Ultra-high-caloric, Fatty Diet in ALS
This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).
- EligibilityCriteria: Inclusion Criteria:  Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria Disease duration (onset of first paresis or bulbar symptoms) < 24 months Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit) Age ≥18 years. Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion Capable of thoroughly understanding all information given full written informed consent according to good clinical practice  Exclusion Criteria:  Previous participation in another interventional study involving an active treatment within the preceding 4 weeks Tracheostomy or continuous permanent ventilator dependence (>22 hours per day) Pregnancy or breastfeeding Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult