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Food Concentrates Supplementation to Alleviate Asthma in Children (FSAC)

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ClinicalTrials.gov Identifier: NCT01366222
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment
Asthma 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Food Concentrates Supplementation to Alleviate Asthma in Children
Study Start Date : November 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Fish oil
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics
comparison the effect of food concentrate
Other Names:
  • fruit and vegetable concentrates
  • fish oil
  • probiotics
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:
  • fruit and vegetable concentrates
  • fish oil
  • probiotics


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. The change of pulmonary functions (FVC, FEV1) at three time points [ Time Frame: Baseline, 8weeks and 16 weeks after intervention ]
  2. The change of medicine usage at three time points [ Time Frame: Baseline, 8 weeks and 16 weeks after intervention ]
  3. The change of asthma control test score(ACT) at three time points [ Time Frame: Baseline, 4, 8,12 and 16 weeks after intervention ]
  4. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366222


Locations
Taiwan
Academia Sinica
Taipei, Taiwan, 115
Sponsors and Collaborators
Academia Sinica, Taiwan
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Han Pan, Ph. D. Academia Sinica, Taiwan
More Information

Responsible Party: Wen-Harn Pan, Principal investigator, Academia Sinica, Taiwan
ClinicalTrials.gov Identifier: NCT01366222     History of Changes
Other Study ID Numbers: AS-IRB02- 07022
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: June 6, 2011
Last Verified: June 2011

Keywords provided by Academia Sinica, Taiwan:
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases