NCT05928676

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Calroy Health Sciences · Industry
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-24
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2023-07-03
• Last updated: 2023-08-02

Locations

1 site across 1 country: United States