Tolerance, Efficacy, revAlidation, Myostim

NCT04684771 | Completed

• 1 other identifier: TEAM
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Cruciate Ligament Rupture

Keywords

food supplement; revalidation after surgery

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

MYOSTIM®

ACTIVE COMPARATOR

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®

PLACEBO

PLACEBO COMPARATOR

PLACEBO 2 bars/day during 12 weeks

Dietary Supplement: PLACEBO

Interventions

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.

MYOSTIM®

PLACEBO DIETARY_SUPPLEMENT

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

PLACEBO

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Related to the pathology:
• Patient who have undergone previous ACL reconstruction surgery on the same knee
• 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 treated with pharmacologic agents like statins, immunosuppressors or anti-malaria
• Patient taking androgens (steroids…)
• Patient under treatments which may interfere with the neuromuscular system
• 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

Sponsors & Collaborators

• Alternativa International S.A: lead
• Artialis: collaborator

Study Sites (2)

Hospital Bois de l'Abbaye et de Hesbaye

Seraing, Liège, 4100, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Two parallel-groups either the MYOSTIM® or a PLACEBO in a double blinded manner.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 28, 2020
• Study Start: March 23, 2015
• Primary Completion: July 27, 2017
• Study Completion: December 31, 2017
• Last Updated: December 28, 2020

Record last verified: 2020-12

Locations

BE (2)