Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06967220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-15
First Post:
2025-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Feasibility of training', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'It will be reported if the subjects can complete a minium of 80% of the twice-daily training sessions.'}], 'primaryOutcomes': [{'measure': 'FSR in high vs. low inflammation group', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'The primary outcome is the muscle protein fractional synthesis rate (FSR) in the high inflammation group vs. the low inflammation group'}], 'secondaryOutcomes': [{'measure': 'Change in muscle size between groups', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'Change in muscle size during the study period between the three groups'}, {'measure': 'FSR in trained vs. non trained leg', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'Effect of training on the muscle protein fractional synthesis rate'}, {'measure': 'Inflammation in regular vs. antiinflammatory diet', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'Comparison of the changes in plasma C-Reactive Protein (CRP) from day 1 till discharge between the group ingesting regular diet vs. the group ingesting an anti-inflammatory diet.'}, {'measure': 'AA uptake following feeding', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'Plasma amino acid profile following a standard meal'}, {'measure': 'Muscle size in trained vs. untrained leg', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'The difference in muscle size in trained vs. untrained leg measured using ultrasound'}, {'measure': 'Change in muscle strength between groups', 'timeFrame': '7 days (or until discharge)', 'description': 'Description: Change in muscle strength during the study period between the three groups. Hand muscle strength is measured using a hand dynamometer, and leg muscle strength (MVC) is measured using an isokinetic dynamometer.\n\nTime Frame: 7 days (or until hospital discharge)'}, {'measure': 'Muscle strength in trained vs. untrained leg', 'timeFrame': '7 days (or until hospital discharge)', 'description': 'The difference in leg muscle strength (MVC) in trained vs. untrained leg measured using an isokinetic dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Disease Related Malnutrition', 'High Systemic Inflammation', 'Geriatric Assessment']}, 'descriptionModule': {'briefSummary': 'The main goal is to elucidate the mechanistic coupling between inflammation and the ability to maintain skeletal muscle through physical exercise while hospitalized. We will investigate protein kinetics in patients who belong to one of three groups 1) high inflammatory state, 2) moderate inflammatory state and 3) low/no inflammation. We will further intervene in group 1 (high inflammatory state) with anti-inflammatory nutrition (primarily green-solution plant-based) to diminish activity in inflammatory pathways. The hypothesis is that inflammation will inhibit protein synthesis in skeletal muscle both in resting muscle and in strength trained skeletal musculature, and that a lowering of the inflammatory status by anti-inflammatory nutrition will enhance the exercise induced formation of new muscle mass. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Hospitalised at the geriatric department at Bispebjerg Hospital with an expected admission time of minimum 7 days\n* Have Disease Related Malnutrition (DRM)\n* Able to carry out strength training\n* Able to understand the study information, as assessed by the research team\n\nExclusion Criteria:\n\n* Current use of anti-inflammatory medication\n* Liver failure\n* Short bowel syndrome\n* Chrohn's or colitis\n* Terminally ill"}, 'identificationModule': {'nctId': 'NCT06967220', 'acronym': 'InflaMus', 'briefTitle': 'The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Impact of Inflammation on Skeletal Muscle Maintenance in Hospitalized Patients', 'orgStudyIdInfo': {'id': 'BBH170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-inflammatory diet and supplements', 'description': 'A sub group of patients with high inflammation will be offered a diet where 50% of the regular hospital diet is switched for diet containing plant based food and nutrients found to lower inflammation', 'interventionNames': ['Other: Single leg training']}], 'interventions': [{'name': 'Single leg training', 'type': 'OTHER', 'description': 'All subjects will train one leg twice daily.', 'armGroupLabels': ['Anti-inflammatory diet and supplements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Grith Højfeldt', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}