EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Asthma Control Questionnaire (Juniper) (ACQ).
研究概览
简要总结
This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.
详细描述
After screening and enrollment, a total of 200 Danish sedentary, non-obese asthma patients will be randomized to one of four groups: 1) control group (no intervention), 2) physical exercise intervention, 3) diet intervention (a diet with an overall high content of protein and a low glycemic index) or 4) exercise plus diet intervention.
Asthma is defined as respiratory symptoms and at least one positive asthma test. Patients will continue their regular doses of anti-asthma treatment unchanged throughout the study period. Type of anti-inflammatory medicine will be recorded and the adherence to the therapy will be assessed before the intervention period and at follow-up using questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •>18 years old
- •Uncontrolled or partly uncontrolled asthma
- •Capable of exercising on bike
- •Sedentary (currently do less than 60 min of structured/planned physical activity per week)
排除标准
- •BMI ≥ 30.0 or <20.5
- •Chronic obstructive pulmonary disease (COPD), pregnancy, other inflammatory or metabolic diseases
- •The use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.
结局指标
主要结局
Asthma Control Questionnaire (Juniper) (ACQ).
时间窗: Within 10 days (+/- 1 day) of completing the intervention
次要结局
- Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.(Within 10 days (+/- 1 day) of completing the intervention)
- Systemic low-grade inflammation, as measured by serum-levels (in microgram/ml) of high sensitivity C-reactive protein, interleukin 6 (IL-6), IL-8, tumor necrosis factor alpha (TNF-alpha) and leptin.(Within 10 days (+/- 1 day) of completing the intervention)
- Fractional exhaled nitric oxide (FeNO)(Within 10 days (+/- 1 day) of completing the intervention)
- Sputum inflammatory cell count(Within 10 days (+/- 1 day) of completing the intervention)
- Adipose tissue inflammatory properties as measured by levels of messenger ribonucleic acid (mRNA) of IL-6, IL-8, leptin and TNF-alpha in abdominal fat biopsies.(Within 10 days (+/- 1 day) of completing the intervention)
研究者
Louise Lindhardt Toennesen
MD
University of Copenhagen