AsthmaAIRNCT01996891
Asthma (and Dietary) Inflammation Reduction
A study testing Anti-Inflammatory Diet in people with Asthma, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of a diet that is low in glycemic load and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids ("anti-inflammatory diet") on pulmonary function in pediatric patients with asthma. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Asthma
- What is being tested?
- Anti-Inflammatory Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to May 2016
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10-21 years
- Clinical diagnosis of moderate or severe persistent asthma
- Currently prescribed inhaled corticosteroids for asthma with anticipated stable dosing regimen for the duration of the study
- Admission to Boston Children's Hospital for clinical asthma exacerbation
- Medical clearance from primary care provider
- Willingness to comply with study diet
Who cannot join
- Body mass index (BMI) < 3rd centile (age- and gender- adjusted normative range from Center for Disease Control)
- Known eating disorder
- Celiac disease
- Any food allergy
- Any other major illness as assessed by medical history or the following screening tests:
- Alanine aminotransferase (ALT) > twice upper limit of normal for age
Show all 10Show fewer
- Creatinine > 1.0 mg/dL for age 10-18 years; > 1.2 mg/dL for females > 18 years; or > 1.4 mg/dL for males > 18 years)
- Random glucose > 200 mg/dL
- Hemoglobin < 11 g/dL for males age 10-18 years; < 11. g/dL for females age 10-18 years; <11.4 g/dL for males >18 years; or <10.9 g/dL for females age > 18 years
- Use of systemic steroids for indication other than asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma
The purpose of this study is to evaluate the effects of a diet that is low in glycemic load and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids ("anti-inflammatory diet") on pulmonary function in pediatric patients with asthma. The primary endpoint will be change in forced expiratory volume in one second in response to the diet intervention. Secondary outcomes will include additional spirometry measures, fraction of exhaled nitric oxide, and assessment of symptomatic asthma control. In addition, we will identify potential physiological mechanisms relating diet with lung function, including changes in systemic inflammation, insulin sensitivity, and intestinal microbiome composition.
Read the detailed description
Asthma, an inflammatory disease of the airway mucosa, is highly correlated with obesity and nutritional intake in multiple cross-sectional studies. Limited interventional data in adults with asthma, relying on behavioral modification, have reported that asthma control significantly improves with caloric restriction and diets enriched with antioxidants, and may improve with increasing omega-3 fatty acid content. A comprehensive diet harnessing anti-inflammatory properties of multiple foods may have synergistic effects on bronchial inflammation and pulmonary function, yet this possibility remains largely untested, especially in children.
We propose a randomized, controlled cross-over trial, with 6-week treatment arms, in pediatric patients with moderate to severe asthma. The experimental diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content. The comparison diet will be each participant's habitual diet. Both diets will be isocaloric and weight maintaining, to isolate the effects of the dietary composition from the known beneficial effects of weight loss. In addition, the home delivery of prepared meals will alleviate the variable and incomplete adherence commonly observed in behavioral studies.
- Conditions
- Asthma
- Being tested
- Anti-Inflammatory Diet
- Keywords
- Asthma, Nutrition, Anti-inflammatory diet
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Inflammatory DietOther
The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.
| Study group | Role | What they receive |
|---|---|---|
| Anti-Inflammatory Diet First | Other | For the first 6 weeks, subjects will receive the anti-inflammatory diet. For the second 6 weeks, subjects will consume their habitual diet. Receives: Other: Anti-Inflammatory Diet |
| Anti-Inflammatory Diet Second | Other | For the first 6 weeks, subjects will consume their habitual diet. For the second 6 weeks, subjects will receive the anti-inflammatory diet. Receives: Other: Anti-Inflammatory Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Measured: End of 6-week intervention
Secondary outcomes (12)
Forced vital capacity (FVC)
Measured: End of 6-week intervention
Forced expiratory flow 25-75% (FEF25-75)
Measured: End of 6-week intervention
Fraction of exhaled nitric oxide (FeNO)
Measured: End of 6-week intervention
Asthma Control Questionnaire (ACQ)
Measured: End of 6-week intervention
Asthma Control Test (ACT)
Measured: End of 6-week intervention
Pediatric Asthma-Related Quality of Life Questionnaire
Measured: End of 6-week intervention
Asthma medication use
Measured: End of 6-week intervention
Serum inflammatory markers, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), tissue necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), plasminogen activator inhibitor-1 (PAI-1)
Measured: End of 6-week intervention
Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
Measured: End of 6-week intervention
Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Measured: End of 6-week intervention
Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels
Measured: End of 6-week intervention
Serologic markers of nutritional status, including vitamin D
Measured: End of 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Unable to recruit adequate number of participants and high attrition rate
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.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David S. Ludwig, MD, PhD, Boston Children's Hospital
- Investigators
- David Ludwig, MD, PhD, Principal investigator, Boston Children's HospitalBridget Hron, MD, Study director, Boston Children's HospitalCara Ebbeling, PhD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996891
- Sponsor's protocol ID
- 00006708
- Acronym
- AIR
- Status last verified
- Aug 2016
- First submitted
- 22 Nov 2013
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma
- ClinicalTrials.gov ID
- NCT01996891
- Acronym / sponsor ID
- AIR / 00006708
- Conditions
- Asthma
- Keywords
- Asthma, Nutrition, Anti-inflammatory diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit adequate number of participants and high attrition rate
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Nov 2013 (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 evaluate the effects of a diet that is low in glycemic load and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids ("anti-inflammatory diet") on pulmonary function in pediatric patients with asthma. The primary endpoint will be change in forced expiratory volume in one second in response to the diet intervention. Secondary outcomes will include additional spirometry measures, fraction of exhaled nitric oxide, and assessment of symptomatic asthma control. In addition, we will identify potential physiological mechanisms relating diet with lung function, including changes in systemic inflammation, insulin sensitivity, and intestinal microbiome composition.
