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Nutritional Strategies After Muscle Strain Injuries

Skeletal Muscle Strain Injuries and the Connective Tissue: Optimal Nutritional Strategies During Rehabilitation After Acute Muscle Strain Injuries

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04100161
Enrollment
50
Registered
2019-09-24
Start date
2020-01-16
Completion date
2029-08-01
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Strain, Multiple Sites

Keywords

muscle strain, atrophy, protein, rehabilitation

Brief summary

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. In 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. The 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. The study includes the following hypotheses: 1. 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. 2. The environment at the site of injury is not only pro-inflammatory, but contains proteins associated with proteolysis. 3. Cells belonging to the group of fibro-adipogenic progenitors will be accumulating intra- and inter-muscularly.

Interventions

DIETARY_SUPPLEMENTProtein supplementation

Daily dose of 40 g whey protein for 3 months

Daily dose of 40 g maltodextrin for 3 months

Progressive rehabilitation following a muscle strain injury for 3 months

Sponsors

University of Copenhagen
CollaboratorOTHER
University Hospital Bispebjerg and Frederiksberg
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Sports-active men and women * Acute muscle strain injury in either the calf muscles or the hamstring muscles * Visible tear at the muscle-connective tissue interface visible on an US scan as a hypo-/ hyperechoic area

Exclusion criteria

* Unwillingness to return to sports * Claustrophobia * Daily intake of non-steroidal anti-inflammatory drugs (NSAIDs) within 3 months prior to the strain injury * Smoking * Diagnosed or suspected type I or type II diabetes * Diagnosed or suspected connective tissue and/or rheumatic diseases * Any observed organ dysfunctions

Design outcomes

Primary

MeasureTime frameDescription
Muscle volume3 months post injuryChange 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.

Secondary

MeasureTime frameDescription
Isokinetic muscle strength3 months post injuryChange in muscle strength in the injured leg compared to muscle strength in healthy, contralateral muscle
Fat infiltration3 months post injuryAssessment 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
Muscle volume12 months post injuryChange 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.
Ultrasound imagesBaseline (Acute post injury)Fascicle length measurement, pennation angle, mechanical properties of the muscle (- tendon unit) in the injured and healthy, contralateral muscle
Assessment injury exudateWithin 7 days post injuryAssessment and characterization of cells and soluble factors released after a strain injury into the intra-/ intermuscular space
Injury screening Questionnaire3 months postAssessment of subjective symptoms and pain during sports and daily activities

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026