Borage and Echium Seed Oils for Asthma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment of Bronchial Asthma With Borage and Echium Seed Oils|
- Cellular changes that occur with borage and echium seed oil supplementation [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ] [ Designated as safety issue: No ]Primary outcome measures will be changes in the generation of LTB4 by neutrophils; changes in LTC4 production by basophils; changes in the production of LTB4 and LTC4 by monocytes; changes in expression levels of cPLA2, 5-LO, FLAP, LTC4S, and LTA4H by these cells; changes in the production of cytokines by basophils and monocytes and the expression and function of PI-3 kinaisoforms (Aim 1); changes in the generation of PGE1 vs. PGE2 and thromboxane and PPARγ expression by monocytes (Aim 2).
- Measure of fatty acid levels in blood [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ] [ Designated as safety issue: No ]Secondary outcome measures include changes in concentrations of essential fatty acids in whole blood (as a measure of compliance).
- Asthma Control [ Time Frame: Assessed at 0, 2, 5, 8, 14, 17, and 20 weeks ] [ Designated as safety issue: No ]Changes in asthma control will be assessed via the Asthma Control Questionnaire at each visit.
- Lung Function [ Time Frame: Assessed at 0, 2, 5, 8, 14, 17, and 20 weeks ] [ Designated as safety issue: No ]Changes in lung function will be assessed via spirometry at each visit.
- Genotype specific variation in response to borage and echium oils [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Active Borage and Echium Seed Oils
Borage and echium seed oils will be taken for six 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.
Placebo Comparator: Corn oil pills
Corn oil pills will be taken for six weeks.
Drug: Corn oil pills
Corn oils pills will be taken three times per day for six weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560988
|Contact: Kyle Nelson, BS||617-732-8630|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Kyle Nelson 617-732-8630 email@example.com|
|Principal Investigator: Joshua Boyce, MD|
|Principal Investigator:||Joshua Boyce, MD||Brigham and Women's Hospital|