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

NCT04172792 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-04-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Nutritia GmbH, 91052 Erlangen, Germany

    collaborator UNKNOWN

  • Albert Christian Ludolph, Prof.

    lead OTHER

Principal Investigators

  • Johannes Dorst, PD Dr. · University of Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2021-04-05
Completion
2021-04-05

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04172792 on ClinicalTrials.gov