Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients.

BACKGROUND: Asthma can have a negative impact on quality of life although this is not well correlated with objective evaluations of pulmonary function. A medical food, EFF1009, containing the fatty acids gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) decreases leukotriene B(4) synthesis in patients with asthma. Two previous clinical studies with EFF1009 provided preliminary evidence that the medical food improves asthma-related quality of life (ARQOL) and asthma management. OBJECTIVE: To evaluate the impact on ARQOL of EFF1009 in adults with asthma. RESEARCH DESIGN AND METHODS: The study was a randomized, prospective, double-blind, placebo-controlled, parallel group study in twenty-one (N = 21 evaluable) subjects with mild to moderate persistent asthma who consumed the medical food emulsion or placebo emulsion daily for 28 days. All participants continued their asthma medications throughout the study. ARQOL, including asthma signs and symptoms, and asthma control were measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and the Asthma Control Questionnaire (ACQ), administered at baseline, Day 14 and Day 28. Safety and tolerability parameters, including adverse events, were monitored. RESULTS: Baseline ARQOL scores, forced expiratory volume in one second (FEV(1)) and other characteristics were balanced between both groups. Mean (standard error) total MiniAQLQ scores changed by 0.73 (0.38) and -0.22 (0.36) in the EFF1009 and placebo groups, respectively, (p < 0.05). The MiniAQLQ symptom domain score was improved in the EFF1009 group (p < 0.05). Total scores for the ACQ were not significantly improved in either group. Levels of the fatty acid EPA in plasma increased in the EFF1009 group but not the placebo group (p < 0.03). The medical food was well tolerated and no safety concerns were identified. CONCLUSIONS: The dietary addition of the medical food EFF1009 to asthma management regimens can improve patient perceived, ARQOL and can also improve asthma management as evidenced by reduced asthma symptoms. An additional study of the medical food, with larger subject population and longer treatment duration, is warranted to confirm these findings.

The impact of a medical food containing gammalinolenic and eicosapentaenoic acids on asthma management and the quality of life of adult asthma patients.

BACKGROUND: Leukotriene synthesis inhibitors and receptor antagonists are efficacious for the treatment of asthma. Diets containing the fatty acids gammalinolenic acid (GLA) and eicosapentaenoic acid (EPA) decrease leukotriene synthesis; however, their impact on asthma management and quality of life (QOL) has not been evaluated in asthmatic subjects. OBJECTIVE: To evaluate asthma management and the QOL of asthmatic adult subjects consuming a medical food emulsion containing GLA and EPA. RESEARCH DESIGN AND METHODS: Trial 1 was a randomized, prospective, double-blind, placebo-controlled, parallel group trial in atopic subjects with mild-to-moderate asthma (n = 35 evaluable) consuming a low dose (0.75 g GLA + 0.5 g EPA), high dose (1.13 g GLA + 0.75 g EPA) or placebo emulsion daily. Subjects were questioned about their asthma management using a non-validated questionnaire after 2 and 4 weeks. Blood leukotrienes were measured at baseline and after 4 weeks. Trial 2 was an open-label study (n = 65 evaluable) where subjects consumed the low-dose medical food emulsion, EFF1009, daily. QOL and asthma management were measured using the validated Mini Asthma Quality of Life (MiniAQLQ) and the Asthma Control (ACQ) questionnaires, respectively, administered at baseline and after 4 weeks. RESULTS: In Trial 1, leukotriene biosynthesis decreased (p < 0.05). Self-reported asthma status and bronchodilator use improved in subjects consuming low- and high-dose emulsion between week 2 and week 4 (p < 0.01), but not compared to placebo (p > 0.1). In Trial 2, mean +/- standard error total MiniAQLQ and ACQ scores improved by 1.5 +/- 0.2 and 1.0 +/- 0.1, respectively (p < 0.001). Subdomain scores from MiniAQLQ improved and rescue bronchodilator use decreased (p < 0.001). CONCLUSION: The inclusion of the medical food EFF1009 in asthma management regimens can improve patient quality of life and decrease reliance on rescue medication.

Evaluation of IgE binding to proteins of hardy (Actinidia arguta), gold (Actinidia chinensis) and green (Actinidia deliciosa) kiwifruits and processed hardy kiwifruit concentrate, using sera of individuals with food allergies to green kiwifruit.

BACKGROUND: Allergy to green kiwifruit has become common since the fruit was introduced in North America and Europe 30 years ago. Gold kiwifruit, more recently introduced commercially, has been shown to bind IgE from some individuals allergic to green kiwifruit. Hardy kiwifruit is a third species that is now cultivated in North America with potential application as a fresh fruit and in processed foods. OBJECTIVE: To compare the IgE binding properties of proteins in hardy kiwifruit extract and processed hardy kiwifruit concentrate to each other and to extracts of green and gold kiwifruits to evaluate the potential for allergic cross-reactions. METHODS: Sera from kiwifruit-allergic subjects and individuals without allergies to kiwifruit were assayed for IgE binding to soluble proteins in green, gold and hardy kiwifruits and heat-processed concentrate from hardy kiwifruit using immunoblots and direct enzyme-linked immunosorbent assay (ELISA). RESULTS: Marked IgE binding to specific hardy kiwifruit proteins was identified. However, IgE binding to heat-processed hardy kiwifruit concentrate was remarkably lower than to the raw fruit extract. CONCLUSIONS: These results suggest that some kiwifruit-allergic individuals may suffer allergic cross-reactions if they consume raw hardy kiwifruit. However, heat processing of the hardy kiwifruit alters allergenic protein structure, dramatically reducing in vitro IgE binding. Processing likely reduces the risk of eliciting an allergic response in those with allergies to raw kiwifruit.