Blood PressureNCT07242066
Effects of Dietary Nitrate and Vitamin C Co-supplementation on Blood Pressure and Endothelial Function in Overweight Individuals
A study testing Beetroot juice plus vitamin C tablet in people with Blood Pressure, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The investigators have shown in two short-term studies in healthy, young participants that the combined supplementation of inorganic nitrate with vitamin C has beneficial effects on blood pressure and blood vessel wall stiffness. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Beetroot juice plus vitamin C tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2024to 22 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Participant is willing and able to comply with the requirements of the study protocol.
- Non-smoking men and women.
- Aged between 50-75 years.
- Overweight and obese (BMI: over 25.0 kg/m2).
Who cannot join
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
- Vegetarian.
- Smoking.
- Resting systolic blood pressure greater than 160 mmHg; diastolic blood pressure greater than 100 mmHg.
- Active cancer and any diagnosis of malignant cancer in the last 5 years.
- Excessive alcohol intake (>21 units per week).
Show all 13Show fewer
- Allergy or intolerance to the intervention food (Beetroot juice).
- Diagnosis of chronic or acute metabolic and inflammatory conditions that may interfere with the study outcomes.
- Major surgical operations.
- Use of prescribed psychiatric drugs (antidepressants, sedatives, antipsychotics), diuretics, organic nitrates, statins and proton pump inhibitors.
- Use of prescribed hormonal therapies (oestrogens, thyroxin, and progesterone), anti-hypertensive (Calcium++ channel blockers, beta-blockers, and angiotensin-converting-enzyme (ACE) inhibitors), only if the prescription had started, or the dose had been started/changed, in the previous three months.
- Non-prescribed dietary supplements if not stopped at least for 2 weeks before starting the trial.
- Use of the mouthwash during the study was not allowed as it interferes with the conversion of oral nitrate into nitrite.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
David Greenfield Human Physiology Lab, Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
The investigators have shown in two short-term studies in healthy, young participants that the combined supplementation of inorganic nitrate with vitamin C has beneficial effects on blood pressure and blood vessel wall stiffness. However, the effects of the combined supplementation have not been tested in individuals at greater cardiovascular disease risk. The investigators would like to show whether inorganic nitrate and vitamin C will produce greater effects on blood pressure and endothelial function when compared to inorganic nitrate alone versus the placebo treatment in people at greater risk of cardiovascular disease.
- Conditions
- Blood Pressure
- Being tested
- Beetroot juice plus vitamin C tablet, Beetroot juice plus placebo tablet, Nitrate-depleted beetroot juice plus placebo tablet
- Keywords
- Cardiovascular disease, endothelial function, nitrate, Vitamin C
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juice plus vitamin C tabletDietary supplement
Concentrated beetroot juice (70 ml in the morning before breakfast and 70 ml in the evening before dinner) plus Vitamin C tablets (500mg/tablet)
Beetroot juice plus placebo tabletDietary supplement
Concentrated beetroot juice (70ml in the morning and 70 ml in the evening) plus placebo tablets (containing 500 mg of the non-nutritive sweetener aspartame)
Nitrate-depleted beetroot juice plus placebo tabletDietary supplement
nitrate-depleted beetroot juice (70ml in the morning and 70 ml in the evening) plus placebo tablets (containing 500 mg of the non-nutritive sweetener aspartame)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo beetroot juice and tablet Receives: Dietary Supplement: Nitrate-depleted beetroot juice plus placebo tablet |
| Beetroot juice + Vitamin C | Experimental | Beetroot juice and Vitamin C Receives: Dietary Supplement: Beetroot juice plus vitamin C tablet |
| Beetroot juice + placebo | Experimental | Beetroot juice + placebo tablet Receives: Dietary Supplement: Beetroot juice plus placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Resting diastolic and systolic blood pressure using portable automated monitor
Measured: Pre, 24 hours, 48 hours and 72 hours after supplementation
Cardiac function
Resting cardiac function using a non-invasive methodology (Finometer)
Measured: Pre and post 3 days of supplementation
Secondary outcomes (6)
Flow-mediated dilation
Assess endothelial function through changes in brachial artery diameter in response to reactive hyperaemia using high-resolution B-mode ultrasound.
Measured: Pre and post 3 days of supplementation
Saliva nitrate concentration
Colorimetric assays based on the Griess reaction will be used to measure nitrate concentration in saliva samples
Measured: Pre and post 3 days supplementation
Urinary nitrate concentration
Colorimetric assays based on the Griess reaction will be used to measure nitrate concentration in urine samples
Measured: Pre and post 3 days supplementation
Saliva nitrite concentration
Colorimetric assays based on the Griess reaction will be used to measure nitrite concentration in saliva samples
Measured: Pre and post 3 days supplementation
Urine vitamin C concentration
A colorimetric assay kit will be used to measure vitamin C in urine samples
Measured: Pre and post 3 days supplementation
Urine 8-isoprastane concentration
An Enzyme Linked Immuosorbant assay will be used to determine 8-isoprostane concentrations in urine.
