NCT04172792

Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Albert Christian Ludolph, Prof. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	high-caloric fatty diet	see arm/group description
DIETARY_SUPPLEMENT	ultra-high-caloric fatty diet	see arm/group description
DIETARY_SUPPLEMENT	ultra-high-caloric carbohydrate-rich diet	see arm/group description

Timeline

• Start date: 2019-11-26
• Primary completion: 2021-04-05
• Completion: 2021-04-05
• First posted: 2019-11-21
• Last updated: 2021-04-29

Locations

1 site across 1 country: Germany