Ultra-high-caloric, Fatty Diet in ALS (NCT06280079) | Clinical Trial Compass
RecruitingNot Applicable
Ultra-high-caloric, Fatty Diet in ALS
Germany392 participantsStarted 2024-06-01
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…