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