Food Concentrates Supplementation to Alleviate Asthma in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Food Concentrates Supplementation to Alleviate Asthma in Children

Conditions
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Asthma

Intervention / Treatment
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* Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics<br>* comparison the effect of food concentrate<br>* Other names: probiotics;|
| Active Comparator: Food concentrates (FC)<br>Food concentrates (FC) was including fruit and vegetable, fish and probiotics. | Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics<br>* comparison the effect of food concentrate<br>* Other names: probiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points |  | Baseline, 8 weeks and 16 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma