Effect of a Polyphenol Rich Diet on Vascular and Platelet Function (PPhIT)
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|ClinicalTrials.gov Identifier: NCT01319786|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : October 28, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: Two portions of fruit and vegetables per day (excluding berries and dark chocolate) Other: Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2015|
|Low- polyphenol diet||
Other: 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)
|Active Comparator: High-polyphenol diet||
Other: 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.
- Vascular function [ Time Frame: Measured at weeks 4 and 12 ]Pharmacological provocation of endothelium-dependent vasomotion.
- Platelet function, biomarkers of cardiovascular risk and heart rate variability [ Time Frame: Measured at weeks 0, 4 and 12 ]
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|Ages Eligible for Study:||40 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 40-65 years old
- Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg
- 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)
- fasting triglyceride concentration > 4 mmol/l
- taking antioxidant supplements
- medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319786
|Belfast Health and Social Care Trust|
|Belfast, United Kingdom, BT12 6BJ|
|Principal Investigator:||Pascal McKeown, MD||Belfast Health and Social Care Trust|
|Study Director:||Jayne Woodside, PhD||Queen's University, Belfast|
|Study Director:||Michelle McKinley, PhD||Queen's University, Belfast|
|Responsible Party:||Rebecca Noad, Professor Pascal McKeown, Queen's University, Belfast|
|Other Study ID Numbers:||
|First Posted:||March 22, 2011 Key Record Dates|
|Last Update Posted:||October 28, 2015|
|Last Verified:||October 2015|