Skip to content

Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02410096
Enrollment
73
Registered
2015-04-07
Start date
2015-04-30
Completion date
2016-07-31
Last updated
2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise-induced Asthma

Keywords

exercise-induced asthma, cold chamber, exercise challenge, cold air challenge, oil supplementation, middle-chain and Polyunsaturated Fatty Acids

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.

Interventions

Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.

Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg

DIETARY_SUPPLEMENTOil supplementation verum

Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks

DIETARY_SUPPLEMENTOil supplementation placebo

Patients and subjects will take double blind sunflower oil for four weeks

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
12 Years to 44 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decrease in FEV1 after exercise challenge in cold air as measured by spirometry (FEV1, percent predicted) - comparison verum vs placebo4 weeksThe 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

MeasureTime frameDescription
Comparison of decrease in exhaled nitric oxide (eNO) as measured by Niox Mino (parts per billion, ppb)4 weeksComparison 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 weeksComparison of increase eicosapentaenoic acid and docosahexaenoic acid and decrease of triglycerides before and after supplementation in verum and placebo group

Other

MeasureTime frameDescription
Comparison of two methods of lung function testing as measured by spirometry (FEV1, percent predicted) and body plethysmography (specific airway resistance, sRAW, kPa*sec)4 weeksBoth 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026