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Clinical Trials/NCT01319786
NCT01319786
Completed
Not Applicable

Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial

Queen's University, Belfast1 site in 1 country104 target enrollmentJanuary 2011
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Queen's University, Belfast
Enrollment
104
Locations
1
Primary Endpoint
Vascular function
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rebecca Noad

Professor Pascal McKeown

Queen's University, Belfast

Eligibility Criteria

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

Outcomes

Primary Outcomes

Vascular function

Time Frame: Measured at weeks 4 and 12

Pharmacological provocation of endothelium-dependent vasomotion.

Secondary Outcomes

  • Platelet function, biomarkers of cardiovascular risk and heart rate variability(Measured at weeks 0, 4 and 12)

Study Sites (1)

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