Protein supplementation after ACL surgery

The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction

This study is testing if adding protein supplements after ACL surgery can help young patients keep their muscle size and strength as they recover.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 16 Years to 40 Years
• Sex: All
• Sponsor: The Methodist Hospital Research Institute (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06311058 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of protein supplementation on muscle atrophy in patients recovering from ACL reconstruction. Participants aged 16 to 40 will be randomly assigned to receive either a placebo, protein supplementation, or protein with amino acids for 12 weeks post-surgery. Muscle size and mass will be measured using DEXA scanning, alongside functional assessments through surveys and physical therapy metrics. The goal is to determine if protein supplementation can standardize post-operative care protocols for ACL reconstruction patients.

Who should consider this trial

Good fit: Ideal candidates are patients aged 16 to 40 who are undergoing primary ACL reconstruction for an acute ACL tear.

Not a fit: Patients with a history of meniscectomy, obesity, diabetes, or other specified health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery outcomes and muscle preservation for patients undergoing ACL reconstruction.

How similar studies have performed: While there is ongoing research into protein supplementation in recovery, this specific approach is novel and has not been extensively tested in the context of ACL reconstruction.

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)
  * Diabetes
  * 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
  * Vegan patients
  * Patient over the age of 40
  * Pregnancy ( As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
  * Any known or diagnosed kidney, GI, or liver disorders
  * Taking any medications known to affect protein metabolism. This includes, but is not limited to any drugs involved in hormone replacement therapy to treat conditions such as:

    * Hypothyroidism: example - levothyroxine
    * Hypogonadism: example - exogenous testosterone, estrogen, or any other forms of androgenic or anabolic hormone compounds
    * Growth hormone or growth hormone analogues
    * Type I or Type II diabetes requiring insulin
  * Currently taking protein supplements, amino acid supplements, or any known ergogenic aids.
  * Notably, all patients would need to confirm they will be doing their rehab through Houston Methodist
  * Patients diagnosed with protein intolerance or digestive issues associated with consuming protein

Where this trial is running

Houston, Texas

• Houston Methodist — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Haley Goble, MHA

Conditions ACL Reconstruction