Status:
RECRUITING
Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals
Lead Sponsor:
Queen Mary University of London
Conditions:
Healthy Volunteers
Nitric Oxide
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Whether adding nitrate to commonly eaten foods can improve nitric oxide levels in the body and help lower blood pressure in healthy volunteers will be investigated. Design: An open-label, randomised,...
Eligibility Criteria
Inclusion
- Healthy volunteer.
- Aged ≥18 years and ≤ 60 years.
- Willing to provide informed consent.
- Able to understand and comply with protocol requirements, instructions, and stated restrictions.
Exclusion
- A volunteer will not be eligible for inclusion in this study if any of the following criteria are met:
- Unwilling to provide consent.
- People with chronic health conditions requiring medication.
- Pregnant females, or those with a possibility of being pregnant.
- History of hypertension and /or diabetes.
- History of any serious illnesses, including recent infections or trauma.
- History of symptomatic coronary artery disease, stroke, or other known atherosclerotic diseases.
- 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.
- Self-declared alcohol or drug abuse within the past 6 months.
- 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.
- Taking systemic medication (other than the oral contraceptive pill).
- Recent (within 2 weeks) self-reported use of mouthwash or tongue scrapers.
- Recent (within 2 weeks) or current antibiotic use.
- Recent (within 1 week) use of NO3- or NO2- supplements.
- History, or recent treatment of (within the last 3 months) for any oral condition (excluding caries), including gingivitis, periodontitis and halitosis.
- History of, or recent treatment for, any blood-borne infectious disease such Hepatitis B or C virus, or HIV.
- Current smokers (including vaping) or have smoked within the last 6 months.
- Diagnosis of rheumatoid arthritis, connective tissue disorders, and other conditions known to be associated with chronic inflammation (e.g., Inflammatory Bowel Disease).
- People who have donated more than 500mL of blood within 56 days prior to the study commencement.
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07172425
Start Date
October 15 2025
End Date
February 1 2027
Last Update
November 24 2025
Active Locations (1)
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1
The William Harvey Research Institute, Centre for Cardiovascular Medicines and Devices, Queen Mary University of London
London, United Kingdom, EC1M 6BQ