Measured: Pre and post 3 days supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start25 Nov 2024
- Primary completion1 Aug 2025
- Study completion22 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kostas Tsintzas, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242066
- Sponsor's protocol ID
- FHMS 128-0224
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.
PubMed 17353456Forstermann U. Nitric oxide and oxidative stress in vascular disease. Pflugers Arch. 2010 May;459(6):923-39. doi: 10.1007/s00424-010-0808-2. Epub 2010 Mar 21.
PubMed 20306272Gori T, Munzel T. Oxidative stress and endothelial dysfunction: therapeutic implications. Ann Med. 2011 Jun;43(4):259-72. doi: 10.3109/07853890.2010.543920. Epub 2011 Feb 1.
PubMed 21284528
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate and Vitamin C Co-supplementation on Blood Pressure and Endothelial Function in Overweight Individuals
- ClinicalTrials.gov ID
- NCT07242066
- Acronym / sponsor ID
- FHMS 128-0224
- Conditions
- Blood Pressure
- Keywords
- Cardiovascular disease, endothelial function, nitrate, Vitamin C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 21 Nov 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.
The investigators have shown in two short-term studies in healthy, young participants that the combined supplementation of inorganic nitrate with vitamin C has beneficial effects on blood pressure and blood vessel wall stiffness. However, the effects of the combined supplementation have not been tested in individuals at greater cardiovascular disease risk. The investigators would like to show whether inorganic nitrate and vitamin C will produce greater effects on blood pressure and endothelial function when compared to inorganic nitrate alone versus the placebo treatment in people at greater risk of cardiovascular disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Nitrate-depleted beetroot juice plus placebo tabletPlacebo beetroot juice and tablet |
| Beetroot juice + Vitamin C | Experimental | Dietary Supplement: Beetroot juice plus vitamin C tabletBeetroot juice and Vitamin C |
| Beetroot juice + placebo | Experimental | Dietary Supplement: Beetroot juice plus placebo tabletBeetroot juice + placebo tablet |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Participant is willing and able to comply with the requirements of the study protocol.
- Non-smoking men and women.
- Aged between 50-75 years.
- Overweight and obese (BMI: over 25.0 kg/m2).
Key exclusion criteria (13 listed)
- Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.
- Vegetarian.
- Smoking.
- Resting systolic blood pressure greater than 160 mmHg; diastolic blood pressure greater than 100 mmHg.
- Active cancer and any diagnosis of malignant cancer in the last 5 years.
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 |
|---|---|---|
| Beetroot juice plus vitamin C tabletConcentrated beetroot juice (70 ml in the morning before breakfast and 70 ml in the evening before dinner) plus Vitamin C tablets (500mg/tablet) | Dietary supplement | Beetroot juice + Vitamin C |
| Beetroot juice plus placebo tabletConcentrated beetroot juice (70ml in the morning and 70 ml in the evening) plus placebo tablets (containing 500 mg of the non-nutritive sweetener aspartame) | Dietary supplement | Beetroot juice + placebo |
| Nitrate-depleted beetroot juice plus placebo tabletnitrate-depleted beetroot juice (70ml in the morning and 70 ml in the evening) plus placebo tablets (containing 500 mg of the non-nutritive sweetener aspartame) | Dietary supplement | Placebo |
Primary outcome
Blood pressure
Time frame: Pre, 24 hours, 48 hours and 72 hours after supplementation
Resting diastolic and systolic blood pressure using portable automated monitor
Cardiac function
Time frame: Pre and post 3 days of supplementation
Resting cardiac function using a non-invasive methodology (Finometer)
6 secondary outcomes
Flow-mediated dilation
Time frame: Pre and post 3 days of supplementation
Saliva nitrate concentration
Time frame: Pre and post 3 days supplementation
Urinary nitrate concentration
Time frame: Pre and post 3 days supplementation
Saliva nitrite concentration
Time frame: Pre and post 3 days supplementation
Urine vitamin C concentration
Time frame: Pre and post 3 days supplementation
Urine 8-isoprastane concentration
Time frame: Pre and post 3 days supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 17353456Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.
- Background: PubMed 20306272Forstermann U. Nitric oxide and oxidative stress in vascular disease. Pflugers Arch. 2010 May;459(6):923-39. doi: 10.1007/s00424-010-0808-2. Epub 2010 Mar 21.
- Background: PubMed 21284528Gori T, Munzel T. Oxidative stress and endothelial dysfunction: therapeutic implications. Ann Med. 2011 Jun;43(4):259-72. doi: 10.3109/07853890.2010.543920. Epub 2011 Feb 1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice plus vitamin C tablet in people with Blood Pressure, run by University of Nottingham 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 2 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Pre, 24 hours, 48 hours and 72 hours after supplementation). The study lists 2 primary outcomes in all. 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 NCT07242066, which also lists 3 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 2 Dec 2025.