Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Recruitment status was: Recruiting
|Bronchial Asthma||Dietary Supplement: Borage Seed Oil and Echium Seed Oil Dietary Supplement: Corn Oil||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Bronchial Asthma With Borage and Echium Seed Oils|
- FEV1 [ Time Frame: 6 weeks ]
- Peak flows [ Time Frame: 6 weeks ]
- Symptoms of bronchial asthma [ Time Frame: 6 weeks ]
- Frequency of rescue use of short acting beta-2 agonists [ Time Frame: 6 weeks ]
- Ex vivo leukotriene generation [ Time Frame: 6 weeks ]
- Plasma fatty acid content [ Time Frame: 6 weeks ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||March 2011|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Dietary Supplement: Borage Seed Oil and Echium Seed Oil
2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.
|Placebo Comparator: 2||
Dietary Supplement: Corn Oil
9 g/day of corn oil
Leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying drugs are now an established treatment for bronchial asthma and rhinitis. Drugs that inhibit the biosynthesis of leukotrienes are likely to be more effective than the currently available drugs that antagonize a single leukotriene receptor. Dietary supplementation with gamma linolenic acid (GLA) in borage seed oil provides effective inhibition of leukotriene generation but also increases circulating free arachidonic acid (AA), which has pro-inflammatory potential. The n-3 fatty acid, eicosapentaenoic acid (EPA), prevented the conversion of GLA to AA. However, EPA is extracted from fish oil, is not well-tolerated due to its taste, and at higher doses appeared to blunt the inhibition of leukotriene biosynthesis by GLA. Stearidonic acid (SDA) is a precursor of EPA that is extracted from Echium plantagineum; it is converted to EPA in humans and it does not have the organoleptic properties of EPA.
We recently completed a dose-ranging study in which we determined the dose of SDA that is sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining effective inhibition of leukotriene generation.
The goal of the present study is to test the efficacy of dietary supplementation with GLA and SDA (provided in borage seed oil and echium seed oil) in treating bronchial asthma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806442
|Contact: Stefanie Dutile, BS||1-888-99-ASTHMAemail@example.com|
|Contact: Suzanne Vogt, MS||1-888-99-ASTHMAfirstname.lastname@example.org|
|United States, Massachusetts|
|Asthma Research Center, Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jonathan P Arm, MD||Brigham and Women's Hospital|