c9,t11-CLA in Children and Adolescents With Allergic Asthma
Primary Purpose
Allergic Bronchial Asthma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
conjugated linoleic acid
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Bronchial Asthma focused on measuring c9,t11-CLA, allergic bronchial asthma, children and adolescents
Eligibility Criteria
Inclusion Criteria:
- age 6-18 years
- 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:
- SIT within the last 2 years
- primary and secondary immune deficiency
- usage of systemic corticoids
- intolerance against milk protein
- alcohol and drug abuse
Sites / Locations
- University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Outcomes
Primary Outcome Measures
lung function parameters
Secondary Outcome Measures
symptom score, serum ECP, ex-vivo and in-vitro cytokine production of PBMC, urinary oxidation parameters, fatty acid distribution in erythrocytes
Full Information
NCT ID
NCT01026506
First Posted
December 3, 2009
Last Updated
December 3, 2009
Sponsor
University of Jena
Collaborators
Cognis Deutschland GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT01026506
Brief Title
c9,t11-CLA in Children and Adolescents With Allergic Asthma
Official Title
Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Jena
Collaborators
Cognis Deutschland GmbH & Co. KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was performed to investigate the effects of a dietary intervention with c9,t11-CLA on clinical and immunological parameters in children and adolescents with allergic bronchial asthma.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchial Asthma
Keywords
c9,t11-CLA, allergic bronchial asthma, children and adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
conjugated linoleic acid
Intervention Description
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
Primary Outcome Measure Information:
Title
lung function parameters
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 6-18 years
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:
SIT within the last 2 years
primary and secondary immune deficiency
usage of systemic corticoids
intolerance against milk protein
alcohol and drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
University of Jena, Dept. of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26843092
Citation
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.
Results Reference
derived
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c9,t11-CLA in Children and Adolescents With Allergic Asthma
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