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Completed

NCT Number: NCT02355964

EFFORT Asthma: Effects of Diet and Exercise in Asthma

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Research Unit, Birpebjerg Hospital

Copenhagen NV, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

Aerobe exercise 3 times a week in 8 weeks

Diet

Behavioral

Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks

Primary outcomes

  1. Asthma Control Questionnaire (Juniper) (ACQ).

    Time frame: Within 10 days (+/- 1 day) of completing the intervention

Secondary outcomes

  1. Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.

    Time frame: 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.

  2. 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.

    Time frame: Within 10 days (+/- 1 day) of completing the intervention

  3. Fractional exhaled nitric oxide (FeNO)

    Time frame: Within 10 days (+/- 1 day) of completing the intervention

    FeNO (a marker of eosinophilic inflammation)

  4. Sputum inflammatory cell count

    Time frame: Within 10 days (+/- 1 day) of completing the intervention

    Number and type of inflammatory cells in induced sputum

  5. 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.

    Time frame: Within 10 days (+/- 1 day) of completing the intervention

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Acronym: EFFORT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 4, 2015
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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