Tolerance, Efficacy, revAlidation, Myostim

Alternativa International S.A

Status: Completed

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Dietary Supplement: MYOSTIM®; Dietary Supplement: PLACEBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684771

TEAM

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups, including a placebo group

MYOSTIM®

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: MYOSTIM®

PLACEBO

Placebo Comparator group

Description:

PLACEBO 2 bars/day during 12 weeks

Treatment:

Dietary Supplement: PLACEBO