Tolerance, Efficacy, revAlidation, Myostim
- Conditions
- Anterior Cruciate Ligament Rupture
- Interventions
- Dietary Supplement: MYOSTIM®Dietary Supplement: PLACEBO
- Registration Number
- NCT04684771
- Lead Sponsor
- Alternativa International S.A
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MYOSTIM® 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 PLACEBO 2 bars/day during 12 weeks
- Primary Outcome Measures
Name Time Method Assess the efficacy of MYOSTIM® on the muscular strength recovery 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 Change from Baseline at 14 weeks post ACL surgery Evaluation by impedancemetry
Assess the efficacy of MYOSTIM® on the global judgment of the patient Change from Baseline at 2 and14 weeks post ACL surgery Evaluation of global judgment of the patient by one visual analogue scale (VAS)
Assess the efficacy of MYOSTIM® on physical performance recovery 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 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 Change from Baseline at 2 and14 weeks post ACL surgery Evaluation of pain of the patient by one visual analogue scale (VAS)
Assessment of the tolerance of the patient with the MYOSTIM® 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® At 14 weeks post ACL surgery Evaluation according the number of remaining bars
Assessment of the satisfaction of the patient with the MYOSTIM® At 14 weeks post ACL surgery Evaluation according the satisfaction scale for the product
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hospital Bois de l'Abbaye et de Hesbaye
🇧🇪Seraing, Liège, Belgium
CHU de Liège
🇧🇪Liège, Belgium