Blood PressureNCT05514821
Inter-individual Variation in the Blood Pressure Lowering Effects of Dietary Nitrate
A study testing Beet It Sport Shot in people with Blood Pressure, run by Newcastle University at 1 site in United Kingdom.
Trial summary
Dietary nitrate supplementation, often in the form of beetroot juice, has been shown to lower blood pressure and could play a role in preventing or treating hypertension. However, it is currently unclear: a) how reproducible this response is within the same individual on different occasions, and b) whether there are… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Beet It Sport Shot
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2022to 25 Sep 2023
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- Aged 18 - 45 years
Who cannot join
- Aged less than 18 or more than 45 years old
- Female
- Currently taking any medication or antibiotics
- Attending general practitioner for a health problem or on a hospital waiting list
- Currently taking part in another research study which could conflict with the requirements for this investigation
- Regularly use antibacterial mouthwash and unwilling to stop using this throughout the study period
Show all 14Show fewer
- Current smoker
- History of kidney, liver or cardiovascular disease
- Have diabetes
- Have a gastrointestinal disorder
- Recent history (past 1 year) of cancer
- Use of other dietary supplements e.g., pre and probiotics
- Currently dieting
- Have a known allergy to any components within the dietary supplement
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Nutrition & Exercise Research Centre
Newcastle upon Tyne, Northumberland, NE24HH
About this study
Official title: Effects of Dietary Nitrate on Blood Pressure: Exploring the Repeatability and Inter-individual Variation in Responses
Dietary nitrate supplementation, often in the form of beetroot juice, has been shown to lower blood pressure and could play a role in preventing or treating hypertension. However, it is currently unclear: a) how reproducible this response is within the same individual on different occasions, and b) whether there are genuine individual differences in the blood pressure lowering effects of dietary nitrate. This study will use a novel replicated cross-over design (2 x nitrate conditions, 2 x placebo conditions) to examine the reproducibility and inter-individual variability in the blood pressure lowering effects of dietary nitrate supplementation.
Read the detailed description
The investigators will undertake a replicated cross-over randomised controlled trial (i.e., a study involving 2 x identical experimental conditions and 2 x identical control conditions), to explore the reproducibility of the blood pressure lowering effects of nitrate-rich beetroot juice, and to identify if there are genuine individual differences in the blood pressure-lowering effects of this supplement. Participants will be recruited via posters, email and social media, and interested individuals will be invited to attend the laboratory on 5 occasions.
Visit 1: Potential participants will be invited to attend a screening session at Newcastle University to identify if they are eligible to participate. They will have an opportunity to discuss the study with a researcher and will provide written consent. They will then complete a screening questionnaire and provide a measure of their height, weight and blood pressure. Eligible participants will be invited to attend 4 experimental trials (2 x nitrate-rich beetroot juice conditions, 2 x placebo conditions) over 2-3 weeks with a minimum of 3 days wash-out between visits. If individuals are ineligible to participate this will be explained to them and they will be thanked for their time.
Visits 2-5: On the day before the first trial, participants will be asked to record what they eat and then replicate this as closely as possible for all future visits. In the morning of each trial, participants will be asked to arrive at the laboratory between 7-9 am having fasted since 10 pm the night before. The participants will be required to rest for 10 minutes, after which a measure of their blood pressure will be obtained. Participants will then be provided with breakfast (a bowl of porridge) and 140 ml concentrated nitrate-rich (~12.5 mmol nitrate) or nitrate-depleted beetroot juice (~0 mmol nitrate). Participants will then be asked to sit in the laboratory for 2.5 hours, during which time they can read quietly or use a computer. The investigators will then obtain a further measure of their blood pressure and collect a blood sample from a vein in their arm via venepuncture, to measure markers of nitric oxide, a signalling molecule in the body which is thought to mediate the blood pressure lowering effects of nitrate-rich beetroot juice.
