Nutritional Strategies After Muscle Strain Injuries

NCT04100161 | Active Not Recruiting DMC

• 1 other identifier: BBH P147
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Muscle Strain, Multiple Sites

Keywords

muscle strain, atrophy, protein, rehabilitation

Outcome Measures

Primary Outcomes (1)

• Muscle volume

  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.

  3 months post injury

Secondary Outcomes (15)

• Muscle volume

  12 months post injury

• Isokinetic muscle strength

  3 months post injury

• Isokinetic muscle strength

  6 months post injury

• Isokinetic muscle strength

  12 months post injury

• Fat infiltration

  3 months post injury

Study Arms (2)

Protein supplementation

EXPERIMENTAL

20g protein supplementation twice daily for 3 months

Dietary Supplement: Protein supplementation; Procedure: Active rehabilitation

Carbohydrate supplementation

ACTIVE COMPARATOR

20g maltodextrin supplementation twice daily for 3 months

Dietary Supplement: Carbohydrate supplementation; Procedure: Active rehabilitation

Interventions

Protein supplementation DIETARY_SUPPLEMENT

Daily dose of 40 g whey protein for 3 months

Protein supplementation

Carbohydrate supplementation DIETARY_SUPPLEMENT

Daily dose of 40 g maltodextrin for 3 months

Carbohydrate supplementation

Active rehabilitation PROCEDURE

Progressive rehabilitation following a muscle strain injury for 3 months

Carbohydrate supplementation; Protein supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Nielsine Nielsen Vej 11, Building 8

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40145631 DERIVED

MeSH Terms

Conditions

Sprains and Strains; Atrophy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika L Bayer, PhD

  Institute of Sports Medicine, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: January 16, 2020
• Primary Completion: January 8, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)