Healthy VolunteersNCT07172425
Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals
A study testing Inorganic potassium nitrate-fortified biscuits supplementation, Inorganic potassium nitrate-fortified cereal bar supplementation and Inorganic potassium nitrate-fortified porridge supplementation in people with Healthy Volunteers and Nitric Oxide, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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 the form of beetroot juice or potassium nitrate capsules, can reduce blood pressure and improve endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Nitric Oxide, Vascular Function
- What is being tested?
- Inorganic potassium nitrate-fortified biscuits supplementation, Inorganic potassium nitrate-fortified cereal bar supplementation and Inorganic potassium nitrate-fortified porridge supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The William Harvey Research Institute, Centre for Cardiovascular Medicines and Devices, Queen Mary University of London
London, EC1M 6BQ
Amrita Ahluwalia, BSc PhD, +44 (0) 2078828377, a.ahluwalia@qmul.ac.uk
a.ahluwalia@qmul.ac.uk
About this study
Official title: An Open-Label, Randomised, Crossover Study to Investigate the Feasibility of Nitrate Fortification in Commonly Consumed Foods for Regulating Nitric Oxide Metabolism in Healthy Individuals
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.
Read the 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, crossover trial. Target population: Thirty healthy participants (15 males and 15 females) will be recruited.
Experimental intervention: Equal numbers of healthy male and female volunteers, aged 18-60 years, will be recruited. Following recruitment, participants will attend the clinical centre on seven occasions. At baseline, clinic blood pressure will be measured, and plasma, urine, and saliva samples will be collected. Participants will then receive one of the three nitrate-fortified food products according to the randomisation plan.
Clinic blood pressure will be measured at 1, 2, 3, and 4 hours post-supplementation. Blood samples will be collected at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours; urine at 4 hours; and saliva at 3 and 4 hours. At 24 hours post-supplementation, participants will return to the clinical centre for repeat blood pressure measurement and collection of blood, urine, and saliva samples. All human biological samples will be stored for subsequent determination of nitrate and nitrite concentrations.
If participants receive nitrate-fortified biscuits during one visit, they will be given either nitrate-fortified porridge or a cereal bar at the following visits, according to the randomisation plan. All participants will eventually receive all three nitrate-fortified food products, each providing approximately 4 mmol nitrate, an amount within the Acceptable Daily Intake (ADI) range.
The study will be conducted at the Clinical Research Centre at the William Harvey Research Institute, Queen Mary University of London.
Analysis: A two-way repeated measures ANOVA will be used to analyse the differences in [NO3-], [NO2-] in plasma, urine, and saliva, plasma [cGMP] across time and between different NO3--fortified foodstuffs (cereal bar, porridge, and biscuits) and clinic BP. Matching the objectives of comparing the changes in measures following the ingestion of the three food products, the description of the analysis will initially focus on the difference between the three food products and so post-hoc tests (accounting for multiple comparisons) will initially focus on comparing measures at each timepoint.
The acceptability of the three different NO3--fortified food products will be analysed using Friedman tests. As this is a crossover study, checks will be conducted for period effect and carry-over effect as part of the statistical analysis plan.
- Conditions
- Healthy Volunteers, Nitric Oxide, Vascular Function
- Being tested
- Inorganic potassium nitrate-fortified biscuits supplementation, Inorganic potassium nitrate-fortified cereal bar supplementation, Inorganic potassium nitrate-fortified porridge supplementation
- Keywords
- Blood pressure, Oral microbiome profiling, Nitric oxide bioavailability, Inorganic nitrate fortification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inorganic potassium nitrate-fortified biscuits supplementationDietary supplement
Four millimoles of inorganic potassium nitrate, within the acceptable daily intake (ADI), were added to commonly consumed oat-based products (biscuits). During the trial, participants will receive nitrate-fortified biscuits as a single-day acute supplementation.
Inorganic potassium nitrate-fortified cereal bar supplementationDietary supplement
Four millimoles of inorganic potassium nitrate, within the acceptable daily intake (ADI), were added to commonly consumed oat-based products (cereal bar). During the trial, participants will receive nitrate-fortified cereal bar as a single-day acute supplementation.
Inorganic potassium nitrate-fortified porridge supplementationDietary supplement
Four millimoles of inorganic potassium nitrate, within the acceptable daily intake (ADI), were added to commonly consumed oat-based products (instant porridge). During the trial, participants will receive nitrate-fortified porridge as a single-day acute supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Nitrate-fortified biscuits (NFB) | Experimental | Biscuits were fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range. Receives: Dietary Supplement: Inorganic potassium nitrate-fortified biscuits supplementation |
| Arm 2: Nitrate-fortified cereal bar (NFCB) | Experimental | A cereal bar was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range. Receives: Dietary Supplement: Inorganic potassium nitrate-fortified cereal bar supplementation |
| Arm 3: Nitrate-fortified porridge (NFP) | Experimental | Porridge was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range. Receives: Dietary Supplement: Inorganic potassium nitrate-fortified porridge supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate and compare the changes of NO3- and NO2- concentrations in plasma following the ingestion of three different NO3--fortified foodstuffs: cereal bar, porridge, and biscuits.
