Recruiting

Protein Supplementation

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06311058

Conditions

ACL Reconstruction

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Not accepted

Interventions

Whey protein isolate

Protein + BAA

Placebo

Study Details

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.

Conditions

ACL Reconstruction

Study ID

NCT06311058

Start date

Feb 16, 2024

Status verified date

May, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

102 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Protein Supplement Group

Participants in this group will receive 25g of whey protein isolate twice a day for 12 weeks.

experimental: Protein + Amino Acid Supplement Group

  • Protein drink - 25g of whey protein isolate
  • Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine)

Twice a day for 12 weeks

placebo comparator: Placebo Group

• isocaloric-matched (25g) maltodextrin supplement

Twice a day for 12 weeks

Interventions

Whey protein isolate

25g of whey protein isolate

Protein + BAA

  • Protein drink - 25g of whey protein isolate
  • Amino Acid Blend - 7g of protein (4g Leucine, 1g iso leucine, 1g valine, 1g arginine)

Placebo

• isocaloric-matched (25g) maltodextrin supplement

Primary outcome measure

  • Muscle mass [ Time Frame: Pre-operation, 4, 8 and 12 weeks post-operation ]

Central Contacts and Locations

Central contacts

Haley Goble, MHA

7134413930hmgoble@houstonmethodist.org

Locations

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Haley Goble, MHA

713-441-3930hmgoble@houstonmethodist.org

Principal Investigator:

Patrick C McCulloch, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

May 6, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-05-06.