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OpenTrials
Completed

NCT Number: NCT02602561

Effects of HMB Supplementation on Recovery Following ACL Surgery

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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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iowa State University

Ames, Iowa, 50011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HMB

Dietary Supplement

Other names: beta-hydroxy-beta-methylbutyrate

Placebo

Dietary Supplement

Primary outcomes

  1. Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer

    Time frame: Six Weeks

    Measurement of muscle mass will indicate if the active comparator has preserved or increased muscle mass during the post-surgical recovery period.

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Collaborators

  • Iowa State University

Registry information

Official study title

Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2015
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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