Effect of Berberis Vulgaris Consumption on Blood Pressure and Plasma Lipids in Subjects With Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- blood pressure
研究概览
简要总结
The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ < 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups.
Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •willingness to participate in the study
- •age between 20-65 years
- •having elevated BP (129/ < 85) and known hypertensive patients on medical treatment
- •at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus
排除标准
- •Unwillingness to continue participation
- •patients on nitrates
- •high doses of statins consumption (Atorvastatin>40 mg/day or Rosuvastatin>20 mg/day)
- •consumption of vitamins or minerals supplements during past month
- •Chronic kidney disease stage 4 or 5
结局指标
主要结局
blood pressure
时间窗: at 8 weeks
mean of systolic and diastolic blood pressure of participants measured by ambulatory 24 hour blood pressure monitoring
次要结局
- lipid profile(at 8 weeks)
- plasma NOx(at 8 weeks)
- Inflammatory cytokine(at 8 weeks)
研究者
Javad Nasrollahzadeh
Director
Shahid Beheshti University of Medical Sciences