Asthma (and Dietary) Inflammation Reduction (AIR)

August 2, 2016 updated by: David S. Ludwig, MD, PhD, Boston Children's Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anti-Inflammatory Diet First
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
The 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 Second
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
The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Forced vital capacity (FVC)
Time Frame: End of 6-week intervention
End of 6-week intervention
Forced expiratory flow 25-75% (FEF25-75)
Time Frame: End of 6-week intervention
End of 6-week intervention
Fraction of exhaled nitric oxide (FeNO)
Time Frame: End of 6-week intervention
End of 6-week intervention
Asthma Control Questionnaire (ACQ)
Time Frame: End of 6-week intervention
End of 6-week intervention
Asthma Control Test (ACT)
Time Frame: End of 6-week intervention
End of 6-week intervention
Pediatric Asthma-Related Quality of Life Questionnaire
Time Frame: End of 6-week intervention
End of 6-week intervention
Asthma medication use
Time Frame: End of 6-week intervention
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
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
End of 6-week intervention
Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Time Frame: End of 6-week intervention
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
End of 6-week intervention
Serologic markers of nutritional status, including vitamin D
Time Frame: End of 6-week intervention
End of 6-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: David Ludwig, MD, PhD, Boston Children's Hospital
  • Study Director: Bridget Hron, MD, Boston Children's Hospital
  • Study Director: Cara Ebbeling, PhD, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00006708

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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