Clinical trial NCT02355964: EFFORT Asthma: Effects of Diet and Exercise in Asthma
Official title: EFFORT Asthma: Effects of a High Protein/Low Glycemic Index Diet and Physical Exercise in Sedentary Non-obese Asthmatics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Asthma Control Questionnaire (Juniper) (ACQ).
timeFrame: Within 10 days (+/- 1 day) of completing the intervention
Secondary outcomes:
measure: Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.
timeFrame: Within 10 days (+/- 1 day) of completing the intervention
measure: 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.
timeFrame: Within 10 days (+/- 1 day) of completing the intervention
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: Within 10 days (+/- 1 day) of completing the intervention
measure: Sputum inflammatory cell count
timeFrame: Within 10 days (+/- 1 day) of completing the intervention
measure: 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.
timeFrame: Within 10 days (+/- 1 day) of completing the intervention
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Respiratory Research Unit, Birpebjerg Hospital
Study officials:
affiliation: Respiratory Research Unit, Bispebjerg hospital
name: Vibeke Backer, Professor
role: STUDY_CHAIR
References: