Effect of a Polyphenol Rich Diet on Vascular and Platelet Function

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: 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.

• Registration Number: NCT01319786
• Lead Sponsor: Queen's University, Belfast

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2013-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• Age 40-65 years old
• Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg

Exclusion Criteria

• 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
• pregnancy/lactation
• taking antioxidant supplements
• medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low- polyphenol diet	Two portions of fruit and vegetables per day (excluding berries and dark chocolate)	-
High-polyphenol diet	Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.	-

Primary Outcome Measures

Name	Time	Method
Vascular function	Measured at weeks 4 and 12	Pharmacological provocation of endothelium-dependent vasomotion.

Secondary Outcome Measures

Name	Time	Method
Platelet function, biomarkers of cardiovascular risk and heart rate variability	Measured at weeks 0, 4 and 12

Trial Locations

Locations (1)

Belfast Health and Social Care Trust; 🇬🇧 Belfast, United Kingdom