Clinical trial Recruiting at 1 site Interventional Ages 16 to 40

Protein supplementation after ACL surgery

Official title: The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction

Run by The Methodist Hospital Research Institute · NCT06311058 · Data updated 2026-11-12

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

Study typeInterventional
Ages16 Years to 40 Years
SexAll
Enrollment102 (estimated)
SponsorThe Methodist Hospital Research Institute
Academic / other
Locations1 site (Houston, Texas)
StatusRecruiting
StartedFebruary 16, 2024
Main results expectedDecember 1, 2026
Study endsDecember 1, 2027
Registry record updatedMay 6, 2025
Trial IDNCT06311058 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Houston Methodist
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.