Efficacy Testing of Djulis-Buckwheat Drink on Cardiovascular Protection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change of blood pressure
研究概览
简要总结
The purpose of the trial is to evaluate the effect of Djulis-Buckwheat drink on cardiovascular protection after ingesting for 8 weeks. In addition, the correlation between the supplement and the cardiovascular disease-related gene expression is evaluated. The results will be used for the application of functional products for cardiovascular protection.
Ninety subjects (age 30~65) with Prehypertension or Hypertension stage 1 will be included and randomly allocated into 3 groups: Placebo, Djulis-Buckwheat and Buckwheat. The subjects will take sample (100 ml/day) for 8 weeks. Blood pressure will be measured on week 0, 1, 2, 4, 6 and 8. The blood biochemical parameters and gene expression analysis will be examined on week 2, 4, 6, 8 and 10 (the follow up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure 121-159 mmHg or Diastolic blood pressure 81-99 mmHg
- •Age: 30-65
排除标准
- •Have diagnosed and documented critical illness(NHI specification)
- •Had emergency record or admission note in the past three months
- •Not be pregnant or breast-feeding a child
结局指标
主要结局
Change of blood pressure
时间窗: Baseline, 1, 2, 4, 6, and 8 weeks
次要结局
未报告次要终点