Skip to main content
Clinical Trials/NCT00876356
NCT00876356CompletedNot Applicable

Conjugated Linoleic Acid (CLA) as Adjunctive Therapy in Mild Asthmatics: A Pilot Study.

University of British Columbia2 sites in 1 country40 target enrollmentStarted: May 2002Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
PC20 - methacholine sensitivity

Study Overview

Brief Summary

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.

Detailed Description

Background and Purpose You are being invited to participate in a study of the effects of a natural supplement, conjugated linoleic acid (CLA), on allergy and asthma. Previous studies show that CLA may control the type of inflammation found in allergy and asthma. CLA is found in dairy products, however the amount found varies greatly depending on what the cows have been fed and has reduced dramatically over the last 30 years. The estimated daily intake of CLA is between 15 and 174 mg/day, but an effective dose of CLA is 3000 to 4000 mg/day for a 70 kg adult. Therefore taking CLA supplements may be beneficial. This will be the first formal study to look at whether CLA does benefit people with allergies and asthma.

Study Procedures

If you qualify for the study and agree to participate, you will be randomly assigned (like flipping a coin) into one of two groups. The two groups are:

Conjugated linoleic acid (active substance) twice daily for 3 months Placebo (inactive substance) twice daily for 3 months

Neither you nor the study doctors will know whether you are receiving CLA or placebo. There will be no change in your asthma medications that are prescribed by your regular physician. Your physician will be made aware that you are participating in this study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Mild asthma - FEV1 > 70% predicted Positive methacholine challenge

Exclusion Criteria

  • Not provided

Arms & Interventions

2

Placebo Comparator

Olive oil 4.5g/day x 12 weeks.

Intervention: Olive oil (Dietary Supplement)

1

Active Comparator

Conjugated Linoleic Acid 4.5g/day in three divided doses p.o. for 12 weeks

Intervention: Conjugated Linoleic Acid (CLA) (Dietary Supplement)

Outcomes

Primary Outcomes

PC20 - methacholine sensitivity

Time Frame: 12 weeks

Secondary Outcomes

  • Quality of life (QoL), body mass index (BMI), systemic cytokine levels, and adverse events.(12 weeks)

Investigators

Sponsor Class
Other

Study Sites (2)

Loading locations...

Similar Trials

The Health Benefits of Conjugated Linoleic... | Clinical Trial