The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Changes in systolic blood pressure from baseline
研究概览
简要总结
Fruit and vegetable rich diets are associated with a reduced risk of cardiovascular disease (CVD). The protective effect may be ascribed to compounds contained within these foods, called flavonoids. Flavanols (epicatechin and procyanidins) are a particular group of flavonoids and are found mostly in apples, berry fruits, dark chocolate, tea and red wine. There is evidence to suggest that ingestion of flavanol rich foods and beverages beneficially alter 'markers' of CVD risk (e.g. blood pressure). The aim of this study is to determine the acute and chronic effects of apple derived flavanols on some risk markers for CVD.
详细描述
This study is a single arm randomized, 4-phase crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 50 years of age
- •Systolic blood pressure 130 - 159 mmHg
排除标准
- •History of cardiovascular events such as stroke, myocardial infarction trans- ischaemic attacks or peripheral vascular disease
- •Kidney or liver disease/problems
- •Asthmatics (unless no medication taken for 1 year - occasional use will be assessed on an individual basis)
- •Prescribed anti-hypertensive medication
- •HRT (unless the participant has used the therapy for ≥ 6 months)
- •Lipid lowering therapies e.g. statins
- •Other medications that may affect any of the study outcome measures e.g. vasodilators (this will be assessed on a case by case basis)
- •Current smoker (or stopped for less than 3 months)
- •Throat surgery or neck injury
- •Allergy to apples
- •Consumption of fish oil supplements unless willing to discontinue them up for 4 weeks preceding the start of the study and for the duration of the study. (All other supplements will be assessed on a case by case basis)
- •Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
- •Parallel participation in another research project which involves dietary intervention
- •Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 ml.
- •Has donated or intends to donate blood within 16 weeks prior to or during the study period.
- •Depressed or elevated blood pressure measurements (<90/50 or 95/55 if symptomatic or >160/100 (mmHg)) during the course of the trial.
结局指标
主要结局
Changes in systolic blood pressure from baseline
时间窗: Baseline, 2 hours and 4 weeks
次要结局
- Changes in plasma lipid profile from baseline(Baseline and 4 weeks)
- Change in plasma endothelin-1 from baseline(Baseline and 4 weeks)
- Changes in plasma nitric oxide metabolites from baseline(Baseline, 2 hours and 4 weeks)
- Changes in blood glucose from baseline(Baseline and 4 weeks)
- Changes in pulse wave velocity from baseline(Baseline, 2 hours and 4 weeks)