Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT04100161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2019-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Strategies After Muscle Strain Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2029-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle volume', 'timeFrame': '3 months post injury', 'description': 'Change in muscle volume in the injured muscle comparing immediate post injury scan with 3 months post scan plus comparison of change with healthy, contralateral muscle over the same time span.'}], 'secondaryOutcomes': [{'measure': 'Muscle volume', 'timeFrame': '12 months post injury', 'description': 'Change in muscle volume in the injured muscle comparing immediate post injury scan with 12 months post scan plus comparison of change with healthy, contralateral muscle over the same time span.'}, {'measure': 'Isokinetic muscle strength', 'timeFrame': '3 months post injury', 'description': 'Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle'}, {'measure': 'Isokinetic muscle strength', 'timeFrame': '6 months post injury', 'description': 'Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle'}, {'measure': 'Isokinetic muscle strength', 'timeFrame': '12 months post injury', 'description': 'Change in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle'}, {'measure': 'Fat infiltration', 'timeFrame': '3 months post injury', 'description': 'Assessment of fat content in the injured muscle comparing immediate post injury scan with 3 months post scan plus comparison of change with healthy, contralateral muscle over same time range'}, {'measure': 'Fat infiltration', 'timeFrame': '12 months post injury', 'description': 'Assessment of fat content in the injured muscle comparing immediate post injury scan with 12 months post scan plus comparison of change with healthy, contralateral muscle over same time range'}, {'measure': 'Injury screening Questionnaire', 'timeFrame': '3 months post', 'description': 'Assessment of subjective symptoms and pain during sports and daily activities'}, {'measure': 'Injury screening Questionnaire', 'timeFrame': '6 months post', 'description': 'Assessment of subjective symptoms and pain during sports and daily activities'}, {'measure': 'Injury screening Questionnaire', 'timeFrame': '12 months post', 'description': 'Assessment of subjective symptoms and pain during sports and daily activities'}, {'measure': 'Ultrasound images', 'timeFrame': 'Baseline (Acute post injury)', 'description': 'Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle'}, {'measure': 'Ultrasound images', 'timeFrame': '3 months post injury', 'description': 'Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle'}, {'measure': 'Ultrasound images', 'timeFrame': '6 months post injury', 'description': 'Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in injured and healthy, contralateral muscle'}, {'measure': 'Ultrasound images', 'timeFrame': '12 months post injury', 'description': 'Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle'}, {'measure': 'Assessment injury exudate', 'timeFrame': 'Within 7 days post injury', 'description': 'Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space'}, {'measure': 'Assessment injury exudate', 'timeFrame': '<1 week post injury -12 weeks post injury', 'description': 'Assessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle strain, atrophy, protein, rehabilitation'], 'conditions': ['Muscle Strain, Multiple Sites']}, 'referencesModule': {'references': [{'pmid': '40145631', 'type': 'DERIVED', 'citation': 'Mertz KH, Sorensen HH, Lorentz C, Johansen E, Fredskild NU, Wulff MW, Svensson RB, Kjaer MB, Linden FH, Kjaer M, Bayer ML. Effects of Protein Supplementation During Early Rehabilitation on Muscle Volume and Function After Acute Muscle Strain Injuries: A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Apr;35(4):e70043. doi: 10.1111/sms.70043.'}]}, 'descriptionModule': {'briefSummary': 'Muscle strain injuries are a particularly frequent type of sports injury in soccer, athletics, badminton/ tennis and cross-fit fitness, thereby affecting a broad range of popular leisure time activities. Depending on severity, sports-active individuals may experience long-term functional impairment and pain. Additionally, individuals having sustained one strain injury have a substantially increased risk of injuring the same muscle again. Strain injuries lead to long-term, potentially permanent, loss of muscle mass, thereby weakening the muscle. Muscle atrophy is likely a major factor in the high re-injury risk. Further, strain injuries are associated with a long-term inflammatory response.\n\nIn the current study, the investigators seek to study interventions to prevent the loss of muscle mass and elaborate on strategies to address the prolonged inflammation observed at the site of the injured muscle.\n\nThe primary aim of this study is to investigate the effect of protein supplementation on the reduction of muscle atrophy following a severe muscle strain injury in comparison to a carbohydrate supplement. As a second purpose, this study aims to elaborate on findings of prolonged inflammation intra-/ intermuscular by large-scale protein analysis and the characterization of cells active at the site of injury.\n\nThe study includes the following hypotheses:\n\n1. Protein supplementation administered in combination with a gradually increasing loading regime (rehabilitation with weekly progression in load/ intensity) will be effective in reducing the injury-related loss of muscle mass.\n2. The environment at the site of injury is not only pro-inflammatory, but contains proteins associated with proteolysis.\n3. Cells belonging to the group of fibro-adipogenic progenitors will be accumulating intra- and inter-muscularly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Sports-active men and women\n* Acute muscle strain injury in either the calf muscles or the hamstring muscles\n* Visible tear at the muscle-connective tissue interface visible on an US scan as a hypo-/ hyperechoic area\n\nExclusion criteria:\n\n* Unwillingness to return to sports\n* Claustrophobia\n* Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within 3 months prior to the strain injury\n* Smoking\n* Diagnosed or suspected type I or type II diabetes\n* Diagnosed or suspected connective tissue and/or rheumatic diseases\n* Any observed organ dysfunctions'}, 'identificationModule': {'nctId': 'NCT04100161', 'briefTitle': 'Nutritional Strategies After Muscle Strain Injuries', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries', 'orgStudyIdInfo': {'id': 'BBH P147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein supplementation', 'description': '20g protein supplementation twice daily for 3 months', 'interventionNames': ['Dietary Supplement: Protein supplementation', 'Procedure: Active rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carbohydrate supplementation', 'description': '20g maltodextrin supplementation twice daily for 3 months', 'interventionNames': ['Dietary Supplement: Carbohydrate supplementation', 'Procedure: Active rehabilitation']}], 'interventions': [{'name': 'Protein supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily dose of 40 g whey protein for 3 months', 'armGroupLabels': ['Protein supplementation']}, {'name': 'Carbohydrate supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily dose of 40 g maltodextrin for 3 months', 'armGroupLabels': ['Carbohydrate supplementation']}, {'name': 'Active rehabilitation', 'type': 'PROCEDURE', 'description': 'Progressive rehabilitation following a muscle strain injury for 3 months', 'armGroupLabels': ['Carbohydrate supplementation', 'Protein supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Monika L Bayer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Sports Medicine, Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual de-identified participant data or other documents such as study protocol will not be shared with any third party. A potential change in the data sharing plan after registration will be acknowledged as a statement in a submitted/ published manuscript. A change in the data sharing statement will furthermore be updated in the registry record.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Monika Lucia Bayer', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}