Asthma
Conditions
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALExercise
Aerobe exercise 3 times a week in 8 weeks
BEHAVIORALDiet
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* \>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)
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma Control Questionnaire (Juniper) (ACQ). | Within 10 days (+/- 1 day) of completing the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway hyperresponsiveness to mannitol, as measured by an airway provocation test. | Within 10 days (+/- 1 day) of completing the intervention | The response-dose-ratio (RDR) will be calculated as the percentage fall in forced expiratory volume in 1 second (FEV1) after the last dose of inhaled dried mannitol powder delivered, divided by the cumulative dose of inhaled mannitol. |
| 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 | FeNO (a marker of eosinophilic inflammation) |
| Sputum inflammatory cell count | Within 10 days (+/- 1 day) of completing the intervention | Number and type of inflammatory cells in induced sputum |
| 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 | — |
Countries
Denmark
Outcome results
None listed