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Completed

NCT Number: NCT04684771

Tolerance, Efficacy, revAlidation, Myostim

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Bois de l'Abbaye et de Hesbaye, Seraing, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MYOSTIM®

Dietary Supplement

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

Dietary Supplement

Bars with no active ingredient and the same flavor (chocolate and red fruits).

Primary outcomes

  1. Assess the efficacy of MYOSTIM® on the muscular strength recovery

    Time frame: Change from Baseline at 14 weeks post ACL surgery

    Evaluation by isokinetic test performed (extension/flexion of the quadriceps)

  2. Assess the efficacy of MYOSTIM® on the muscular strength recovery

    Time frame: Change from Baseline at 14 weeks post ACL surgery

    Evaluation by isokinetic test performed (extension/flexion of the hamstrings)

  3. Assess the efficacy of MYOSTIM® on the muscular mass recovery

    Time frame: Change from Baseline at 14 weeks post ACL surgery

    Evaluation by Magnetic Resonance Imaging (MRI)

  4. Assess the efficacy of MYOSTIM® on the muscular mass recovery

    Time frame: Change from Baseline at 14 weeks post ACL surgery

    Evaluation by impedancemetry

  5. Assess the efficacy of MYOSTIM® on physical performance recovery

    Time frame: Change from Baseline at 14 weeks post ACL surgery

    Evaluation with one self-administrated knee evaluation questionnaire from the International Knee Documentation Committee

  6. Assess the effect of MYOSTIM® on blood biomarker

    Time frame: 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))

  7. Assess the efficacy of MYOSTIM® on the pain of the patient

    Time frame: Change from Baseline at 2 and14 weeks post ACL surgery

    Evaluation of pain of the patient by one visual analogue scale (VAS)

  8. Assess the efficacy of MYOSTIM® on the global judgment of the patient

    Time frame: Change from Baseline at 2 and14 weeks post ACL surgery

    Evaluation of global judgment of the patient by one visual analogue scale (VAS)

  9. Assessment of the tolerance of the patient with the MYOSTIM®

    Time frame: At 14 weeks post ACL surgery

    Evaluation according the number of Adverse Events (AE), remaining bars and satisfaction scale for the product

  10. Assessment of the compliance of the patient with the MYOSTIM®

    Time frame: At 14 weeks post ACL surgery

    Evaluation according the number of remaining bars

  11. Assessment of the satisfaction of the patient with the MYOSTIM®

    Time frame: At 14 weeks post ACL surgery

    Evaluation according the satisfaction scale for the product

Sponsors and collaborators

Lead sponsor

Alternativa International S.A

Industry

Collaborators

  • Artialis

Registry information

Official study title

Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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