Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Changes in endothelial function
研究概览
简要总结
The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.
详细描述
Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.
The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women between the ages of 18 and 40 years.
- •Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.
排除标准
- •Hypertension requiring medication.
- •Currently or previously use of medications interfering with glucose or lipids metabolism.
- •Use of supplements or natural health products that interfere with blood pressure.
- •Consumption of 1 or more alcohol drink per day.
- •Allergy or intolerance to nuts or chocolate.
结局指标
主要结局
Changes in endothelial function
时间窗: within the first 12 weeks of chocolate intake
次要结局
- Doppler of uterine arteries(within the first 12 weeks of chocolate intake)
- Blood pressure(within the first 12 weeks of chocolate intake)
- Plasma biomarker of endothelium function(within the first 12 weeks of chocolate intake)
- Plasma biomarker of chocolate intake(within the first 12 weeks of chocolate intake)