Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

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).

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Dietary Supplement

Intervention Name:

high-caloric fatty diet, ultra-high-caloric fatty diet, ultra-high-caloric carbohydrate-rich diet

Placebo:

Phase:

Phase 1

Study Chair(s)/Principal Investigator(s):

Johannes Dorst, PD Dr., University of Ulm

Clinicaltrials.gov ID:

NCT04172792

Neals Affiliated?

No

Coordinating Center Contact Information