- Conditions
- Blood Pressure
- Being tested
- Beet It Sport Shot, Beet It Sport Shot Placebo
- Keywords
- Hypertension, Personalized nutrition, Nitric oxide, Beetroot juice
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beet It Sport ShotDietary supplement
Acute supplementation with 140 ml Beet It Sport Shots, James White Ltd, containing ~400mg dietary nitrate
Beet It Sport Shot PlaceboDietary supplement
Acute supplementation with 140 ml Beet It Sport Shots Placebo, James White Ltd, in which the nitrate has been removed via an ion exchange resin, containing ~ 0 mg dietary nitrate
| Study group | Role | What they receive |
|---|---|---|
| Experimental condition 1 | Experimental | Acute supplementation with 140 ml Beet It Sport Shots, James White Ltd (~400mg dietary nitrate) Receives: Dietary Supplement: Beet It Sport Shot |
| Experimental condition 2 | Experimental | Acute supplementation with 140 ml Beet It Sport Shots, James White Ltd (~400mg dietary nitrate) Receives: Dietary Supplement: Beet It Sport Shot |
| Control condition 1 | Placebo comparator | Acute supplementation with 140 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate) Receives: Dietary Supplement: Beet It Sport Shot Placebo |
| Control condition 2 | Placebo comparator | Acute supplementation with 140 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate) Receives: Dietary Supplement: Beet It Sport Shot Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure of the brachial artery
Blood pressure of the brachial artery
Measured: Immediately prior to supplementation and for 2.5 hours after supplementation
Secondary outcomes (1)
Plasma nitrite concentrations
Plasma nitrite concentrations
Measured: 2.5 hours after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start15 Oct 2022
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Replicated cross-over trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle University
- Sponsor type
- University, hospital or other
- Collaborators
- University of the West of Scotland, University of Nottingham, Aspire Academy, Liverpool John Moores University
- Responsible party
- Sponsor
- Investigators
- Oliver Shannon, PhD, Principal investigator, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514821
- Sponsor's protocol ID
- NU013253
- Status last verified
- Dec 2023
- First submitted
- 22 Aug 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded to a repository following publication of the study results
Publications
Hayes E, Alhulaefi S, Siervo M, Whyte E, Kimble R, Matu J, Griffiths A, Sim M, Burleigh M, Easton C, Lolli L, Atkinson G, Mathers JC, Shannon OM. Inter-individual differences in the blood pressure lowering effects of dietary nitrate: a randomised double-blind placebo-controlled replicate crossover trial. Eur J Nutr. 2025 Feb 24;64(2):101. doi: 10.1007/s00394-025-03616-x.
PubMed 39992469
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate on Blood Pressure: Exploring the Repeatability and Inter-individual Variation in Responses
- ClinicalTrials.gov ID
- NCT05514821
- Acronym / sponsor ID
- NU013253
- Conditions
- Blood Pressure
- Keywords
- Hypertension, Personalized nutrition, Nitric oxide, Beetroot juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Newcastle UniversityUniversity, hospital or other
- Collaborators
- University of the West of Scotland, University of Nottingham, Aspire Academy, Liverpool John Moores University
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 24 Aug 2022 (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.
Dietary nitrate supplementation, often in the form of beetroot juice, has been shown to lower blood pressure and could play a role in preventing or treating hypertension. However, it is currently unclear: a) how reproducible this response is within the same individual on different occasions, and b) whether there are genuine individual differences in the blood pressure lowering effects of dietary nitrate. This study will use a novel replicated cross-over design (2 x nitrate conditions, 2 x placebo conditions) to examine the reproducibility and inter-individual variability in the blood pressure lowering effects of dietary nitrate supplementation.
Detailed description
The investigators will undertake a replicated cross-over randomised controlled trial (i.e., a study involving 2 x identical experimental conditions and 2 x identical control conditions), to explore the reproducibility of the blood pressure lowering effects of nitrate-rich beetroot juice, and to identify if there are genuine individual differences in the blood pressure-lowering effects of this supplement. Participants will be recruited via posters, email and social media, and interested individuals will be invited to attend the laboratory on 5 occasions.