Detailed description
Asthma, an inflammatory disease of the airway mucosa, is highly correlated with obesity and nutritional intake in multiple cross-sectional studies. Limited interventional data in adults with asthma, relying on behavioral modification, have reported that asthma control significantly improves with caloric restriction and diets enriched with antioxidants, and may improve with increasing omega-3 fatty acid content. A comprehensive diet harnessing anti-inflammatory properties of multiple foods may have synergistic effects on bronchial inflammation and pulmonary function, yet this possibility remains largely untested, especially in children.
We propose a randomized, controlled cross-over trial, with 6-week treatment arms, in pediatric patients with moderate to severe asthma. The experimental diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content. The comparison diet will be each participant's habitual diet. Both diets will be isocaloric and weight maintaining, to isolate the effects of the dietary composition from the known beneficial effects of weight loss. In addition, the home delivery of prepared meals will alleviate the variable and incomplete adherence commonly observed in behavioral studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-Inflammatory Diet First | Other | Other: Anti-Inflammatory DietFor the first 6 weeks, subjects will receive the anti-inflammatory diet. For the second 6 weeks, subjects will consume their habitual diet. |
| Anti-Inflammatory Diet Second | Other | Other: Anti-Inflammatory DietFor the first 6 weeks, subjects will consume their habitual diet. For the second 6 weeks, subjects will receive the anti-inflammatory diet. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 10-21 years
- Clinical diagnosis of moderate or severe persistent asthma
- Currently prescribed inhaled corticosteroids for asthma with anticipated stable dosing regimen for the duration of the study
- Admission to Boston Children's Hospital for clinical asthma exacerbation
- Medical clearance from primary care provider
Key exclusion criteria (10 listed)
- Body mass index (BMI) < 3rd centile (age- and gender- adjusted normative range from Center for Disease Control)
- Known eating disorder
- Celiac disease
- Any food allergy
- Any other major illness as assessed by medical history or the following screening tests:
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 |
|---|---|---|
| Anti-Inflammatory DietThe anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content. | Other | Anti-Inflammatory Diet First, Anti-Inflammatory Diet Second |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: End of 6-week intervention
12 secondary outcomes
Forced vital capacity (FVC)
Time frame: End of 6-week intervention
Forced expiratory flow 25-75% (FEF25-75)
Time frame: End of 6-week intervention
Fraction of exhaled nitric oxide (FeNO)
Time frame: End of 6-week intervention
Asthma Control Questionnaire (ACQ)
Time frame: End of 6-week intervention
Asthma Control Test (ACT)
Time frame: End of 6-week intervention
Pediatric Asthma-Related Quality of Life Questionnaire
Time frame: End of 6-week intervention
Asthma medication use
Time frame: End of 6-week intervention
Serum inflammatory markers, including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), tissue necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), plasminogen activator inhibitor-1 (PAI-1)
Time frame: End of 6-week intervention
Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
Time frame: End of 6-week intervention
Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Time frame: End of 6-week intervention
Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels
Time frame: End of 6-week intervention
Serologic markers of nutritional status, including vitamin D
Time frame: End of 6-week intervention
Results and safety
The study was stopped early (reason given: Unable to recruit adequate number of participants and high attrition rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
David Ludwig, MD, PhD principal investigator
Boston Children's Hospital
Bridget Hron, MD study director
Boston Children's Hospital
Cara Ebbeling, PhD study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-Inflammatory Diet in people with Asthma, run by Boston Children's Hospital at 1 site in United States.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 4 Aug 2016. 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 United States. 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. 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 was stopped early (reason given: Unable to recruit adequate number of participants and high attrition rate). Results are not available in the source record.
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?
Forced expiratory volume in one second (FEV1) (time frame: End of 6-week 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 4 Aug 2016.