Mean Plasma NO3- and NO2- concentrations at baseline, 0.5-, 1-, 1.5-, 2-, 2.5-, 3-, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs as well as area under the curve (AUC) across the 24 hours.
Measured: Up to 1 year
Secondary outcomes (4)
To investigate and compare the changes of NO3- and NO2- concentrations in other human biological samples, such as saliva and urine, following the ingestion of the three different NO3--fortified foodstuffs.
- Mean NO3- and NO2- concentrations in saliva at baseline, 3-, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs as well as AUC across the 24 hours.
- Mean NO3- and NO2- concentrations in urine at baseline, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs.
- The AUC of the NO3- and NO2- across the 24 hours.
Measured: Up to 1 year.
To investigate and compare the changes in cGMP concentration in plasma following the ingestion of the three different NO3--fortified foodstuffs.
- Mean plasma cGMP concentration at baseline and at 3 hours post-ingestion of the three NO3--fortified foodstuffs.
- The change at 3 hours from baseline plasma cGMP concentration.
Measured: Up to 1 year.
To assess participants' acceptability of the three different NO3--fortified food products.
Participants' acceptability of the three different NO₃--fortified food products will be assessed through a food sensory test.
Measured: Final laboratory visit (assessed at this time).
To investigate and compare the blood pressure-lowering effects of the three different NO3--fortified foodstuffs.
- Mean blood pressure at baseline, 1-, 2-, 3-, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs.
- The AUC of the blood pressure across the 24 hours.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Oct 2025
- Primary completion15 May 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amrita Ahluwalia, BSc PhD, Study director, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172425
- Sponsor's protocol ID
- 180233
- Other IDs
- 10127157
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghosh SM, Kapil V, Fuentes-Calvo I, Bubb KJ, Pearl V, Milsom AB, Khambata R, Maleki-Toyserkani S, Yousuf M, Benjamin N, Webb AJ, Caulfield MJ, Hobbs AJ, Ahluwalia A. Enhanced vasodilator activity of nitrite in hypertension: critical role for erythrocytic xanthine oxidoreductase and translational potential. Hypertension. 2013 May;61(5):1091-102. doi: 10.1161/HYPERTENSIONAHA.111.00933. Epub 2013 Apr 15.
PubMed 23589565Rathod KS, Mathur A, Shabbir A, Khambata RS, Lau C, Beirne AM, Chhetri I, Ono M, Belgaid DR, Massimo G, Ramasamy A, Tufaro V, Jain AK, Poulter N, Falaschetti E, Jones DA, Garcia-Garcia HM, Bourantas C, Learoyd A, Warren HR, Ahluwalia A. The NITRATE-OCT study-inorganic nitrate reduces in-stent restenosis in patients with stable coronary artery disease: a double-blind, randomised controlled trial. EClinicalMedicine. 2024 Oct 18;77:102885. doi: 10.1016/j.eclinm.2024.102885. eCollection 2024 Nov.
PubMed 39469537Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.
PubMed 25421976Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28.
PubMed 20585108
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomised, Crossover Study to Investigate the Feasibility of Nitrate Fortification in Commonly Consumed Foods for Regulating Nitric Oxide Metabolism in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07172425
- Acronym / sponsor ID
- 180233
- Conditions
- Healthy Volunteers, Nitric Oxide, Vascular Function
- Keywords
- Blood pressure, Oral microbiome profiling, Nitric oxide bioavailability, Inorganic nitrate fortification
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, crossover trial. Target population: Thirty healthy participants (15 males and 15 females) will be recruited.
Experimental intervention: Equal numbers of healthy male and female volunteers, aged 18-60 years, will be recruited. Following recruitment, participants will attend the clinical centre on seven occasions. At baseline, clinic blood pressure will be measured, and plasma, urine, and saliva samples will be collected. Participants will then receive one of the three nitrate-fortified food products according to the randomisation plan.
Clinic blood pressure will be measured at 1, 2, 3, and 4 hours post-supplementation. Blood samples will be collected at 0.5, 1, 1.5, 2, 2.5, 3, and 4 hours; urine at 4 hours; and saliva at 3 and 4 hours. At 24 hours post-supplementation, participants will return to the clinical centre for repeat blood pressure measurement and collection of blood, urine, and saliva samples. All human biological samples will be stored for subsequent determination of nitrate and nitrite concentrations.
If participants receive nitrate-fortified biscuits during one visit, they will be given either nitrate-fortified porridge or a cereal bar at the following visits, according to the randomisation plan. All participants will eventually receive all three nitrate-fortified food products, each providing approximately 4 mmol nitrate, an amount within the Acceptable Daily Intake (ADI) range.
The study will be conducted at the Clinical Research Centre at the William Harvey Research Institute, Queen Mary University of London.
