Food Concentrates Supplementation to Alleviate Asthma in Children

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT01366222
• Lead Sponsor: Academia Sinica, Taiwan

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2011-05-25
• Status Verified: 2011-06
• Study First Submitted QC: 2011-06-02
• Last Update Submitted: 2011-06-02
• Study First Posted: 2011-06-06
• Last Update Posted: 2011-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Academia Sinica; 🇨🇳 Taipei, Taiwan