Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT03405727
Status:
WITHDRAWN
Last Update Posted:
2020-08-07
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improvement of Sarcopenia in Patients Following Two Different Diets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of human ressources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-05', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-15', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prehension force', 'timeFrame': '3 months after first consultation', 'description': 'Prehension force, as measured by a dynamometer on the dominant hand'}, {'measure': 'Prehension force', 'timeFrame': '6 months after first consultation', 'description': 'Prehension force, as measured by a dynamometer on the dominant hand'}, {'measure': 'Fat mass evaluation', 'timeFrame': '3 months after first consultation', 'description': 'Measured by a Harpaden compass on the tricipital skin fold'}, {'measure': 'Fat mass evaluation', 'timeFrame': '6 months after first consultation', 'description': 'Measured by a Harpaden compass on the tricipital skin fold'}, {'measure': 'Muscle mass evaluation', 'timeFrame': '3 months after first consultation', 'description': 'Brachial muscular circumference (measured by tape)'}, {'measure': 'Muscle mass evaluation', 'timeFrame': '6 months after first consultation', 'description': 'Brachial muscular circumference (measured by tape)'}, {'measure': 'Walking speed', 'timeFrame': '3 months after first consultation', 'description': 'Walking speed on a 4 meters distance'}, {'measure': 'Walking speed', 'timeFrame': '6 months after first consultation', 'description': 'Walking speed on a 4 meters distance'}, {'measure': '"Time Up and Go" test', 'timeFrame': '3 months after first consultation', 'description': 'Mobility assessment of the patient'}, {'measure': '"Time Up and Go" test', 'timeFrame': '6 months after first consultation', 'description': 'Mobility assessment of the patient'}, {'measure': 'Sedentary lifestyle questionnaire', 'timeFrame': '3 months after first consultation', 'description': 'Evaluation of the physical activity by means of a questionnaire'}, {'measure': 'Sedentary lifestyle questionnaire', 'timeFrame': '6 months after first consultation', 'description': 'Evaluation of the physical activity by means of a questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Sarcopenia is defined as a decrease in muscular strength and muscle mass, accompanied by a decrease in physical performance. Seniors might develop sarcopenia because of a decreased physical activity and a decreased protein intake. Many patients also develop sarcopenia after a long stay in an intensive care unit.\n\nProtein intake is very important when treating sarcopenia. However, meeting the protein requirements at home proves difficult. Oral dietary supplements, given in addition to the other known recommendations, might provide a solution.\n\nThis study will assess the efficacy of the oral dietary supplements for the treatment of sarcopenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized within the CHU Brugmann, Brussels\n* Patients diagnosed with sarcopenia (by means of a dynamometer)\n* Patients having stayed in an intensive care unit for longer than 5 weeks\n\nExclusion Criteria:\n\n* Oncology patients\n* Anorexic patients\n* Patients having a life expectancy of less than 6 months\n* Demented patients\n* BPCO patients\n* Patients with neuropathies'}, 'identificationModule': {'nctId': 'NCT03405727', 'briefTitle': 'Improvement of Sarcopenia in Patients Following Two Different Diets', 'organization': {'class': 'OTHER', 'fullName': 'Brugmann University Hospital'}, 'officialTitle': 'Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets', 'orgStudyIdInfo': {'id': 'CHUB-diet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard treatment'}, {'type': 'EXPERIMENTAL', 'label': 'Oral dietary supplements', 'interventionNames': ['Dietary Supplement: Oral dietary supplements']}], 'interventions': [{'name': 'Oral dietary supplements', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein enriched diet', 'armGroupLabels': ['Oral dietary supplements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Turkan Dalgic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haute Ecole Lucia De Brouckère'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brugmann University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Tatiana Besse-Hammer', 'investigatorAffiliation': 'Brugmann University Hospital'}}}}