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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
35
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.
Bars with no active ingredient and the same flavor (chocolate and red fruits).
Hospital Bois de l'Abbaye et de Hesbaye
Seraing, Liège, Belgium
CHU de Liège
Liège, Belgium
Assess the efficacy of MYOSTIM® on the muscular strength recovery
Evaluation by isokinetic test performed (extension/flexion of the quadriceps)
Time frame: 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)
Time frame: 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)
Time frame: Change from Baseline at 14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the muscular mass recovery
Evaluation by impedancemetry
Time frame: 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
Time frame: 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))
Time frame: 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)
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Time frame: 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)
Time frame: 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
Time frame: At 14 weeks post ACL surgery
Assessment of the compliance of the patient with the MYOSTIM®
Evaluation according the number of remaining bars
Time frame: At 14 weeks post ACL surgery
Assessment of the satisfaction of the patient with the MYOSTIM®
Evaluation according the satisfaction scale for the product
Time frame: At 14 weeks post ACL surgery