Tolerance, Efficacy, revAlidation, Myostim

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Dietary Supplement: MYOSTIM®
* Dietary Supplement: PLACEBO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MYOSTIM®<br>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. | Dietary Supplement: MYOSTIM®<br>* 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.<br>|
| Placebo Comparator: PLACEBO<br>PLACEBO 2 bars/day during 12 weeks | Dietary Supplement: PLACEBO<br>* Bars with no active ingredient and the same flavor (chocolate and red fruits).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of MYOSTIM® on the muscular strength recovery | Evaluation by isokinetic test performed (extension/flexion of the quadriceps) | 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) | 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) | Change from Baseline at 14 weeks post ACL surgery | 
| Assess the efficacy of MYOSTIM® on the muscular mass recovery | Evaluation by impedancemetry | 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 | 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)) | 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) | 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) | 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 | At 14 weeks post ACL surgery | 
| Assessment of the compliance of the patient with the MYOSTIM® | Evaluation according the number of remaining bars | At 14 weeks post ACL surgery | 
| Assessment of the satisfaction of the patient with the MYOSTIM® | Evaluation according the satisfaction scale for the product | At 14 weeks post ACL surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food supplement, revalidation after surgery