Clinical trial NCT04684771: Tolerance, Efficacy, revAlidation, Myostim
Official title: Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: food supplement
revalidation after surgery
Lead sponsor: Alternativa International S.A
Sponsor class: INDUSTRY
Collaborators: name: Artialis
First posted: 2020-12-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assess the efficacy of MYOSTIM® on the muscular strength recovery
timeFrame: Change from Baseline at 14 weeks post ACL surgery
measure: Assess the efficacy of MYOSTIM® on the muscular strength recovery
timeFrame: Change from Baseline at 14 weeks post ACL surgery
measure: Assess the efficacy of MYOSTIM® on the muscular mass recovery
timeFrame: Change from Baseline at 14 weeks post ACL surgery
measure: Assess the efficacy of MYOSTIM® on the muscular mass recovery
timeFrame: Change from Baseline at 14 weeks post ACL surgery
measure: Assess the efficacy of MYOSTIM® on physical performance recovery
timeFrame: Change from Baseline at 14 weeks post ACL surgery
measure: Assess the effect of MYOSTIM® on blood biomarker
timeFrame: Change from Baseline at 2 and14 weeks post ACL surgery
measure: Assess the efficacy of MYOSTIM® on the pain of the patient
timeFrame: Change from Baseline at 2 and14 weeks post ACL surgery
measure: Assess the efficacy of MYOSTIM® on the global judgment of the patient
timeFrame: Change from Baseline at 2 and14 weeks post ACL surgery
measure: Assessment of the tolerance of the patient with the MYOSTIM®
timeFrame: At 14 weeks post ACL surgery
measure: Assessment of the compliance of the patient with the MYOSTIM®
timeFrame: At 14 weeks post ACL surgery
measure: Assessment of the satisfaction of the patient with the MYOSTIM®
timeFrame: At 14 weeks post ACL surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seraing
country: Belgium
facility: Hospital Bois de l'Abbaye et de Hesbaye
state: Liège
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References: