Effects of HMB Supplementation on Recovery Following ACL Surgery

ACL Injury Clinical Trial

Official title:

Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602561
• Other study ID #: MTI2015-CS02
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2019
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Dietary Supplement:
• HMB

• Placebo

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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