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Effects of HMB Supplementation on Recovery Following ACL Surgery

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ClinicalTrials.gov Identifier: NCT02602561
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Iowa State University
Information provided by (Responsible Party):
Metabolic Technologies Inc.

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.

Condition or disease Intervention/treatment Phase
ACL Injury Dietary Supplement: HMB Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery
Study Start Date : November 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Active Comparator: HMB
3 g HMB/day
Dietary Supplement: HMB
Other Name: beta-hydroxy-beta-methylbutyrate

Placebo Comparator: Placebo
Placebo administered similar to the active comparator
Dietary Supplement: Placebo



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602561


Locations
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United States, Iowa
Iowa State University
Ames, Iowa, United States, 50011
Sponsors and Collaborators
Metabolic Technologies Inc.
Iowa State University
Investigators
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Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
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Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT02602561    
Other Study ID Numbers: MTI2015-CS02
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Metabolic Technologies Inc.:
HMB
beta-hydroxy-beta-methylbutyrate
ACL
surgery
muscle mass
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries