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OpenTrials
Completed

NCT Number: NCT03492021

Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction

Musculoskeletal injury, particularly injuries requiring surgical repair, induce significant muscle atrophy, resulting in diminished physical function. The protein turnover-associated (diminished protein synthesis, elevated protein breakdown, negative net muscle protein balance) etiology of injury and surgical-induced atrophy are, in part, similar to those observed with muscle wasting induced by hyper-catabolic and inflammatory conditions and prolonged periods of skeletal muscle disuse (e.g., cachexia and joint immobilization). Combining dietary strategies to optimize the anabolic properties of beef as a high quality protein source that provides essential amino acids prior to surgery and throughout post-surgery rehabilitation may attenuate muscle atrophy and accelerate the restoration of muscle function. This project will examine the efficacy of habitual consumption of a beef-based higher protein meal pattern and post-physical rehabilitation beef protein supplementation throughout post-surgical rehabilitation intervention on skeletal muscle function in response to anterior cruciate ligament (ACL) repair in healthy, physically active adults.

Stable isotope methodologies, proteomic analysis of muscle protein synthesis, and molecular assessments of skeletal muscle atrophy and remodeling will be assessed to evaluate the effects of increased protein intake, including consumption of a high quality beef-based protein supplement following patient physical therapy sessions on:

1. Skeletal muscle protein fractional synthetic rates during and in recovery from surgery; 2. Inflammatory, proteolytic, and anabolic intramuscular signaling during surgery and their association with skeletal muscle protein synthesis and muscle function; 3. Muscle size and functional recovery; 4. Duration to return to routine exercise, sport, or physical activity.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Associates of Hartford

Hartford, Connecticut, 06106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 50 years of age
  • identified as appropriate for study recruitment by their respective orthopedic surgeon
  • undergoing their first anterior cruciate ligament (ACL) repair
  • undergo ACL reconstruction under general anesthesia
  • body mass indexes (BMIs) within normal to overweight ranges

Exclusion criteria

  • reporting metabolic or cardiovascular abnormalities, food allergies, gastrointestinal disorders (i.e. lactose intolerance)
  • use of nutritional/herbal/sports supplements including anabolic steroids, and tobacco products will be excluded from the study
  • BMIs above 29.9

Treatment and study plan

Diet Intervention_AP-CPT

Other

Adequate Protein_Carbohydrate Post Therapy (AP-CPT) where protein intake will be 1 g/kg/d for the duration of the study .

Diet Intervention_PP-PPT

Other

Optimal Protein_Protein Post Therapy (OP-PPT) with protein intake set at 2.0 g/kg/day for the duration of the study

Primary outcomes

  1. Skeletal muscle protein fractional synthetic rates

    Time frame: Following 16 weeks of physical rehabilitation post surgery for subjects in both diet intervention groups.

    Using stable isotope techniques skeletal muscle protein fractional synthetic rates will be determined

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Orthopedic Associates of Hartford
  • United States Army Research Institute of Environmental Medicine
  • University of California, Berkeley

Registry information

Official study title

The Role of Beef in Optimal Protein and Feeding Strategies to Accelerate Muscle Mass and Functional Recovery From Anterior Cruciate Ligament (ACL) Repair

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 9, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.