Effects of HMB Supplementation on Recovery Following ACL Surgery
Primary Purpose
ACL Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HMB
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for ACL Injury focused on measuring HMB, beta-hydroxy-beta-methylbutyrate, ACL, surgery, muscle mass
Eligibility Criteria
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
Sites / Locations
- Iowa State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
HMB
Placebo
Arm Description
3 g HMB/day
Placebo administered similar to the active comparator
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02602561
First Posted
November 6, 2015
Last Updated
March 11, 2019
Sponsor
Metabolic Technologies Inc.
Collaborators
Iowa State University
1. Study Identification
Unique Protocol Identification Number
NCT02602561
Brief Title
Effects of HMB Supplementation on Recovery Following ACL Surgery
Official Title
Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metabolic Technologies Inc.
Collaborators
Iowa State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
HMB, beta-hydroxy-beta-methylbutyrate, ACL, surgery, muscle mass
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HMB
Arm Type
Active Comparator
Arm Description
3 g HMB/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered similar to the active comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
HMB
Other Intervention Name(s)
beta-hydroxy-beta-methylbutyrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer
Description
Measurement of muscle mass will indicate if the active comparator has preserved or increased muscle mass during the post-surgical recovery period.
Time Frame
Six Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Rathmacher, PhD
Organizational Affiliation
Metabolic Technologies Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa State University
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011
Country
United States
12. IPD Sharing Statement
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Effects of HMB Supplementation on Recovery Following ACL Surgery
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