c9,t11-CLA in Children and Adolescents With Allergic Asthma
NCT ID: NCT01026506
Last Updated: 2009-12-04
Study Results
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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COMPLETED
NA
29 participants
INTERVENTIONAL
2008-01-31
2008-12-31
Brief Summary
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Detailed Description
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Thirty subjects (14 girls, 16 boys, age 6-18 years) were recruited from regular patients in the Clinic for Pediatric Allergology of the Friedrich Schiller University Jena. Informed consent was obtained from all participants/parents. 29 subjects completed the study.
The study was designed as a randomized and placebo-controlled study. After a 1-week run-in period to ascertain the current state of disease and categorization of allergic sensitization by RAST, the participants were randomized and evenly distributed to receive either 3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or 3 g/d of a placebo oil mixed in 100 g portions of milk fat-free yoghurt for 12 weeks. The yoghurt was freshly prepared and distributed in frequent intervals.
At the beginning and at the end of the study, lung function parameters were assessed by whole body plethysmography, and venous blood and 24h-urine samples were collected for further analyses. Throughout the entire study, the participants daily recorded their peak-flow data and kept protocol about their symptoms and drug usage.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Interventions
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conjugated linoleic acid
3 g/d of an esterified CLA preparation free of t10,c12-CLA (75% c9,t11-CLA, 87% purity) or placebo oil mixed in yoghurt for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* doctor-diagnosed bronchial asthma
* allergic sensitization (house dust mite, grass pollen)
* willingness to use only the recommended drugs
* competence regarding the daily documentation of peak-flow data and symptoms
Exclusion Criteria
* primary and secondary immune deficiency
* usage of systemic corticoids
* intolerance against milk protein
* alcohol and drug abuse
6 Years
18 Years
ALL
No
Sponsors
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Cognis Deutschland GmbH & Co. KG
INDUSTRY
University of Jena
OTHER
Responsible Party
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University of Jena, Dept. of Nutritional Physiology
Principal Investigators
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Gerhard Jahreis, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Jena, Dept. of Nutritional Physiology
Locations
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University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany
Countries
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References
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Jaudszus A, Mainz JG, Pittag S, Dornaus S, Dopfer C, Roth A, Jahreis G. Effects of a dietary intervention with conjugated linoleic acid on immunological and metabolic parameters in children and adolescents with allergic asthma--a placebo-controlled pilot trial. Lipids Health Dis. 2016 Feb 3;15:21. doi: 10.1186/s12944-016-0187-6.
Other Identifiers
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LSEP H34-08
Identifier Type: -
Identifier Source: org_study_id