Food Concentrates Supplementation to Alleviate Asthma in Children (FSAC)
2011年6月2日 更新者:Academia Sinica, Taiwan
The purpose of this study is to determine whether food concentrates supplementation (vegetable plus fruit, fish, probiotics) are effective to alleviate drug used, asthma symptoms and lung function in children due to asthma.
研究概览
详细说明
The prevalence of asthma is increasing in Taiwan and worldwide.
This could be related to dietary factors and their interactions with genes and the environment.
Ample evidence from cross-sectional and case-control observational studies suggested that consumption level of fruits, vegetables, and potentially vitamins A, C, E from foods have negative association with asthma risk, and positive association with lung function.
However, single nutrient supplementation neither improved asthma symptoms and lung function, nor reduced inflammatory mediators.
Some studies had shown probiotics could regulate human immunity.
A number of trials have suggested that fish oil supplement improves lung function and reduces inflammatory mediator.
The potential interactions among multiple components in foods have been neglected in the past.
Recently, observational studies on dietary pattern analyses or intervention trials modifying the overall dietary composition have caught tremendous scientific attentions.
Therefore, the investigators will design an intervention trial with food-based principle to investigate the the joint effect of several beneficial dietary components on asthma symptoms.
For practicality and efficiency, vegetable plus fruit concentrates, fish oil, and probiotic concentrate are considered as supplements to asthmatic children.
The investigators hope that the study can provided a direction for dietary modification in asthma children.
研究类型
介入性
注册 (实际的)
192
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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Taipei、台湾、115
- Academia Sinica
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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
10年 至 12年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Clinical diagnosis of asthma
Exclusion Criteria:
- subjects received immunotherapy over the past 6 months
- Long-term used oral corticosteroids
- have other diseases such as heart disease, kidney disease, liver abnormalities
- have been supplement fish oil, probiotics, and high levels of vitamin supplements in the past three months
- vegetarian
- subjects have hemorrhagic disease
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:三倍
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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comparison the effect of food concentrate
其他名称:
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有源比较器:Food concentrates (FC)
Food concentrates (FC) was including fruit and vegetable, fish and probiotics.
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comparison the effect of food concentrate
其他名称:
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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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The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points
大体时间:Baseline, 8 weeks and 16 weeks after intervention
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Baseline, 8 weeks and 16 weeks after intervention
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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The change of pulmonary functions (FVC, FEV1) at three time points
大体时间:Baseline, 8weeks and 16 weeks after intervention
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Baseline, 8weeks and 16 weeks after intervention
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The change of medicine usage at three time points
大体时间:Baseline, 8 weeks and 16 weeks after intervention
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Baseline, 8 weeks and 16 weeks after intervention
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The change of asthma control test score(ACT) at three time points
大体时间:Baseline, 4, 8,12 and 16 weeks after intervention
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Baseline, 4, 8,12 and 16 weeks after intervention
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weekly diary
大体时间:Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention
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Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention
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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:Wen-Han Pan, Ph. D.、Academia Sinica, Taiwan
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
2007年11月1日
初级完成 (实际的)
2009年2月1日
研究完成 (实际的)
2009年2月1日
研究注册日期
首次提交
2011年5月25日
首先提交符合 QC 标准的
2011年6月2日
首次发布 (估计)
2011年6月6日
研究记录更新
最后更新发布 (估计)
2011年6月6日
上次提交的符合 QC 标准的更新
2011年6月2日
最后验证
2011年6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.