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Tolerance, Efficacy, revAlidation, Myostim

Primary Purpose

Anterior Cruciate Ligament Rupture

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

MYOSTIM®

PLACEBO

About this trial

This is an interventional supportive care trial for Anterior Cruciate Ligament Rupture focused on measuring food supplement, revalidation after surgery

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Bois de l'Abbaye et de Hesbaye
CHU de Liège

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MYOSTIM®

PLACEBO

Arm 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.

PLACEBO 2 bars/day during 12 weeks

Outcomes

Primary Outcome Measures

Assess the efficacy of MYOSTIM® on the muscular strength recovery

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

Assess the efficacy of MYOSTIM® on the muscular strength recovery

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

Assess the efficacy of MYOSTIM® on the muscular mass recovery

Evaluation by Magnetic Resonance Imaging (MRI)

Assess the efficacy of MYOSTIM® on the muscular mass recovery

Evaluation by impedancemetry

Assess the efficacy of MYOSTIM® on physical performance recovery

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

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))

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

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

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)

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

Assessment of the compliance of the patient with the MYOSTIM®

Evaluation according the number of remaining bars

Assessment of the satisfaction of the patient with the MYOSTIM®

Evaluation according the satisfaction scale for the product

Secondary Outcome Measures

Full Information

NCT ID

NCT04684771

First Posted

December 11, 2020

Last Updated

December 21, 2020

Sponsor

Alternativa International S.A

Collaborators

Artialis

1. Study Identification

Unique Protocol Identification Number

NCT04684771

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

March 23, 2015 (Actual)

Primary Completion Date

July 27, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alternativa International S.A

Collaborators

Artialis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Rupture

Keywords

food supplement, revalidation after surgery

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Two parallel-groups either the MYOSTIM® or a PLACEBO in a double blinded manner.

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MYOSTIM®

Arm Type

Active Comparator

Arm Description

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

PLACEBO 2 bars/day during 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

MYOSTIM®

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

PLACEBO

Intervention Description

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

Primary Outcome Measure Information:

Title

Assess the efficacy of MYOSTIM® on the muscular strength recovery

Description

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

Time Frame