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c9,t11-CLA in Children and Adolescents With Allergic Asthma

Pilot Study on the Effects of Oral Intervention With c9,t11-conjugated Linoleic Acid in Children and Adolescents With Allergic Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01026506
Enrollment
29
Registered
2009-12-04
Start date
2008-01-31
Completion date
2008-12-31
Last updated
2009-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Bronchial Asthma

Keywords

c9,t11-CLA, allergic bronchial asthma, children and adolescents

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.

Interventions

DIETARY_SUPPLEMENTconjugated 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

Sponsors

Cognis Deutschland GmbH & Co. KG
CollaboratorINDUSTRY
University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
lung function parameters12 weeks

Secondary

MeasureTime frame
symptom score, serum ECP, ex-vivo and in-vitro cytokine production of PBMC, urinary oxidation parameters, fatty acid distribution in erythrocytes12 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026