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Tolerance, Efficacy, revAlidation, Myostim

NCT04684771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2020-12-28

No results posted yet for this study

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

Interventions

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.

DIETARY_SUPPLEMENT

PLACEBO

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

Sponsors & Collaborators

  • Artialis

    collaborator INDUSTRY

  • Alternativa International S.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-23
Primary Completion
2017-07-27
Completion
2017-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04684771 on ClinicalTrials.gov