Tolerance, Efficacy, revAlidation, Myostim

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

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 Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Rupture
• Intervention / Treatment: Dietary supplement: MYOSTIM®; Dietary supplement: PLACEBO

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liège
  • Liège
    • Seraing, Liège, Belgium, 4100
      • Hospital Bois de l'Abbaye et de Hesbaye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: 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 Comparator: PLACEBO; PLACEBO 2 bars/day during 12 weeks	Dietary supplement: PLACEBO; Bars with no active ingredient and the same flavor (chocolate and red fruits).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the efficacy of MYOSTIM® on the muscular strength recovery	Evaluation by isokinetic test performed (extension/flexion of the quadriceps)	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)	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)	Change from Baseline at 14 weeks post ACL surgery
Assess the efficacy of MYOSTIM® on the muscular mass recovery	Evaluation by impedancemetry	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	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))	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)	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)	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	At 14 weeks post ACL surgery
Assessment of the compliance of the patient with the MYOSTIM®	Evaluation according the number of remaining bars	At 14 weeks post ACL surgery
Assessment of the satisfaction of the patient with the MYOSTIM®	Evaluation according the satisfaction scale for the product	At 14 weeks post ACL surgery

Collaborators and Investigators

• Sponsor: Alternativa International S.A
• Collaborators: Artialis

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2015
• Primary Completion (Actual): July 27, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: food supplement; revalidation after surgery
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: TEAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No