Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
392 participants
INTERVENTIONAL
2024-06-01
2027-06-01
Brief Summary
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Detailed Description
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In the precursor-study LIPCAL-ALS-I, a randomized, placebo-controlled, multicenter trial, evaluating the effects of a high-caloric fatty diet (HCFD), the primary endpoint (survival in the whole study population) was missed. However, post-hoc analysis revealed showed that HCFD (1) increased survival and reduced weight loss in normal to fast-progressing patients (patients with a functional decline measured by ALS Functional Rating Scale Revised) above the median at baseline; p=0.02), (2) slowed down functional decline (measured by Amyotrophic Lateral Sclerosis Functional Rating Scale Revised) in the whole study population (p\<0.0125), and (3) lowered neurofilament light chain (NfL) serum levels as a prognostic biomarker in the whole study population (p=0.0225).
Therefore, this study aims at prolonging survival in ALS patients by applying 1.5-fold dosage of the same intervention as in LIPCAL-ALS I in a larger number of patients, excluding patients with slow disease progression.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ultra-high-caloric fatty diet
ultra-high-caloric, high-fat, fluid nutritional supplement oral intake of 4 times 35 ml per day in addition to normal food intake, corresponding to +630 kcal and +70g fat per day
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
Placebo
placebo, fluid nutritional supplement oral intake of 4 times 35 ml per day in addition to normal food intake, corresponding to +50 kcal and +3,5g fat per day
Placebo
\<5% fat (\<3,5g), protein 0g, carbohydrates 0g, fiber 0g
Interventions
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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
Placebo
\<5% fat (\<3,5g), protein 0g, carbohydrates 0g, fiber 0g
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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University of Ulm
OTHER
Responsible Party
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Albert Christian Ludolph, Prof.
Prof. Dr.
Principal Investigators
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Johannes Dorst, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Ulm
Locations
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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
University of Ulm
Ulm, , Germany
DKD HELIOS Clinic Wiesbaden
Wiesbaden, , Germany
University Clinic Würzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Robert Brunkhorst, Dr.
Role: primary
André Maier, Dr.
Role: primary
Ute Weyen, Dr.
Role: primary
Patrick Weydt, Dr.
Role: primary
René Günther, Dr.
Role: primary
Jürgen Winkler, Prof. Dr.
Role: primary
Torsten Grehl, Dr.
Role: primary
Jan C Koch, Dr.
Role: primary
Elena Schlapakow, Dr.
Role: primary
Susanne Petri, Prof. Dr.
Role: primary
Annekathrin Rödiger, Dr.
Role: primary
Clemens Eickhoff, Dr.
Role: primary
Elmar Pinkhardt, Dr.
Role: primary
Moritz Metelmann, Dr.
Role: primary
Julian Großkreutz, Prof. Dr.
Role: primary
Joachim Wolf, Dr.
Role: primary
Paul Lingor, Prof. Dr.
Role: primary
Matthias Böntert, Dr.
Role: primary
Zacharias Kohl, Dr.
Role: primary
Johannes Prudlo, Prof. Dr.
Role: primary
Johannes Dorst, Prof. Dr.
Role: primary
Bertold Schrank, Dr.
Role: primary
Daniel Zeller, Dr.
Role: primary
Other Identifiers
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LIPCAL-ALS II 1.1
Identifier Type: -
Identifier Source: org_study_id