ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 主要终点
- Change in resting systolic blood pressure after daily dark chocolate
研究概览
简要总结
The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.
详细描述
The COCOA-BP Trial is a prospective, single-center, single-arm, Boston Scientific volunteer trial, designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18 years of age
- •Subject has an iPhone (5 or higher)
- •Subject is willing to comply with all trial requirements
- •Subject understands the trial requirements and procedures and provides written informed consent before any trial-specific procedures are performed
排除标准
- •Anyone part of the study execution team cannot be part of the trial
- •Current smoker or history of smoking in the last 5 years (including E-cigarettes)
- •Diabetes mellitus including those managed by diet alone
- •Medically treated hypertension
- •Diagnosed with persistent or frequent irregular heart beat (e.g. atrial flutter, atrial fibrillation)
- •Permanent pacemaker or defibrillator implanted
- •Subject is a women who is pregnant
- •Known allergy to chocolate or cacao products
- •Known allergy to skin adhesives
研究组 & 干预措施
Chocolate consumption
Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate
干预措施: Wearable devices (Device)
Chocolate consumption
Subjects will consume 50g of dark chocolate for 2 weeks and have their blood pressure compared before chocolate and after chocolate
干预措施: Dark Chocolate (Other)
结局指标
主要结局
Change in resting systolic blood pressure after daily dark chocolate
时间窗: 14 days after daily consumption of dark chocolate
次要结局
- Correlation of physical activity (steps) to resting blood pressure and heart rate(daily, for four weeks)
- Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods(End of week two and end of week four)
- Comparison of heart rate derived from wearable digital health devices to data derived from standard methods(End of week two and end of week four)