The Health Benefits of Conjugated Linoleic Acid (CLA) for Asthma & Allergy

NCT00876356 | Completed

• 1 other identifier: P01-0180
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Conjugated Linoleic Acid (CLA); dietary supplement

Outcome Measures

Primary Outcomes (1)

• PC20 - methacholine sensitivity

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: Conjugated Linoleic Acid (CLA)

2

PLACEBO COMPARATOR

Olive oil 4.5g/day x 12 weeks.

Dietary Supplement: Olive oil

Interventions

Conjugated Linoleic Acid (CLA) DIETARY_SUPPLEMENT

CLA 4.5g/day in three divided doses p.o. for 12 weeks

1

Olive oil DIETARY_SUPPLEMENT

Olive oil 4.5g/day x 12 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Lung Association/British Columbia Lung Association: collaborator
• Natural Inc./Cognis GmbH (Dusseldorf, Germany): collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Linoleic Acids, Conjugated; Olive Oil

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Linoleic Acids; Fatty Acids, Omega-6; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Delbert Dorscheid, MD, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Ruth MacRedmond, MD, FRCPC

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: May 1, 2002
• Primary Completion: May 1, 2002
• Study Completion: September 1, 2004
• Last Updated: April 6, 2009

Record last verified: 2009-04

Locations

CA (1)