HypertensionNCT01236872
The Acute Effect of Beetroot Juice in Normal and Hypertensive Subjects
A study testing Beetroot juice and Water in people with Hypertension, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric oxide is normally produced by the inner lining of blood vessels and helps keep blood vessels open and therefore blood pressure lower. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Beetroot juice and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2009to Dec 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and females between 18 and 85 years of age, inclusive.
- To be eligible, female subjects will be required to state that they are not pregnant, and will not become pregnant during the course of the study.
- Body mass index (BMI) between 18 and 40 kg/m2
- A signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
- Grade 1 hypertensive SBP 140-159 or DBP 90-99 on no anti-hypertensives, no target organ damage (TOD), low cardiovascular disease (CVD) risk
Who cannot join
- History of symptomatic coronary artery disease, stroke, or other known atherosclerotic disease.
- History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
- History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, 3x above the upper limit of normal or bilirubin 1.5x above the upper limit of normal at screening.
- Renal impairment with creatinine clearance (eGFR) of <50 ml/min at screening.
- Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screen.
- Subjects with LDLc, >7.5 mmol/l. Fasting TG level >6mmol/l.
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- History of heart failure defined as NYHA class II - IV or those with known severe LV dysfunction (EF<30%) regardless of symptomatic status
- History of malignancy within the past 5 years, other than non-melanoma skin cancer.
- Current life-threatening condition other than vascular disease (e.g., very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study.
- Alcohol or drug abuse within the past 6 months.
- Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
- Subjects who will commence or who are likely to commence treatment with non-steroidal anti-inflammatory drugs (NSAIDs) (other than aspirin), from screening until study completion.
- Any non-stable dosing of ongoing medication regimens throughout the study trial.
- The subject has a three month prior history of regular alcohol consumption exceeding an average weekly intake of > 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of > 21 units (or an average daily intake of greater than 2 units) for females. 1 unit is equivalent to a halfpint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine; or a positive alcohol breath test at the screening visit
- A positive urine test for drugs of abuse (not related to known medications the subject is taking, ie, codeine for pain management) or alcohol at screening or prior to study medication administration.
- Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication noncompliance, or subject's unwillingness to comply with all study-related study procedures).
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- Subjects with any acute infection, or significant trauma (burns, fractures).
- Subjects who have donated more than 500 mL of blood within 56 days prior to the initiation of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of Beetroot Juice on Circulating Nitrate and Nitrite Levels and Blood Pressure in Normotensives and Hypertensives
Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric oxide is normally produced by the inner lining of blood vessels and helps keep blood vessels open and therefore blood pressure lower. In subjects with high blood pressure, the inner lining of the blood vessels does not function adequately. The investigators wish to investigate whether elevating systemic levels of inorganic nitrate (through provision of dietary nitrate-rich vegetables) can elevate levels of nitrate/nitrite in hypertensive subjects, and whether this has a beneficial effect on blood pressure.
- Conditions
- Hypertension
- Being tested
- Beetroot juice, Water
- Keywords
- Nitrate, Nitrite, Vegetable, Aortic stiffness
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
250ml once of beetroot juice
WaterDietary supplement
250ml once of low-nitrate mineral water
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Experimental | 250ml beetroot juice ingestion Receives: Dietary Supplement: Beetroot juice |
| Water | Placebo comparator | 250ml low-nitrate water placebo Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in circulating nitrate/nitrite/cGMP levels
Measured: 24 hours
Secondary outcomes (2)
Changes in blood pressure
Measured: 24 hours
arterial stiffness
pulse wave velocity
Measured: 3hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Investigators
- Amrita Ahluwalia, Principal investigator, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236872
- Sponsor's protocol ID
- 08/H0703/91 Acute
- Status last verified
- Jul 2011
- First submitted
- 8 Nov 2010
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28.
PubMed 20585108Webb AJ, Patel N, Loukogeorgakis S, Okorie M, Aboud Z, Misra S, Rashid R, Miall P, Deanfield J, Benjamin N, MacAllister R, Hobbs AJ, Ahluwalia A. Acute blood pressure lowering, vasoprotective, and antiplatelet properties of dietary nitrate via bioconversion to nitrite. Hypertension. 2008 Mar;51(3):784-90. doi: 10.1161/HYPERTENSIONAHA.107.103523. Epub 2008 Feb 4.
