In 2024, the LIPCAL-ALS II study will start in the German MND-NET. This is a multicentre, randomized, placebo-controlled study in which a high-calorie, fat-based dietary supplement (+630 kcal/day) will be tested in 392 ALS patients over 18 months. The aim of this intervention is to compensate for the energy deficit resulting from intrinsic hypermetabolism, which regularly leads to weight loss and is associated with shorter survival. In the predecessor study LIPCAL-ALS I, the same dietary supplement was used at a lower dosage (+405 kcal/day). Here, a significant survival advantage was shown in the subgroup of rapidly progressive patients (ALSFRS-slope >0.62/month), which was also associated with a significant reduction in neurofilament light chain (NfL) in serum and ALSFRS-slope over the course of the study.
The LIPCAL-ALS II study is planned with a higher dosage of the study intervention, a larger number of patients and the exclusion of atypical slow-onset forms of the disease. A total of 5 on-site study visits and 5 telephone visits are planned over the study period of 18 months.
392 patients in 26 German ALS centers are to be included. The current recruitment status of the individual centers can be viewed below. If you are interested in the study, please contact the respective center or the following contact persons:
