RECRUITINGINTERVENTIONAL
Ultra-high-caloric, Fatty Diet in ALS
Efficacy, Safety, and Tolerability of Ultra-high-caloric, Fatty Diet (UFD) in Amyotrophic Lateral Sclerosis (ALS)
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form according to good clinical practice
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DIETARY_SUPPLEMENT
Ultra-high-caloric fatty diet
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
OTHER
Placebo
\<5% fat (\<3,5g), protein 0g, carbohydrates 0g, fiber 0g
Locations (20)
RWTH Aachen
Aachen, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
University Clinic Bochum
Bochum, Germany
University Clinic Bonn
Bonn, Germany
Technical University Dresden
Dresden, Germany
University Clinic Erlangen
Erlangen, Germany
Alfried Krupp Krankenhaus Essen
Essen, Germany
University Clinic Göttingen
Göttingen, Germany
University Clinic Halle
Halle, Germany
Hannover Medical School
Hanover, Germany
University Clinic Jena
Jena, Germany
DRK Clinic Kassel
Kassel, Germany
Klinikum Kempten
Kempten, Germany
University Clinic Leipzig
Leipzig, Germany
University Clinic Lübeck
Lübeck, Germany
Diakonissenkrankenhaus Mannheim
Mannheim, Germany
Technical University Munich
Munich, Germany
University Clinic Münster
Münster, Germany
University Clinic Regensburg
Regensburg, Germany
University Clinic Rostock
Rostock, Germany