The Effect of Berry Consumption on Indicators of Cardiovascular Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Blood pressure
研究概览
简要总结
The purpose of this study is to investigate the effects of berry consumption on indicators of cardiovascular disease risk (blood pressure, cardiovascular biomarkers, nutrigenomics).
详细描述
The study has a randomized crossover design. It consists of two 8-wk dietary treatments, with no washout period between periods. The participants are blinded to treatments. The subjects are randomly assigned to either a berry diet or a control diet which they follow for 8 weeks. After that they are crossed over to the other diet for another 8 weeks. The main visits to the study site are at baseline and after 8 and 16 weeks (for blood pressure measurement/ cardiovascular measurements and sample collection). The additional visits are at 4 and 12 wk; these visits are for compliance checks, meeting the study nurse and receiving the study products. The subjects are asked to maintain their normal dietary and lifestyle habits, as well as to keep alcohol intake and physical activity constant during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild hypertension (systolic blood pressure 130-159 mmHg, diastolic blood pressure 85-99 mmHg)
排除标准
- •regular use of medications (except hormone replacement therapy) or dietary supplements
- •intestinal disorders
- •obesity (BMI> 35 kg/m2)
- •vegetarianism
- •pregnancy
结局指标
主要结局
Blood pressure
时间窗: 0, 8 and 16 weeks
次要结局
- PFA-100 measurement(0, 8 and 16 weeks)
- biomarkers of cardiovascular disease risk(0, 8 and 16 weeks)