- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01996891
Asthma (and Dietary) Inflammation Reduction (AIR)
Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Boston Children's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Altro: 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.
|
The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.
|
Altro: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Forced expiratory volume in one second (FEV1)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Forced vital capacity (FVC)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Forced expiratory flow 25-75% (FEF25-75)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Fraction of exhaled nitric oxide (FeNO)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Asthma Control Questionnaire (ACQ)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
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Asthma Control Test (ACT)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Pediatric Asthma-Related Quality of Life Questionnaire
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Asthma medication use
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
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)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
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Measures of insulin sensitivity, including fasting glucose, fasting insulin and adiponectin
Lasso di tempo: 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
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
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Serologic markers of nutritional status, including vitamin D
Lasso di tempo: End of 6-week intervention
|
End of 6-week intervention
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: David Ludwig, MD, PhD, Boston Children's Hospital
- Direttore dello studio: Bridget Hron, MD, Boston Children's Hospital
- Direttore dello studio: Cara Ebbeling, PhD, Boston Children's Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 00006708
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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