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| Sponsors and Collaborators: |
University of British Columbia CIHR Canadian Lung Association/British Columbia Lung Association Natural Inc./Cognis GmbH (Dusseldorf, Germany) |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00876356 |
Purpose
Conjugated linoleic acids (CLA) are naturally occurring free fatty acids derived from the tissues and milk of ruminant animals such as cows. CLA has multiple biological properties including regulation of metabolism and immune processes, including tissue inflammation. Asthma symptoms are caused by irritation and inflammation of the airways. Our hypothesis was that CLA may reduce airway inflammation in asthma and thus reduce asthma symptoms. The aim of this pilot study was to investigate the efficacy and safety of CLA as a dietary supplement in mild asthma. Subjects will be assigned to take CLA dietary supplements or placebo (olive oil) for 12 weeks in addition to their usual asthma treatment. They will be monitored for asthma symptoms, side effects, lung function and blood markers of inflammation.
| Condition | Intervention |
|---|---|
|
Asthma |
Dietary Supplement: Conjugated Linoleic Acid (CLA) Dietary Supplement: Olive oil |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Conjugated Linoleic Acid (CLA) as Adjunctive Therapy in Mild Asthmatics: A Pilot Study. |
| Enrollment: | 40 |
| Study Start Date: | May 2002 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Conjugated Linoleic Acid 4.5g/day in three divided doses p.o. for 12 weeks
|
Dietary Supplement: Conjugated Linoleic Acid (CLA)
CLA 4.5g/day in three divided doses p.o. for 12 weeks
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|
2: Placebo Comparator
Olive oil 4.5g/day x 12 weeks.
|
Dietary Supplement: Olive oil
Olive oil 4.5g/day x 12 weeks
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Mild asthma - FEV1 > 70% predicted Positive methacholine challenge
Exclusion Criteria:
-
Contacts and Locations| Canada, British Columbia | |
| St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Principal Investigator: | Delbert Dorscheid, MD, Ph.D | University of British Columbia |
| Study Director: | Ruth MacRedmond, MD, FRCPC | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Delbert R. Dorscheid ) |
| Study ID Numbers: | P01-0180 |
| Study First Received: | April 3, 2009 |
| Last Updated: | April 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00876356 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Asthma Conjugated Linoleic Acid (CLA) dietary supplement |
|
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
|
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
