Effects of HMB Supplementation on Recovery Following ACL Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-08-31

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.

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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.

Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HMB

3 g HMB/day

Group Type ACTIVE_COMPARATOR

HMB

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo administered similar to the active comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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HMB

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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beta-hydroxy-beta-methylbutyrate

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes