Inhibition of leukotriene biosynthesis by a novel dietary fatty acid formulation in patients with atopic asthma: a randomized, placebo-controlled, parallel-group, prospective trial.
BACKGROUND
Leukotriene inhibitors and leukotriene-receptor antagonists are effective in the treatment of inflammatory diseases such as asthma. A search of the entirety of MEDLINE using the terms diet plus leukotrienes identified numerous studies that have explored dietary-management strategies to reduce leukotriene levels through supplementation with polyunsaturated fatty acids such as gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA). However, the search found no studies on the use of combinations of these fatty acids in patients with asthma.


OBJECTIVE
The goal of this study was to determine the effect of daily intake of an emulsion (PLT 3514) containing dietary GLA and EPA on ex vivo stimulated whole blood leukotriene biosynthesis in patients with atopic asthma.


METHODS
This was a randomized, double-blind, placebo-controlled, parallel-group, prospective trial in patients with mild to moderate atopic asthma. Patients consumed 10 g PLT 3514 emulsion (containing 0.75 g GLA + 0.5 g EPA), 15 g PLT 3514 emulsion (containing 1.13 g GLA + 0.75 g EPA), or placebo (olive oil) emulsion daily for 4 weeks. Plasma fatty acids were measured by gas chromatography, and stimulated whole blood leukotrienes were measured by reverse-phase high-performance liquid chromatography with ultraviolet detection using a diode array detector.


RESULTS
Forty-three patients (33 women, 10 men) participated in the study. Leukotriene biosynthesis was significantly decreased in patients consuming 10 or 15 g PLT 3514 compared with placebo (P < 0.05, analysis of covariance). No clinically significant changes in vital signs were observed throughout the study, and there were no significant between-group differences in treatment-emergent adverse events or mean clinical laboratory values.


CONCLUSIONS
Daily consumption of dietary GLA and EPA in a novel emulsion formulation inhibited leukotriene biosynthesis in this population of patients with atopic asthma and was well tolerated.
Surette
Marc E
ME
Department of Research and Development, Pilot Therapeutics Inc., Charleston, South Carolina, USA. marcs@pilott.com
Koumenis
Iphigenia L
IL
Edens
Michelle B
MB
Tramposch
Kenneth M
KM
Clayton
Bert
B
Bowton
David
D
Chilton
Floyd H
FH
D000328:Adult; D001249:Asthma / Q000097:blood / Q000628:therapy*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000627:therapeutic use; D004655:Emulsions; D005227:Fatty Acids / Q000097:blood; D005231:Fatty Acids, Unsaturated / Q000627:therapeutic use*; D005260:Female; D005526:Food, Formulated; D006801:Humans; D017572:Leukotriene A4 / Q000037:antagonists & inhibitors / Q000096:biosynthesis* / Q000097:blood; D008297:Male; D011446:Prospective Studies; D017965:gamma-Linolenic Acid / Q000627:therapeutic use
D004655:Emulsions; D005227:Fatty Acids; D005231:Fatty Acids, Unsaturated; D017572:Leukotriene A4; D017965:gamma-Linolenic Acid; D015118:Eicosapentaenoic Acid