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Food Concentrates Supplementation to Alleviate Asthma in Children (FSAC)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
food concentrates: fruit, vegetable, fish oil and probiotics
Sponsored by
Academia Sinica, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma

Eligibility Criteria

10 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academia Sinica

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Food concentrates (FC)

Arm Description

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

Outcomes

Primary Outcome Measures

The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points

Secondary Outcome Measures

The change of pulmonary functions (FVC, FEV1) at three time points
The change of medicine usage at three time points
The change of asthma control test score(ACT) at three time points
weekly diary

Full Information

First Posted
May 25, 2011
Last Updated
June 2, 2011
Sponsor
Academia Sinica, Taiwan
Collaborators
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01366222
Brief Title
Food Concentrates Supplementation to Alleviate Asthma in Children
Acronym
FSAC
Official Title
Food Concentrates Supplementation to Alleviate Asthma in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Academia Sinica, Taiwan
Collaborators
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Food concentrates (FC)
Arm Type
Active Comparator
Arm Description
Food concentrates (FC) was including fruit and vegetable, fish and probiotics.
Intervention Type
Dietary Supplement
Intervention Name(s)
food concentrates: fruit, vegetable, fish oil and probiotics
Other Intervention Name(s)
fruit and vegetable concentrates, fish oil, probiotics
Intervention Description
comparison the effect of food concentrate
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The change of pulmonary functions (FVC, FEV1) at three time points
Time Frame
Baseline, 8weeks and 16 weeks after intervention
Title
The change of medicine usage at three time points
Time Frame
Baseline, 8 weeks and 16 weeks after intervention
Title
The change of asthma control test score(ACT) at three time points
Time Frame
Baseline, 4, 8,12 and 16 weeks after intervention
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Han Pan, Ph. D.
Organizational Affiliation
Academia Sinica, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academia Sinica
City
Taipei
ZIP/Postal Code
115
Country
Taiwan

12. IPD Sharing Statement

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Food Concentrates Supplementation to Alleviate Asthma in Children

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