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- Klinische proef NCT01996891
Asthma (and Dietary) Inflammation Reduction (AIR)
Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Boston Children's Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: 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.
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The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.
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Ander: 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.
|
The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Forced expiratory volume in one second (FEV1)
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Forced vital capacity (FVC)
Tijdsspanne: End of 6-week intervention
|
End of 6-week intervention
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Forced expiratory flow 25-75% (FEF25-75)
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Fraction of exhaled nitric oxide (FeNO)
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Asthma Control Questionnaire (ACQ)
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Asthma Control Test (ACT)
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Pediatric Asthma-Related Quality of Life Questionnaire
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Asthma medication use
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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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)
Tijdsspanne: End of 6-week intervention
|
End of 6-week intervention
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Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Intestinal Microbiome Composition, including 16S sequencing and fecal short chain fatty acid levels
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Serologic markers of nutritional status, including vitamin D
Tijdsspanne: End of 6-week intervention
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End of 6-week intervention
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: David Ludwig, MD, PhD, Boston Children's Hospital
- Studie directeur: Bridget Hron, MD, Boston Children's Hospital
- Studie directeur: Cara Ebbeling, PhD, Boston Children's Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 00006708
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