Food Concentrates Supplementation to Alleviate Asthma in Children

NCT ID: NCT01366222

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-02-28

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

food concentrates: fruit, vegetable, fish oil and probiotics

Intervention Type: DIETARY_SUPPLEMENT

comparison the effect of food concentrate

Food concentrates (FC)

Food concentrates (FC) was including fruit and vegetable, fish and probiotics.

Group Type: ACTIVE_COMPARATOR

food concentrates: fruit, vegetable, fish oil and probiotics

Intervention Type: DIETARY_SUPPLEMENT

comparison the effect of food concentrate

Interventions

food concentrates: fruit, vegetable, fish oil and probiotics

comparison the effect of food concentrate

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

fruit and vegetable concentrates; fish oil; probiotics

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Academia Sinica, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Academia Sinica, Taiwan

Principal Investigators

Wen-Han Pan, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Academia Sinica, Taiwan

Locations

Academia Sinica

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

AS-IRB02- 07022

Identifier Type: -

Identifier Source: org_study_id