HypertensionNCT05928676
Open Label Clinical Trial of Vascanox® HP on Nitric Oxide and Blood Pressure
A study testing Vascanox® HP in people with Hypertension and Elevated Blood Pressure, run by Calroy Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Hypertension, Elevated Blood Pressure
- What is being tested?
- Vascanox® HP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Hypertension Institute
Nashville, Tennessee, 37205
About this study
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
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
- Being tested
- Vascanox® HP
- Keywords
- hypertension, elevated blood pressure, nitric oxide, S-allylcysteine, dietary nitrate, Vascanox HP
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascanox® HPDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Vascanox® HP | Experimental | Not described Receives: Dietary Supplement: Vascanox® HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Change in blood pressure in millimeters of mercury (mmHg) assessed in the branchial artery
Measured: Assessed at baseline, at 2 weeks, and at the 4 week conclusion of study
Secondary outcomes (1)
Salivary nitric oxide
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start24 Jun 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calroy Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Houston, M.D., Principal investigator, The Hypertension Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928676
- Sponsor's protocol ID
- 022-CalroyHS
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05928676
- Acronym / sponsor ID
- 022-CalroyHS
- Conditions
- Hypertension, Elevated Blood Pressure
- Keywords
- hypertension, elevated blood pressure, nitric oxide, S-allylcysteine, dietary nitrate, Vascanox HP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Calroy Health SciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascanox® HP | Experimental | Dietary Supplement: Vascanox® HP |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascanox® HPVascanox® 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. | Dietary supplement | Vascanox® HP |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Houston, M.D. principal investigator
The Hypertension Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascanox® HP in people with Hypertension and Elevated Blood Pressure, run by Calroy Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Assessed at baseline, at 2 weeks, and at the 4 week conclusion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.