Asthma (and Dietary) Inflammation Reduction (AIR)
Primary Purpose
Asthma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-Inflammatory Diet
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Nutrition, Anti-inflammatory diet
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Anti-Inflammatory Diet First
Anti-Inflammatory Diet Second
Arm Description
For the first 6 weeks, subjects will receive the anti-inflammatory diet. For the second 6 weeks, subjects will consume their habitual diet.
For the first 6 weeks, subjects will consume their habitual diet. For the second 6 weeks, subjects will receive the anti-inflammatory diet.
Outcomes
Primary Outcome Measures
Forced expiratory volume in one second (FEV1)
Secondary Outcome Measures
Forced vital capacity (FVC)
Forced expiratory flow 25-75% (FEF25-75)
Fraction of exhaled nitric oxide (FeNO)
Asthma Control Questionnaire (ACQ)
Asthma Control Test (ACT)
Pediatric Asthma-Related Quality of Life Questionnaire
Asthma medication use
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)
Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels
Serologic markers of nutritional status, including vitamin D
Full Information
NCT ID
NCT01996891
First Posted
November 22, 2013
Last Updated
August 2, 2016
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01996891
Brief Title
Asthma (and Dietary) Inflammation Reduction
Acronym
AIR
Official Title
Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit adequate number of participants and high attrition rate
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Nutrition, Anti-inflammatory diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anti-Inflammatory Diet First
Arm Type
Other
Arm Description
For the first 6 weeks, subjects will receive the anti-inflammatory diet. For the second 6 weeks, subjects will consume their habitual diet.
Arm Title
Anti-Inflammatory Diet Second
Arm Type
Other
Arm Description
For the first 6 weeks, subjects will consume their habitual diet. For the second 6 weeks, subjects will receive the anti-inflammatory diet.
Intervention Type
Other
Intervention Name(s)
Anti-Inflammatory Diet
Intervention Description
The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1)
Time Frame
End of 6-week intervention
Secondary Outcome Measure Information:
Title
Forced vital capacity (FVC)
Time Frame
End of 6-week intervention
Title
Forced expiratory flow 25-75% (FEF25-75)
Time Frame
End of 6-week intervention
Title
Fraction of exhaled nitric oxide (FeNO)
Time Frame
End of 6-week intervention
Title
Asthma Control Questionnaire (ACQ)
Time Frame
End of 6-week intervention
Title
Asthma Control Test (ACT)
Time Frame
End of 6-week intervention
Title
Pediatric Asthma-Related Quality of Life Questionnaire
Time Frame
End of 6-week intervention
Title
Asthma medication use
Time Frame
End of 6-week intervention
Title
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
Title
Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
Time Frame
End of 6-week intervention
Title
Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Time Frame
End of 6-week intervention
Title
Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels
Time Frame
End of 6-week intervention
Title
Serologic markers of nutritional status, including vitamin D
Time Frame
End of 6-week intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ludwig, MD, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bridget Hron, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cara Ebbeling, PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Asthma (and Dietary) Inflammation Reduction
We'll reach out to this number within 24 hrs