Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT07172425

Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals

Led by Queen Mary University of London · Updated on 2025-11-24

30

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Inorganic nitrate, found in leafy green vegetables and beetroot, can help lower blood pressure and support heart health. Early experimental work has suggested that dietary nitrate supplementation, in the form of beetroot juice or potassium nitrate capsules, can reduce blood pressure and improve endothelial function. Consequently, concentrated nitrate supplements like beetroot juice have become popular. However, these supplements can be expensive, high in sugar, and not to everyone's taste. Since more than three-quarters of adults with high blood pressure live in low- and middle-income countries, it is important to find safe, affordable ways to add nitrate to commonly eaten foods. The team at Queen Mary University of London has been developing nitrate-fortified products that may be more appealing to a wider population. With support from the food manufacturer Reading Scientific Services Ltd. (RSSL), they have successfully added nitrate to three oat-based products: cereal bar, porridge, and biscuits. This study aims to explore whether adding nitrate to commonly eaten foods can improve nitric oxide levels in the body and help lower blood pressure in healthy volunteers. Participants will receive the three nitrate-fortified food products in a randomised, crossover design. Nitrate and nitrite concentrations in biological samples, along with blood pressure, will be measured before and at multiple time points after supplementation with the nitrate-fortified products.

CONDITIONS

Official Title

Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteer
  • Aged 18 years and 60 years or younger
  • Willing to provide informed consent
  • Able to understand and follow study instructions and requirements
Not Eligible

You will not qualify if you...

  • Unwilling to provide consent
  • Chronic health conditions requiring medication
  • Pregnant or possibly pregnant females
  • History of hypertension or diabetes
  • History of serious illnesses, recent infections, or trauma
  • History of symptomatic coronary artery disease, stroke, or atherosclerotic diseases
  • Planning or likely to start treatment with non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin during the study
  • Alcohol or drug abuse within the past 6 months
  • Regular alcohol consumption exceeding weekly or daily limits in the past 3 months
  • Taking systemic medication other than oral contraceptive pill
  • Recent use of mouthwash or tongue scrapers within 2 weeks
  • Recent or current antibiotic use within 2 weeks
  • Recent use of nitrate or nitrite supplements within 1 week
  • History or recent treatment of oral conditions like gingivitis, periodontitis, or halitosis within 3 months
  • History or recent treatment for blood-borne infectious diseases such as Hepatitis B, C, or HIV
  • Current smokers or smoked within last 6 months
  • Diagnosis of rheumatoid arthritis, connective tissue disorders, or chronic inflammatory conditions
  • Donated more than 500mL of blood within 56 days prior to study
  • Known allergy to celery, gluten, crustaceans, eggs, lupin, milk, mustard, peanuts, sesame, soybeans, tree nuts, oats, palm oil, sugar, cranberries, sunflower oil, invert syrup, or sodium bicarbonate

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Trial Site Locations

Total: 1 location

1

The William Harvey Research Institute, Centre for Cardiovascular Medicines and Devices, Queen Mary University of London

London, United Kingdom, EC1M 6BQ

Actively Recruiting

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Research Team

A

Amrita Ahluwalia, BSc PhD

CONTACT

C

Chenguang Wei, BSc PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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