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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exercise | Experimental | exercise (Aerobe training) 3 times per week |
|
| Diet | Experimental | A diet with an overall high protein content and a low glycemic index |
|
| Diet+Exercise | Experimental | A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week. |
|
| control | No Intervention | Regular lifestyle (no intervention) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | Aerobe exercise 3 times a week in 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (Juniper) (ACQ). | Within 10 days (+/- 1 day) of completing the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 10 days (+/- 1 day) of completing the intervention |
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Inclusion Criteria:
Exclusion Criteria:
BMI ≥ 30.0 or <20.5
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| Name | Affiliation | Role |
|---|---|---|
| Vibeke Backer, Professor | Respiratory Research Unit, Bispebjerg hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Research Unit, Birpebjerg Hospital | Copenhagen NV | 2400 | Denmark |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Diet |
| Behavioral |
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks |
|
| 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) | FeNO (a marker of eosinophilic inflammation) | Within 10 days (+/- 1 day) of completing the intervention |
| Sputum inflammatory cell count | Number and type of inflammatory cells in induced sputum | 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |