Borage and echium oil capsules administered daily for six weeks, then a 6 week washout period, followed by ingestion of placebo (corn oil capsules) daily for 6 weeks.

Corn oil capsules daily for six weeks, then a 6 week washout period, followed by ingestion of Borage and echium oil capsules daily for 6 weeks.

Participants were randomized to receive either borage and echium oils first, and corn oil second, or vice versa

All Study Participants

Sex: Female, Male

Region of Enrollment

Primary outcome measures will be changes in the generation of LTC4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).

Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks.

Borage and Echium Seed Oils

Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks.

Corn Oil Pills

Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation

Primary outcome measures will be changes in the generation of LTB4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta). A negative number implies that the level of LTB4 produced by granulocytes at the end of the arm was less than the amount produced at the start of the arm, while a positive number means that more was generated at the end than at the beginning.

Corn oil pills will be taken for six weeks.
Corn oil pills will be taken three times per day for six weeks.

Change in LTB4 Production

Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).

Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks

Measure of DHA in Cell Pellets

Changes in lung function (forced expiratory volume in 1 second) will be assessed via spirometry at each visit. This was calculated by the difference between the FEV1 at weeks 2 and 8 versus weeks 14 and 20. The differences were compared as a delta-delta. A negative number for this parameter means that the FEV1 was lower at the end of the arm than at the beginning, while a positive number means that the FEV1 was higher at the end.

Borage and echium seed oils will be taken for six weeks.
Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil.

Lung Function

Changes in plasma level of gamma linolenic acid (GLA), a major constituent of Borage oil, as a measure of compliance. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).

Corn oil pills will be taken for six weeks.
Corn oil pills: Corn oils pills will be taken three times per day for six weeks

Plasma Level of Gamma Linolenic Acid (GLA)

All individuals will be genotyped at the LTC4S locus.

All study participants, regardless of arm assignment, were genotyped at the LTC4S locus.

Number of Subjects Bearing a Polymorphic Variant of LTC4 Synthase

Changes in asthma control will be assessed via the Asthma Control Questionnaire (ACQ) at each visit. The ACQ is a 6-point questionnaire that reflects the degree of asthma activity. Each point is assigned a scale of 0-5, with 5 being the worst. Thus, the range is from 0 (no asthma symptoms) to 30 (severe asthma symptoms). For each arm, we generate two values (week 2 vs. week 8 and week 14 vs.week 20). These values are then averaged for each arm to obtain the final single value. A negative number implies improved symptoms.

Asthma Control

Measure of EPA in Cell Pellets

Differences in LTC4S activity while receiving borage/echium oils versus corn oil stratified by LTC4S genotype. We analyzed the genotype for 32 subjects for the borage arm and 30 subjects for the placebo arm.

Change in Activity of LTC4 Synthase

FEV1 was measured in all subjects at the beginning and end of both study arms. Subjects were genotyped at LTC4S locus and those bearing at least one A to C polymorphism were compared with those bearing two A alleles.

Genotype-specific Differences in Change in Lung Function While Receiving Borage and Echium Oils Versus Corn Oil.

Borage and Echium Seed Oils: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks, followed by a 6 week washout. Then, subjects were crossed over to receive corn oil (10 g) daily for six weeks

First Borage and Echium, Then Corn Oil

Corn oil pills will be taken for six weeks, followed by a 6 week washout. Then subjects received borage and echium oil tablets for six week.

First Corn Oil, Then Borage and Echium Seed Oil

First Intervention (Six Weeks)

Washout (Six Weeks)

Second Intervention (Six Weeks)

Dr. Joshua Boyce

Asthma

4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks.

Corn oils pills will be taken three times per day for six weeks.

Corn oil pills

Brigham and Women's Hospital

Borage and Echium Seed Oils for Asthma

Treatment of Bronchial Asthma With Borage and Echium Seed Oils

Joshua Boyce

Professor of Medicine

Wake Forest University

Borage/Echium plant seed oils: 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.

Includes patients scheduled to receive Borage and Echium seed oil first and participants scheduled to receive placebo first.

All Study Particpants

Age, Customized

Sex/Gender, Customized

Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo

Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA)

Plant Seed Oil

Placebo

Forced Expiratory Volume in 1 Second (FEV1)

Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm

Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes

Morning Peak Flow Rate in plant seed oil vs. placebo

Peak Flow Rate (PEFR)

Average number of puffs of albuterol daily in plant seed oil vs. placebo

Frequency of Rescue Use of Short Acting Beta-2 Agonists

Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms
= Mild: Symptom did not interfere with normal daily activity or sleep
= Moderate: Symptom was sufficient to interfere with normal daily activity or sleep
= 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.

Day-time Symptoms of Bronchial Asthma

Average number of night-time wakenings in plant seed oil vs. placebo

Night-time Wakenings

Urinary leukotriene levels in plant seed oil vs. placebo

Urinary Leukotriene Levels

Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks followed a 3-week washout period, then Placebo (11 g/day corn oil) 3x day for 3 weeks.

1 - Borage Seed Oil and Echium Seed Oil, Then Placebo

Placebo (11 g of corn oil/day) 3x day for 3 weeks followed by a 3-week washout period, then Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of ~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks.

2 - Placebo, Then Borage Seed Oil and Echium Seed Oil

Overall Study

Elliot Israel, MD

Washout period between first (plant seed oil) and second (placebo) treatment assignments

Washout After Plant Seed Oil

Washout period between first (placebo) and second (plant seed oil) treatment assignments

Washout After Placebo

Bronchial Asthma

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.

echium/inflammation

Borage and Echium Seed Oils for Asthma

Treatment of Bronchial Asthma With Borage and Echium Seed Oils

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