Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Exercise-induced Asthma

Intervention / Treatment
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* Other: Exercise challenge in a cold chamber
* Other: Methacholine challenge
* Dietary Supplement: Oil supplementation verum
* Dietary Supplement: Oil supplementation placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Patients: Age ≥12 and 44 years known exercise induced asthma basic lung function FVC ≥ 75%, FEV1 ≥ 70% decrease in FEV1 after exercise ≥ 15% Exclusion Criteria: lung function Forced vital capacity (FVC) <75% and Forced expiratory volume in 1 second (FEV1) <70% chronic diseases or infections (e.g. HIV, Tbc) pregnancy systemic corticosteroid-treatment inhalative corticosteroid therapy or leukotriene antagonists alcohol, substance or drug abuse smokers inability to capture extend and consequences of the study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oil supplementation verum<br>30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach ones daily 1190 mg of middle-chain and polyunsaturated fatty acids for four weeks. Before and after supplementation an exercise challenge in a cold chamber will be performed. | Other: Exercise challenge in a cold chamber<br>* Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.<br>Other: Methacholine challenge<br>* Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg<br>Dietary Supplement: Oil supplementation verum<br>* Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks<br>|
| Placebo Comparator: Oil supplementation placebo<br>30 patients aged 12-44 years with a diagnosis of exercise induced asthma undergo a methacholine challenge and a prick test. After randomization patients will receive in double blind approach placebo for four weeks. Before and after placebo treatment an exercise challenge in a cold chamber will be performed. | Other: Exercise challenge in a cold chamber<br>* Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.<br>Other: Methacholine challenge<br>* Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg<br>Dietary Supplement: Oil supplementation placebo<br>* Patients and subjects will take double blind sunflower oil for four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo | 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. | 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, oil supplementation, middle-chain and Polyunsaturated Fatty Acids