AsthmaFSACNCT01366222
Food Concentrates Supplementation to Alleviate Asthma in Children
A study testing food concentrates: fruit, vegetable, fish oil and probiotics in people with Asthma, run by Academia Sinica, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- food concentrates: fruit, vegetable, fish oil and probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of asthma
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- food concentrates: fruit, vegetable, fish oil and probiotics
- Keywords
- asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food concentrates: fruit, vegetable, fish oil and probioticsDietary supplement
Also called fruit and vegetable concentrates, fish oil, probiotics
comparison the effect of food concentrate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: 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. Receives: Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of pediatric asthma quality of life questionnaire score (PAQLQ score) at three time points
Measured: Baseline, 8 weeks and 16 weeks after intervention
Secondary outcomes (4)
The change of pulmonary functions (FVC, FEV1) at three time points
Measured: Baseline, 8weeks and 16 weeks after intervention
The change of medicine usage at three time points
Measured: Baseline, 8 weeks and 16 weeks after intervention
The change of asthma control test score(ACT) at three time points
Measured: Baseline, 4, 8,12 and 16 weeks after intervention
weekly diary
Measured: Baseline and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startNov 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital
- Investigators
- Wen-Han Pan, Ph. D., Principal investigator, Academia Sinica, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366222
- Sponsor's protocol ID
- AS-IRB02- 07022
- Acronym
- FSAC
- Status last verified
- Jun 2011
- First submitted
- 25 May 2011
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Concentrates Supplementation to Alleviate Asthma in Children
- ClinicalTrials.gov ID
- NCT01366222
- Acronym / sponsor ID
- FSAC / AS-IRB02- 07022
- Conditions
- Asthma
- Keywords
- asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probiotics |
| Food concentrates (FC) | Active comparator | Dietary Supplement: food concentrates: fruit, vegetable, fish oil and probioticsFood concentrates (FC) was including fruit and vegetable, fish and probiotics. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of asthma
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food concentrates: fruit, vegetable, fish oil and probioticsAlso: fruit and vegetable concentrates, fish oil, probioticscomparison the effect of food concentrate | Dietary supplement | Food concentrates (FC), Placebo |
Primary outcome
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
4 secondary outcomes
The change of pulmonary functions (FVC, FEV1) at three time points
Time frame: Baseline, 8weeks and 16 weeks after intervention
The change of medicine usage at three time points
Time frame: Baseline, 8 weeks and 16 weeks after intervention
The change of asthma control test score(ACT) at three time points
Time frame: Baseline, 4, 8,12 and 16 weeks after intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Han Pan, Ph. D. principal investigator
Academia Sinica, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food concentrates: fruit, vegetable, fish oil and probiotics in people with Asthma, run by Academia Sinica, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2011.