HypertensionNCT01706718
Beetroot Enriched Bread, Blood Pressure and Vascular Function
A study testing Bread in people with Hypertension, run by University of Reading at 1 site in United Kingdom.
Trial summary
Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Oct 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 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- A signed consent form
- Age 18-64 years
- Body mass index - 18.5-30 kg/m2
- Non-smoking, healthy individuals
- Normal blood pressure at screening (< 150/90)
Who cannot join
- Subjects with anaemia
- Sufferers of chronic illnesses
- Individuals with food allergies
- People with diabetes
- People with coeliac disease
- Women
- Vegetarians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men
Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.
- Conditions
- Hypertension
- Being tested
- Bread
- Keywords
- Beetroot, Blood pressure, Vascular function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreadDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control white bread | Placebo comparator | Not described Receives: Dietary Supplement: Bread |
| Beetroot bread | Experimental | Not described Receives: Dietary Supplement: Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reactivity
Forearm blood flow by Laser Doppler Imaging with iontophoresis
Measured: Change from baseline at 2, 4 and 6 hours after bread consumption
Secondary outcomes (4)
Arterial stiffness
Pulse wave analysis (PWA) and velocity (PWV)
Measured: Change from baseline at 2, 4 and 6 hours after bread consumption
Blood pressure
By ambulatory blood pressure monitor
Measured: Change from baseline at 30 minute intervals for 7 hours
Plasma nitrate
Measured: Every 30 minutes for 7 hours
Plasma nitrite
Measured: Every 30 minutes for 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706718
- Sponsor's protocol ID
- 10/18
- Other IDs
- University of Reading
- Status last verified
- Oct 2012
- First submitted
- 27 Sep 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
PubMed 22414688Hobbs DA, Goulding MG, Nguyen A, Malaver T, Walker CF, George TW, Methven L, Lovegrove JA. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial. J Nutr. 2013 Sep;143(9):1399-405. doi: 10.3945/jn.113.175778. Epub 2013 Jul 24.
PubMed 23884387
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men
- ClinicalTrials.gov ID
- NCT01706718
- Acronym / sponsor ID
- 10/18
- Conditions
- Hypertension
- Keywords
- Beetroot, Blood pressure, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Oct 2012 (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.
Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control white bread | Placebo comparator | Dietary Supplement: Bread |
| Beetroot bread | Experimental | Dietary Supplement: Bread |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- A signed consent form
- Age 18-64 years
- Body mass index - 18.5-30 kg/m2
- Non-smoking, healthy individuals
Key exclusion criteria (7 listed)
- Subjects with anaemia
- Sufferers of chronic illnesses
- Individuals with food allergies
- People with diabetes
- People with coeliac disease
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 |
|---|---|---|
| Bread | Dietary supplement | Beetroot bread, Control white bread |
Primary outcome
Vascular reactivity
Time frame: Change from baseline at 2, 4 and 6 hours after bread consumption
Forearm blood flow by Laser Doppler Imaging with iontophoresis
4 secondary outcomes
Arterial stiffness
Time frame: Change from baseline at 2, 4 and 6 hours after bread consumption
Blood pressure
Time frame: Change from baseline at 30 minute intervals for 7 hours
Plasma nitrate
Time frame: Every 30 minutes for 7 hours
Plasma nitrite
Time frame: Every 30 minutes for 7 hours
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 15 Oct 2012.
- Background: PubMed 22414688Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
- Derived from this study: PubMed 23884387Hobbs DA, Goulding MG, Nguyen A, Malaver T, Walker CF, George TW, Methven L, Lovegrove JA. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial. J Nutr. 2013 Sep;143(9):1399-405. doi: 10.3945/jn.113.175778. Epub 2013 Jul 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.
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 Bread in people with Hypertension, run by University of Reading 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 7 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 15 Oct 2012. 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?
Vascular reactivity (time frame: Change from baseline at 2, 4 and 6 hours after bread consumption). 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 NCT01706718, 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 15 Oct 2012.