The aim of this trial is to determine the efficacy of a combination of two botanicals oils, borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
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.
9 g/day of corn oil
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, United States
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo
Time frame: 6 weeks
Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes
Number of participants with positive change in FEV1 % predicted (\>0%) among C allele carriers and A homozygotes in each arm
Time frame: 6 weeks on each treatment assignment
Peak Flow Rate (PEFR)
Morning Peak Flow Rate in plant seed oil vs. placebo
Time frame: 6 weeks
Frequency of Rescue Use of Short Acting Beta-2 Agonists
Average number of puffs of albuterol daily in plant seed oil vs. placebo
Time frame: 6 weeks
Day-time Symptoms of Bronchial Asthma
Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms 1. = Mild: Symptom did not interfere with normal daily activity or sleep 2. = Moderate: Symptom was sufficient to interfere with normal daily activity or sleep 3. = Severe: Symptom was so severe as to prevent normal daily activity or sleep These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus. The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures.
Time frame: 6 weeks
Night-time Wakenings
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Average number of night-time wakenings in plant seed oil vs. placebo
Time frame: 6 weeks
Urinary Leukotriene Levels
Urinary leukotriene levels in plant seed oil vs. placebo
Time frame: 6 weeks