Could a fatty diet fight ALS?
NCT ID NCT06280079
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an ultra-high-caloric diet made almost entirely of fat can help people with ALS live longer and slow the disease. Researchers will compare the diet to a low-fat placebo in 392 participants. The main goal is to see if the diet extends survival without the need for a breathing tube.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ultra-high-caloric fatty diet (100% fat, no protein or carbs)
- What this could lead to
- If it works, this could point toward a dietary approach to extend survival and slow decline in ALS.
- What could go wrong
- This is an early-stage trial without a standard phase, and the diet is extreme—it may be hard to tolerate or show no benefit over placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 392 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria * Disease duration (onset of first paresis or bulbar symptoms) \< 24 months * Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points/month based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) / (months between onset and screening visit) * Age ≥18 years. * Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion * Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion * Either continuously treated with a stable dose of sodium-phenylbutyrate/taurursodiol, OR not treated with sodium-phenylbutyrate/taurursodiol for the last 4 weeks prior to inclusion * Capable of thoroughly understanding all information given * full written informed consent according to good clinical practice Exclusion Criteria: * Previous participation in another interventional study involving an active treatment within the preceding 4 weeks * Tracheostomy or continuous permanent ventilator dependence (\>22 hours per day) * Pregnancy or breastfeeding * Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS * Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment. * Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms. * Liable to be not cooperative or comply with study requirements as assessed by the investigator, or unable to be reached in the case of emergency
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
23 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alfried Krupp Krankenhaus Essen
NOT_YET_RECRUITINGEssen, Germany
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Charité Universitätsmedizin Berlin
RECRUITINGBerlin, Germany
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DKD HELIOS Clinic Wiesbaden
RECRUITINGWiesbaden, Germany
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DRK Clinic Kassel
NOT_YET_RECRUITINGKassel, Germany
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Diakonissenkrankenhaus Mannheim
RECRUITINGMannheim, Germany
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Hannover Medical School
NOT_YET_RECRUITINGHanover, Germany
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Klinikum Kempten
NOT_YET_RECRUITINGKempten, Germany
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RWTH Aachen
NOT_YET_RECRUITINGAachen, Germany
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Technical University Dresden
NOT_YET_RECRUITINGDresden, Germany
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Technical University Munich
NOT_YET_RECRUITINGMunich, Germany
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University Clinic Bochum
NOT_YET_RECRUITINGBochum, Germany
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University Clinic Bonn
NOT_YET_RECRUITINGBonn, Germany
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University Clinic Erlangen
NOT_YET_RECRUITINGErlangen, Germany
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University Clinic Göttingen
NOT_YET_RECRUITINGGöttingen, Germany
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University Clinic Halle
NOT_YET_RECRUITINGHalle, Germany
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University Clinic Jena
NOT_YET_RECRUITINGJena, Germany
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University Clinic Leipzig
NOT_YET_RECRUITINGLeipzig, Germany
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University Clinic Lübeck
RECRUITINGLübeck, Germany
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University Clinic Münster
NOT_YET_RECRUITINGMünster, Germany
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University Clinic Regensburg
NOT_YET_RECRUITINGRegensburg, Germany
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University Clinic Rostock
NOT_YET_RECRUITINGRostock, Germany
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University Clinic Würzburg
NOT_YET_RECRUITINGWürzburg, Germany
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University of Ulm
RECRUITINGUlm, Germany
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