Actively Recruiting
Ultra-high-caloric, Fatty Diet in ALS
Led by University of Ulm · Updated on 2026-05-01
392
Participants Needed
23
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims at evaluating efficacy and tolerability of an ultra-high-caloric, fatty diet (UFD) compared to placebo in patients with amyotrophic lateral sclerosis (ALS).
CONDITIONS
Official Title
Ultra-high-caloric, Fatty Diet in ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of possible, probable (clinically or laboratory supported), or definite amyotrophic lateral sclerosis based on revised El Escorial criteria
- Disease duration less than 24 months since first muscle weakness or bulbar symptoms
- ALS functional rating scale decline of 0.33 points or more per month
- Age 18 years or older
- Stable dose or no treatment with riluzole in the last 4 weeks
- Stable dose or no treatment with edaravone in the last 4 weeks
- Stable dose or no treatment with sodium-phenylbutyrate/taurursodiol in the last 4 weeks
- Ability to fully understand study information
- Signed written informed consent according to good clinical practice
You will not qualify if you...
- Participation in another interventional study with active treatment within the last 4 weeks
- Tracheostomy or continuous permanent ventilator use more than 22 hours per day
- Pregnancy or breastfeeding
- Presence of medical conditions associated with motor neuron dysfunction other than ALS
- Any life-threatening disease or condition interfering with functional assessment
- Major psychiatric disorder or dementia preventing symptom evaluation
- Inability or unwillingness to comply with study requirements or to be reached in emergency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
RWTH Aachen
Aachen, Germany
Not Yet Recruiting
2
Charité Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
3
University Clinic Bochum
Bochum, Germany
Not Yet Recruiting
4
University Clinic Bonn
Bonn, Germany
Not Yet Recruiting
5
Technical University Dresden
Dresden, Germany
Not Yet Recruiting
6
University Clinic Erlangen
Erlangen, Germany
Not Yet Recruiting
7
Alfried Krupp Krankenhaus Essen
Essen, Germany
Not Yet Recruiting
8
University Clinic Göttingen
Göttingen, Germany
Not Yet Recruiting
9
University Clinic Halle
Halle, Germany
Not Yet Recruiting
10
Hannover Medical School
Hanover, Germany
Not Yet Recruiting
11
University Clinic Jena
Jena, Germany
Not Yet Recruiting
12
DRK Clinic Kassel
Kassel, Germany
Not Yet Recruiting
13
Klinikum Kempten
Kempten, Germany
Not Yet Recruiting
14
University Clinic Leipzig
Leipzig, Germany
Not Yet Recruiting
15
University Clinic Lübeck
Lübeck, Germany
Actively Recruiting
16
Diakonissenkrankenhaus Mannheim
Mannheim, Germany
Actively Recruiting
17
Technical University Munich
Munich, Germany
Not Yet Recruiting
18
University Clinic Münster
Münster, Germany
Not Yet Recruiting
19
University Clinic Regensburg
Regensburg, Germany
Not Yet Recruiting
20
University Clinic Rostock
Rostock, Germany
Not Yet Recruiting
21
University of Ulm
Ulm, Germany
Actively Recruiting
22
DKD HELIOS Clinic Wiesbaden
Wiesbaden, Germany
Actively Recruiting
23
University Clinic Würzburg
Würzburg, Germany
Not Yet Recruiting
Research Team
J
Johannes Dorst, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here