Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women
2016年2月27日 更新者：Jintanaporn Wattanathorn、Khon Kaen University
This study is set up to determine the cognitive enhancing effect and consumption safety of the novel cognitive enhancement product made from the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.
研究概览
详细说明
Memory impairment is one of the common health problems in menopausal women.
Due to the therapeutic efficiency limitation, the searching for the protective intervention for this condition is required.
Based on the previous findings that the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) could attenuate memory impairment in animal model of menopause, the investigators aimed to investigate the effect of MP1 functional drink on working memory, psychological fitness, possible underlying mechanism and the consumption safety in menopausal volunteers.
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段1
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
45年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Healthy perimenopausal and postmenopausal women (<5 years menstruation cessation) who live in Northeastern of Thailand.
Exclusion Criteria:
- Subject who is diagnosed with one of the following: cardiovascular diseases, respiratory diseases,neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
- Hysterectomy and/or Oophorectomy
- Subject who use hormone or any drug exerts the influence on Hypothalamic Pituitary Gonadal axis and nervous system.
- Body mass index >27
- Athlete or subject who has a regular exercise.
- Smoker or heavy drinker
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
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：MP1 group
Subjects receive the MP1 product at the dose of 400 mg/day for 8 weeks.
|
Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.
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安慰剂比较：Placebo group
Subject receive the Placebo product for 8 weeks.
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Subjects receive Placebo drink after meal for 8 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Cognitive processing (P300) and attention (N100) using Event Related Potential
大体时间：7 months
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7 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Accuracy and speed of working memory using computerized battery test
大体时间：7 months
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7 months
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Psychological fitness using Bond-Ladder test and Symptom Check List-90 test (SCL-90)
大体时间：7 months
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7 months
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Malondialdehyde level in serum
大体时间：7 month
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7 month
|
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The activity of Superoxide dismutase enzyme in serum
大体时间：7 month
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The activity of Superoxide dismutase (SOD) enzyme in serum is measured by using the biochemical assay method and the activity of SOD is expressed as units/mg protein.
The higher activity of SOD enzyme is the better antioxidant effect of the intervention.
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7 month
|
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The activity of Glutathione Peroxidase enzyme in serum
大体时间：7 month
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The activity of Glutathione Peroxidase (GSH-Px) enzyme in serum is measured by using the biochemical assay method and the activity of GSH-Px is expressed as units/mg protein.
The higher activity of GSH-Px enzyme is the better antioxidant effect of the intervention.
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7 month
|
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The activity of Catalase enzyme in serum
大体时间：7 month
|
The activity of Catalase enzyme in serum is measured by using the biochemical assay method and the activity of CAT is expressed as units/mg protein.
The higher activity of CAT enzyme is the better antioxidant effect of the intervention.
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7 month
|
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The activity of Acetylcholinesterase enzyme in serum
大体时间：7 month
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Acetylcholinesterase (AChE) is an enzyme that catalyzes the breakdown of Acetylcholine, a neurotransmitter for learning and memory.The activity of AChE enzyme in serum is measured by using the biochemical assay method and the result is express as mmol/min.g
protein.
The lower activity of AChE is the better cognitive enhancing effect of the intervention.
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7 month
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The activity of Monoamine oxidase enzyme in serum
大体时间：7 month
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Monoamine oxidase (MAO) is an enzyme that catalyzes the breakdown of Monoamine neurotransmitter , a neurotransmitter for learning and memory.The activity of MAO enzyme in serum is measured by using the biochemical assay method and the result is express as nmol/h/mg protein.
The lower activity of MAO is the better cognitive enhancing effect of the intervention.
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7 month
|
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Consumption safety of MP1 by using the electrocardiogram (ECG), Blood chemistry, hematology, blood pressure measurement
大体时间：7 months
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7 months
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Adverse events by using adverse event record form
大体时间：7 months
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7 months
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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。
调查人员
- 首席研究员：Jintanaporn Wattanathorn, PhD、Khon Kaen University
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
2015年4月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年1月1日
研究注册日期
首次提交
2015年9月18日
首先提交符合 QC 标准的
2015年10月2日
首次发布 (估计)
2015年10月5日
研究记录更新
最后更新发布 (估计)
2016年3月1日
上次提交的符合 QC 标准的更新
2016年2月27日
最后验证
2016年2月1日
更多信息
与本研究相关的术语
其他研究编号
- HE 571329
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.