Food Concentrates Supplementation to Alleviate Asthma in Children (FSAC)

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Dietary supplement: food concentrates: fruit, vegetable, fish oil and probiotics

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 Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 115
    • Academia Sinica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: food concentrates: fruit, vegetable, fish oil and probiotics; comparison the effect of food concentrate; Other Names: fish oil; probiotics; fruit and vegetable concentrates
Active Comparator: Food concentrates (FC); Food concentrates (FC) was including fruit and vegetable, fish and probiotics.	Dietary supplement: food concentrates: fruit, vegetable, fish oil and probiotics; comparison the effect of food concentrate; Other Names: fish oil; probiotics; fruit and vegetable concentrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Academia Sinica, Taiwan
• Collaborators: National Taiwan University Hospital
• Investigators: Principal Investigator: Wen-Han Pan, Ph. D., Academia Sinica, Taiwan

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: May 25, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2011
• Last Update Submitted That Met QC Criteria: June 2, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AS-IRB02- 07022