Analysis: A two-way repeated measures ANOVA will be used to analyse the differences in [NO3-], [NO2-] in plasma, urine, and saliva, plasma [cGMP] across time and between different NO3--fortified foodstuffs (cereal bar, porridge, and biscuits) and clinic BP. Matching the objectives of comparing the changes in measures following the ingestion of the three food products, the description of the analysis will initially focus on the difference between the three food products and so post-hoc tests (accounting for multiple comparisons) will initially focus on comparing measures at each timepoint.
The acceptability of the three different NO3--fortified food products will be analysed using Friedman tests. As this is a crossover study, checks will be conducted for period effect and carry-over effect as part of the statistical analysis plan.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Nitrate-fortified biscuits (NFB) | Experimental | Dietary Supplement: Inorganic potassium nitrate-fortified biscuits supplementationBiscuits were fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range. |
| Arm 2: Nitrate-fortified cereal bar (NFCB) | Experimental | Dietary Supplement: Inorganic potassium nitrate-fortified cereal bar supplementationA cereal bar was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range. |
| Arm 3: Nitrate-fortified porridge (NFP) | Experimental | Dietary Supplement: Inorganic potassium nitrate-fortified porridge supplementationPorridge was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inorganic potassium nitrate-fortified biscuits supplementationFour millimoles of inorganic potassium nitrate, within the acceptable daily intake (ADI), were added to commonly consumed oat-based products (biscuits). During the trial, participants will receive nitrate-fortified biscuits as a single-day acute supplementation. | Dietary supplement | Arm 1: Nitrate-fortified biscuits (NFB) |
| Inorganic potassium nitrate-fortified cereal bar supplementationFour millimoles of inorganic potassium nitrate, within the acceptable daily intake (ADI), were added to commonly consumed oat-based products (cereal bar). During the trial, participants will receive nitrate-fortified cereal bar as a single-day acute supplementation. | Dietary supplement | Arm 2: Nitrate-fortified cereal bar (NFCB) |
| Inorganic potassium nitrate-fortified porridge supplementationFour millimoles of inorganic potassium nitrate, within the acceptable daily intake (ADI), were added to commonly consumed oat-based products (instant porridge). During the trial, participants will receive nitrate-fortified porridge as a single-day acute supplementation. | Dietary supplement | Arm 3: Nitrate-fortified porridge (NFP) |
Primary outcome
To investigate and compare the changes of NO3- and NO2- concentrations in plasma following the ingestion of three different NO3--fortified foodstuffs: cereal bar, porridge, and biscuits.
Time frame: Up to 1 year
Mean Plasma NO3- and NO2- concentrations at baseline, 0.5-, 1-, 1.5-, 2-, 2.5-, 3-, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs as well as area under the curve (AUC) across the 24 hours.
4 secondary outcomes
To investigate and compare the changes of NO3- and NO2- concentrations in other human biological samples, such as saliva and urine, following the ingestion of the three different NO3--fortified foodstuffs.
Time frame: Up to 1 year.
To investigate and compare the changes in cGMP concentration in plasma following the ingestion of the three different NO3--fortified foodstuffs.
Time frame: Up to 1 year.
To assess participants' acceptability of the three different NO3--fortified food products.
Time frame: Final laboratory visit (assessed at this time).
To investigate and compare the blood pressure-lowering effects of the three different NO3--fortified foodstuffs.
Time frame: Up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 23589565Ghosh SM, Kapil V, Fuentes-Calvo I, Bubb KJ, Pearl V, Milsom AB, Khambata R, Maleki-Toyserkani S, Yousuf M, Benjamin N, Webb AJ, Caulfield MJ, Hobbs AJ, Ahluwalia A. Enhanced vasodilator activity of nitrite in hypertension: critical role for erythrocytic xanthine oxidoreductase and translational potential. Hypertension. 2013 May;61(5):1091-102. doi: 10.1161/HYPERTENSIONAHA.111.00933. Epub 2013 Apr 15.
- Background: PubMed 39469537Rathod KS, Mathur A, Shabbir A, Khambata RS, Lau C, Beirne AM, Chhetri I, Ono M, Belgaid DR, Massimo G, Ramasamy A, Tufaro V, Jain AK, Poulter N, Falaschetti E, Jones DA, Garcia-Garcia HM, Bourantas C, Learoyd A, Warren HR, Ahluwalia A. The NITRATE-OCT study-inorganic nitrate reduces in-stent restenosis in patients with stable coronary artery disease: a double-blind, randomised controlled trial. EClinicalMedicine. 2024 Oct 18;77:102885. doi: 10.1016/j.eclinm.2024.102885. eCollection 2024 Nov.
- Background: PubMed 25421976Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.
- Background: PubMed 20585108Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amrita Ahluwalia, BSc PhD study director
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inorganic potassium nitrate-fortified biscuits supplementation, Inorganic potassium nitrate-fortified cereal bar supplementation and Inorganic potassium nitrate-fortified porridge supplementation in people with Healthy Volunteers and Nitric Oxide, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amrita Ahluwalia, BSc PhD (+44(0)2078828377, a.ahluwalia@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate and compare the changes of NO3- and NO2- concentrations in plasma following the ingestion of three different NO3--fortified foodstuffs: cereal bar, porridge, and biscuits. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07172425, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.