Blood PressureNIVJUSNCT04736784
Effect of High Nitrate Vegetable Juice Supplementation on Plasma Nitrate and Blood Pressure in Healthy Adults
A study testing Food-based - beetroot juice and Food-based - leafy green vegetable juice in people with Blood Pressure, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Aims: The aim of this study is to carry out a randomised crossover intervention study examining the effect of two different high nitrate vegetable juices on plasma nitrate levels and blood pressure (BP) in healthy adults. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Food-based - beetroot juice and Food-based - leafy green vegetable juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2017to 15 May 2017
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Aged 30-65 years
Who cannot join
- Diabetes mellitus
- An acute coronary syndrome or transient ischaemic attack within the past 3 months
- Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
- Oral anticoagulation therapy
- Recent beetroot juice (or other nitrate) supplementation.
- BMI>35 kg/m2
Show all 10Show fewer
- Excessive alcohol consumption ( >14 U/week for men and women)
- Current smoker
- Pregnancy/ lactation
- Medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, Northern Ireland, BT12 6BJ
About this study
Official title: Effect of High Nitrate Vegetable Juice Supplementation on Plasma Nitrate and Blood Pressure in Healthy Adults: a Pilot Randomised Crossover Intervention in Healthy Volunteers
Aims: The aim of this study is to carry out a randomised crossover intervention study examining the effect of two different high nitrate vegetable juices on plasma nitrate levels and blood pressure (BP) in healthy adults.
Objectives: 1) to conduct a pilot cross-over randomized intervention study testing the hypothesis that the health benefits of two different high nitrate vegetable juices products will be similar; 2) to measure the volunteers' BP as the primary outcome; and 3) to collect biological samples over the course of this study for the measurement of proposed biomarkers of nutritional status, including plasma nitrate.
Read the detailed description
In this study, it is hypothesized that oral supplementation with different vegetable juices (beetroot and green leafy vegetable) juice, with similar nitrate content, over a one week period, will decrease BP in healthy volunteers to a similar extent.
Plan of Investigation: This study will be a randomised, controlled, crossover (2 groups) trial of beetroot juice and green leafy vegetable juice.
Participants A total of 16 healthy volunteers will be recruited (male and female), according to the stated inclusion and exclusion criteria.
Recruitment Subjects will be screened and recruited from the general population through advertisement, through local community groups and staff intranet postings (university setting). The investigators have established mechanisms for recruiting from these populations that have proven to be effective in previous studies.
Study design Following screening, eligible participants will give informed written consent. Participants will be randomized, using computer-generated random numbers, to two groups.
Before starting the intervention (one week before), participants will be asked to complete a four day food diary.
Participants will consume one of the stated interventions daily (in the evening) for one week. Then, the participant will follow their normal diet and will not consume nitrate-rich juices for two weeks (washout period). In the fourth week, participants will consume the alternative intervention to that already consumed - beetroot juice or green leafy vegetables juice for a further one week.
Intervention products The beetroot juice will be Organic beetroot and apple juice (James White Drinks Ltd, UK), while the leafy green vegetable juice will be Leanandgreen (Cold Pressed Juice) composed of 30% celery, 30% cucumber, 15% romaine, 15% spinach, 5% kale, 2.5% ginger and 2.5% lemon (B. Fresh, UK). Both juices are available at Sainsbury's supermarket.
Both juices contain 5.5 mmol nitrate with different amount of the other nutrients. 250 ml of green leafy vegetable juice and 115 ml of beetroot juice will provide 5.5 mmol of nitrate daily to the participants.
Juices will provided to the volunteers by the researcher before the intervention week and both juices will have expiry dates that are beyond the intervention duration.
Other lifestyle practices Participants will be asked to not change any other part of their diet and to keep physical activity, alcohol, and caffeine and water source normal. Participants will be asked to avoid using mouthwash during the intervention weeks, as this can interfere with nitrate metabolism.
Justification for one-week intervention period. Inorganic nitrate and BP will respond quickly to the intervention, so a one week intervention period will be sufficiently long to ensure that participants will reach a steady state with regard to nitrate status.
Study assessments (for participant characterisation, in addition to primary and secondary outcome data collection as described) During each intervention week participants will be asked to complete a further four day food diary. Participants will also attend the Centre for Public Health (CPH) to give a blood sample and have BP measured at the start and end of each intervention period. Anthropometric data (weight and height) will also be obtained by standard procedures and BMI will be calculated as weight in kg divided by the squared height in metres.
