Clinical trial NCT01366222: Food Concentrates Supplementation to Alleviate Asthma in Children
Official title: Food Concentrates Supplementation to Alleviate Asthma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital
First posted: 2011-06-06
Enrollment: 192
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points
timeFrame: Baseline, 8 weeks and 16 weeks after intervention
Secondary outcomes:
measure: The change of pulmonary functions (FVC, FEV1) at three time points
timeFrame: Baseline, 8weeks and 16 weeks after intervention
measure: The change of medicine usage at three time points
timeFrame: Baseline, 8 weeks and 16 weeks after intervention
measure: The change of asthma control test score(ACT) at three time points
timeFrame: Baseline, 4, 8,12 and 16 weeks after intervention
measure: weekly diary
timeFrame: Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Academia Sinica
Study officials:
affiliation: Academia Sinica, Taiwan
name: Wen-Han Pan, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: