Clinical Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on Prediabetic Subjects (PRED)
2019年12月11日 更新者：Francisco Javier López Román、Universidad Católica San Antonio de Murcia
Clinical-nutritional Trial to Evaluate the Effect of an Extract of Sclerocaya Birrea on the Glycemic Profile in Prediabetic Subjects
It consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract of Sclerocarya birrea).
It is a clinical trial, during which certain parameters of the glucidic metabolism will be measured analytically.
Other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.
研究概览
研究类型
介入性
注册 (实际的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Murcia、西班牙、30107
- Catholic University of Murcia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age: 18-65 years.
Diagnosis of prediabetes according to the American Diabetes Association.
- Altered fasting glucose (95-125 mg / dl).
- Glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl).
- Hemoglobin glycated between 5.7 and 6.4%.
- Subjects with body mass index between 18-35 Kg / m2.
- Stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks.
- I do not consume foods rich in Screrocaria Birrea.
Exclusion Criteria:
- Subjects with a history of any type of liver or kidney pathology.
- Use of medications that may interfere with glucose metabolism.
- Consumption of alcohol greater than 20 g / day.
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Participation in another clinical trial in the three months prior to the study
- Lack of will or inability to comply with clinical trial procedures.
- Pregnancy.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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Subjects will consume two capsules at breakfast and dinner for ten weeks.
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实验性的：Sclerocarya birrea
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Subjects will consume two capsules at breakfast and dinner for ten weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
endothelial function
大体时间：The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after ten weeks of product consumption. Up to 10 weeks
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Changes in the dilatation of the Humeral artery.
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The measurements of endothelial function are taken with an ultrasound on two different occasions. The measurements will be made at baseline and after ten weeks of product consumption. Up to 10 weeks
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blood samples
大体时间：It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Changes in glycemic profile
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It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Physical activity test
大体时间：Quality of life measurements are taken with physical activity test on two different occasions. The measurements are made at the beginning and after ten weeks of consumption of the product. Up to 10 weeks
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Change in physical activity with the World Physical Activity Questionnaire (GPAQ)
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Quality of life measurements are taken with physical activity test on two different occasions. The measurements are made at the beginning and after ten weeks of consumption of the product. Up to 10 weeks
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nutritional record
大体时间：The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Potential changes in the dietary survey were controlled with a food diary
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The dietary intake will be controlled by a diary in which meals will be recorded for three days and on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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body composition
大体时间：Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Changes in body composition were measured with a TANITA
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Body measurements are taken with a Tanita on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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glucose tolerance test
大体时间：The glucose measurements in venous blood are taken with a glucometer on three different occasions (1: at baseline before consumption of the product, 2: at five weeks and 3: ten weeks after ingestion of the layer product observe the changes) .
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Venous blood samples are taken from the finger at different times.
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The glucose measurements in venous blood are taken with a glucometer on three different occasions (1: at baseline before consumption of the product, 2: at five weeks and 3: ten weeks after ingestion of the layer product observe the changes) .
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blood samples
大体时间：It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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Changes in lipidic profile:( total cholesterol, HDL and LDL) , it will be measured in mg/dl.
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It is performed in the laboratory with the ILAB 600 analyzer. Blood samples are analyzed on two different occasions. The measurements are made at the beginning and after eight weeks of consumption of the product. Up to 10 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年10月1日
初级完成 (实际的)
2018年12月30日
研究完成 (实际的)
2019年1月4日
研究注册日期
首次提交
2018年4月19日
首先提交符合 QC 标准的
2019年10月16日
首次发布 (实际的)
2019年10月21日
研究记录更新
最后更新发布 (实际的)
2019年12月13日
上次提交的符合 QC 标准的更新
2019年12月11日
最后验证
2019年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.