EFFORT Asthma: Effects of Diet and Exercise in Asthma

Study Overview
=================
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

Official Title
-----------------
EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>exercise (Aerobe training) 3 times per week | Behavioral: Exercise<br>* Aerobe exercise 3 times a week in 8 weeks<br>|
| Experimental: Diet<br>A diet with an overall high protein content and a low glycemic index | Behavioral: Diet<br>* Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks<br>|
| Experimental: Diet+Exercise<br>A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week. | Behavioral: Exercise<br>* Aerobe exercise 3 times a week in 8 weeks<br>Behavioral: Diet<br>* Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks<br>|
| No Intervention: control<br>Regular lifestyle (no intervention) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire (Juniper) (ACQ). |  | Within 10 days (+/- 1 day) of completing the intervention | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |