[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537611":3},{"organization":4,"outcomesModule":7,"designInfo":170,"detailedDescription":182,"studyPopulation":173,"armGroups":183,"interventions":196,"overallOfficials":204,"centralContacts":208,"locations":213,"responsibleParty":472,"collaborators":173,"id":475,"slug":173,"hasResults":476,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":476,"sex":482,"minAge":483,"maxAge":173,"enrollmentInfo":484,"targetDuration":173,"studyType":487,"phases":488,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":231,"whyStopped":173,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":505},{"fullName":5,"class":6},"University of Ulm","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"Survival","Time from date of randomization until date of death, tracheostomy, or permanent continous ventilation (\\>22 hours per day)","18 months",[14,17,20,23,26,28,30,33,36,40,43,46,49,52,55,58],{"measure":15,"description":16,"timeFrame":12},"Amyotrophic Lateral Sclerosis Functional Rating Scale Revised","Change per month of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised",{"measure":18,"description":19,"timeFrame":12},"Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale","Change per month of Rasch Overall Amyotrophic Lateral Sclerosis Disability Scale",{"measure":21,"description":22,"timeFrame":12},"Individual Quality of Life","Change of Euro Quality of Life 5D 5L (EQ-5D-5L) compared to baseline",{"measure":24,"description":25,"timeFrame":12},"Slow vital capacity","Change of slow vital capacity compared to baseline",{"measure":10,"description":11,"timeFrame":27},"6 months",{"measure":10,"description":11,"timeFrame":29},"12 months",{"measure":31,"description":32,"timeFrame":12},"Time to death","Time from date of randomization until date of death",{"measure":34,"description":35,"timeFrame":12},"Time to tracheostomy","Time from date of randomization until date of tracheostomy",{"measure":37,"description":38,"timeFrame":39},"Time to permanent continous ventilator dependence","Time from date of randomization to permanent continous ventilator dependence (\\>22 hours per day)","18 month",{"measure":41,"description":42,"timeFrame":12},"Ventilation assistance-free survival","Time from date of randomization until implementation of mechanical ventilation",{"measure":44,"description":45,"timeFrame":12},"Body Mass Index","Change of body mass index compared to baseline",{"measure":47,"description":48,"timeFrame":12},"Council of Nutrition Appetite Questionnaire","Change of Council of Nutrition Appetite Questionnaire sum score compared to baseline",{"measure":50,"description":51,"timeFrame":12},"Eating Habits","Change of Ulm Nutrition Questionnaire compared to baseline; qualitative changes on a descriptional level (the questionnaire has no sum score); the score is meant to detect changes of eating habits and has been used in the precursor study LIPCAL-ALS I (see doi: 10.1002\u002Fana.25661).",{"measure":53,"description":54,"timeFrame":12},"Neurofilament light chain","Change of neurofilament light chain serum levels compared to baseline",{"measure":56,"description":57,"timeFrame":12},"Amyotrophic Lateral Sclerosis Functional Rating Scale Revised Prediction Model","Difference between observed and predicted decrease of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (measured as points lost per month), based on the a prediction model, which estimates disease progression based on neurofilament light chain serum baseline levels",{"measure":59,"description":60,"timeFrame":12},"Neurofilament Assess Score","Difference between observed and predicted survival based on the Neurofilament Assess Score, a score estimating survival based on the neurofilament light chain serum baseline levels",[62,65,68,71,74,77,80,83,86,89,92,95,98,101,104,107,110,113,116,119,122,125,128,131,134,137,140,143,146,149,152,155,158,161,164,167],{"measure":63,"description":64,"timeFrame":12},"Microtubule-associated protein 2 in serum","change of Microtubule-associated protein 2 levels in serum compared to baseline",{"measure":66,"description":67,"timeFrame":12},"Microtubule-associated protein 2 in cerebrospinal fluid","change of microtubule-associated protein 2 levels in cerebrospinal fluid compared to baseline",{"measure":69,"description":70,"timeFrame":12},"Ubiquitin carboxy-terminal hydrolase L1 in serum","change of ubiquitin carboxy-terminal hydrolase L1 levels in serum