Blood samples (20 ml) will be drawn from the antecubital vein and immediately separated and stored for the proposed assays detailed below. All blood samples will be stored at -70°C until analysis.
Power As this is a pilot study, power calculations have not been conducted.
Statistical analysis Statistical analysis will be carried out using SPSS for Windows, version 17. A medical statistician within CPH will give statistical advice where required. Analysis of this two-period crossover study will be carried out according to the Hills \& Armitage method. If there are no significant period or carry-over effects, which will be tested for, paired samples t-tests will be used to compare the intervention group.
Data protection issues: Data collected in association with this study will be anonymised and archived in password-protected study databases. All biological samples collected will be anonymised.
- Conditions
- Blood Pressure
- Being tested
- Food-based - beetroot juice, Food-based - leafy green vegetable juice
- Keywords
- nitrate rich juices, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-based - beetroot juiceOther
Beetroot juice containing approximately 340 mg nitrate daily
Food-based - leafy green vegetable juiceOther
Leafy green vegetable juice containing approximately 340 mg nitrate daily
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Experimental | 115 ml of beetroot juice per day for seven days Receives: Other: Food-based - beetroot juice |
| Leafy green vegetable juice | Experimental | 250 ml of green leafy vegetable juice per day for seven days Receives: Other: Food-based - leafy green vegetable juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure (clinic-based)
Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.
Measured: At baseline
Blood pressure (clinic-based)
Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.
Measured: After seven days
Blood pressure (home-assessed)
An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.
Measured: Pre juice consumption during the intervention
Blood pressure (home-assessed)
An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.
Measured: Two hours post juice consumption during the intervention
Secondary outcomes (3)
Serum nitrate and nitrite concentrations
Serum concentrations of nitrate and nitrite. Total Nitric Oxide, nitrate and nitrite in plasma will be determined by an automated ELISA method (R\&D Systems).
Measured: At baseline
Serum nitrate and nitrite concentrations
Serum concentrations of nitrate and nitrite. Total Nitric Oxide, nitrate and nitrite in plasma will be determined by an automated ELISA method (R\&D Systems).
Measured: After seven days
Participant views on interventions
Acceptability and ease of consumption assessed via questionnaire with Likert scale responses
Measured: At end of the seven day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start30 Jan 2017
- Primary completion30 Apr 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayne Woodside, PhD, Queen's University, Belfast
- Investigators
- Jayne Woodside, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736784
- Sponsor's protocol ID
- QUB 16.60
- Acronym
- NIVJUS
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Nitrate Vegetable Juice Supplementation on Plasma Nitrate and Blood Pressure in Healthy Adults: a Pilot Randomised Crossover Intervention in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04736784
- Acronym / sponsor ID
- NIVJUS / QUB 16.60
- Conditions
- Blood Pressure
- Keywords
- nitrate rich juices, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 3 Feb 2021 (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.
Aims: The aim of this study is to carry out a randomised crossover intervention study examining the effect of two different high nitrate vegetable juices on plasma nitrate levels and blood pressure (BP) in healthy adults.
Objectives: 1) to conduct a pilot cross-over randomized intervention study testing the hypothesis that the health benefits of two different high nitrate vegetable juices products will be similar; 2) to measure the volunteers' BP as the primary outcome; and 3) to collect biological samples over the course of this study for the measurement of proposed biomarkers of nutritional status, including plasma nitrate.
Detailed description
In this study, it is hypothesized that oral supplementation with different vegetable juices (beetroot and green leafy vegetable) juice, with similar nitrate content, over a one week period, will decrease BP in healthy volunteers to a similar extent.
Plan of Investigation: This study will be a randomised, controlled, crossover (2 groups) trial of beetroot juice and green leafy vegetable juice.
Participants A total of 16 healthy volunteers will be recruited (male and female), according to the stated inclusion and exclusion criteria.
Recruitment Subjects will be screened and recruited from the general population through advertisement, through local community groups and staff intranet postings (university setting). The investigators have established mechanisms for recruiting from these populations that have proven to be effective in previous studies.
Study design Following screening, eligible participants will give informed written consent. Participants will be randomized, using computer-generated random numbers, to two groups.
Before starting the intervention (one week before), participants will be asked to complete a four day food diary.
Participants will consume one of the stated interventions daily (in the evening) for one week. Then, the participant will follow their normal diet and will not consume nitrate-rich juices for two weeks (washout period). In the fourth week, participants will consume the alternative intervention to that already consumed - beetroot juice or green leafy vegetables juice for a further one week.
