Protein Supplementation After ACL Surgery

NCT06311058 | Recruiting

• 1 other identifier: PRO00032531
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  Lean mass in the effected limb

  Pre-operation, 4, 8 and 12 weeks post-operation

Secondary Outcomes (2)

• Patient Reported Outcomes

  Pre-operation 4, 8 and 12 weeks post-operation

• Patient Reported Outcomes

  Pre-operation 4, 8 and 12 weeks post-operation

Study Arms (3)

Protein Supplement Group

EXPERIMENTAL

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

Dietary Supplement: Whey protein isolate

Protein + Amino Acid Supplement Group

EXPERIMENTAL

* 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

Dietary Supplement: Whey protein isolate; Dietary Supplement: Protein + BAA

Placebo Group

PLACEBO COMPARATOR

• isocaloric-matched (25g) maltodextrin supplement Twice a day for 12 weeks

Dietary Supplement: Placebo

Interventions

Whey protein isolate DIETARY_SUPPLEMENT

25g of whey protein isolate

Protein + Amino Acid Supplement Group; Protein Supplement Group

Protein + BAA DIETARY_SUPPLEMENT

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

Protein + Amino Acid Supplement Group

Placebo DIETARY_SUPPLEMENT

• isocaloric-matched (25g) maltodextrin supplement

Placebo Group

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Central Study Contacts

Haley Goble, MHA

CONTACT

7134413930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded randomized controlled trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects are randomized to 1 of 3 intervention groups

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 15, 2024
• Study Start: February 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)