Protein Supplementation After ACL Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06311058
Status
Recruiting
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Conditions

  • ACL Reconstruction

Eligibility Criteria

Sex
ALL
Age
16 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Whey protein isolate — DIETARY_SUPPLEMENT
    25g of whey protein isolate
  • 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)
  • Placebo — DIETARY_SUPPLEMENT
    • isocaloric-matched (25g) maltodextrin supplement

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
May 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston MethodistHoustonTexas77030
Haley Goble, MHA
[email protected]
713-441-3930
Robert A Jack, MD (SUB_INVESTIGATOR)
Patrick C McCulloch, MD (PRINCIPAL_INVESTIGATOR)
David M Lintner, MD (SUB_INVESTIGATOR)

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By research site
Houston Methodist· Houston, TX

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