Nutritional Strategies to Enhance Lung Function in Asthmatics with Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Asthma Control
研究概览
简要总结
This study will test the effect of diet on asthma in individuals with obesity.
详细描述
This is a crossover design pilot trial that will recruit 12 adults with obesity and asthma. Participants will undergo screening and a lead-in period before being randomized to a series of three, 7-day diets with a 7+ day washout period between each diet. Asthma control and lung function will be assessed at the completion of each diet.
The goal of this pilot trial is to understand the effect of diet on asthma and conduct an exploratory analysis on factors that may predict the response to diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will not be made aware of the diet allocation. However, due inherent differences in macronutrient content of the diets, participants may perceive differences in the quantity of various food groups or in the taste, texture or smell of foods present in the diet. To address this, diets will be designed to minimize noticeable differences for the participant. The investigator and outcomes assessor will remain fully masked to diet provision.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •BMI: 30-45 kg/m2
- •asthma diagnosed by medical specialist (confirmed in medical history)
- •partly controlled or uncontrolled asthma by Asthma Control Test score ≤22
- •owns a device compatible with ZEPHYRx platform
- •stable asthma medication use (no change in the past 2 months).
排除标准
- •Diabetes or using diabetes medications that may lower blood glucose levels
- •point of care fasting blood glucose ≥126 mg/dl or triglycerides ≥400 mg/dl
- •current smoking or smoking history of greater than 10 pack-years
- •other significant respiratory or cardiac disease or the presence of clinically important comorbidities, e.g., COPD, renal failure, liver disease; uncontrolled hypertension defined as systolic blood pressure ≥160 mm/Hg, or diastolic blood pressure ≥100 mm/Hg
- •pregnant or nursing women
- •food preferences or allergies inconsistent with study diet capabilities
- •noncompliance with lead-in period requirements.
结局指标
主要结局
Asthma Control
时间窗: After 7 days on Diet#3
Asthma Control Questionnaire score (Juniper; 1 week recall period) Score range: 0-6. Minimally important difference = 0.5.
次要结局
- FENO(After 7 days on Diet#3)
- FEV1/FVC(After 7 days on Diet#3)
- Lung Function(After 7 days on Diet#3)
研究者
Jacob T. Mey, PhD RD
Principal Investigator
Pennington Biomedical Research Center