compared to baseline",{"measure":72,"description":73,"timeFrame":12},"Ubiquitin carboxy-terminal hydrolase L1 in cerebrospinal fluid","change of ubiquitin carboxy-terminal hydrolase L1 levels in cerebrospinal fluid compared to baseline",{"measure":75,"description":76,"timeFrame":12},"Transmembrane glycoprotein NMB in serum","change of transmembrane glycoprotein NMB levels in serum compared to baseline",{"measure":78,"description":79,"timeFrame":12},"Transmembrane glycoprotein NMB in cerebrospinal fluid","change of transmembrane glycoprotein NMB levels in cerebrospinal fluid compared to baseline",{"measure":81,"description":82,"timeFrame":12},"Human cartilage glycoprotein 39 in serum","change of human cartilage glycoprotein 39 levels in serum compared to baseline",{"measure":84,"description":85,"timeFrame":12},"Human cartilage glycoprotein 39 in cerebrospinal fluid","change of human cartilage glycoprotein 39 levels in cerebrospinal fluid compared to baseline",{"measure":87,"description":88,"timeFrame":12},"SNAP-25 in serum","change of SNAP-25 levels in serum compared to baseline",{"measure":90,"description":91,"timeFrame":12},"SNAP-25 in cerebrospinal fluid","change of SNAP-25 levels in cerebrospinal fluid compared to baseline",{"measure":93,"description":94,"timeFrame":12},"Beta-synuclein in serum","change of beta-synuclein levels in serum compared to baseline",{"measure":96,"description":97,"timeFrame":12},"Beta-synuclein in cerebrospinal fluid","change of beta-synuclein levels in cerebrospinal fluid compared to baseline",{"measure":99,"description":100,"timeFrame":12},"Aquaporin-4 in serum","change of aquaporin-4 levels in serum compared to baseline",{"measure":102,"description":103,"timeFrame":12},"Aquaporin-4 in cerebrospinal fluid","change of aquaporin-4 levels in cerebrospinal fluid compared to baseline",{"measure":105,"description":106,"timeFrame":29},"Glial fibrillary acidic protein in serum","change of glial fibrillary acidic protein levels in serum compared to baseline",{"measure":108,"description":109,"timeFrame":29},"Glial fibrillary acidic protein in cerebrospinal fluid","change of glial fibrillary acidic protein levels in cerebrospinal fluid compared to baseline",{"measure":111,"description":112,"timeFrame":29},"Soluble triggering receptor expressed on myeloid cell-1 in serum","change of soluble triggering receptor expressed on myeloid cell-1 levels in serum compared to baseline",{"measure":114,"description":115,"timeFrame":29},"Soluble triggering receptor expressed on myeloid cell-1 in cerebrospinal fluid","change of soluble triggering receptor expressed on myeloid cell-1 levels in cerebrospinal fluid compared to baseline",{"measure":117,"description":118,"timeFrame":29},"CC-chemokine ligand 2 in serum","change of CC-chemokine ligand 2 levels in serum compared to baseline",{"measure":120,"description":121,"timeFrame":29},"CC-chemokine ligand 2 in cerebrospinal fluid","change of CC-chemokine ligand 2 levels in cerebrospinal fluid compared to baseline",{"measure":123,"description":124,"timeFrame":29},"interleukin-1b in serum","change of interleukin-1b levels in serum compared to baseline",{"measure":126,"description":127,"timeFrame":29},"interleukin-1b in cerebrospinal fluid","change of interleukin-1b levels in cerebrospinal fluid compared to baseline",{"measure":129,"description":130,"timeFrame":29},"interleukin-2 in serum","change of interleukin-2 levels in serum compared to baseline",{"measure":132,"description":133,"timeFrame":29},"interleukin-2 in cerebrospinal fluid","change of interleukin-2 levels in cerebrospinal fluid compared to baseline",{"measure":135,"description":136,"timeFrame":29},"interleukin-4 in serum","change of interleukin-4 levels in serum compared to baseline",{"measure":138,"description":139,"timeFrame":29},"interleukin-4 in cerebrospinal fluid","change of interleukin-4 levels in cerebrospinal fluid compared to baseline",{"measure":141,"description":142,"timeFrame":29},"interleukin-6 in serum","change of interleukin-6 levels in serum compared to baseline",{"measure":144,"description":145,"timeFrame":29},"interleukin-6 in cerebrospinal fluid","change of interleukin-6 levels in cerebrospinal fluid compared to baseline",{"measure":147,"description":148,"timeFrame":29},"interleukin-10 in serum","change of interleukin-10 levels in serum compared to baseline",{"measure":150,"description":151,"timeFrame":29},"interleukin-10 in cerebrospinal fluid","change of interleukin-10 levels in cerebrospinal fluid compared to baseline",{"measure":153,"description":154,"timeFrame":29},"interleukin-12p70 in serum","change of interleukin-12p70 levels in serum compared to baseline",{"measure":156,"description":157,"timeFrame":29},"interleukin-12p70 in cerebrospinal fluid","change of interleukin-12p70 levels in cerebrospinal fluid compared to baseline",{"measure":159,"description":160,"timeFrame":29},"interleukin-17 in serum","change of interleukin-17 levels in serum compared to baseline",{"measure":162,"description":163,"timeFrame":29},"interleukin-17 in cerebrospinal fluid","change of interleukin-17 levels in cerebrospinal fluid compared to baseline",{"measure":165,"description":166,"timeFrame":29},"Tumor necrosis factor alpha in serum","change of tumor necrosis factor alpha levels in serum compared to baseline",{"measure":168,"description":169,"timeFrame":29},"Tumor necrosis factor alpha in cerebrospinal fluid","change of tumor necrosis factor alpha levels in cerebrospinal fluid compared to baseline",{"allocation":171,"interventionModel":172,"interventionModelDescription":173,"primaryPurpose":174,"observationalModel":173,"timePerspective":173,"maskingInfo":175},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":176,"maskingDescription":173,"whoMasked":177},"QUADRUPLE",[178,179,180,181],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","ALS is a fatal neurodegenerative disease, leading to progressive paralysis of voluntarily innervated muscles and to death caused by respiratory failure after a mean disease duration of 2-4 years.The proposed study aims at improving survival of ALS patients by targeting metabolic parameters. ALS patients feature an intrinsic hypermetabolism as signified by an increased resting energy expenditure, which significantly contributes to progressive weight loss and cachexia. The extent of weight loss is an independent prognostic factor for survival in ALS. It has been shown that survival of ALS mice can be prolonged by applying a high-caloric nutrition. Furthermore, ALS patients feature distinct alterations of lipid metabolism, and various studies suggest a protective effect of high triglyceride serum levels.\n\nIn 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\\\u003C0.0125), and (3) lowered neurofilament light chain (NfL) serum levels as a prognostic biomarker in the whole study population (p=0.0225).\n\nTherefore, 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.",[184,190],{"label":185,"type":186,"description":187,"interventionNames":188},"Ultra-high-caloric fatty diet","EXPERIMENTAL","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",[189],"Dietary Supplement: Ultra-high-caloric fatty diet",{"label":191,"type":192,"description":193,"interventionNames":194},"Placebo","PLACEBO_COMPARATOR","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",[195],"Other: Placebo",[197,201],{"type":198,"name":185,"description":199,"armGroupLabels":200,"otherNames":173},"DIETARY_SUPPLEMENT","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",[185],{"type":6,"name":191,"description":202,"armGroupLabels":203,"otherNames":173},"\\\u003C5% fat (\\\u003C3,5g), protein 0g, carbohydrates 0g, fiber 0g",[191],[205],{"name":206,"affiliation":5,"role":207},"Johannes Dorst, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[209],{"name":206,"role":210,"phone":211,"phoneExt":173,"email":212},"CONTACT","+497311775285","johannes.dorst@uni-ulm.de",[214,229,241,252,263,274,285,296,307,318,329,340,351,362,373,384,395,406,417,428,441,450,461],{"facility":215,"status":216,"city":217,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":220,"geoPoint":225,"contacts":226},"RWTH Aachen","NOT_YET_RECRUITING","Aachen","Germany","DE",{"type":221,"coordinates":222},"Point",[223,224],6.08342,50.77664,{"lat":224,"lon":223},[227],{"name":228,"role":210,"phone":173,"phoneExt":173,"email":173},"Robert Brunkhorst, Dr.",{"facility":230,"status":231,"city":232,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Charité Universitätsmedizin Berlin","RECRUITING","Berlin",{"type":221,"coordinates":234},[235,236],13.41053,52.52437,{"lat":236,"lon":235},[239],{"name":240,"role":210,"phone":173,"phoneExt":173,"email":173},"André Maier, Dr.",{"facility":242,"status":216,"city":243,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"University Clinic