Respiratory Research Unit, Birpebjerg Hospital
Copenhagen NV, 2400, Denmark
NCT Number: NCT02355964
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Copenhagen NV, 2400, Denmark
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BMI ≥ 30.0 or <20.5
Aerobe exercise 3 times a week in 8 weeks
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Time frame: 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.
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Time frame: Within 10 days (+/- 1 day) of completing the intervention
FeNO (a marker of eosinophilic inflammation)
Time frame: Within 10 days (+/- 1 day) of completing the intervention
Number and type of inflammatory cells in induced sputum
Time frame: Within 10 days (+/- 1 day) of completing the intervention
University of Copenhagen
Other
EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.
Acronym: EFFORT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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