Food Concentrates Supplementation to Alleviate Asthma in... | NCT01366222

Studies
Food Concentrates Supplementation to Alleviate Asthma in Children

NCT01366222

Sponsor

Academia Sinica, Taiwan

Status

Completed

Last Update Posted

Jun 6, 2011Estimated

Enrollment

192Actual

Phase

Not Applicable

Conditions

Asthma

Interventions

food concentrates: fruit, vegetable, fish oil and probiotics

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

May 25, 2011

First Submission Date that Met QC Criteria

Jun 2, 2011

First Posted Date

Jun 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2011

Last Update Posted Date

Jun 6, 2011Estimated

Name	Class
National Taiwan University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics
Food concentrates (FC)	Active Comparator	Food concentrates (FC) was including fruit and vegetable, fish and probiotics.	Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
food concentrates: fruit, vegetable, fish oil and probiotics	Dietary Supplement	comparison the effect of food concentrate	Food concentrates (FC) Placebo

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wen-Han Pan, Ph. D.	Academia Sinica, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academia Sinica		Taipei		115	Taiwan

Type	Date	Date Unknown
Release	Jan 24, 2022
Reset	Mar 24, 2022

Submission Tracking

Estimated Results First Submitted Date

Jan 24, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 24, 2022			Mar 24, 2022

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014675	Vegetables
D005395	Fish Oils
D019936	Probiotics
D005638	Fruit

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided