Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorQueen Mary University of London
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Inorganic potassium nitrate-fortified biscuits supplementation
Dietary supplementFour 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 supplementation
Dietary supplementFour 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 supplementation
Dietary supplementFour 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.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Arm 1: Nitrate-fortified biscuits (NFB)Experimental treatment 1 intervention
Group B: Arm 2: Nitrate-fortified cereal bar (NFCB)Experimental treatment 1 intervention
Group C: Arm 3: Nitrate-fortified porridge (NFP)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 1 yearSecondary outcomes
1
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.
1. 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. 2. Mean NO3- and NO2- concentrations in urine at baseline, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs. 3. The AUC of the NO3- and NO2- across the 24 hours.
Time frame
Up to 1 year.2
To investigate and compare the changes in cGMP concentration in plasma following the ingestion of the three different NO3--fortified foodstuffs.
1. Mean plasma cGMP concentration at baseline and at 3 hours post-ingestion of the three NO3--fortified foodstuffs. 2. The change at 3 hours from baseline plasma cGMP concentration.
Time frame
Up to 1 year.3
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.
Time frame
Final laboratory visit (assessed at this time).4
To investigate and compare the blood pressure-lowering effects of the three different NO3--fortified foodstuffs.
1. Mean blood pressure at baseline, 1-, 2-, 3-, 4-, and 24-hours post-ingestion of the three NO3--fortified foodstuffs. 2. The AUC of the blood pressure across the 24 hours.
Time frame
Up to 6 months.Sponsors and contacts
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Source ClinicalTrials.gov