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 |
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.
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.
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
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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