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


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:

Dietary Supplement

Intervention Name:

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



Phase 1

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

Johannes Dorst, PD Dr., University of Ulm ID:


Neals Affiliated?


Coordinating Center Contact Information

Study Sponsor:

Albert Christian Ludolph, Prof.

Estimated Enrollment:


Estimated Study Start Date:

11 / 26 / 2019

Estimated Study Completion Date:

04 / 05 / 2021

Posting Last Modified Date:

04 / 29 / 2021

Date Study Added to

11 / 21 / 2019

Minimum Age:

18 Years

Maximum Age:


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

University of Ulm, Department of Neurology

Ulm, Baden-Wurttemberg 89081