Asthma (and Dietary) Inflammation Reduction



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:10 - 21
Updated:4/21/2016
Start Date:January 2014
End Date:December 2016
Contact:Bridget Hron, MD
Email:bridget.hron@childrens.harvard.edu
Phone:617-355-2399

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials