Evidence map›Paper›PMID 37715222›Full record

ArticleTrials2023

A double-blind, randomised, placebo-controlled parallel study to investigate the effect of sex and dietary nitrate on COVID-19 vaccine-induced vascular dysfunction in healthy men and women: protocol of the DiNOVasc-COVID-19 study.

Asad Shabbir, Ismita Chhetri, Rayomand S Khambata, Tipparat Parakaw, Clement Lau, Muhammad A B N Aubdool, Gianmichele Massimo, Nicki Dyson, Vikas Kapil, Thomas Godec and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04889274 (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), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 48% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04889274 phase1active not recruitingnot on this map

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

TypeinterventionalSponsorQueen Mary University of LondonRan2021 to 2026Enrolled98ConditionsCardiovascular Diseases, Endothelial DysfunctionArmsCOVID-19 vaccine, Concentrate beetroot Juice, Nitrate-deplete beetroot juice
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Asad ShabbirBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Ismita ChhetriBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Rayomand S KhambataBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Tipparat ParakawBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Clement LauBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Muhammad A B N AubdoolBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Gianmichele MassimoBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Nicki DysonBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Vikas KapilBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Thomas GodecBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Vanessa ApeaBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Jan FlintBarts Health NHS Trust, The Royal London Hospital, London, UK.
Chloe OrkinBarts Health NHS Trust, The Royal London Hospital, London, UK.
Krishnaraj S RathodBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK.
Amrita AhluwaliaBarts and The London Faculty of Medicine and Dentistry, Queen Mary University of London, London, EC1M 6BQ, UK. a.ahluwalia@qmul.ac.uk.ORCID http://orcid.org/0000-0001-7626-6399
Queen Mary University of London · GBSt Bartholomew's Hospital · GBBarts Health NHS Trust · GB

Funding

British Heart Foundation FS/19/62/34901
6 · The paper itself

Abstract

backgroundCardiovascular events, driven by endothelial dysfunction, are a recognised complication of COVID-19. SARS-CoV-2 infections remain a persistent concern globally, and an understanding of the mechanisms causing endothelial dysfunction, particularly the role of inflammation, nitric oxide, and whether sex differences exist in this response, is lacking. We have previously demonstrated important sex differences in the inflammatory response and its impact on endothelial function and separately that the ingestion of inorganic nitrate can protect the endothelium against this dysfunction. In this study, we will investigate whether sex or a dietary inorganic nitrate intervention modulates endothelial function and inflammatory responses after the COVID-19 vaccine.

methodsDiNOVasc-COVID-19 is a double-blind, randomised, single-centre, placebo-controlled clinical trial. A total of 98 healthy volunteers (49 males and 49 females) will be recruited. Participants will be randomised into 1 of 2 sub-studies: part A or part B. Part A will investigate the effects of sex on vascular and inflammatory responses to the COVID-19 vaccine. Part B will investigate the effects of sex and dietary inorganic nitrate on vascular and inflammatory responses to the COVID-19 vaccine. In part B, participants will be randomised to receive 3 days of either nitrate-containing beetroot juice (intervention) or nitrate-deplete beetroot juice (placebo). The primary outcome for both sub-studies is a comparison of the change in flow-mediated dilatation (FMD) from baseline after COVID-19 vaccination. The study has a power of > 80% to assess the primary endpoint. Secondary endpoints include change from baseline in inflammatory and leukocyte counts and in pulse wave analysis (PWA) and pulse wave velocity (PWV) following the COVID-19 vaccination. DISCUSSION: This study aims to evaluate whether sex or dietary influences endothelial function and inflammatory responses in healthy volunteers after receiving the COVID-19 vaccine.

trial registrationClinicalTrials.gov NCT04889274. Registered on 5 May 2023. The study was approved by the South Central - Oxford C Research Ethics Committee (21/SC/0154).

Indexed as

COVID-19Vascular DiseasesCOVID-19 VaccinesFemaleHumansMaleNitratesPulse Wave AnalysisRandomized Controlled Trials as TopicSARS-CoV-2COVID-19 VaccinesNitratesCOVID-19EndotheliumInflammationNitrateSexVascular

Identifiers

PMID37715222
PMCPMC10504715
OpenAlexW4386760246

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.