Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction
• Intervention / Treatment: Other: Diet Intervention_AP-CPT; Other: Diet Intervention_PP-PPT

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Orthopedic Associates of Hartford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adequate Protein_Carbohydrate Post Therapy; Diet Intervention - Adequate Protein (1.0 g/kg/d) - Carbohydrate Post Therapy [AP-CPT]	Other: 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 .
Experimental: Optimal Protein_Protein Post Therapy; Diet Intervention - Optimal Protein (2.0 g/kg/d) - Protein Post Therapy [OP-PPT]	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle protein fractional synthetic rates	Using stable isotope techniques skeletal muscle protein fractional synthetic rates will be determined	Following 16 weeks of physical rehabilitation post surgery for subjects in both diet intervention groups.

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: University of California, Berkeley; United States Army Research Institute of Environmental Medicine; Orthopedic Associates of Hartford
• Investigators: Principal Investigator: Nancy R Rodriguez, PhD, University of Connecticut-Storrs

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: April 2, 2018
• First Submitted That Met QC Criteria: April 6, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: muscle strength; muscle mass; ACL reconstruction; protein synthesis; protein; beef; rehabilitative nutrition; proteolysis
• Other Study ID Numbers: HHC-E-HHC-2016-0126; KFS63669550 (Other Grant/Funding Number: National Cattlemen's Beef Association)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No