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Clinical Trials/NCT06311058
NCT06311058
Recruiting
Not Applicable

The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction

The Methodist Hospital Research Institute1 site in 1 country102 target enrollmentFebruary 16, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL Reconstruction
Sponsor
The Methodist Hospital Research Institute
Enrollment
102
Locations
1
Primary Endpoint
Muscle mass
Status
Recruiting
Last Updated
12 months ago

Overview

Brief Summary

The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction.

Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy.

Detailed Description

This study is designed to evaluate non-interventional longitudinal post-operative clinical improvement. The proposed study is a randomized non-interventional, double blind study. Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear. Demographic information including age, sex, BMI, and sport participation will be obtained from patients at the time of recruitment. Subjects will be randomized to one of three categories: 1)placebo, 2)protein supplementation, or 3)protein supplementation with amino acids. The probability is is a 1 in 3 chance to be enrolled in each group. Participants will be provided the supplement drink immediately following surgery and will be asked to consume the supplement 2-times daily following ACL reconstruction for a total of 12 weeks post-op. In addition, participants will be asked to complete a weekly food diary in which they track their diet for 2 week days and 1 weekend day each week for all 12 weeks. This will help account for dietary proteins. Subjects will also be asked to complete the KOOS Jr and Tampa Scale surveys (attached in the application) through Houston Methodist's Redcap system at each time point (Pre-op, 4, 8 and 12 weeks postop). Briefly, BCAAs (particularly leucine) represent primary triggers for the stimulation of protein synthesis via signaling through the mammalian target of rapamycin complex 1 pathway (mTORC1) in skeletal muscle and other tissues. Whey hydrolysate is a complete protein source that is considered to be "fast absorbing." Casein is a complete protein source that is "slow absorbing" relative to whey.9 All protein sources used in this investigation are commercially available nutritional supplements. The placebo will include a crystallite drink. Standard of care clinic assessments such as bilateral muscle strength and stability screening will be performed in all patients at 8 and 12 weeks of rehabilitation. Time to return to sport for those subjects participating in a recreational or professional sport activities will also be recorded. Lastly, quadriceps muscle mass measured through dual energy x-ray absorptiometry (DEXA) scanning. Participants in all 3 groups will undergo DEXA scanning at once pre-operatively, 4 weeks post-op,8 weeks, post-op and 12 weeks post-op following ACL reconstruction. The Tampa Scale and KOOS JR surveys will be administered at each study visit. The purpose of these surveys are to evaluate patient perception of surgery and their injury. As stated in the purpose, these will act as secondary outcomes to this study.

Registry
clinicaltrials.gov
Start Date
February 16, 2024
End Date
December 1, 2027
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick McCulloch,MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

Inclusion Criteria

  • Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators

Exclusion Criteria

  • Subjects will not be included if they meet one of the following criteria
  • History of meniscectomy or meniscus repair
  • Obesity (BMI\>35)
  • Cardiovascular, renal, liver or pulmonary disease
  • Active infections
  • Cancer (current or treated within the past 2 years) or coagulation disorder
  • Rapid weight change within the past year
  • Physically unable to participate in the intervention
  • Are currently taking, or recently (w/in 1 month of participation) taken prescribed, or over the counter ergogenic aids or compounds known to be banned by the NCAA.
  • Less than 16 years of age

Outcomes

Primary Outcomes

Muscle mass

Time Frame: Pre-operation, 4, 8 and 12 weeks post-operation

Lean mass in the effected limb

Secondary Outcomes

  • Patient Reported Outcomes(Pre-operation 4, 8 and 12 weeks post-operation)

Study Sites (1)

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