Clinical trial NCT04172792: Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)
Official title: Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: Nutritia GmbH, 91052 Erlangen, Germany
First posted: 2019-11-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: 4 weeks
measure: Laboratory values
timeFrame: 4 weeks
Secondary outcomes:
measure: Appetite
timeFrame: 2 weeks; 4 weeks
measure: Eating Habits
timeFrame: 2 weeks; 4 weeks
measure: Taste of Intervention
timeFrame: 2 weeks; 4 weeks
measure: Body Weight
timeFrame: 2 weeks; 4 weeks
measure: Biomarkers
timeFrame: 4 weeks
measure: Adverse Events and Serious Adverse Events
timeFrame: 6 weeks
measure: ALSFRS-R
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm, Department of Neurology
state: Baden-Wurttemberg
Study officials:
affiliation: University of Ulm
name: Johannes Dorst, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ludolph A, Drory V, Hardiman O, Nakano I, Ravits J, Robberecht W, Shefner J; WFN Research Group On ALS/MND. A revision of the El Escorial criteria - 2015. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(5-6):291-2. doi: 10.3109/21678421.2015.1049183. Epub 2015 Jun 29. No abstract available.