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

Tracking Information

• First Submitted Date: June 26, 2023
• First Posted Date: July 3, 2023
• Last Update Posted Date: August 2, 2023
• Actual Study Start Date: June 24, 2023
• Actual Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 26, 2023)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Label Clinical Trial of Vascanox® HP on Nitric Oxide and Blood Pressure
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Hypertension
• Elevated Blood Pressure

Intervention

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.

Study Arms

Experimental: Vascanox® HP

Intervention: Dietary Supplement: Vascanox® HP

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 26, 2023): 12
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 31, 2023
• Actual Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05928676
• Other Study ID Numbers: 022-CalroyHS
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Calroy Health Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Calroy Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Calroy Health Sciences
• Verification Date: June 2023