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The BASALIT multicenter trial: Gly m 4 quantification for consistency control of challenge meal batches and toward Gly m 4 threshold data
Author(s) -
Holzhauser Thomas,
Franke Annegret,
Treudler Regina,
Schmiedeknecht Anett,
Randow Stefanie,
Becker WolfMeinhard,
Lidholm Jonas,
Vieths Stefan,
Simon JanChristoph
Publication year - 2017
Publication title -
molecular nutrition and food research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.495
H-Index - 131
eISSN - 1613-4133
pISSN - 1613-4125
DOI - 10.1002/mnfr.201600527
Subject(s) - meal , placebo , allergen , medicine , coefficient of variation , adverse effect , soy protein , food science , allergy , zoology , chemistry , chromatography , immunology , biology , alternative medicine , pathology
Scope The BASALIT clinical trial (EudraCT 2009‐011737‐27) investigated efficacy of birch allergen immunotherapy on lowest observed adverse effect levels after soy food challenge in patients with birch‐associated and Gly m 4 allergen mediated soy allergy. Thus, consistently stable Gly m 4 levels were required in standardized challenge meals. Methods and results Soy meal included soy protein isolate (SPI, 88% total protein). A Gly m 4 specific ELISA was developed and validated. Six SPIs and 24 meal batches were analyzed for Gly m 4. (Repeated‐measures) analyses of variance were done to identify potential changes between batches and time intervals. Gly m 4 was below the ELISA detection limit (2 ng/mL) in placebo batches. With <20% mean coefficient of variation, Gly m 4 levels were consistent in 24 soy meal batches and within individual 12‐wk shelf‐life. Conclusion The novel Gly m 4 specific ELISA proved consistency of challenge meal batches over a 56‐month study period. With an average of 178 μg/g Gly m 4 in SPI, Gly m 4 lowest observed adverse effect level can be calculated once clinical lowest observed adverse effect level data based on SPI are available. Hence, sensitivity of patients can be correlated to the relevant allergen content instead of total protein of the allergenic source.