Effects of HMB Supplementation on Recovery Following ACL Surgery

Study Overview
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Brief Summary
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The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL injury occurs participation in physical activity is compromised. Reconstructive surgery is often necessary to repair the damage which is then followed by a regimen of physical therapy in order to regain full activity. Nutritional intervention after the surgery could help the patient maintain muscle mass during recovery, thus allowing for a quicker return to normal activity.

Detailed Description
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Beta-hydroxy-beta-methylbutyrate (HMB) is a nutritional supplement shown to improve muscle mass with exercise, and also in muscle loss conditions caused by a decrease in physical activity. Participants will be recruited who will undergo reconstructive surgery for a complete ACL tear and will then enter a standard physical therapy program during a six week recovery period. Subjects will receive either HMB or a placebo supplement during the recovery period. Muscle mass will be measured two weeks prior to the surgery and again after the recovery period using an InBody 720 body composition analyzer. Additionally, the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered as a measure of recovery and activity level during the study.

Official Title
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Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery

Conditions
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ACL Injury

Intervention / Treatment
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* Dietary Supplement: HMB
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete anterior cruciate ligament (ACL) tear Will benefit from ACL reconstructive surgery Are able to participate in the physical therapy program No previous major knee injuries or surgeries No health conditions affecting muscle mass Exclusion Criteria: Incomplete ACL tear Have multiple or bilateral ligament tears Are unable to participate in the physical therapy program Have had previous major knee injuries or surgeries Have health conditions affecting muscle mass

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HMB<br>3 g HMB/day | Dietary Supplement: HMB<br> <br> * Other names: beta-hydroxy-beta-methylbutyrate;|
| Placebo Comparator: Placebo<br>Placebo administered similar to the active comparator | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer | Measurement of muscle mass will indicate if the active comparator has preserved or increased muscle mass during the post-surgical recovery period. | Six Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HMB, beta-hydroxy-beta-methylbutyrate, ACL, surgery, muscle mass