HypertensionPPhITNCT01319786
Effect of a Polyphenol Rich Diet on Vascular and Platelet Function
A study testing Two portions of fruit and vegetables per day (excluding berries and dark chocolate) and Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. in people with Hypertension, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Two portions of fruit and vegetables per day (excluding berries and dark chocolate) and Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Aug 2015
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-65 years old
- Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg
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
- body mass index greater than 35kg/m2
- excessive alcohol consumption (defined as > 28 units/week in men and 21 units/week in women)
Show all 10Show fewer
- fasting triglyceride concentration > 4 mmol/l
- pregnancy/lactation
- taking antioxidant supplements
- 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
Belfast Health and Social Care Trust
Belfast, BT12 6BJ
About this study
Official title: Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial
Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. The investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. A total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). They will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study.
Assessment of microvascular and platelet function will be undertaken before and after consuming this diet. Improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. This study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.
- Conditions
- Hypertension
- Being tested
- Two portions of fruit and vegetables per day (excluding berries and dark chocolate), Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.
- Keywords
- Hypertension, Microvascular function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two portions of fruit and vegetables per day (excluding berries and dark chocolate)Other
Two portions of fruit and vegetables per day (excluding berries and dark chocolate)
Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.Other
Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.
| Study group | Role | What they receive |
|---|---|---|
| Low- polyphenol diet | Other | Not described Receives: Other: Two portions of fruit and vegetables per day (excluding berries and dark chocolate) |
| High-polyphenol diet | Active comparator | Not described Receives: Other: Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Pharmacological provocation of endothelium-dependent vasomotion.
Measured: Measured at weeks 4 and 12
Secondary outcomes (1)
Platelet function, biomarkers of cardiovascular risk and heart rate variability
Measured: Measured at weeks 0, 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2013
- Study completionAug 2015
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Responsible party
- Principal investigator, Rebecca Noad, Queen's University, Belfast
- Investigators
- Pascal McKeown, MD, Principal investigator, Belfast Health and Social Care TrustJayne Woodside, PhD, Study director, Queen's University, BelfastMichelle McKinley, PhD, Study director, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319786
- Sponsor's protocol ID
- QueensUBelfast
- Acronym
- PPhIT
- Status last verified
- Oct 2015
- First submitted
- 21 Mar 2011
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Noad RL, Rooney C, McCall D, Young IS, McCance D, McKinley MC, Woodside JV, McKeown PP. Beneficial effect of a polyphenol-rich diet on cardiovascular risk: a randomised control trial. Heart. 2016 Sep 1;102(17):1371-9. doi: 10.1136/heartjnl-2015-309218. Epub 2016 May 10.
PubMed 27164919
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT01319786
- Acronym / sponsor ID
- PPhIT / QueensUBelfast
- Conditions
- Hypertension
- Keywords
- Hypertension, Microvascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust
- Study start
- Jan 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Mar 2011 (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.
Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. The investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. A total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). They will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study.
Assessment of microvascular and platelet function will be undertaken before and after consuming this diet. Improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. This study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low- polyphenol diet | Other | Other: Two portions of fruit and vegetables per day (excluding berries and dark chocolate) |
| High-polyphenol diet | Active comparator | Other: Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 40-65 years old
- Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg
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
- body mass index greater than 35kg/m2
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 |
|---|---|---|
| Two portions of fruit and vegetables per day (excluding berries and dark chocolate)Two portions of fruit and vegetables per day (excluding berries and dark chocolate) | Other | Low- polyphenol diet |
| Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. | Other | High-polyphenol diet |
Primary outcome
Vascular function
Time frame: Measured at weeks 4 and 12
Pharmacological provocation of endothelium-dependent vasomotion.
1 secondary outcome
Platelet function, biomarkers of cardiovascular risk and heart rate variability
Time frame: Measured at weeks 0, 4 and 12
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 28 Oct 2015.
- Derived from this study: PubMed 27164919Noad RL, Rooney C, McCall D, Young IS, McCance D, McKinley MC, Woodside JV, McKeown PP. Beneficial effect of a polyphenol-rich diet on cardiovascular risk: a randomised control trial. Heart. 2016 Sep 1;102(17):1371-9. doi: 10.1136/heartjnl-2015-309218. Epub 2016 May 10.
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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.
Pascal McKeown, MD principal investigator
Belfast Health and Social Care Trust
Jayne Woodside, PhD study director
Queen's University, Belfast
Michelle McKinley, PhD study director
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 Two portions of fruit and vegetables per day (excluding berries and dark chocolate) and Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. in people with Hypertension, 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 28 Oct 2015. 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?
Vascular function (time frame: Measured at weeks 4 and 12). 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 NCT01319786, 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 28 Oct 2015.