Asthma (and Dietary) Inflammation Reduction

NCT01996891 | Terminated

• 1 other identifier: 00006708
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Nutrition; Anti-inflammatory diet

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume in one second (FEV1)

  End of 6-week intervention

Secondary Outcomes (12)

• 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

Study Arms (2)

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.

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.

Other: Anti-Inflammatory Diet

Interventions

Anti-Inflammatory Diet OTHER

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

Anti-Inflammatory Diet First; Anti-Inflammatory Diet Second

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• David Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Bridget Hron, MD

  Boston Children's Hospital

  STUDY DIRECTOR

• Cara Ebbeling, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Obesity Prevention Center

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

US (1)