Food Concentrates Supplementation to Alleviate Asthma in Children

Asthma Clinical Trial

— FSAC  

Official title:

Food Concentrates Supplementation to Alleviate Asthma in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01366222
• Other study ID #: AS-IRB02- 07022
• Status: Completed
• Phase: N/A
• First received: May 25, 2011
• Last updated: June 2, 2011
• Start date: November 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2011
• Source: Academia Sinica, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Taiwan	Academia Sinica	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Academia Sinica, Taiwan	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points		Baseline, 8 weeks and 16 weeks after intervention	No
Secondary	The change of pulmonary functions (FVC, FEV1) at three time points		Baseline, 8weeks and 16 weeks after intervention	No
Secondary	The change of medicine usage at three time points		Baseline, 8 weeks and 16 weeks after intervention	No
Secondary	The change of asthma control test score(ACT) at three time points		Baseline, 4, 8,12 and 16 weeks after intervention	No
Secondary	weekly diary		Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention	No