Intervention products The beetroot juice will be Organic beetroot and apple juice (James White Drinks Ltd, UK), while the leafy green vegetable juice will be Leanandgreen (Cold Pressed Juice) composed of 30% celery, 30% cucumber, 15% romaine, 15% spinach, 5% kale, 2.5% ginger and 2.5% lemon (B. Fresh, UK). Both juices are available at Sainsbury's supermarket.
Both juices contain 5.5 mmol nitrate with different amount of the other nutrients. 250 ml of green leafy vegetable juice and 115 ml of beetroot juice will provide 5.5 mmol of nitrate daily to the participants.
Juices will provided to the volunteers by the researcher before the intervention week and both juices will have expiry dates that are beyond the intervention duration.
Other lifestyle practices Participants will be asked to not change any other part of their diet and to keep physical activity, alcohol, and caffeine and water source normal. Participants will be asked to avoid using mouthwash during the intervention weeks, as this can interfere with nitrate metabolism.
Justification for one-week intervention period. Inorganic nitrate and BP will respond quickly to the intervention, so a one week intervention period will be sufficiently long to ensure that participants will reach a steady state with regard to nitrate status.
Study assessments (for participant characterisation, in addition to primary and secondary outcome data collection as described) During each intervention week participants will be asked to complete a further four day food diary. Participants will also attend the Centre for Public Health (CPH) to give a blood sample and have BP measured at the start and end of each intervention period. Anthropometric data (weight and height) will also be obtained by standard procedures and BMI will be calculated as weight in kg divided by the squared height in metres.
Blood samples (20 ml) will be drawn from the antecubital vein and immediately separated and stored for the proposed assays detailed below. All blood samples will be stored at -70°C until analysis.
Power As this is a pilot study, power calculations have not been conducted.
Statistical analysis Statistical analysis will be carried out using SPSS for Windows, version 17. A medical statistician within CPH will give statistical advice where required. Analysis of this two-period crossover study will be carried out according to the Hills \& Armitage method. If there are no significant period or carry-over effects, which will be tested for, paired samples t-tests will be used to compare the intervention group.
Data protection issues: Data collected in association with this study will be anonymised and archived in password-protected study databases. All biological samples collected will be anonymised.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Experimental | Other: Food-based - beetroot juice115 ml of beetroot juice per day for seven days |
| Leafy green vegetable juice | Experimental | Other: Food-based - leafy green vegetable juice250 ml of green leafy vegetable juice per day for seven days |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Aged 30-65 years
Key exclusion criteria (10 listed)
- Diabetes mellitus
- An acute coronary syndrome or transient ischaemic attack within the past 3 months
- Special dietary requirements, food sensitivities or vegetarian/ vegan diet by choice
- Oral anticoagulation therapy
- Recent beetroot juice (or other nitrate) supplementation.
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 |
|---|---|---|
| Food-based - beetroot juiceBeetroot juice containing approximately 340 mg nitrate daily | Other | Beetroot juice |
| Food-based - leafy green vegetable juiceLeafy green vegetable juice containing approximately 340 mg nitrate daily | Other | Leafy green vegetable juice |
Primary outcome
Blood pressure (clinic-based)
Time frame: At baseline
Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.
Blood pressure (clinic-based)
Time frame: After seven days
Clinic-based blood pressure using automated, calibrated blood pressure monitor, measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes.
Blood pressure (home-assessed)
Time frame: Pre juice consumption during the intervention
An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.
Blood pressure (home-assessed)
Time frame: Two hours post juice consumption during the intervention
An automated BP monitor (Omron M2Basic, Omron Healthcare) will be provided to each participant to measure daily resting BP at home. Participants will be asked to conduct duplicate measurements, in a seated position prior to juice consumption and at 2 hours after juice drinking and they will be trained on how to use the monitor, with an emphasis on the correct positioning of the cuff and arm. In addition, written instructions on measuring BP will be provided. Participants will be provided with a record sheet to record their measurements.
3 secondary outcomes
Serum nitrate and nitrite concentrations
Time frame: At baseline
Serum nitrate and nitrite concentrations
Time frame: After seven days
Participant views on interventions
Time frame: At end of the seven day intervention
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 3 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Jayne Woodside principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food-based - beetroot juice and Food-based - leafy green vegetable juice in people with Blood Pressure, run by Queen's University, Belfast 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 10 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 3 Feb 2021. 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. 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 (clinic-based) (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2021.