Asthma (and Dietary) Inflammation Reduction

Stopped early · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01996891

Run by

Boston Children's Hospital

People needed

14

Starts

2014-01-01

Expected to finish

2016-05-01

Last updated by the study team

2016-08-04

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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