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OpenTrials
Completed

NCT Number: NCT01319786

Effect of a Polyphenol Rich Diet on Vascular and Platelet Function

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Belfast Health and Social Care Trust

Belfast, BT12 6BJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Vascular function

    Time frame: Measured at weeks 4 and 12

    Pharmacological provocation of endothelium-dependent vasomotion.

Secondary outcomes

  1. Platelet function, biomarkers of cardiovascular risk and heart rate variability

    Time frame: Measured at weeks 0, 4 and 12

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust

Registry information

Official study title

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

Acronym: PPhIT

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Mar 22, 2011
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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