Bochum","Bochum",{"type":221,"coordinates":245},[246,247],7.21648,51.48165,{"lat":247,"lon":246},[250],{"name":251,"role":210,"phone":173,"phoneExt":173,"email":173},"Ute Weyen, Dr.",{"facility":253,"status":216,"city":254,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"University Clinic Bonn","Bonn",{"type":221,"coordinates":256},[257,258],7.09549,50.73438,{"lat":258,"lon":257},[261],{"name":262,"role":210,"phone":173,"phoneExt":173,"email":173},"Patrick Weydt, Dr.",{"facility":264,"status":216,"city":265,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Technical University Dresden","Dresden",{"type":221,"coordinates":267},[268,269],13.73832,51.05089,{"lat":269,"lon":268},[272],{"name":273,"role":210,"phone":173,"phoneExt":173,"email":173},"René Günther, Dr.",{"facility":275,"status":216,"city":276,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"University Clinic Erlangen","Erlangen",{"type":221,"coordinates":278},[279,280],11.00783,49.59099,{"lat":280,"lon":279},[283],{"name":284,"role":210,"phone":173,"phoneExt":173,"email":173},"Jürgen Winkler, Prof. Dr.",{"facility":286,"status":216,"city":287,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":288,"geoPoint":292,"contacts":293},"Alfried Krupp Krankenhaus Essen","Essen",{"type":221,"coordinates":289},[290,291],7.01228,51.45657,{"lat":291,"lon":290},[294],{"name":295,"role":210,"phone":173,"phoneExt":173,"email":173},"Torsten Grehl, Dr.",{"facility":297,"status":216,"city":298,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"University Clinic Göttingen","Göttingen",{"type":221,"coordinates":300},[301,302],9.93228,51.53443,{"lat":302,"lon":301},[305],{"name":306,"role":210,"phone":173,"phoneExt":173,"email":173},"Jan C Koch, Dr.",{"facility":308,"status":216,"city":309,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":310,"geoPoint":314,"contacts":315},"University Clinic Halle","Halle",{"type":221,"coordinates":311},[312,313],11.97947,51.48158,{"lat":313,"lon":312},[316],{"name":317,"role":210,"phone":173,"phoneExt":173,"email":173},"Elena Schlapakow, Dr.",{"facility":319,"status":216,"city":320,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"Hannover Medical School","Hanover",{"type":221,"coordinates":322},[323,324],9.73322,52.37052,{"lat":324,"lon":323},[327],{"name":328,"role":210,"phone":173,"phoneExt":173,"email":173},"Susanne Petri, Prof. Dr.",{"facility":330,"status":216,"city":331,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"University Clinic Jena","Jena",{"type":221,"coordinates":333},[334,335],11.5899,50.92878,{"lat":335,"lon":334},[338],{"name":339,"role":210,"phone":173,"phoneExt":173,"email":173},"Annekathrin Rödiger, Dr.",{"facility":341,"status":216,"city":342,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"DRK Clinic Kassel","Kassel",{"type":221,"coordinates":344},[345,346],9.5,51.31667,{"lat":346,"lon":345},[349],{"name":350,"role":210,"phone":173,"phoneExt":173,"email":173},"Clemens Eickhoff, Dr.",{"facility":352,"status":216,"city":353,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"Klinikum Kempten","Kempten",{"type":221,"coordinates":355},[356,357],7.93702,49.96729,{"lat":357,"lon":356},[360],{"name":361,"role":210,"phone":173,"phoneExt":173,"email":173},"Elmar Pinkhardt, Dr.",{"facility":363,"status":216,"city":364,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":365,"geoPoint":369,"contacts":370},"University Clinic Leipzig","Leipzig",{"type":221,"coordinates":366},[367,368],12.37129,51.33962,{"lat":368,"lon":367},[371],{"name":372,"role":210,"phone":173,"phoneExt":173,"email":173},"Moritz Metelmann, Dr.",{"facility":374,"status":231,"city":375,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"University Clinic Lübeck","Lübeck",{"type":221,"coordinates":377},[378,379],10.68729,53.86893,{"lat":379,"lon":378},[382],{"name":383,"role":210,"phone":173,"phoneExt":173,"email":173},"Julian Großkreutz, Prof. Dr.",{"facility":385,"status":231,"city":386,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"Diakonissenkrankenhaus Mannheim","Mannheim",{"type":221,"coordinates":388},[389,390],8.46694,49.4891,{"lat":390,"lon":389},[393],{"name":394,"role":210,"phone":173,"phoneExt":173,"email":173},"Joachim Wolf, Dr.",{"facility":396,"status":216,"city":397,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"Technical University Munich","Munich",{"type":221,"coordinates":399},[400,401],11.57549,48.13743,{"lat":401,"lon":400},[404],{"name":405,"role":210,"phone":173,"phoneExt":173,"email":173},"Paul