Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2015-03-23
2017-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Two parallel-groups receiving during 12 weeks either the MYOSTIM® or a PLACEBO in a double blinded manner.
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
MYOSTIM®
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 2 bars/day during 12 weeks
PLACEBO
Bars with no active ingredient and the same flavor (chocolate and red fruits).
Interventions
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MYOSTIM®
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
Bars with no active ingredient and the same flavor (chocolate and red fruits).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
No
Sponsors
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Artialis
INDUSTRY
Alternativa International S.A
INDUSTRY
Responsible Party
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Locations
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Hospital Bois de l'Abbaye et de Hesbaye
Seraing, Liège, Belgium
CHU de Liège
Liège, , Belgium
Countries
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Other Identifiers
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TEAM
Identifier Type: -
Identifier Source: org_study_id