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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
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
COVID-19 vaccine
COVID-19 vaccine as offered by NHS England
Concentrate beetroot Juice
Beetroot juice containing approximately 5mmol/l nitrate
Nitrate-deplete beetroot juice
Beetroot juice with nitrate removed
Locations (1)
The William Harvey Research Institute
London, United Kingdom