Lingor, Prof. Dr.",{"facility":407,"status":216,"city":408,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":409,"geoPoint":413,"contacts":414},"University Clinic Münster","Münster",{"type":221,"coordinates":410},[411,412],7.62571,51.96236,{"lat":412,"lon":411},[415],{"name":416,"role":210,"phone":173,"phoneExt":173,"email":173},"Matthias Böntert, Dr.",{"facility":418,"status":216,"city":419,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":420,"geoPoint":424,"contacts":425},"University Clinic Regensburg","Regensburg",{"type":221,"coordinates":421},[422,423],12.10161,49.01513,{"lat":423,"lon":422},[426],{"name":427,"role":210,"phone":173,"phoneExt":173,"email":173},"Zacharias Kohl, Dr.",{"facility":429,"status":216,"city":430,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"University Clinic Rostock","Rostock",{"type":221,"coordinates":432},[433,434],12.14049,54.0887,{"lat":434,"lon":433},[437,439],{"name":438,"role":210,"phone":173,"phoneExt":173,"email":173},"Johannes Prudlo, Prof. Dr.",{"name":440,"role":207,"phone":173,"phoneExt":173,"email":173},"Andreas Herrmann",{"facility":5,"status":231,"city":442,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"Ulm",{"type":221,"coordinates":444},[445,446],9.99155,48.39841,{"lat":446,"lon":445},[449],{"name":206,"role":210,"phone":173,"phoneExt":173,"email":173},{"facility":451,"status":231,"city":452,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":453,"geoPoint":457,"contacts":458},"DKD HELIOS Clinic Wiesbaden","Wiesbaden",{"type":221,"coordinates":454},[455,456],8.24435,50.08601,{"lat":456,"lon":455},[459],{"name":460,"role":210,"phone":173,"phoneExt":173,"email":173},"Bertold Schrank, Dr.",{"facility":462,"status":216,"city":463,"state":173,"zip":173,"country":218,"countryCode":219,"cosmosGeoPoint":464,"geoPoint":468,"contacts":469},"University Clinic Würzburg","Würzburg",{"type":221,"coordinates":465},[466,467],9.95121,49.79391,{"lat":467,"lon":466},[470],{"name":471,"role":210,"phone":173,"phoneExt":173,"email":173},"Daniel Zeller, Dr.",{"type":207,"investigatorFullName":473,"investigatorTitle":474,"investigatorAffiliation":5,"oldNameTitle":173,"oldOrganization":173},"Albert Christian Ludolph, Prof.","Prof. Dr.","100537611",false,"NCT06280079","Ultra-high-caloric, Fatty Diet in ALS","Efficacy, Safety, and Tolerability of Ultra-high-caloric, Fatty Diet (UFD) in Amyotrophic Lateral Sclerosis (ALS)","LIPCAL-ALS II","Inclusion Criteria:\n\n* Possible, probable (clinically or laboratory supported) or definite amyotrophic lateral sclerosis according to the revised version of the El Escorial criteria\n* Disease duration (onset of first paresis or bulbar symptoms) \\\u003C 24 months\n* Loss of amyotrophic lateral sclerosis functional rating scale revised of ≥ 0.33 points\u002Fmonth based on the formula: (48 - myotrophic lateral sclerosis functional rating scale revised score at screening visit) \u002F (months between onset and screening visit)\n* Age ≥18 years.\n* Either continuously treated with a stable dose of riluzole, OR not treated with riluzole for the last 4 weeks prior to inclusion\n* Either continuously treated with a stable dose of edaravone, OR not treated with edaravone for the last 4 weeks prior to inclusion\n* Either continuously treated with a stable dose of sodium-phenylbutyrate\u002Ftaurursodiol, OR not treated with sodium-phenylbutyrate\u002Ftaurursodiol for the last 4 weeks prior to inclusion\n* Capable of thoroughly understanding all information given\n* full written informed consent according to good clinical practice\n\nExclusion Criteria:\n\n* Previous participation in another interventional study involving an active treatment within the preceding 4 weeks\n* Tracheostomy or continuous permanent ventilator dependence (\\>22 hours per day)\n* Pregnancy or breastfeeding\n* Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS\n* Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment.\n* Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms.\n* 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","ALL","18 Years",{"count":485,"type":486},392,"ESTIMATED","INTERVENTIONAL",[489],"NA","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).",[492],"Amyotrophic Lateral Sclerosis",[492,494,10,495],"High-caloric, high-fat nutrition","Randomized controlled trial","2026-04-30",{"date":498,"type":499},"2026-05-01","ACTUAL",{"date":501,"type":499},"2024-06-01",{"date":503,"type":486},"2028-01-01",{"name":5,"class":6},23]