BridgeMD
New treatment option for ACL Reconstruction
Official title Protein Supplementation After ACL Surgery
ClinicalTrials.gov ID: NCT06311058
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 40
You may be able to join if
- people will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators
You likely can't join if
- people 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
See the full eligibility criteria
- people will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.