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临床试验/NCT01366222
NCT01366222已完成不适用

Food Concentrates Supplementation to Alleviate Asthma in Children

Academia Sinica, Taiwan2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2007年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
192
试验地点
2
主要终点
The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of asthma

排除标准

  • 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

结局指标

主要结局

The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points

时间窗: Baseline, 8 weeks and 16 weeks after intervention

次要结局

  • The change of pulmonary functions (FVC, FEV1) at three time points(Baseline, 8weeks and 16 weeks after intervention)
  • The change of medicine usage at three time points(Baseline, 8 weeks and 16 weeks after intervention)
  • The change of asthma control test score(ACT) at three time points(Baseline, 4, 8,12 and 16 weeks after intervention)
  • weekly diary(Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention)

研究者

发起方
Academia Sinica, Taiwan
申办方类型
Other

研究点 (2)

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