NCT01659060已完成2 期
Assessment of Blood Pressure and Endothelial Function Pregnancy After Acute and Daily Consumption Flavanol-rich Chocolate Among Healthy Pregnant Women: a Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Changes in endothelial function and blood pressure
研究概览
简要总结
The purpose of this study is to to test the feasibility of design methods and procedures for later use on a larger scale and to examine the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •non-smoking normotensive women aged from 18 to 35 years, between the 7 and 12 weeks of gestation (documented by ultrasound) and having a live fetus confirmed by fetal heart auscultation
排除标准
- •Patients with family history of premature cardiovascular disease
- •Chronic hypertension
- •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 and blood pressure
时间窗: within the first 12 weeks of chocolate intake (week 12 and baseline)
次要结局
- Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks(within the first 12 weeks of chocolate intake (week 12 and baseline))
- Weight change from baseline at 12 weeks(within the first 12 weeks of chocolate intake (week 12 and baseline))
- Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache)(within the first 12 weeks of chocolate intake (week 12 and baseline))
研究者
研究点 (2)
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