Actively Recruiting
The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction
Led by The Methodist Hospital Research Institute · Updated on 2025-05-06
102
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of protein supplementation on muscle loss after ACL reconstruction surgery in patients aged 16 to 40. This study aims to understand whether adding protein supplements can help reduce muscle atrophy during the post-operative period. The study is randomized, double-blind, and non-interventional, focusing on muscle mass changes and patient-reported outcomes over time. Participants will be randomly assigned to one of three groups: a placebo group receiving a maltodextrin supplement, a protein supplement group receiving 25 grams of whey protein isolate twice daily, or a protein plus amino acid supplement group receiving the same whey protein along with an amino acid blend twice daily. These supplements are taken for 12 weeks following surgery. Participants will also keep weekly food diaries to track their dietary protein intake during this time. Throughout the study, muscle mass will be measured using DEXA scans before surgery and at 4, 8, and 12 weeks after surgery. Patients will complete KOOS Jr and Tampa Scale surveys at these same time points to assess their perception of recovery. Additional assessments include muscle strength and stability screenings at 8 and 12 weeks, and recording the time it takes to return to sports for those involved in recreational or professional activities. The total participation duration is 12 weeks post-operation.
CONDITIONS
Brief Title
Protein Supplementation After ACL Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear
You will not qualify if you...
- History of meniscectomy or meniscus repair
- Obesity with BMI over 35
- Diabetes
- Cardiovascular, renal, liver, or pulmonary disease
- Active infections
- Current or recent cancer (within 2 years) or coagulation disorders
- Rapid weight change within the past year
- Physically unable to participate in the intervention
- Current or recent use (within 1 month) of ergogenic aids or banned compounds
- Age under 16 or over 40
- Vegan diet
- Pregnancy (must have negative pregnancy test before surgery)
- Known kidney, gastrointestinal, or liver disorders
- Taking medications affecting protein metabolism, including hormone therapies and insulin for diabetes
- Current use of protein or amino acid supplements or ergogenic aids
- Not completing rehabilitation through Houston Methodist
- Diagnosed protein intolerance or digestive issues related to protein consumption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo ACL reconstruction surgery and receive their assigned supplement drink immediately following surgery.
1 visit (in-person)
Duration - 12 weeks
Participants consume their assigned supplement twice daily for 12 weeks following ACL reconstruction. They also complete a weekly food diary and surveys to track diet and patient-reported outcomes.
Weekly visits or surveys for 12 weeks
Duration - 12 weeks
Participants attend clinic visits for muscle strength and stability assessments at 8 and 12 weeks post-surgery, and undergo DEXA scans pre-operatively and at 4, 8, and 12 weeks post-op to measure quadriceps muscle mass.
Approximately 5 visits (pre-op, 4, 8, and 12 weeks post-op plus 8 and 12 week clinical assessments)
Trial Site Locations
Total: 1 location
1
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Haley Goble, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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