HypertensionNCT01405898
The Chronic Effects of Beetroot Juice in Hypertensive Subjects
A study testing beetroot juice and Nitrate-free beetroot juice in people with Hypertension, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
We are interested in the effect of diet on blood pressure. Our previous research has shown that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot juice has this effect in people with high blood pressure. 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 Nitrate-free beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy 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.
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- and either of the following categories of blood pressure
- Category 1---Pre---hypertensive SBP 130---139 or DBP 85---89 on no antihypertensives and will not commence antihypertensives during the course of the study.
- Category 2---Grade 1 hypertensive SBP 140---159 or DBP 90---99 on no anti---hypertensives, no target organ damage (TOD), low cardiovascular disease (CVD) risk Category 3---Uncontrolled severe resistant (Grade 3) hypertensive with evidence of difficulty treating to target BP (140/85 or 130/80), with satisfactory adherence to at least one antihypertensive, but insufficient efficacy or intolerance of medications. (Category 3 patients may also be on aspirin and/or a stable dose of cholesterol---lowering medications e.g statins).
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
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- Subjects with LDLc, >7.5 mmol/l. Fasting TG level >6mmol/l.
- 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 half---pint (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, i.e., 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 study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Mary University London
London, London, EC1M 6BQ
About this study
Official title: The Chronic Effects of Beetroot Juice on Circulating Plasma Nitrate and Nitrite Levels and Blood Pressure in Hypertensive Subjects
We are interested in the effect of diet on blood pressure. Our previous research has shown that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot juice has this effect in people with high blood pressure. Beetroot juice is naturally rich in nitrate (also found in most other vegetables but particularly in green leafy vegetables). We think that it is the nitrate that lowers the blood pressure.
- Conditions
- Hypertension
- Being tested
- beetroot juice, Nitrate-free beetroot juice
- Keywords
- hypertension, nitrite, blood pressure, endothelial function
- 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
Beetroot juice 4 weeks 250ml daily
Nitrate-free beetroot juiceDietary supplement
Nitrate-free beetroot juice 4 weeks 250ml daily
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Juice | Experimental | Not described Receives: Dietary Supplement: beetroot juice |
| Nitrate-free beetroot juice | Placebo comparator | Not described Receives: Dietary Supplement: Nitrate-free beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in Clinic Systolic Blood Pressure From Baseline
Measured: 4 weeks
Difference in Change in Clinic Diastolic Blood Pressure From Baseline
Measured: 4 weeks
Difference in Change in Ambulatory Systolic Blood Pressure From Baseline
Measured: 4 weeks
Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline
Measured: 4 weeks
Secondary outcomes (3)
Difference in Change in Plasma Nitrite Concentration From Baseline
Measured: 4 weeks
Difference in Change in Endothelial Function From Baseline
as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function
Measured: 4 weeks
Difference in Change in Arterial Stiffness From Baseline
carotid-femoral pulse wave velocity [m/s] measured by Vicorder
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amrita Ahluwalia, Queen Mary University of London
- Investigators
- Amrita Ahluwalia, Principal investigator, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405898
- Sponsor's protocol ID
- 08/H0703/91 Chronic
- Status last verified
- Dec 2015
- First submitted
- 28 Jul 2011
- Last updated
- 8 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.
PubMed 25421976
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Effects of Beetroot Juice on Circulating Plasma Nitrate and Nitrite Levels and Blood Pressure in Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT01405898
- Acronym / sponsor ID
- 08/H0703/91 Chronic
- Conditions
- Hypertension
- Keywords
- hypertension, nitrite, blood pressure, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Posted 9 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are interested in the effect of diet on blood pressure. Our previous research has shown that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot juice has this effect in people with high blood pressure. Beetroot juice is naturally rich in nitrate (also found in most other vegetables but particularly in green leafy vegetables). We think that it is the nitrate that lowers the blood pressure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot Juice | Experimental | Dietary Supplement: beetroot juice |
| Nitrate-free beetroot juice | Placebo comparator | Dietary Supplement: Nitrate-free beetroot juice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Healthy 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
Key exclusion criteria (20 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
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 juiceBeetroot juice 4 weeks 250ml daily | Dietary supplement | Beetroot Juice |
| Nitrate-free beetroot juiceNitrate-free beetroot juice 4 weeks 250ml daily | Dietary supplement | Nitrate-free beetroot juice |
Primary outcome
Difference in Change in Clinic Systolic Blood Pressure From Baseline
Time frame: 4 weeks
Difference in Change in Clinic Diastolic Blood Pressure From Baseline
Time frame: 4 weeks
Difference in Change in Ambulatory Systolic Blood Pressure From Baseline
Time frame: 4 weeks
Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline
Time frame: 4 weeks
3 secondary outcomes
Difference in Change in Plasma Nitrite Concentration From Baseline
Time frame: 4 weeks
Difference in Change in Endothelial Function From Baseline
Time frame: 4 weeks
Difference in Change in Arterial Stiffness From Baseline
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25421976Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24.
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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
Queen Mary University London
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 Nitrate-free beetroot juice 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 9 inclusion and 20 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 Jan 2016. 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?
Yes. Results are posted in the registry (first posted 9 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Change in Clinic Systolic Blood Pressure From Baseline (time frame: 4 weeks). 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?
On the ClinicalTrials.gov record for NCT01405898, 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 8 Jan 2016.