Efficacy, Safety and Tolerability of High Lipid and Calorie Supplementation in Amyotrophic Lateral Sclerosis

Inclusion criteria

• Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria (Brooks et al. 2000)
• Disease duration < 36 months
• Vital capacity of more than 50% of normal (defined as slow vital capacity, best of three measurements)
• Age ≥18 years
• Continuously treated with 100 mg riluzole daily for at least four weeks
• Capable of thoroughly understanding all information given and giving full informed consent according to GCP
• Willing to complete a diet questionnaire throughout participation in the study

Exclusion criteria

• Simultaneous participation in another interventional clinical study
• Previous participation in a drug clinical trial where last intake of the trial drug was within the last 12 weeks
• Known sensitivity or intolerance to rape oil or sunflower oil, or components thereof
• Tracheostomy
• Patients with gastrostomy
• 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.