Trial of Acceptability, Tolerability and Biochemical Indicators of Hibiscus Sabdariffa L. Drink in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Acceptability of Hibiscus sabdariffa drink
研究概览
简要总结
The goal of this phase I pilot clinical trial is to evaluate the acceptability, tolerability and effect on blood pressure and biomarkers of Hibiscus sabdariffa drink in pregnant women in the second trimester of pregnancy. The main questions it aims to answer are:
Is the drink acceptable to take as a daily dose for a long time? Does drinking the beverage cause negative effects? What is the effect of drink consumption on blood pressure and biomarkers in pregnant women?
Each participant was their own control with the values measured before consumption of the beverage and after four weeks of consumption.
The participants:
- Took a daily dose of the beverage for 4 weeks
- Once a week for the four weeks, they answered the acceptability and tolerability questionnaires
- Before starting to consume the beverage and after the 4 weeks of consumption, they had their blood pressure measured, and samples taken for biomarker measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
This trial included only one group, assessing the acceptability and tolerability of a beverage, as well as its effects on markers. The results will be used to promote a study with a larger number of participants and a longer timeframe.
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
- •Women in the second trimester of pregnancy (14 to 28 gestation weeks)
- •Age 18 to 35 years
- •Blood pressure <140/90 mmHg
排除标准
- •Multiple or high-risk pregnancy
- •Hypertensive disorder in previous pregnancies
- •Body mass index >32 kg/m2
- •Present chronic diseases
结局指标
主要结局
Acceptability of Hibiscus sabdariffa drink
时间窗: 4 weeks
Beverage acceptability was measured using a sensory evaluation with 7-point hedonic scale of the attributes of odor, color, flavor, mouthfeel, aftertaste, and overall appearance through questionnaires applied once a week for 4 weeks. The outcome measures are based on a 7-point hedonic scale where every participant can answer in every attribute evaluated: 1. I dislike it a lot 2. I dislike it moderately 3. I dislike it a little 4. I neither like it nor dislike it 5. I like it a little 6. I like it moderately 7. I like it a lot
Tolerability of Hibiscus sabdariffa Drink
时间窗: 4 weeks
Tolerability was measured by the presence or absence of gastrointestinal symptoms such as nausea, regurgitation, vomiting, constipation, diarrhea, flatulence, and abdominal pain through questionnaires applied once a week for 4 weeks. The outcome measures for the tolerability assessment were the presence or absence of gastrointestinal symptoms mentioned in the previous paragraph, where participants had the option to respond: 1. Symptom absent 2. Symptom present but not bothersome 3. Symptom present and somewhat bothersome, but does not interfere with daily activities or sleep 4. Symptom present and bothersome because it interferes with daily activities or sleep 5. Required medical attention
次要结局
- Blood pressure(4 weeks)
- Biomarkers glucose(4 weeks)
- Biomarkers cholesterol(4 weeks)
- Biomarkers triglycerides(4 weeks)
- Biomarkers creatinine(4 weeks)
- Biomarkers proteinuria(4 weeks)
研究者
Victor Eduardo Alcantar Rodríguez
Associate Research Professor B
National Polytechnic Institute, Mexico