Dietary Interventions in Asthma Treatment:Healthy Eating Better Breathing Asthma Diet Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Feasibility as assessed by the number of participant drop outs
研究概览
简要总结
The study is a randomized, crossover meal-replacement pilot intervention to determine feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the impact of a healthy diet on asthma outcomes. Participants with doctor-diagnosed asthma were randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week washout period. During the dietary intervention, all meals and snacks were provided by the study.
详细描述
The objective of the study is to demonstrate feasibility of a randomized, controlled clinical trial of a dietary intervention in a population of adults with asthma and to determine sample size estimates for a larger, more definitive trial aimed at improving asthma clinical outcomes and improving markers of inflammation and oxidative stress. The study uses a feeding trial design comprised of a 4 week dietary intervention in which all meals are provided to study participants and a 4 week control diet comprised of usual dietary intake. Participants are randomized to the intervention or control diet and then cross over to the alternate assignment after a 4 week washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18-50, self-reported physician diagnosis and treatment for asthma within the 12 months prior to enrollment, stable asthma defined as no asthma exacerbation (emergency department visit, systemic steroid treatment, or urgent care visit) or respiratory infection in the 4 weeks prior to enrollment.
排除标准
- •active smokers,pregnant or breastfeeding, using systemic corticosteroids or warfarin, had another major pulmonary diagnosis or significant systemic illness, reported excessive alcohol consumption (over 14 drinks per week or six or more drinks on one or more occasions per week), reported food allergy, or weighed over 350 pounds or changed weight by over ten pounds in the two months prior to screening
结局指标
主要结局
Feasibility as assessed by the number of participant drop outs
时间窗: Change from baseline and 4 weeks
Feasibility will be assessed by the number of drop outs.
Adherence assessed by serum carotenoids
时间窗: Change from baseline to 4 weeks
Serum carotenoids will be measured at baseline and at 4 weeks. An increase in serum carotenoids is expected with adherence to the dietary intervention.
Adherence using 24 hour diet recall
时间窗: Change from baseline to 4 weeks
Adherence to the dietary intervention will be assessed using self-report of dietary intake via 24 hour dietary recall.
次要结局
- FEV1(Difference between baseline and 2 weeks)
- FVC(Difference between baseline and 4 weeks)
- Asthma status(Difference between baseline and 2 weeks)
- Asthma Quality of Life Questionnaire (AQLQ)(Difference between baseline and 2 weeks)
- FEV1/FVC ratio(Difference between baseline and 2 weeks)
- Exhaled nitric oxide(Difference between baseline and 2 weeks)
- Adherence assessed by serum carotenoids(Difference between baseline and 2 weeks)
- Asthma Symptom Utility Index(Difference between baseline and 2 weeks)