Effect of a Polyphenol Rich Diet on Vascular and Platelet Function- a Randomised Control Trial
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
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
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
Rebecca Noad
Professor Pascal McKeown
Queen's University, Belfast
