Effect of a Polyphenol Rich Diet on Vascular and Platelet Function (PPhIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01319786|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : October 28, 2015
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 ]
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|