protocolSection identificationModule nctId: NCT06280079, orgStudyIdInfo id: LIPCAL-ALS II 1.1, briefTitle: Ultra-high-caloric, Fatty Diet in ALS, acronym: LIPCAL-ALS II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Ulm, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 392, type: ESTIMATED, armsInterventionsModule interventions name: Ultra-high-caloric fatty diet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Survival, secondaryOutcomes measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised, secondaryOutcomes measure: Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale, secondaryOutcomes measure: Individual Quality of Life, secondaryOutcomes measure: Slow vital capacity, secondaryOutcomes measure: Survival, secondaryOutcomes measure: Survival, secondaryOutcomes measure: Time to death, secondaryOutcomes measure: Time to tracheostomy, secondaryOutcomes measure: Time to permanent continous ventilator dependence, secondaryOutcomes measure: Ventilation assistance-free survival, secondaryOutcomes measure: Body Mass Index, secondaryOutcomes measure: Council of Nutrition Appetite Questionnaire, secondaryOutcomes measure: Eating Habits, secondaryOutcomes measure: Neurofilament light chain, secondaryOutcomes measure: Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model, secondaryOutcomes measure: Neurofilament Assess Score, otherOutcomes measure: Microtubule-associated protein 2 in serum, otherOutcomes measure: Microtubule-associated protein 2 in cerebrospinal fluid, otherOutcomes measure: Ubiquitin carboxy-terminal hydrolase L1 in serum, otherOutcomes measure: Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid, otherOutcomes measure: Transmembrane glycoprotein NMB in serum, otherOutcomes measure: Transmembrane glycoprotein NMB in cerebrospinal fluid, otherOutcomes measure: Human cartilage glycoprotein 39 in serum, otherOutcomes measure: Human cartilage glycoprotein 39 in cerebrospinal fluid, otherOutcomes measure: SNAP-25 in serum, otherOutcomes measure: SNAP-25 in cerebrospinal fluid, otherOutcomes measure: Beta-synuclein in serum, otherOutcomes measure: Beta-synuclein in cerebrospinal fluid, otherOutcomes measure: Aquaporin-4 in serum, otherOutcomes measure: Aquaporin-4 in cerebrospinal fluid, otherOutcomes measure: Glial fibrillary acidic protein in serum, otherOutcomes measure: Glial fibrillary acidic protein in cerebrospinal fluid, otherOutcomes measure: Soluble triggering receptor expressed on myeloid cell-1 in serum, otherOutcomes measure: Soluble triggering receptor expressed on myeloid cell-1 in cerebrospinal fluid, otherOutcomes measure: CC-chemokine ligand 2 in serum, otherOutcomes measure: CC-chemokine ligand 2 in cerebrospinal fluid, otherOutcomes measure: interleukin-1b in serum, otherOutcomes measure: interleukin-1b in cerebrospinal fluid, otherOutcomes measure: interleukin-2 in serum, otherOutcomes measure: interleukin-2 in cerebrospinal fluid, otherOutcomes measure: interleukin-4 in serum, otherOutcomes measure: interleukin-4 in cerebrospinal fluid, otherOutcomes measure: interleukin-6 in serum, otherOutcomes measure: interleukin-6 in cerebrospinal fluid, otherOutcomes measure: interleukin-10 in serum, otherOutcomes measure: interleukin-10 in cerebrospinal fluid, otherOutcomes measure: interleukin-12p70 in serum, otherOutcomes measure: interleukin-12p70 in cerebrospinal fluid, otherOutcomes measure: interleukin-17 in serum, otherOutcomes measure: interleukin-17 in cerebrospinal fluid, otherOutcomes measure: Tumor necrosis factor alpha in serum, otherOutcomes measure: Tumor necrosis factor alpha in cerebrospinal fluid, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RWTH Aachen, city: Aachen, country: Germany, geoPoint lat: 50.77664, lon: 