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Completed

NCT Number: NCT01366222

Food Concentrates Supplementation to Alleviate Asthma in Children

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.

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Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academia Sinica

Taipei, 115, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

food concentrates: fruit, vegetable, fish oil and probiotics

Dietary Supplement

comparison the effect of food concentrate

Other names: fruit and vegetable concentrates, fish oil, probiotics

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Academia Sinica, Taiwan

Other

Collaborators

  • National Taiwan University Hospital

Registry information

Acronym: FSAC

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 6, 2011
Registry last updated
Jun 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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