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Borage and Echium Seed Oils for Asthma (Borage)

This study has been completed.
Sponsor:
Collaborator:
Wake Forest University
Information provided by (Responsible Party):
Joshua Boyce, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01560988
First received: March 9, 2012
Last updated: July 11, 2017
Last verified: July 2017
  Purpose
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 Intervention Phase
Asthma Drug: Borage and Echium Seed Oils Dietary Supplement: Corn oil pills Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Joshua Boyce, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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).

  • 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:
  • 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).

  • 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.

  • 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).

  • Genotyping at LTC4 Synthase Locus [ Time Frame: two weeks ]
    All individuals will be genotyped at the LTC4S locus. At the end of the study, the investigators will use the information to determine whether the individuals with at least one copy of the C variant of LTC4S display higher levels of lung function while on borage/echium than on placebo and whether their levels of LTC4S protein and mRNA expression in CD14+ monocytes and peripheral blood eosinophils are higher than in individuals with two A alleles.

  • 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.

  • 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).


Enrollment: 62
Study Start Date: February 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: March 9, 2012
Results First Received: February 15, 2017
Last Updated: July 11, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017