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

NCT07172425 | Recruiting

• 2 other identifiers: 18023310127157
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Healthy Volunteers; Nitric Oxide; Vascular Function

Keywords

Blood pressure; Oral microbiome profiling; Nitric oxide bioavailability; Inorganic nitrate fortification

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  Up to 1 year.

• To assess participants' acceptability of the three different NO3--fortified food products.

  Final laboratory visit (assessed at this time).

• To investigate and compare the blood pressure-lowering effects of the three different NO3--fortified foodstuffs.

  Up to 6 months.

Study Arms (3)

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.

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.

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.

Dietary Supplement: Inorganic potassium nitrate-fortified porridge supplementation

Interventions

Inorganic potassium nitrate-fortified biscuits supplementation DIETARY_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.

Arm 1: Nitrate-fortified biscuits (NFB)

Inorganic potassium nitrate-fortified cereal bar supplementation DIETARY_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.

Arm 2: Nitrate-fortified cereal bar (NFCB)

Inorganic potassium nitrate-fortified porridge supplementation DIETARY_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.

Arm 3: Nitrate-fortified porridge (NFP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

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

London, EC1M 6BQ, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 23589565 BACKGROUND

• Rathod 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.

  PMID: 39469537 BACKGROUND

• Kapil 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.

  PMID: 25421976 BACKGROUND

• Kapil 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.

  PMID: 20585108 BACKGROUND

Study Officials

• Amrita Ahluwalia, BSc PhD

  Queen Mary University of London

  STUDY DIRECTOR

Central Study Contacts

Amrita Ahluwalia, BSc PhD

CONTACT

+44(0)2078828377; a.ahluwalia@qmul.ac.uk

Chenguang Wei, BSc PhD

CONTACT

+44(0)7529281905; chenguang.wei@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 15, 2025
• Study Start: October 15, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)