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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
Metabolic Technologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
November 6, 2015
Last Updated
March 11, 2019
Sponsor
Metabolic Technologies Inc.
Collaborators
Iowa State University
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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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