Lunasin does not slow ALS progression: results of an open-label, single-center, hybrid-virtual 12-month trial.

Lunasin, a soy peptide that reportedly alters histone acetylation , was associated with a single ALS reversal in the media. Following an ALSUntangled report, we sought to determine whether Lunasin altered histone acetylation and improved progression in people with ALS, and whether patient-centric trial design features might improve enrollment and retention. This single-center, year-long trial (NCT02709330) featured broad inclusion criteria, historical controls, primarily virtual data collection, and real-time results.