Ultra-high-caloric, Fatty Diet in ALS
Efficacy, Safety, and Tolerability of Ultra-high-caloric, Fatty Diet (UFD) in Amyotrophic Lateral Sclerosis (ALS)
University of Ulm
392 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria9
- 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 Criteria7
- 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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Interventions
100% fat (70g), saturated fatty acids 7,5g, monounsaturated fatty acids 42,6g, polyunsaturated fatty acids 19,9g, long-chain fatty acids 100%, ratio omega-6 to omega-3 fatty acids 5:1, protein 0g, carbohydrates 0g, fiber 0g
\<5% fat (\<3,5g), protein 0g, carbohydrates 0g, fiber 0g
Locations(23)
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NCT06280079