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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
149
Respiratory Research Unit, Birpebjerg Hospital
Copenhagen NV, Denmark
Asthma Control Questionnaire (Juniper) (ACQ).
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.
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.
Time frame: 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.
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Fractional exhaled nitric oxide (FeNO)
FeNO (a marker of eosinophilic inflammation)
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Sputum inflammatory cell count
Number and type of inflammatory cells in induced sputum
Time frame: 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.
Time frame: Within 10 days (+/- 1 day) of completing the intervention
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