Acute Impact of Hibiscus Sabdariffa Calyces (HSC) Extract Consumption on Blood Pressure, Vascular Function and Other Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in baseline and hourly blood pressure
研究概览
简要总结
Hibiscus sabdariffa calyces (HSC) extract is consumed in different parts of the world as a cold or hot drink and is available in the United Kingdom (UK) markets in different forms including tea bags. There is preliminary data that support the hypothesis that HSC extract consumption has beneficial effect on blood vessel health and blood pressure reduction. Hypertension, vascular dysfunction, inflammation and lipid abnormalities are all key modifiable risk factors of cardiovascular diseases (CVD), the leading causes of death throughout the world. In the PHYTOVAS (PHYTOchemicals and VAScular Function) study the effect of the acute consumption a potentially bioactive food extracts: Hibiscus sabdariffa calyces (HSC) compared with a matched control (water) on blood pressure and blood vessels function will be investigated after a high - fat mixed meal. This is with a view to determining the impacts of the extract on postprandial (after meal) blood pressure and other CVD risk factors. Results from the PHYTOVAS study could lead to identification of more dietary approaches that will contribute to CVD risk prevention and management.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •30 - 65 years
- •1 to 10 % Cardiovascular disease risk in 10 years
- •Not taking blood pressure medication
- •Not having liver or kidney disease
- •Not anaemic
- •A signed consent form
排除标准
- •<30 or > 65 years
- •<1 or >10 % Cardiovascular disease risk in 10 years
- •Taking blood pressure medication
- •Having liver or kidney disease
- •Lack of signing consent form
- •Individual with food allergy
- •Sufferers of chronic illness
结局指标
主要结局
Change in baseline and hourly blood pressure
时间窗: Baseline, hourly 4 times post baseline and then hourly for twelve hours at night
次要结局
- Change in Flow Mediated Vasodilation(Baseline, 2 and 4 hours post treatment)
- Change in serum total antioxidant capacity(Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment)
- Change in plasma nitric oxide level(Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment)
- Change in blood lipids profile(Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment)
- Change in Inflammatory marker: C - reactive protein (CRP)(Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment)
- Changes in serum or plasma glucose and insulin levels(Baseline and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours post treatment)
研究者
Julie Lovegrove
Professor
University of Reading