Effects of HMB Supplementation on Recovery Following ACL Surgery

March 11, 2019 updated by: Metabolic Technologies Inc.

Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Ames, Iowa, United States, 50011
        • Iowa State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HMB
3 g HMB/day
Dietary supplement: HMB
Other Names:
  • beta-hydroxy-beta-methylbutyrate
Placebo Comparator: Placebo
Placebo administered similar to the active comparator
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metabolic Technologies Inc.

Collaborators

Iowa State University

Investigators

  • Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 6, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTI2015-CS02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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