Asthma (and Dietary) Inflammation Reduction

Asthma Clinical Trial

— AIR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01996891
• Other study ID #: 00006708
• Status: Terminated
• Phase: N/A
• First received: November 22, 2013
• Last updated: August 2, 2016
• Start date: January 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Anti-Inflammatory Diet
The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)		End of 6-week intervention	No
Secondary	Forced vital capacity (FVC)		End of 6-week intervention	No
Secondary	Forced expiratory flow 25-75% (FEF25-75)		End of 6-week intervention	No
Secondary	Fraction of exhaled nitric oxide (FeNO)		End of 6-week intervention	No
Secondary	Asthma Control Questionnaire (ACQ)		End of 6-week intervention	No
Secondary	Asthma Control Test (ACT)		End of 6-week intervention	No
Secondary	Pediatric Asthma-Related Quality of Life Questionnaire		End of 6-week intervention	No
Secondary	Asthma medication use		End of 6-week intervention	No
Secondary	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	No
Secondary	Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)		End of 6-week intervention	No
Secondary	Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin		End of 6-week intervention	No
Secondary	Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels		End of 6-week intervention	No
Secondary	Serologic markers of nutritional status, including vitamin D		End of 6-week intervention	No