The LIPCAL-ALS study (NCT02306590) has provided preliminary evidence that a high-caloric nutrition might prolong survival in fast-progressing ALS patients. Since increasing the amount of calories of the intervention might possibly increase the beneficial effect, the investigators seek to investigate whether an ultra-high caloric diet (UHCD), featuring the double amount of calories compared to LIPCAL-ALS, will be well tolerated by ALS patients and may serve as an intervention for a potential LIPCALII study. For this purpose, the investigators will compare two different UHCDs (one fat-rich and one carbohydrate-rich) with regard to safety and tolerability over a time frame of 4 weeks. A third group will receive the original diet from LIPCAL, and a fourth group will receive no intervention (control group).
Inclusion Criteria:
- Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the revised version of
the El Escorial criteria (Ludolph et al. 2015)
- Slope of ALS Functional Rating Scale Revised (ALSFRS-R) of >0.25 points per month at
baseline visit based on the formula (48 - score at baseline visit) / (time between
date of first symptom and baseline visit)
- stable on standard therapy riluzole (100 mg/day) for at least 4 weeks
- capable of thoroughly understanding all information given and giving full informed
consent according to good clinical practice (GCP)
Exclusion Criteria:
- already taking any dietary supplements
- participation in another clinical trial within the preceding 8 weeks
- tracheostomy or assisted ventilation of any type which exceeds 23 hours per day
- pregnancy or breast-feeding females