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Nutritional Strategies After Muscle Strain Injuries

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date changed from estimate of Jul 1, 2023 to Jan 8, 2024v5
  2. Minor Primary completion date: Feb 12, 2023 to Jul 1, 2023v4
  3. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 31, 2022 to Feb 12, 2023
    • Site contact updated
    v3
  4. Notable Start date: Oct 1, 2019 to Jan 16, 2020v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04100161
Lead Sponsor Bispebjerg Hospital
Collaborators: University of Copenhagen, University Hospital Bispebjerg and Frederiksberg
Conditions
(from sponsor)
Muscle Strain, Multiple Sites
Related terms Atrophy, Sprains and Strains
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov