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临床试验/NCT01319786
NCT01319786已完成不适用

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

Queen's University, Belfast1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
1
主要终点
Vascular function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

High-polyphenol diet

Active Comparator

干预措施: Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. (Other)

Low- polyphenol diet

Other

干预措施: Two portions of fruit and vegetables per day (excluding berries and dark chocolate) (Other)

结局指标

主要结局

Vascular function

时间窗: Measured at weeks 4 and 12

Pharmacological provocation of endothelium-dependent vasomotion.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Noad

Professor Pascal McKeown

Queen's University, Belfast

研究点 (1)

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