitivity to study products or their ingredients.
• Current drug or alcohol use or dependence that, in the opinion of the principal investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of individual to give written informed consent.
• Current or past participation within 30 calendar days in another clinical trial, as warranted by the administration of this intervention.

Contacts and Locations

Locations

United States, Tennessee

The Hypertension Institute

Nashville, Tennessee, United States, 37205

Sponsors and Collaborators

Calroy Health Sciences

Investigators

• Principal Investigator: Mark Houston, M.D.; The Hypertension Institute

More Information

• Responsible Party: Calroy Health Sciences
• ClinicalTrials.gov Identifier: NCT05928676
• Other Study ID Numbers: 022-CalroyHS
• First Posted: July 3, 2023
• Last Update Posted: August 2, 2023
• Last Verified: June 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Calroy Health Sciences:

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

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases