O047 - NUTRITIONAL INTERVENTION IN AMYOTROPHIC LATERALSCLEROSIS: EFFECTS OF HIGH-CALORIC FAT SUPPLEMENTATION ON DISEASE PROGRESSION AND SURVIVAL (LIPCAL-ALS I&II TRIAL)
O047
NUTRITIONAL INTERVENTION IN AMYOTROPHIC LATERALSCLEROSIS: EFFECTS OF HIGH-CALORIC FAT SUPPLEMENTATION ON DISEASE PROGRESSION AND SURVIVAL (LIPCAL-ALS I&II TRIAL)
J. Schuster1,*, C. Herrmann1, J. Dorst1
1Neurology, University Clinic Ulm, Ulm, Germany
Rationale: Stabilization of body weight and elevated triglyceride levels are known positive prognostic factors in amyotrophic lateral sclerosis (ALS). In a randomized, placebo-controlled trial, the effect of a high-caloric, fat-rich nutritional supplement on survival and disease progression was investigated (LIPCAL I, NCT04172792). The intervention aimed to stabilize body weight, slow functional decline, and prolong survival.
Methods: A total of 201 patients were randomized to either the intervention or placebo group. The intervention consisted of 90 mL of a fat emulsion providing 405 kcal, administered over 18 months. The primary endpoint was survival. Secondary endpoints included functional outcome parameters.
Results: No significant effect of nutritional supplementation on survival was observed in the overall study population. However, a significant survival benefit (p=0.02) and reduced weight loss (p=0.02) were found in the subgroup of patients with rapid disease progression. Additionally, a slowing of disease progression was observed in the intervention group (p<0.01), along with a more favorable disease course compared to placebo (p<0.01) among patients who survived the entire study period.
Conclusion: High-caloric, fat-rich nutritional supplementation was associated with a slowing of disease progression and, in patients with rapid disease progression and pronounced weight loss, with prolonged survival and improved weight stabilization. These findings provide the rationale for the ongoing LIPCAL II study (NCT06280079) in Germany, which aims to further evaluate the therapeutic potential of this intervention.
References: Dorst J*, Schuster J*, et. al, J Neurol Neurosurg Psychiatry. 2020 Sep;91(9):1007-1009. doi: 10.1136/jnnp-2020-323372. Epub 2020 Aug 11.
Ludolph AC*, Dorst J*, et. al, Ann Neurol. 2020 Feb;87(2):206-216. doi: 10.1002/ana.25661. Epub 2020 Jan 6.
Disclosure of Interest: None declared