NCT02731755已完成不适用
Acute Cardiovascular Effects of Phenolic Rich Oats in Men With Above Average Blood Pressure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Flow Mediated Dilatation
研究概览
简要总结
In this proposed human trial, the investigators aim to establish whether consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly elevated blood pressure.
详细描述
A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole grains contain a wide range dietary components including potentially vasoactive phenolic acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)
排除标准
- •Abnormal biochemical, haematological results as assessed at health screening
- •Hypertension (i.e. systolic/diastolic blood pressure ≥160/100 mm Hg) BMI >35
- •Current smoker or ex-smoker ceasing <3 months ago
- •Past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer
- •Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
- •Allergies to whole grains
- •Parallel participation in another research project
- •Having flu vaccination or antibiotics within 3 months of trial start
- •On a weight reduction regime or taking food supplements within 3 months of trial start
- •Performing high level of physical activity (i.e. >3 x 20 min aerobic exercise/week)
- •Consumption of ≥21 units of alcohol/week
- •Small veins not allowing cannulation
结局指标
主要结局
Flow Mediated Dilatation
时间窗: 1 hour, 6 hours and 24 hours
Technique to assess the flexibility of the endothelium in larger peripheral blood vessels
次要结局
- Laser Doppler Iontophoresis(Baseline(BL), 2hours and 24hours)
- Plasma Glucose(Acute postprandial timecourse from Baseline, 1hour to 24hours.)
- Phenolic Acids Metabolites - Ferulic Acid(Baseline, 1hour, 2 hours and 24hours)
- Plasma Nitric Oxide Analysis(Acute postprandial timecourse from Baseline, 1hour to 24hours.)
- NADPH Oxidase Activity in Neutrophil Blood Cells(Baseline, 2 hours and 24 hours)
- Plasma Insulin(Acute postprandial timecourse from Baseline, 1hour to 24hours.)
- Renin Activity(Acute postprandial timecourse from Baseline, 1hour to 24hours.)
研究者
Jeremy Paul Edward Spencer
Professor
University of Reading
研究点 (3)
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