Active not recruitingPHASE1INTERVENTIONAL

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

This research wants to understand how the COVID-19 vaccine might affect your blood vessels, particularly looking at any temporary changes. We're also investigating if a natural ingredient found in beetroot, called nitrate, could help protect these blood vessels. The study also aims to see if men and women react differently to the vaccine in terms of their blood vessel health. We know that nitrate in food can help keep blood vessels healthy, and we want to see if this protective effect could be useful when you get your COVID-19 vaccination. By joining, you'll help us learn more about how to keep our hearts and blood vessels healthy, especially after vaccinations, and understand how treatments might work differently for men and women.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Queen Mary University of London

Enrolment target

Start

10 May 2021

Estimated completion

30 Apr 2026

Cardiovascular Diseases Endothelial Dysfunction

What is this study about?

You might be wondering what this study is all about. Well, we're looking into how the COVID-19 vaccine affects your blood vessels. Sometimes, when your body reacts to an infection or a vaccine, it can cause a small, temporary stress on your blood vessels. This study wants to understand this reaction better.

We're also interested in something found naturally in beetroot called 'nitrate'. Previous research has suggested that this nitrate can help protect blood vessels from damage and reduce inflammation. We want to see if having a bit more nitrate in your diet, specifically from beetroot juice, could help keep your blood vessels healthy when you get your COVID-19 vaccine. We'll also be carefully checking if there are any differences in these effects between men and women.

Ultimately, this research aims to give us a clearer picture of how our bodies react to vaccination at a very detailed level and whether simple dietary changes could offer a protective boost. This information could be very useful in helping to keep people healthy in the future.

Key takeaways

This study investigates how the COVID-19 vaccine affects blood vessels.
It explores if natural nitrate from beetroot juice can help protect blood vessels.
Differences between men and women in vaccine response are being examined.
Participation involves blood tests and vital sign measurements.
There's a follow-up questionnaire about a month after vaccination.
Your involvement helps us understand more about vaccine effects and blood vessel health.

Who may be eligible?

To be considered for this study, you need to be a healthy person between 18 and 60 years old and have an appointment booked for a COVID-19 vaccination, following government guidelines. You also need to be willing to sign a consent form, showing you understand and agree to take part.

There are some reasons why you wouldn't be able to join. For example, if you are under 18 or over 60, or if there's any chance you might be pregnant. We also can't include people who have had serious illnesses recently, are taking most regular medications (except the contraceptive pill), use mouthwash or tongue scrapers, or have taken antibiotics in the last two weeks.

Additionally, if you've had certain oral health problems in the last three months, had a previous COVID-19 vaccination, or have a history of blood-borne infections, you wouldn't be able to participate. This helps us ensure the study is safe and that we can clearly see the effects we're testing.

Quick self-check

Are you between 18 and 60 years old?
Do you have a COVID-19 vaccination booked?
Are you generally healthy and not pregnant?
Are you currently not taking most regular medications (except the contraceptive pill)?
Have you not had a COVID-19 vaccine before?
Do you agree to sign a consent form?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have some measurements taken to check your blood vessel health, like blood pressure readings and blood tests. Then, you'll either be placed into Part A or Part B of the study. All participants will receive a COVID-19 vaccine.

If you're in Part A, you won't take any special drink. If you're in Part B, for three days, you'll either drink beetroot juice containing nitrate or a beetroot juice that doesn't (a placebo). You won't know which one you're getting. After these three days, you'll have your COVID-19 vaccine. About 8 hours after your vaccine, your blood vessel health will be measured again. Finally, about 28 days after your vaccine, you'll be asked to fill out a short questionnaire about your general well-being. The total involvement period is short, mostly centred around your vaccination date and a follow-up questionnaire.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that it might help us understand more about how our bodies react to vaccines and how to keep blood vessels healthy. While there's no direct personal benefit from the treatments in this study, the information gained could help others in the future. As with any medical procedure, there are minimal risks involved with blood tests and blood pressure measurements. You might also experience common, mild side effects from the COVID-19 vaccine itself, which are generally well-known. You will be fully informed of all procedures, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

The William Harvey Research Institute
London, United Kingdom

Common questions

What is 'vascular dysfunction'?

It's a way of describing when your blood vessels aren't working as well as they should, potentially affecting blood flow.

Why are you looking at beetroot juice?

Beetroot juice contains natural nitrate, which some studies suggest can help keep blood vessels healthy.

Will I know if I'm getting the active beetroot juice or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the research team will know until after the study is complete. This helps keep the results unbiased.

How long will I need to be involved in the study?

Most of the active participation, like drinking the juice and having measurements, will be around your vaccination day. You'll also complete a questionnaire about a month later.

Will taking part affect my COVID-19 vaccination?

No, your vaccination will happen as planned. This study is designed to observe how your body reacts to it and how natural nitrate might influence that reaction.