EFFORT Asthma: Effects of Diet and Exercise in Asthma

Asthma Clinical Trial

— EFFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355964
• Other study ID #: EFFORT Asthma
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: July 27, 2016
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Exercise
Aerobe exercise 3 times a week in 8 weeks
• Diet
Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks

Locations

Country	Name	City	State
Denmark	Respiratory Research Unit, Birpebjerg Hospital	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire (Juniper) (ACQ).		Within 10 days (+/- 1 day) of completing the intervention	No
Secondary	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	No
Secondary	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	No
Secondary	Fractional exhaled nitric oxide (FeNO)	FeNO (a marker of eosinophilic inflammation)	Within 10 days (+/- 1 day) of completing the intervention	No
Secondary	Sputum inflammatory cell count	Number and type of inflammatory cells in induced sputum	Within 10 days (+/- 1 day) of completing the intervention	No
Secondary	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	No