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Effect of high-caloric nutrition on survival in amyotrophic lateral sclerosis

Annals of Neurology Jan 24, 2020

Ludolph AC, Dorst J, Dreyhaupt J, et al. - Researchers tested the effectiveness and tolerability of a high-caloric fatty diet (HCFD) in amyotrophic lateral sclerosis (ALS), most frequent adult-onset motor neuron disease. This trial (LIPCAL-ALS study) was carried out between February 2015 and September 2018. Participants in the study were 201 individuals, aged 62.4 ± 10.8. Participants were followed up 3, 6, 9, 12, 15, and 18 months after randomization. In addition to riluzole (100 mg/day), qualifying patients were randomly assigned (1:1) to either receive HCFD (405 kcal/day, 100% fat) or placebo. Both after 28 months (point in time of the last event), the confirmatory analysis of the primary outcome survival demonstrated a survival probability of 0.39 in the placebo group and 0.37 in the HCFD group. According to this prospective, double-blind, randomized, placebo-controlled clinical trial, no evidence was found for a life-prolonging impact of HCFD for the whole ALS population. Post-hoc analysis, however, exhibited a significant survival advantage for the subgroup of fast-progressing individuals.
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