6.08342, locations facility: Charité Universitätsmedizin Berlin, city: Berlin, country: Germany, contacts name: André Maier, Dr., role: CONTACT, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Clinic Bochum, city: Bochum, country: Germany, geoPoint lat: 51.48165, lon: 7.21648, locations facility: University Clinic Bonn, city: Bonn, country: Germany, contacts name: Patrick Weydt, Dr., role: CONTACT, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Technical University Dresden, city: Dresden, country: Germany, contacts name: René Günther, Dr., role: CONTACT, geoPoint lat: 51.05089, lon: 13.73832, locations facility: University Clinic Erlangen, city: Erlangen, country: Germany, contacts name: Jürgen Winkler, Prof. Dr., role: CONTACT, geoPoint lat: 49.59099, lon: 11.00783, locations facility: Alfried Krupp Krankenhaus Essen, city: Essen, country: Germany, contacts name: Torsten Grehl, Dr., role: CONTACT, geoPoint lat: 51.45657, lon: 7.01228, locations facility: University Clinic Göttingen, city: Göttingen, country: Germany, contacts name: Jan C Koch, Dr., role: CONTACT, geoPoint lat: 51.53443, lon: 9.93228, locations facility: University Clinic Halle, city: Halle, country: Germany, contacts name: Elena Schlapakow, Dr., role: CONTACT, geoPoint lat: 51.48159, lon: 11.97948, locations facility: Hannover Medical School, city: Hannover, country: Germany, contacts name: Susanne Petri, Prof. Dr., role: CONTACT, geoPoint lat: 52.37052, lon: 9.73322, locations facility: University Clinic Jena, city: Jena, country: Germany, contacts name: Annekathrin Rödiger, Dr., role: CONTACT, geoPoint lat: 50.92878, lon: 11.5899, locations facility: DRK Clinic Kassel, city: Kassel, country: Germany, contacts name: Clemens Eickhoff, Dr., role: CONTACT, geoPoint lat: 51.31667, lon: 9.5, locations facility: Klinikum Kempten, city: Kempten, country: Germany, contacts name: Elmar Pinkhardt, Dr., role: CONTACT, geoPoint lat: 47.72674, lon: 10.31389, locations facility: University Clinic Leipzig, city: Leipzig, country: Germany, contacts name: Moritz Metelmann, Dr., role: CONTACT, geoPoint lat: 51.33962, lon: 12.37129, locations facility: University Clinic Lübeck, city: Lübeck, country: Germany, contacts name: Julian Großkreutz, Prof. Dr., role: CONTACT, geoPoint lat: 53.86893, lon: 10.68729, locations facility: University Clinic Mannheim, city: Mannheim, country: Germany, contacts name: Joachim Wolf, Dr., role: CONTACT, geoPoint lat: 49.4891, lon: 8.46694, locations facility: Technical University Munich, city: Munich, country: Germany, contacts name: Paul Lingor, Prof. Dr., role: CONTACT, geoPoint lat: 48.13743, lon: 11.57549, locations facility: University Clinic Münster, city: Münster, country: Germany, contacts name: Matthias Böntert, Dr., role: CONTACT, geoPoint lat: 51.96236, lon: 7.62571, locations facility: University Clinic Regensburg, city: Regensburg, country: Germany, contacts name: Zacharias Kohl, Dr., role: CONTACT, geoPoint lat: 49.01513, lon: 12.10161, locations facility: University Clinic Rostock, city: Rostock, country: Germany, contacts name: Johannes Prudlo, Prof. Dr., role: CONTACT, contacts name: Andreas Herrmann, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.0887, lon: 12.14049, locations facility: University of Ulm, city: Ulm, country: Germany, contacts name: Johannes Dorst, Prof. Dr., role: CONTACT, geoPoint lat: 48.39841, lon: 9.99155, locations facility: DKD HELIOS Clinic Wiesbaden, city: Wiesbaden, country: Germany, contacts name: Bertold Schrank, Dr., role: CONTACT, geoPoint lat: 50.08258, lon: 8.24932, locations facility: University Clinic Würzburg, city: Würzburg, country: Germany, contacts name: Daniel Zeller, Dr., role: CONTACT, geoPoint lat: 49.79391, lon: 9.95121, hasResults: False