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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03492021
Other study ID # HHC-E-HHC-2016-0126
Secondary ID KFS63669550
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date February 1, 2022

Study information

Verified date September 2022
Source University of Connecticut
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date February 1, 2022
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction

Intervention

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 .
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

Locations

Country Name City State
United States Orthopedic Associates of Hartford Hartford Connecticut

Sponsors (4)

Lead Sponsor Collaborator
University of Connecticut Orthopedic Associates of Hartford, United States Army Research Institute of Environmental Medicine, University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.