Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction

NCT ID: NCT03492021

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2022-02-01

Brief Summary

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.

Conditions

Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Adequate Protein_Carbohydrate Post Therapy

Diet Intervention - Adequate Protein (1.0 g/kg/d) - Carbohydrate Post Therapy \[AP-CPT\]

Group Type: EXPERIMENTAL

Diet Intervention_AP-CPT

Intervention Type: OTHER

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

Optimal Protein_Protein Post Therapy

Diet Intervention - Optimal Protein (2.0 g/kg/d) - Protein Post Therapy \[OP-PPT\]

Group Type: EXPERIMENTAL

Diet Intervention_PP-PPT

Intervention Type: OTHER

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

Interventions

Diet Intervention_AP-CPT

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

Intervention Type: OTHER

Diet Intervention_PP-PPT

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Orthopedic Associates of Hartford

UNKNOWN

Sponsor Role: collaborator

United States Army Research Institute of Environmental Medicine

FED

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Nancy Rodriguez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy R Rodriguez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut-Storrs

Locations

Orthopedic Associates of Hartford

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

KFS63669550

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HHC-E-HHC-2016-0126

Identifier Type: -

Identifier Source: org_study_id