Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation
- Conditions
- Exercise-induced Asthma
- Interventions
- Other: Exercise challenge in a cold chamberOther: Methacholine challengeDietary Supplement: Oil supplementation placeboDietary Supplement: Oil supplementation verum
- Registration Number
- NCT02410096
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- 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 Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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%
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oil supplementation placebo Oil supplementation placebo 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. Oil supplementation verum Exercise challenge in a cold chamber 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. Oil supplementation placebo Methacholine challenge 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. Oil supplementation verum Oil supplementation verum 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. Oil supplementation verum Methacholine challenge 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. Oil supplementation placebo Exercise challenge in a cold chamber 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.
- Primary Outcome Measures
Name Time Method Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo 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.
- Secondary Outcome Measures
Name Time Method Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb) 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%) 4 weeks Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group
Trial Locations
- Locations (1)
Goethe University Hospital Frankfurt
🇩🇪Frankfurt, Hessen, Germany