Protein in Feeding Strategies to Accelerate Muscle Recovery From ACL Reconstruction

Sponsor

University of Connecticut (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03492021

Collaborator

Orthopedic Associates of Hartford (Other), United States Army Research Institute of Environmental Medicine (U.S. Fed), University of California, Berkeley (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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:

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

Condition or Disease	Intervention/Treatment	Phase
Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction	Other: Diet Intervention_AP-CPT Other: Diet Intervention_PP-PPT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 1, 2018

Actual Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Skeletal muscle protein fractional synthetic rates [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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