- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05928676
Open Label Clinical Trial of Vascanox® HP on Nitric Oxide and Blood Pressure
July 31, 2023 updated by: Calroy Health Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
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 Contact
- Name: Chen Chen, PhD
- Phone Number: 1-800-609-6409
- Email: chen.chen@calroy.com
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37205
- The 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Assessed at baseline, at 2 weeks, and at the 4 week conclusion of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Houston, M.D., The Hypertension Institute
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)
June 24, 2023
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
June 26, 2023
First Submitted That Met QC Criteria
June 26, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
August 2, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 022-CalroyHS
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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