Bronchial Inflammation and Hyperresponsiveness After Oil Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

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.

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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.

Conditions

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Exercise-induced Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exercise challenge in a cold chamber

Intervention Type OTHER

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

Methacholine challenge

Intervention Type OTHER

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

Oil supplementation verum

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Exercise challenge in a cold chamber

Intervention Type OTHER

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

Methacholine challenge

Intervention Type OTHER

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

Oil supplementation placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Exercise challenge in a cold chamber

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

Intervention Type OTHER

Methacholine challenge

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

Intervention Type OTHER

Oil supplementation verum

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

Intervention Type DIETARY_SUPPLEMENT

Oil supplementation placebo

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

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No