An Acute, Double-blind, Randomised, Placebo-controlled, Crossover Intervention Trial Investigating the Dose-dependent Vascular Effects of Pure (-)-Epicatechin (≤1 mg/kg BW) in Healthy Men.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Flow mediated dilatation
研究概览
简要总结
Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 & 1.0 mg/kg BW) in healthy men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 20-27.5 kg/m2
- •Normal blood pressure at screening (< 150/90)
- •Non-smoker
- •Non-vegetarian
- •'Normal - low' chocolate consumer (<2 potions per week)
- •'Normal - low' coffee/ tea drinker (<3 cups per day)
- •Regular exercise routine
- •Signed consent form
排除标准
- •Haemoglobin (anaemia marker) < 125 g/l
- •Gamma GT (liver enzymes) > 80 IU/l
- •Cholesterol > 6.5 mmol/l
- •Suffered a myocardial infarction or stroke in the last 12 months
- •Suffers from any cardiovascular or metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- •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
0.5 mg/ kg BW pure (-)-epicatechin
0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 0.5 mg/kg (Dietary Supplement)
0.1 mg/ kg BW pure (-)-epicatechin
0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Water (Dietary Supplement)
0.5 mg/ kg BW pure (-)-epicatechin
0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 0.1 mg/kg (Dietary Supplement)
0.1 mg/ kg BW pure (-)-epicatechin
0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 0.1 mg/kg (Dietary Supplement)
0.1 mg/ kg BW pure (-)-epicatechin
0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 0.5 mg/kg (Dietary Supplement)
0.1 mg/ kg BW pure (-)-epicatechin
0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 1.0 mg/kg (Dietary Supplement)
0.5 mg/ kg BW pure (-)-epicatechin
0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 1.0 mg/kg (Dietary Supplement)
1.0 mg/ kg BW pure (-)-epicatechin
1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 0.1 mg/kg (Dietary Supplement)
1.0 mg/ kg BW pure (-)-epicatechin
1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 0.5 mg/kg (Dietary Supplement)
1.0 mg/ kg BW pure (-)-epicatechin
1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Epicatechin 1.0 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
干预措施: Epicatechin 0.1 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
干预措施: Epicatechin 0.5 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
干预措施: Epicatechin 1.0 mg/kg (Dietary Supplement)
0.0 mg/ kg BW pure (-)-epicatechin
Water only (3 ml/kg BW)
干预措施: Water (Dietary Supplement)
1.0 mg/ kg BW pure (-)-epicatechin
1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Water (Dietary Supplement)
0.5 mg/ kg BW pure (-)-epicatechin
0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
干预措施: Water (Dietary Supplement)
结局指标
主要结局
Flow mediated dilatation
时间窗: baseline to 2h
次要结局
- Plasma (-)-epicatechin metabolites(baseline to 24h)
- Laser Doppler Imaging with Iontophoresis(baseline to 2h)
- Plasma nitrate/nitrite(baseline to 2h)
研究者
Jeremy Paul Edward Spencer
Professor Jeremy P.E. Spencer
University of Reading