Study Protocol: Efficacy, safety, and tolerability of ultra-high-caloric, fatty diet (UFD) in amyotrophic lateral sclerosis
Dorst, J.; Schuster, J.
Show abstract
The LIPCAL-ALS II study investigates the efficacy, safety, and tolerability of an ultra-high-caloric, fatty diet (UFD) in amyotrophic lateral sclerosis (ALS). It is a multicenter, 1:1-randomized, prospective, stratified, parallel-group, double-blind, placebo-controlled, confirmatory study with 392 patients conducted in 25 centers of the German network for motor neuron diseases (MND Net). Patients will be randomized to receive either the experimental intervention, consisting of an ultra-high-caloric fatty dietary supplement for drinking (100% lipid, 4.5 kcal/ml) 140 ml/day (630 kcal) or matching placebo (140 ml/day, <5% fat, <50 kcal) in addition to normal food intake. The primary endpoint is survival after 18 months of intervention. Patients with possible, probable (clinically or laboratory supported) or definite ALS according to revised El Escorial criteria with a disease duration of <36 months and a loss of ALS functional rating scale revised (ALSFRS-R) [≥]0.33 points/months will be included. Synopsis O_TBL View this table: org.highwire.dtl.DTLVardef@1b4bac7org.highwire.dtl.DTLVardef@5263cborg.highwire.dtl.DTLVardef@115c150org.highwire.dtl.DTLVardef@1468042org.highwire.dtl.DTLVardef@18e97c4_HPS_FORMAT_FIGEXP M_TBL C_TBL
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