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临床试验/NCT02013856
NCT02013856
已完成
不适用

The Effects of Apple Derived Flavanols on Cardiovascular Disease Risk

Quadram Institute Bioscience1 个研究点 分布在 1 个国家目标入组 42 人2014年7月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Blood Pressure
发起方
Quadram Institute Bioscience
入组人数
42
试验地点
1
主要终点
Changes in systolic blood pressure from baseline
状态
已完成
最后更新
9年前

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.

注册库
clinicaltrials.gov
开始日期
2014年7月
结束日期
2016年10月
最后更新
9年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

入排标准

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

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)

研究点 (1)

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