Asthma (and Dietary) Inflammation Reduction (AIR)
Effects of an Anti-Inflammatory Diet on Pulmonary Function in Pediatric Asthma
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Boston Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Forced expiratory volume in one second (FEV1)
기간: End of 6-week intervention
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End of 6-week intervention
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Forced vital capacity (FVC)
기간: End of 6-week intervention
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End of 6-week intervention
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Forced expiratory flow 25-75% (FEF25-75)
기간: End of 6-week intervention
|
End of 6-week intervention
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Fraction of exhaled nitric oxide (FeNO)
기간: End of 6-week intervention
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End of 6-week intervention
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Asthma Control Questionnaire (ACQ)
기간: End of 6-week intervention
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End of 6-week intervention
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Asthma Control Test (ACT)
기간: 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
기간: End of 6-week intervention
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End of 6-week intervention
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Asthma medication use
기간: 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)
기간: End of 6-week intervention
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End of 6-week intervention
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Asthma-related inflammatory markers, including eosinophilic cationic protein (ECP), monocyte chemoattractant protein (MCP-1)
기간: 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
기간: 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
기간: 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
기간: End of 6-week intervention
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End of 6-week intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: David Ludwig, MD, PhD, Boston Children's Hospital
- 연구 책임자: Bridget Hron, MD, Boston Children's Hospital
- 연구 책임자: Cara Ebbeling, PhD, Boston Children's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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