Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-25 @ 1:47 PM
Study NCT ID:
NCT04172792
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2019-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': '4 weeks', 'description': 'Incidence of Adverse Events and Serious Adverse Events'}, {'measure': 'Laboratory values', 'timeFrame': '4 weeks', 'description': 'Incidence of abnormalities in clinical laboratory assessments, vital signs and physical examinations'}], 'secondaryOutcomes': [{'measure': 'Appetite', 'timeFrame': '2 weeks; 4 weeks', 'description': 'Change of Appetite-Score (Council of Nutrition appetite questionnaire, CNAQ) compared to baseline; values 8-40; higher values mean better appetite'}, {'measure': 'Eating Habits', 'timeFrame': '2 weeks; 4 weeks', 'description': 'Change in eating habits as evaluated by a standardized questionnaire (Ulmer eating habits questionnaire); descriptive information and evaluation; no overall score'}, {'measure': 'Taste of Intervention', 'timeFrame': '2 weeks; 4 weeks', 'description': 'taste of intervention (visual analogous scale); values 1-9, higher values mean better taste'}, {'measure': 'Body Weight', 'timeFrame': '2 weeks; 4 weeks', 'description': 'change of body weight compared to baseline'}, {'measure': 'Biomarkers', 'timeFrame': '4 weeks', 'description': 'change of neurofilament light chains (NfL) in serum'}, {'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': '6 weeks', 'description': 'Incidence of Adverse Events and Serious Adverse Events (evaluation via phone call 2 weeks after intervention was finished)'}, {'measure': 'ALSFRS-R', 'timeFrame': '4 weeks', 'description': 'change of Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) compared to baseline; values 0-48; higher values mean less impairment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '26121170', 'type': 'BACKGROUND', 'citation': 'Ludolph A, Drory V, Hardiman O, Nakano I, Ravits J, Robberecht W, Shefner J; WFN Research Group On ALS/MND. A revision of the El Escorial criteria - 2015. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(5-6):291-2. doi: 10.3109/21678421.2015.1049183. Epub 2015 Jun 29. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The LIPCAL-ALS study (NCT02306590) has provided preliminary evidence that a high-caloric nutrition might prolong survival in fast-progressing ALS patients. Since increasing the amount of calories of the intervention might possibly increase the beneficial effect, the investigators seek to investigate whether an ultra-high caloric diet (UHCD), featuring the double amount of calories compared to LIPCAL-ALS, will be well tolerated by ALS patients and may serve as an intervention for a potential LIPCALII study. For this purpose, the investigators will compare two different UHCDs (one fat-rich and one carbohydrate-rich) with regard to safety and tolerability over a time frame of 4 weeks. A third group will receive the original diet from LIPCAL, and a fourth group will receive no intervention (control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the revised version of the El Escorial criteria (Ludolph et al. 2015)\n* Slope of ALS Functional Rating Scale Revised (ALSFRS-R) of \\>0.25 points per month at baseline visit based on the formula (48 - score at baseline visit) / (time between date of first symptom and baseline visit)\n* stable on standard therapy riluzole (100 mg/day) for at least 4 weeks\n* capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)\n\nExclusion Criteria:\n\n* already taking any dietary supplements\n* participation in another clinical trial within the preceding 8 weeks\n* tracheostomy or assisted ventilation of any type which exceeds 23 hours per day\n* pregnancy or breast-feeding females'}, 'identificationModule': {'nctId': 'NCT04172792', 'acronym': 'TOLCAL', 'briefTitle': 'Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Safety and Tolerability of Fat-rich vs. Carbohydrate-rich High-caloric Food Supplements in Patients With Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': 'TOLCAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high-caloric fatty diet', 'description': 'intake of 405 kcal (45g fat) per day in addition to normal food intake', 'interventionNames': ['Dietary Supplement: high-caloric fatty diet']}, {'type': 'EXPERIMENTAL', 'label': 'ultra-high-caloric fatty diet', 'description': 'intake of 810 kcal (90g fat) per day in addition to normal food intake', 'interventionNames': ['Dietary Supplement: ultra-high-caloric fatty diet']}, {'type': 'EXPERIMENTAL', 'label': 'ultra-high-caloric carbohydrate-rich diet', 'description': 'intake of 900 kcal (111.4g carbohydrate, 34.9g fat, 36.0g protein) in addition to normal food intake', 'interventionNames': ['Dietary Supplement: ultra-high-caloric carbohydrate-rich diet']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'normal food intake (no intervention)'}], 'interventions': [{'name': 'high-caloric fatty diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'see arm/group description', 'armGroupLabels': ['high-caloric fatty diet']}, {'name': 'ultra-high-caloric fatty diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'see arm/group description', 'armGroupLabels': ['ultra-high-caloric fatty diet']}, {'name': 'ultra-high-caloric carbohydrate-rich diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'see arm/group description', 'armGroupLabels': ['ultra-high-caloric carbohydrate-rich diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Ulm, Department of Neurology', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Johannes Dorst, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'ipdSharingStatementModule': {'url': 'https://www.uniklinik-ulm.de/neurologie.html', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '3 month after publication until 5 years after publication', 'ipdSharing': 'YES', 'description': 'Data will be available beginning 3 months and ending 5 years following article publication. Data will be shard with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data acess agreement. The study protocol will be available for 5 years at htpps://www.uniklinik-ulm.de/neurologie.html.', 'accessCriteria': 'Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data acess agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Christian Ludolph, Prof.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nutritia GmbH, 91052 Erlangen, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Albert Christian Ludolph, Prof.', 'investigatorAffiliation': 'University of Ulm'}}}}