Ultra-high-caloric, Fatty Diet in ALS
ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ulm
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ultra-high-caloric fatty diet
- Placebo
Treatment groups
392 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov