Asthma (and Dietary) Inflammation Reduction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: Anti-Inflammatory Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anti-Inflammatory Diet First<br>For the first 6 weeks, subjects will receive the anti-inflammatory diet. For the second 6 weeks, subjects will consume their habitual diet. | Other: Anti-Inflammatory Diet<br>* The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.<br>|
| Other: Anti-Inflammatory Diet Second<br>For the first 6 weeks, subjects will consume their habitual diet. For the second 6 weeks, subjects will receive the anti-inflammatory diet. | Other: Anti-Inflammatory Diet<br>* The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in one second (FEV1) |  | End of 6-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced vital capacity (FVC) |  | End of 6-week intervention | 
| Forced expiratory flow 25-75% (FEF25-75) |  | End of 6-week intervention | 
| Fraction of exhaled nitric oxide (FeNO) |  | End of 6-week intervention | 
| Asthma Control Questionnaire (ACQ) |  | End of 6-week intervention | 
| Asthma Control Test (ACT) |  | End of 6-week intervention | 
| Pediatric Asthma-Related Quality of Life Questionnaire |  | End of 6-week intervention | 
| Asthma medication use |  | 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) |  | End of 6-week intervention | 
| Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1) |  | End of 6-week intervention | 
| Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin |  | End of 6-week intervention | 
| Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels |  | End of 6-week intervention | 
| Serologic markers of nutritional status, including vitamin D |  | End of 6-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Nutrition, Anti-inflammatory diet