Food Concentrates Supplementation to Alleviate Asthma in Children

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: February 2009

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.

Interventions

  • Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics
    • comparison the effect of food concentrate

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Active Comparator: Food concentrates (FC)
    • Food concentrates (FC) was including fruit and vegetable, fish and probiotics.

Clinical Trial Outcome Measures

Primary Measures

  • The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points
    • Time Frame: Baseline, 8 weeks and 16 weeks after intervention

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Academia Sinica, Taiwan
  • Collaborator
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Wen-Harn Pan, Principal investigator, Academia Sinica, Taiwan
  • Overall Official(s)
    • Wen-Han Pan, Ph. D., Principal Investigator, Academia Sinica, Taiwan

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