Clinical Trial

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

Active, Not Recruiting Phase 1
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Record status
This record was last updated August 6, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-05-14; most recent amendment 2025-08-01.
Status change: Recruiting → Active, Not Recruiting 2025-08-01
Status change: Active, Not Recruiting → Recruiting 2025-06-06
Status change: Recruiting → Active, Not Recruiting 2023-10-25
Trial Details
NCT Number NCT04889274
Lead Sponsor Queen Mary University of London
Conditions Cardiovascular Diseases, Endothelial Dysfunction
Enrollment 98 participants
Start Date 2021-05-10
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-06