PubMed 18250365
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Beetroot Juice on Circulating Nitrate and Nitrite Levels and Blood Pressure in Normotensives and Hypertensives
- ClinicalTrials.gov ID
- NCT01236872
- Acronym / sponsor ID
- 08/H0703/91 Acute
- Conditions
- Hypertension
- Keywords
- Nitrate, Nitrite, Vegetable, Aortic stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Nov 2010 (estimated)
- 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.
Inorganic nitrate can be converted to nitrite and thence nitric oxide in humans. Nitric oxide is normally produced by the inner lining of blood vessels and helps keep blood vessels open and therefore blood pressure lower. In subjects with high blood pressure, the inner lining of the blood vessels does not function adequately. The investigators wish to investigate whether elevating systemic levels of inorganic nitrate (through provision of dietary nitrate-rich vegetables) can elevate levels of nitrate/nitrite in hypertensive subjects, and whether this has a beneficial effect on blood pressure.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Experimental | Dietary Supplement: Beetroot juice250ml beetroot juice ingestion |
| Water | Placebo comparator | Dietary Supplement: Water250ml low-nitrate water placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male and females between 18 and 85 years of age, inclusive.
- To be eligible, female subjects will be required to state that they are not pregnant, and will not become pregnant during the course of the study.
- Body mass index (BMI) between 18 and 40 kg/m2
- A signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Key exclusion criteria (19 listed)
- History of symptomatic coronary artery disease, stroke, or other known atherosclerotic disease.
- History of chronic viral hepatitis (including presence of hepatitis B surface antigen or hepatitis C antibody), or other chronic hepatic disorders.
- History of increased liver function tests (ALT, AST) due to acute or chronic liver conditions, 3x above the upper limit of normal or bilirubin 1.5x above the upper limit of normal at screening.
- Renal impairment with creatinine clearance (eGFR) of <50 ml/min at screening.
- Current poorly controlled diabetes mellitus, defined as HbA1c >10% at Screen.
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 juice250ml once of beetroot juice | Dietary supplement | Beetroot juice |
| Water250ml once of low-nitrate mineral water | Dietary supplement | Water |
Primary outcome
Changes in circulating nitrate/nitrite/cGMP levels
Time frame: 24 hours
2 secondary outcomes
Changes in blood pressure
Time frame: 24 hours
arterial stiffness
Time frame: 3hours
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 8 Aug 2011.
- Background: PubMed 20585108Kapil V, Milsom AB, Okorie M, Maleki-Toyserkani S, Akram F, Rehman F, Arghandawi S, Pearl V, Benjamin N, Loukogeorgakis S, Macallister R, Hobbs AJ, Webb AJ, Ahluwalia A. Inorganic nitrate supplementation lowers blood pressure in humans: role for nitrite-derived NO. Hypertension. 2010 Aug;56(2):274-81. doi: 10.1161/HYPERTENSIONAHA.110.153536. Epub 2010 Jun 28.
- Background: PubMed 18250365Webb AJ, Patel N, Loukogeorgakis S, Okorie M, Aboud Z, Misra S, Rashid R, Miall P, Deanfield J, Benjamin N, MacAllister R, Hobbs AJ, Ahluwalia A. Acute blood pressure lowering, vasoprotective, and antiplatelet properties of dietary nitrate via bioconversion to nitrite. Hypertension. 2008 Mar;51(3):784-90. doi: 10.1161/HYPERTENSIONAHA.107.103523. Epub 2008 Feb 4.
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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.
Amrita Ahluwalia principal investigator
QMUL
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 and Water in people with Hypertension, run by Queen Mary University of London 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 6 inclusion and 19 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 8 Aug 2011. 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?
Changes in circulating nitrate/nitrite/cGMP levels (time frame: 24 hours). 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 NCT01236872, which also lists 2 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 8 Aug 2011.