The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 主要终点
- Flow-mediated Dilation (FMD)
研究概览
简要总结
A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index 18.5-27.5 kg/m2
- •Normal Blood pressure (< 150/90)
- •Non-smoker
- •Regular exercise routine
- •Signed consent form
排除标准
- •Haemoglobin (anaemia marker) < 125 g/l
- •Gamma GT (liver enzymes) > 80 IU/l
- •Total Cholesterol > 6.5 mmol/l
- •Suffered a myocardial infarction or stroke in the last 12 months
- •Suffers from any cardiovascular or metabolic disorders
- •Suffers from any blood-clotting disorder, and/or takes supporting medication
- •Any dietary restrictions or on a weight reducing diet
- •On any lipid-modifying or blood pressure lowering medication
- •Consuming any specific vitamin/ herbal supplements or fish oils
研究组 & 干预措施
Low-flavanol milk chocolate
Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately <1 mg of (-)-epicatechin for 2-weeks (14 days)
干预措施: Low-flavanol milk chocolate (Dietary Supplement)
High-flavanol milk chocolate
Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days)
干预措施: High-flavanol milk choocolate (Dietary Supplement)
结局指标
主要结局
Flow-mediated Dilation (FMD)
时间窗: Change from baseline at 14 days
Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia
次要结局
- Blood pressure (BP)(Change from baseline at 14 days)
- Plasma Nitrite & Nitrate analysis(Change from baseline at 14 days)
- Endothelial progenitor cells and Microparticles(Change from baseline at 14 days)
- Serum analysis of insulin(Change from baseline at 14 days)
- Plasma flavanol metabolite analysis(Change from baseline at 14 days)
- Serum analysis of cardivascular-related blood marker(s) concentration(Change from baseline at 14 days)
- Executive Function(Change from baseline at 14 days)
研究者
Jeremy Paul Edward Spencer
Professor of Biochemistry
University of Reading