NCT02847312Unknown不适用
Chronic Cardiovascular and Gut-bacteria Effects of Phenolic Rich Oats in Adults With Above Average Blood Pressure
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 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 4 weeks of daily consumption of beta-glucan matched meals providing either a high dose or a moderate dose of oat avenanthramides and phenolic acids leads to dose-dependent chronic improvements in markers of CVD risk and gut health relative to an energy matched control intervention in healthy adults with above average blood pressure.
详细描述
- To investigate the chronic effects of daily intake of oat products on flow mediated dilatation of the brachial artery (FMD; primary endpoint), microvascular endothelial function (measured by laser Doppler iontophoresis), pulse wave analysis, gut microbiota diversity, 24h blood pressure, activity of the renin angiotensin system, markers related to cellular production of nitric oxide and reactive oxygen species, inflammatory cytokines, and further potentially emerging biochemical markers of CVD risk.
- To establish if phenolic acids and avenanthramides from oat products exert cardiovascular and microbial effects in a dose dependent manner.
- To measure urinary and fecal excretion of avenanthramide and phenolic acid metabolites.
To explore correlations between bacterial population changes and CVD risk markers.
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
- All
- 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. SBP/DBP ≥160/100 mm Hg)
- •Current smoker or ex-smoker ceasing <3 months ago
- •Past or existing medical history of vascular disease, diabetes, hepatic, renal, 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
- •Chronic constipation, diarrhea or other chronic gastrointestinal complaint
- •On a weight reduction regime or taking food, probiotics or prebiotics supplements or laxative within 3 months of trial start
- •Performing high level of physical activity (i.e. ≥150min aerobic exercise/week)
- •Consumption of ≥21 units of alcohol/week
- •Females who are breast-feeding, may be pregnant, lactating or, if of reproductive age and not using a reliable form of contraception (including abstinence)
结局指标
主要结局
Flow mediated dilatation
时间窗: 20 weeks
Technique to assess the flexibility of teh endothelium in larger peripheral blood vessels, magnitude of increase in percentage from baseline to after 4 weeks treatment.
次要结局
- Renin activity(22 weeks)
- Plasma nitric oxide analysis(22 weeks)
- Urine and plasma metabolomic footprint using NMR(22 weeks)
- Gut microbiota changes(22 weeks)
- NADPH oxidase activity in neutrophil blood cells(22 weeks)
- Inflammatory markers(22 weeks)
- Laser Doppler Iontophoresis(20 weeks)
- Plasma microparticles(22 weeks)
研究者
Jeremy Paul Edward Spencer
Professor
University of Reading
研究点 (2)
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