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ACTIVE NOT RECRUITING
NCT04889274
PHASE1

Investigation of the Effects of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women (DiNOVasc-COVID-19)

Sponsor: Queen Mary University of London

View on ClinicalTrials.gov

Summary

Inorganic nitrate can protect blood vessels from the damage that occurs during cardiovascular disease. Early experimental work suggests that nitrate-induced improvements in vascular function relate to the suppression of inflammatory pathways. Whether this protection against inflammation-induced damage to the blood vessel wall might also be functional in the setting of COVID-19 vaccination will be investigated. Vascular function will be assessed before and after the healthy participant has received their COVID-19-vaccination. Whether there might be differences in the response to the vaccine between the sexes and whether a dietary nitrate intervention impacts upon the effects of vaccination will be investigated. The study is in two parts: Part A: To assess sex differences in the vascular response to COVID-19 vaccination. Part B: To assess whether inorganic nitrate, in the form of dietary inorganic nitrate supplementation compared to placebo control, can raise circulating plasma nitrite levels and thereby prevent the systemic inflammation that causes vascular dysfunction.

Official title: A Double-blind, Randomised, Placebo-controlled Parallel Study to Investigate the Effect of Dietary Nitrate and Sex on COVID-19 Vaccine Induced Vascular Dysfunction in Healthy Men and Women

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2021-05-10

Completion Date

2026-04-30

Last Updated

2025-08-06

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

COVID-19 vaccine

COVID-19 vaccine as offered by NHS England

BIOLOGICAL

Concentrate beetroot Juice

Beetroot juice containing approximately 5mmol/l nitrate

BIOLOGICAL

Nitrate-deplete beetroot juice

Beetroot juice with nitrate removed

Locations (1)

The William Harvey Research Institute

London, United Kingdom