Food Concentrates Supplementation to Alleviate Asthma in Children (FSAC)

Academia Sinica, Taiwan

Status: Completed

Conditions: Asthma

Treatments: Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01366222

AS-IRB02- 07022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Ages: 10 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics

Food concentrates (FC)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics