Anterior Cruciate Ligament RuptureNCT04684771
Tolerance, Efficacy, revAlidation, Myostim
A study testing MYOSTIM® in people with Anterior Cruciate Ligament Rupture, run by Alternativa International S.A at 2 sites in Belgium.
Trial summary
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- MYOSTIM®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 2 sitesBelgium
- Study dates
- 23 Mar 2015to 31 Dec 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male between the age of 18 and 40
- BMI (Body Mass Index) ≤ 27
- Candidates for ACL reconstruction surgery of DIDT (Droit Interne et du Demi Tendineux) type
- Able to follow the instruction of the study, to go to the postoperative visits to the investigator, to go to the isokinetic and to the MRI visits
- Having signed an informed consent
Who cannot join
- Related to the pathology:
- Patient who have undergone previous ACL reconstruction surgery on the same knee
- Patient who have participated to a therapeutic clinical study 3 months before inclusion
- Patient who plan to follow a workout or a revalidation program after surgery different from classical physiotherapy prescribed by the orthopedic surgeon
- Contralateral limb suffered from trauma, surgery, fracture, tear, tendinopathy, sepsis or immobilization for more than 3 weeks during the last 5 years
- Related to treatment:
Show all 30Show fewer
- Patient who have eaten doping substances or food supplement building mass and muscle strength during 3 months before inclusion excepted for creatine and beta-alanine for which the washout period is of 6 month before inclusion
- Patient who were treated with antibiotics in the month preceding the inclusion
- Patient treated with pharmacologic agents like statins, immunosuppressors or anti-malaria
- Patient taking androgens (steroids…)
- Patient under treatments which may interfere with the neuromuscular system
- Patient who were treated with analgesic or non-steroidal anti-inflammatory drugs (NSAIDS) 24 hours before inclusion visit
- Related to associated diseases:
- Patient with associated uncontrolled severe disease: severe liver or kidney disease, severe and uncontrolled cardiovascular disease, HIV, B or C hepatitis, tumor
- Patient with thromboembolism disorders
- Patient with inflammatory bowel disease
- Anorexic patient
- Diabetic patient
- Patient with traumatic, neurologic or rheumatic history of the lower limbs
- Related to patient:
- Allergy or contraindication to soy, milk, gluten, nuts or wheat
- Forecasting a high protein diet during the study
- Under guardianship or judicial protection
- Related to MRI counter-indication:
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
- Patient with a ferromagnetic splinter in the body, or having wire sutures
- Serious mobility problem (Parkinson, tremors)
- Claustrophobia
- Related to impedancemeter test:
- Patient with a metal plate at the right ankle
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
CHU de Liège
Liège, 4000
Hospital Bois de l'Abbaye et de Hesbaye
Seraing, Liège, 4100
About this study
Official title: Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.
The food supplement (MYOSTIM®) has been developped and is supplied as food bars and composed of pomegranate, leucine, creatine, proteins and D vitamin. The aim of this exploratory study is to assess the efficacy and tolerance of MYOSTIM® on muscle performance after ACL reconstructive surgery and in postoperative revalidation phase.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- MYOSTIM®, PLACEBO
- Keywords
- food supplement, revalidation after surgery
- 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.
MYOSTIM®Dietary supplement
Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment.
PLACEBODietary supplement
Bars with no active ingredient and the same flavor (chocolate and red fruits).
| Study group | Role | What they receive |
|---|---|---|
| MYOSTIM® | Active comparator | MYOSTIM® 2 bars/day during 12 weeks MYOSTIM® as a food bar. Active ingredient: Pomegranate extract, L-leucine, Creatine, D3 Vitamin, Proteins IP Status: Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment. Receives: Dietary Supplement: MYOSTIM® |
| PLACEBO | Placebo comparator | PLACEBO 2 bars/day during 12 weeks Receives: Dietary Supplement: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of MYOSTIM® on the muscular strength recovery
Evaluation by isokinetic test performed (extension/flexion of the quadriceps)
Measured: Change from Baseline at 14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the muscular strength recovery
Evaluation by isokinetic test performed (extension/flexion of the hamstrings)
Measured: Change from Baseline at 14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the muscular mass recovery
Evaluation by Magnetic Resonance Imaging (MRI)
Measured: Change from Baseline at 14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the muscular mass recovery
Evaluation by impedancemetry
Measured: Change from Baseline at 14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on physical performance recovery
Evaluation with one self-administrated knee evaluation questionnaire from the International Knee Documentation Committee
Measured: Change from Baseline at 14 weeks post ACL surgery
Assess the effect of MYOSTIM® on blood biomarker
Evaluation of blood concentration of biomarker (Myostatin (muscular atrophy), Myeloperoxidase (chronic joint inflammation), Coll2-1 and Coll2-1NO2 (Cartilage inflammation and degradation), IL6 (muscular atrophy and inflammation), MMP3 and NT-CAF (cartilage and neuro-muscular junction), TNFa (inflammation))
Measured: Change from Baseline at 2 and14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the pain of the patient
Evaluation of pain of the patient by one visual analogue scale (VAS)
Measured: Change from Baseline at 2 and14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the global judgment of the patient
Evaluation of global judgment of the patient by one visual analogue scale (VAS)
Measured: Change from Baseline at 2 and14 weeks post ACL surgery
Assessment of the tolerance of the patient with the MYOSTIM®
Evaluation according the number of Adverse Events (AE), remaining bars and satisfaction scale for the product
Measured: At 14 weeks post ACL surgery
Assessment of the compliance of the patient with the MYOSTIM®
Evaluation according the number of remaining bars
Measured: At 14 weeks post ACL surgery
Assessment of the satisfaction of the patient with the MYOSTIM®
Evaluation according the satisfaction scale for the product
Measured: At 14 weeks post ACL surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start23 Mar 2015
- Primary completion27 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, exploratory study, monocentric, with a group of control patient with placebo. Two parallel-groups receiving during 12 weeks either the MYOSTIM® or a PLACEBO in a double blinded manner.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alternativa International S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684771
- Sponsor's protocol ID
- TEAM
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT04684771
- Acronym / sponsor ID
- TEAM
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- food supplement, revalidation after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Alternativa International S.AIndustry (pharma, biotech, devices)
- Collaborators
- Artialis
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 Dec 2020 (actual)
- 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.
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.
The food supplement (MYOSTIM®) has been developped and is supplied as food bars and composed of pomegranate, leucine, creatine, proteins and D vitamin. The aim of this exploratory study is to assess the efficacy and tolerance of MYOSTIM® on muscle performance after ACL reconstructive surgery and in postoperative revalidation phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind, exploratory study, monocentric, with a group of control patient with placebo. Two parallel-groups receiving during 12 weeks either the MYOSTIM® or a PLACEBO in a double blinded manner.
| Arm | Type | Receives |
|---|---|---|
| MYOSTIM® | Active comparator | Dietary Supplement: MYOSTIM®MYOSTIM® 2 bars/day during 12 weeks MYOSTIM® as a food bar. Active ingredient: Pomegranate extract, L-leucine, Creatine, D3 Vitamin, Proteins IP Status: Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment. |
| PLACEBO | Placebo comparator | Dietary Supplement: PLACEBOPLACEBO 2 bars/day during 12 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male between the age of 18 and 40
- BMI (Body Mass Index) ≤ 27
- Candidates for ACL reconstruction surgery of DIDT (Droit Interne et du Demi Tendineux) type
- Able to follow the instruction of the study, to go to the postoperative visits to the investigator, to go to the isokinetic and to the MRI visits
- Having signed an informed consent
Key exclusion criteria (30 listed)
- Patient who have undergone previous ACL reconstruction surgery on the same knee
- Patient who have participated to a therapeutic clinical study 3 months before inclusion
- Patient who plan to follow a workout or a revalidation program after surgery different from classical physiotherapy prescribed by the orthopedic surgeon
- Contralateral limb suffered from trauma, surgery, fracture, tear, tendinopathy, sepsis or immobilization for more than 3 weeks during the last 5 years
- Patient who have eaten doping substances or food supplement building mass and muscle strength during 3 months before inclusion excepted for creatine and beta-alanine for which the washout period is of 6 month before inclusion
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 |
|---|---|---|
| MYOSTIM®Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment. | Dietary supplement | MYOSTIM® |
| PLACEBOBars with no active ingredient and the same flavor (chocolate and red fruits). | Dietary supplement | PLACEBO |
Primary outcome
Assess the efficacy of MYOSTIM® on the muscular strength recovery
Time frame: Change from Baseline at 14 weeks post ACL surgery
Evaluation by isokinetic test performed (extension/flexion of the quadriceps)
Assess the efficacy of MYOSTIM® on the muscular strength recovery
Time frame: Change from Baseline at 14 weeks post ACL surgery
Evaluation by isokinetic test performed (extension/flexion of the hamstrings)
Assess the efficacy of MYOSTIM® on the muscular mass recovery
Time frame: Change from Baseline at 14 weeks post ACL surgery
Evaluation by Magnetic Resonance Imaging (MRI)
Assess the efficacy of MYOSTIM® on the muscular mass recovery
Time frame: Change from Baseline at 14 weeks post ACL surgery
Evaluation by impedancemetry
Assess the efficacy of MYOSTIM® on physical performance recovery
Time frame: Change from Baseline at 14 weeks post ACL surgery
Evaluation with one self-administrated knee evaluation questionnaire from the International Knee Documentation Committee
Assess the effect of MYOSTIM® on blood biomarker
Time frame: Change from Baseline at 2 and14 weeks post ACL surgery
Evaluation of blood concentration of biomarker (Myostatin (muscular atrophy), Myeloperoxidase (chronic joint inflammation), Coll2-1 and Coll2-1NO2 (Cartilage inflammation and degradation), IL6 (muscular atrophy and inflammation), MMP3 and NT-CAF (cartilage and neuro-muscular junction), TNFa (inflammation))
Assess the efficacy of MYOSTIM® on the pain of the patient
Time frame: Change from Baseline at 2 and14 weeks post ACL surgery
Evaluation of pain of the patient by one visual analogue scale (VAS)
Assess the efficacy of MYOSTIM® on the global judgment of the patient
Time frame: Change from Baseline at 2 and14 weeks post ACL surgery
Evaluation of global judgment of the patient by one visual analogue scale (VAS)
Assessment of the tolerance of the patient with the MYOSTIM®
Time frame: At 14 weeks post ACL surgery
Evaluation according the number of Adverse Events (AE), remaining bars and satisfaction scale for the product
Assessment of the compliance of the patient with the MYOSTIM®
Time frame: At 14 weeks post ACL surgery
Evaluation according the number of remaining bars
Assessment of the satisfaction of the patient with the MYOSTIM®
Time frame: At 14 weeks post ACL surgery
Evaluation according the satisfaction scale for the product
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 28 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MYOSTIM® in people with Anterior Cruciate Ligament Rupture, run by Alternativa International S.A at 2 sites in Belgium.
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 30 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 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Assess the efficacy of MYOSTIM® on the muscular strength recovery (time frame: Change from Baseline at 14 weeks post ACL surgery). The study lists 11 primary outcomes in all. 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 28 Dec 2020.