c9,t11-CLA in Children and Adolescents With Allergic Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01026506|
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 4, 2009
|Condition or disease||Intervention/treatment||Phase|
|Allergic Bronchial Asthma||Dietary Supplement: conjugated linoleic acid||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- Dietary Supplement: 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
- lung function parameters [ Time Frame: 12 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|