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Borage and Echium Seed Oils for Asthma (Borage)

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ClinicalTrials.gov Identifier: NCT01560988
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : August 9, 2017
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
Wake Forest University
Information provided by (Responsible Party):
Joshua Boyce, Brigham and Women's Hospital

Brief Summary:
This study plans to look at whether borage and echium seed oils (natural oils from two plants) help decrease asthma symptoms and affect cells involved in inflammation. The investigators also want to look at how these plant oils decrease the generation of inflammatory cells in people with asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Borage and Echium Seed Oils Dietary Supplement: Corn oil pills Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Study Start Date : February 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Corn oil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active Borage and Echium Seed Oils
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.
Drug: 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.
Dietary Supplement: Corn oil pills
Corn oils pills will be taken three times per day for six weeks.
Experimental: Corn oil pills
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.
Drug: 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.
Dietary Supplement: Corn oil pills
Corn oils pills will be taken three times per day for six weeks.



Primary Outcome Measures :
  1. Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ]
    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).

  2. Change in LTB4 Production [ Time Frame: At 2, 8, 14, and 20 weeks ]
    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.


Secondary Outcome Measures :
  1. Measure of DHA in Cell Pellets [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ]
    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).

  2. Lung Function [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ]
    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.

  3. Plasma Level of Gamma Linolenic Acid (GLA) [ Time Frame: Measurements obtained at 2, 8, 14, and 20 weeks ]
    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).

  4. Number of Subjects Bearing a Polymorphic Variant of LTC4 Synthase [ Time Frame: two weeks ]
    All individuals will be genotyped at the LTC4S locus.

  5. Asthma Control [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ]
    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.

  6. Measure of EPA in Cell Pellets [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ]
    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).

  7. Change in Activity of LTC4 Synthase [ Time Frame: Days 0, 42, 84, and 126 ]
    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.

  8. Genotype-specific Differences in Change in Lung Function While Receiving Borage and Echium Oils Versus Corn Oil. [ Time Frame: 0, 42, 84, and 126 days ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18 years to 65 years of age
  2. Stable physician diagnosed asthma with FEV1 of greater than 50% of predicted but less than 90% of predicted or less than 90% of known best and an asthma control questionnaire(ACQ) < 1.5.

Exclusion Criteria:

  1. Pregnant or nursing
  2. Smoking history of > 10 pack years or active smoking within the past year.
  3. Due to possible effects on LT biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:

    • LT modifying drugs (zileuton, montelukast, zafirlukast)
    • theophylline
    • oral steroids
    • dietary supplements with fatty acids or other products that may interfere with LT generation.
  4. Treatment within the previous three months with omalizumab (monoclonal antibody directed against IgE)
  5. Subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo LT generation because of their effects on LT biosynthesis via inhibition of prostaglandin generation.
  6. A history of aspirin-sensitive asthma will be an exclusion criterion as the effects of GLA/SDA on prostanoid biosynthesis have not been adequately elucidated.
  7. Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
  8. No subjects will have any serious co-morbid medical condition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560988


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Wake Forest University
Investigators
Principal Investigator: Joshua Boyce, MD Brigham and Women's Hospital

Additional Information:
Responsible Party: Joshua Boyce, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01560988     History of Changes
Other Study ID Numbers: 2010p002041
First Posted: March 22, 2012    Key Record Dates
Results First Posted: August 9, 2017
Last Update Posted: April 9, 2018
Last Verified: April 2018

Keywords provided by Joshua Boyce, Brigham and Women's Hospital:
Asthma
Borage
Echium
Botanical

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases