NCT02715635

Influence of Dietary Nitrate on Vascular Dysfunction and Inflammation

A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate on a Model of Vascular Dysfunction in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The principal research objective is to determine whether inorganic nitrate in the form of beetroot juice compared to placebo control prevents the systemic inflammation that underlies typhoid vaccine-induced endothelial dysfunction

Detailed description

We wish to determine in a prospective manner whether inorganic nitrate affects the endothelial dysfunction induced by systemic inflammation. At baseline we will measure flow-mediated dilatation (FMD) and peripheral augmentation index, as well as aortic stiffness, as measured by pulse wave velocity (PWV). Volunteers will then receive \~8 mmols of dietary nitrate or nitrate free placebo juice once daily for 6 days. After this, depending on availability, volunteers will receive a typhoid vaccine Typherix®, GlaxoSmithKline UK or Typhim Vi ™, AAH Pharmaceuticals Ltd). This vaccine generates a mild systemic inflammation that is associated with vascular dysfunction. All vascular function measures will be repeated at 8 hours and 32 hours after vaccine administration.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Typhoid vaccine	The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution
DIETARY_SUPPLEMENT	Concentrate beetroot Juice	140 ml containing \~8 mmol of inorganic nitrate
DIETARY_SUPPLEMENT	Concentrate beetroot Juice (Placebo)	140 ml which is nitrate-depleted

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-12-01
• Completion: 2021-08-01
• First posted: 2016-03-22
• Last updated: 2022-07-20

Locations

1 site across 1 country: United Kingdom