Phase 3
Completed N=62
Borage and Echium Seed Oils for Asthma
Source: ClinicalTrials.gov NCT01560988 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation — 5.06; 2.56 ng
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation |
5.06; 2.56 | — |
| PRIMARY Change in LTB4 Production |
-.99; 0.12 | — |
| SECONDARY Measure of DHA in Cell Pellets |
1.18; -1.01 | — |
| SECONDARY Lung Function |
-.12; 0.22 | — |
| SECONDARY Plasma Level of Gamma Linolenic Acid (GLA) |
6.11; -.25 | — |
| SECONDARY Number of Subjects Bearing a Polymorphic Variant of LTC4 Synthase |
10 | — |
| SECONDARY Asthma Control |
-.18; -.12 | — |
| SECONDARY Measure of EPA in Cell Pellets |
.094; -0.02 | — |
| SECONDARY Change in Activity of LTC4 Synthase |
.95; -.10; 18.0; 11.7 | — |
| SECONDARY Genotype-specific Differences in Change in Lung Function While Receiving Borage and Echium Oils Versus Corn Oil. |
-.02; -.02; 0.08; .18 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female 18 years to 65 years of age
- 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) 10 pack years or active smoking within the past year.
- 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.
- Treatment within the previous three months with omalizumab (monoclonal antibody directed against IgE)
- 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.
- 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.
- Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
- No subjects will have any serious co-morbid medical condition.
Data sourced from ClinicalTrials.gov (NCT01560988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.