EFFORT Asthma: Effects of Diet and Exercise in Asthma (EFFORT)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Diet

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 Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen NV, Denmark, 2400
    • Respiratory Research Unit, Birpebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Study Chair: Vibeke Backer, Professor, Respiratory Research Unit, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: EFFORT Asthma