Visit 1: Potential participants will be invited to attend a screening session at Newcastle University to identify if they are eligible to participate. They will have an opportunity to discuss the study with a researcher and will provide written consent. They will then complete a screening questionnaire and provide a measure of their height, weight and blood pressure. Eligible participants will be invited to attend 4 experimental trials (2 x nitrate-rich beetroot juice conditions, 2 x placebo conditions) over 2-3 weeks with a minimum of 3 days wash-out between visits. If individuals are ineligible to participate this will be explained to them and they will be thanked for their time.
Visits 2-5: On the day before the first trial, participants will be asked to record what they eat and then replicate this as closely as possible for all future visits. In the morning of each trial, participants will be asked to arrive at the laboratory between 7-9 am having fasted since 10 pm the night before. The participants will be required to rest for 10 minutes, after which a measure of their blood pressure will be obtained. Participants will then be provided with breakfast (a bowl of porridge) and 140 ml concentrated nitrate-rich (~12.5 mmol nitrate) or nitrate-depleted beetroot juice (~0 mmol nitrate). Participants will then be asked to sit in the laboratory for 2.5 hours, during which time they can read quietly or use a computer. The investigators will then obtain a further measure of their blood pressure and collect a blood sample from a vein in their arm via venepuncture, to measure markers of nitric oxide, a signalling molecule in the body which is thought to mediate the blood pressure lowering effects of nitrate-rich beetroot juice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Replicated cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Experimental condition 1 | Experimental | Dietary Supplement: Beet It Sport ShotAcute supplementation with 140 ml Beet It Sport Shots, James White Ltd (~400mg dietary nitrate) |
| Experimental condition 2 | Experimental | Dietary Supplement: Beet It Sport ShotAcute supplementation with 140 ml Beet It Sport Shots, James White Ltd (~400mg dietary nitrate) |
| Control condition 1 | Placebo comparator | Dietary Supplement: Beet It Sport Shot PlaceboAcute supplementation with 140 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate) |
| Control condition 2 | Placebo comparator | Dietary Supplement: Beet It Sport Shot PlaceboAcute supplementation with 140 ml nitrate-depleted Beet It Sport Shots, James White Ltd (~0mg dietary nitrate) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteers
- Aged 18 - 45 years
Key exclusion criteria (14 listed)
- Aged less than 18 or more than 45 years old
- Female
- Currently taking any medication or antibiotics
- Attending general practitioner for a health problem or on a hospital waiting list
- Currently taking part in another research study which could conflict with the requirements for this investigation
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 |
|---|---|---|
| Beet It Sport ShotAcute supplementation with 140 ml Beet It Sport Shots, James White Ltd, containing ~400mg dietary nitrate | Dietary supplement | Experimental condition 1, Experimental condition 2 |
| Beet It Sport Shot PlaceboAcute supplementation with 140 ml Beet It Sport Shots Placebo, James White Ltd, in which the nitrate has been removed via an ion exchange resin, containing ~ 0 mg dietary nitrate | Dietary supplement | Control condition 1, Control condition 2 |
Primary outcome
Blood pressure of the brachial artery
Time frame: Immediately prior to supplementation and for 2.5 hours after supplementation
Blood pressure of the brachial artery
1 secondary outcome
Plasma nitrite concentrations
Time frame: 2.5 hours after 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 5 Dec 2023.
- Derived from this study: PubMed 39992469Hayes E, Alhulaefi S, Siervo M, Whyte E, Kimble R, Matu J, Griffiths A, Sim M, Burleigh M, Easton C, Lolli L, Atkinson G, Mathers JC, Shannon OM. Inter-individual differences in the blood pressure lowering effects of dietary nitrate: a randomised double-blind placebo-controlled replicate crossover trial. Eur J Nutr. 2025 Feb 24;64(2):101. doi: 10.1007/s00394-025-03616-x.
- Individual participant dataSharing planned: Yes. Data will be uploaded to a repository following publication of the study results
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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.
Oliver Shannon, PhD principal investigator
Newcastle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beet It Sport Shot in people with Blood Pressure, run by Newcastle University 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 2 inclusion and 14 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 5 Dec 2023. 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 of the brachial artery (time frame: Immediately prior to supplementation and for 2.5 hours after supplementation). 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 NCT05514821, which also lists 1 linked publication.
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 5 Dec 2023.