c9,t11-CLA in Children and Adolescents With Allergic Asthma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma|
- lung function parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- symptom score, serum ECP, ex-vivo and in-vitro cytokine production of PBMC, urinary oxidation parameters, fatty acid distribution in erythrocytes [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Dietary Supplement: conjugated linoleic acid
In-vitro and animal studies strongly suggest that c9,t11-CLA reduces inflammatory processes in asthma-models. Aim of this study was to determine possible beneficial effects of orally administered c9,t11-CLA in children and adolescents with allergic bronchial asthma.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026506
|University of Jena, Institute of Nutrition, Department of Nutritional Physiology|
|Jena, Thuringia, Germany, 07743|
|Principal Investigator:||Gerhard Jahreis, Prof. Dr.||University of Jena, Dept. of Nutritional Physiology|