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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oil supplementation verum | Active Comparator | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise challenge in a cold chamber | Other | Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber. |
|
| 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 |
| 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of two methods of lung function testing as measured by spirometry (FEV1, percent predicted) and body plethysmography (specific airway resistance, sRAW, kPa*sec) | Both methods will be done in parallel before and 4 times after exercise challenge in cold air. Afterwards the investigators can compare both methods and calculate the sensitivity for both methods to indicate exercise induced bronchoconstriction. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Schulze, MD | Johann Wolfgang Goethe University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University Hospital Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19001792 | Background | Schubert R, Kitz R, Beermann C, Rose MA, Lieb A, Sommerer PC, Moskovits J, Alberternst H, Bohles HJ, Schulze J, Zielen S. Effect of n-3 polyunsaturated fatty acids in asthma after low-dose allergen challenge. Int Arch Allergy Immunol. 2009;148(4):321-9. doi: 10.1159/000170386. Epub 2008 Nov 11. | |
| 22326606 | Background |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Methacholine challenge | Other | Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg |
|
| Oil supplementation verum | Dietary Supplement | Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks |
|
| Oil supplementation placebo | Dietary Supplement | Patients and subjects will take double blind sunflower oil for four weeks |
|
Comparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group |
| 4 weeks |
| 4 weeks |
| Schulze J, Smith HJ, Fuchs J, Herrmann E, Dressler M, Rose MA, Zielen S. Methacholine challenge in young children as evaluated by spirometry and impulse oscillometry. Respir Med. 2012 May;106(5):627-34. doi: 10.1016/j.rmed.2012.01.007. Epub 2012 Feb 10. |
| 22826043 | Background | Nensa F, Kotschy-Lang N, Smith HJ, Marek W, Merget R. Assessment of airway hyperresponsiveness: comparison of spirometry and body plethysmography. Adv Exp Med Biol. 2013;755:1-9. doi: 10.1007/978-94-007-4546-9_1. |
| 19596563 | Background | Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10. |
| 511010 | Background | Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314. |
| 2783477 | Background | Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501. |
| 12904324 | Background | Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6. |
| 23634861 | Background | Parsons JP, Hallstrand TS, Mastronarde JG, Kaminsky DA, Rundell KW, Hull JH, Storms WW, Weiler JM, Cheek FM, Wilson KC, Anderson SD; American Thoracic Society Subcommittee on Exercise-induced Bronchoconstriction. An official American Thoracic Society clinical practice guideline: exercise-induced bronchoconstriction. Am J Respir Crit Care Med. 2013 May 1;187(9):1016-27. doi: 10.1164/rccm.201303-0437ST. |
| 32660564 | Derived | Dressler M, Fussbroich D, Bohler L, Herrmann E, Benker N, Tytyk M, Schulze J, Schubert R, Beermann C, Zielen S. Oil supplementation with a special combination of n-3 and n-6 long-chain polyunsaturated fatty acids does not protect for exercise induced asthma: a double-blind placebo-controlled trial. Lipids Health Dis. 2020 Jul 13;19(1):167. doi: 10.1186/s12944-020-01343-2. |
| D000092202 |
| Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |