Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT06311058
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT06311058
Study Brief:
Protocol Section:
NCT06311058