EICHORCondition: ACL Reconstruction · Sponsor: The Methodist Hospital Research Institute
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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.
This description comes directly from the study's public registry record.
Haley Goble, MHA · 7134413930 · hmgoble@houstonmethodist.org
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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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Houston Methodist | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06311058