NCT06311058 Protein Supplementation After ACL Surgery
| NCT ID | NCT06311058 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | ACL Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2024-02-16 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06311058 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 40 Years, studying ACL Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06311058 currently recruiting?
Yes, NCT06311058 is actively recruiting participants. Contact the research team at hmgoble@houstonmethodist.org for enrollment information.
Where is the NCT06311058 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06311058 clinical trial?
NCT06311058 is sponsored by The Methodist Hospital Research Institute. The trial plans to enroll 102 participants.