ACL InjuryNCT02602561
Effects of HMB Supplementation on Recovery Following ACL Surgery
A study testing HMB in people with ACL Injury, run by Metabolic Technologies Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- HMB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ACL Injury
- Being tested
- HMB, Placebo
- Keywords
- HMB, beta-hydroxy-beta-methylbutyrate, ACL, surgery, muscle mass
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMBDietary supplement
Also called beta-hydroxy-beta-methylbutyrate
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| HMB | Active comparator | 3 g HMB/day Receives: Dietary Supplement: HMB |
| Placebo | Placebo comparator | Placebo administered similar to the active comparator Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Responsible party
- Sponsor
- Investigators
- John A Rathmacher, PhD, Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602561
- Sponsor's protocol ID
- MTI2015-CS02
- Status last verified
- Mar 2019
- First submitted
- 6 Nov 2015
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT02602561
- Acronym / sponsor ID
- MTI2015-CS02
- Conditions
- ACL Injury
- Keywords
- HMB, beta-hydroxy-beta-methylbutyrate, ACL, surgery, muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Study start
- Nov 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HMB | Active comparator | Dietary Supplement: HMB3 g HMB/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo administered similar to the active comparator |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMBAlso: beta-hydroxy-beta-methylbutyrate | Dietary supplement | HMB |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Rathmacher, PhD principal investigator
Metabolic Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB in people with ACL Injury, run by Metabolic Technologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer (time frame: Six Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.