EFFORT Asthma: Effects of Diet and Exercise in Asthma

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT02355964
• Lead Sponsor: University of Copenhagen

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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-30
• Study First Posted: 2015-02-04
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire (Juniper) (ACQ).	Within 10 days (+/- 1 day) of completing the intervention

Secondary Outcome Measures

Name	Time	Method
Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.	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.
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)	Within 10 days (+/- 1 day) of completing the intervention	FeNO (a marker of eosinophilic inflammation)
Sputum inflammatory cell count	Within 10 days (+/- 1 day) of completing the intervention	Number and type of inflammatory cells in induced sputum
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

Trial Locations

Locations (1)

Respiratory Research Unit, Birpebjerg Hospital; 🇩🇰 Copenhagen NV, Denmark