Adding nitrate to everyday oat-based foods to boost nitric oxide and support blood vessel health.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized crossover study will recruit 30 healthy adults (15 men, 15 women) to receive three different potassium nitrate–fortified oat-based foods (biscuits, porridge, cereal bar) across separate visits. Participants will attend seven clinic visits for serial blood pressure measurements and collection of blood, urine, and saliva samples up to 24 hours after each supplement to measure nitrate, nitrite, and vascular responses. Each participant acts as their own control by receiving all three fortified products in random order. The primary focus is short-term changes in nitric oxide bioavailability and clinic blood pressure following single consumption of each fortified food.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy volunteer.
2. Aged ≥18 years and ≤ 60 years.
3. Willing to provide informed consent.
4. Able to understand and comply with protocol requirements, instructions, and stated restrictions.

Exclusion Criteria:

A volunteer will not be eligible for inclusion in this study if any of the following criteria are met:

1. Unwilling to provide consent.
2. People with chronic health conditions requiring medication.
3. Pregnant females, or those with a possibility of being pregnant.
4. History of hypertension and /or diabetes.
5. History of any serious illnesses, including recent infections or trauma.
6. History of symptomatic coronary artery disease, stroke, or other known atherosclerotic diseases.
7. People who will commence or who are likely to commence treatment with non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin, from screening until study completion.
8. Self-declared alcohol or drug abuse within the past 6 months.
9. Three-month prior history of regular alcohol consumption exceeding an average weekly intake of \> 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of \> 21 units (or an average daily intake of greater than 2 units) for females. One unit is equivalent to a half pint (284mL) of beer/lager; 25mL of spirits, or 125mL of wine.
10. Taking systemic medication (other than the oral contraceptive pill).
11. Recent (within 2 weeks) self-reported use of mouthwash or tongue scrapers.
12. Recent (within 2 weeks) or current antibiotic use.
13. Recent (within 1 week) use of NO3- or NO2- supplements.
14. History, or recent treatment of (within the last 3 months) for any oral condition (excluding caries), including gingivitis, periodontitis and halitosis.
15. History of, or recent treatment for, any blood-borne infectious disease such Hepatitis B or C virus, or HIV.
16. Current smokers (including vaping) or have smoked within the last 6 months.
17. Diagnosis of rheumatoid arthritis, connective tissue disorders, and other conditions known to be associated with chronic inflammation (e.g., Inflammatory Bowel Disease).
18. People who have donated more than 500mL of blood within 56 days prior to the study commencement.
19. Known allergy to celery, gluten, crustaceans, eggs, lupin, milk, mustard, peanuts, sesame, soybeans, tree nuts, oats, palm oil, sugar, cranberries, sunflower oil, invert syrup, sodium bicarbonate.

Where it's running

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

Study contacts

• Study coordinator: Amrita Ahluwalia, BSc PhD
• Email: a.ahluwalia@qmul.ac.uk
• Phone: +44(0)2078828377

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.