Clinical Trial: Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Examination of Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation With Middle-chain and Polyunsaturated Fatty Acids in an Exercise-induced Asthma Pro

Brief Summary: The purpose of this study is to investigate the bronchial inflammation and hyperresponsiveness after oil supplementation. Before and after oil supplementation the investigators measure decrease in lung function after exercise-challenge in a cold chamber and increase of inflammatory markers in the blood.

Detailed Summary:

Subjects suffering form exercise-induced bronchoconstriction (EIB) usually have a normal lung function testing at rest and show a decrease in lung function when they do sports or an exercise-challenge. In a previous study the investigators could show, that the combination of exercise test and inhalation of cold air ist more sensitive and specific than exercise-challenge in ambient temperature.

It is known that omega - 3 -fatty acids could reduce the production of inflammatory mediators.

In this study the investigators will investigate the protective effect of oil supplementation with middle-chain and polyunsaturated fatty acids in an exercise-induced asthma provocation model.

Therefore the investigators will measure the decrease in lung function and a increase of inflammatory markers in the blood before and after oil supplementation.

Before and after the exercise-challenge the investigators will measure spirometry and body plethysmography. The investigators want to examine if the body plethysmography is more sensitive in the measurement of exercise induced bronchoconstriction than spirometry.

The investigators hypothesize that the oil supplementation can reduce bronchial inflammation and hyperresponsiveness.


Sponsor: Johann Wolfgang Goethe University Hospital

Current Primary Outcome: Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo [ Time Frame: 4 weeks ]

The exercise challenge in cold air will be done on two timepoints. Before and after oil supplementation versus placebo supplementation. After exercise challenge spirometry will be measured. Decrease in FEV1 in verum and control group will be compared with t-test and Wilcoxon-Mann-Whitney-Test.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb) [ Time Frame: 4 weeks ]
    Comparison of decrease in eNO before and after supplementation in verum and placebo group
  • Comparison of change in lipids in serum as measured by capillary gas chromatography (weight percent, wt%) [ Time Frame: 4 weeks ]
    Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group


Original Secondary Outcome:

  • Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb) [ Time Frame: 4 weeks ]
    Comparison of decrease in eNO before and after supplementation in verum and placebo group
  • Comparison of change in lipids in serum as measured by gas chromatography (mcg/mL) [ Time Frame: 4 weeks ]
    Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group


Information By: Johann Wolfgang Goethe University Hospital

Dates:
Date Received: March 18, 2015
Date Started: April 2015
Date Completion:
Last Updated: September 2, 2016
Last Verified: September 2016