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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
The William Harvey Research Institute, Centre for Cardiovascular Medicines and Devices, Queen Mary University of London
RECRUITING
London
Contact Information
Primary
Amrita Ahluwalia, BSc PhD
a.ahluwalia@qmul.ac.uk
+44(0)2078828377
Backup
Chenguang Wei, BSc PhD
chenguang.wei@qmul.ac.uk
+44(0)7529281905
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2027-02
Participants
Target number of participants: 30
Treatments
Experimental: Arm 1: Nitrate-fortified biscuits (NFB)
Biscuits were fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range.
Experimental: Arm 2: Nitrate-fortified cereal bar (NFCB)
A cereal bar was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range.
Experimental: Arm 3: Nitrate-fortified porridge (NFP)
Porridge was fortified with 4 mmol of inorganic potassium nitrate, an amount within the acceptable daily intake (ADI) range.
Related Therapeutic Areas
Sponsors
Leads: Queen Mary University of London

This content was sourced from clinicaltrials.gov