Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans

August 29, 2014 updated by: Assistance Publique Hopitaux De Marseille

Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation ? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans.

Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in order to increase or restore muscle capacities of hypoactive patients or patients with articular trauma. Although this technique seems to be particularly adapted to muscle rehabilitation, growing evidence is emerging regarding potential damaging effects of electrically- induced isometric contractions in healthy humans. Recent studies have reported a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased muscle soreness and impaired force production as a result of NMESs. On that basis, further studies should be conducted on these deleterious effects which might limit the clinical application of NMES.

Over the last decade, many studies paid attention to branched-chain amino acids (BCAA) supplementation as a potential prophylactic/therapeutic approach. The rationale of this approach is that BCAA might increase protein synthesis and reduce protein breakdown through physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin). Additionally, BCAA could also be used as energetic substrate during exercise when glycogen stores are depleted. Overall, previous results have supported the efficacy of BCAA supplementation in attenuating muscle damage. Nevertheless, comprehensive studies investigating the effect of amino acid supplementation on markers of muscle damage are still scarce.

Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS) are powerful non invasive tools allowing the exploration of skeletal muscle structure and energy metabolism.

This ambitious project is devoted to the anatomical, functional and metabolic characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of muscle damage, including maximal voluntary force production, T2 values and apparent diffusion coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance for improving our knowledge of anatomic, metabolic and functional events related to BCAA supplementation in the context of exercise-induced muscle damage

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • Between 18 and 35 years
  • Subjects will have to be unhurt:

    • Any general disease
    • Psychiatric disorders(confusions)
    • Any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology
  • They will have to follow no chronic treatment
  • They will have to be unhurt of any history of alcoholism or drug addiction

Exclusion Criteria:

  • Contraindications for an examination MRI
  • Suffering from claustrophobia
  • Having stimulating one cardiac, carriers of a system Holter, carriers of hook(staple) (clip) surgical metallic, carriers of a prosthesis or a metallic implant (or quite other metallic foreign bodies), carriers of a prosthesis dental (device), carriers of a hearing aid, carriers of an insulin pump
  • Having been hurt by pieces of shrapnel or lead
  • Having had a dislocation, a fracture or a recent surgical operation (less than 6 months before the inclusion)
  • Having followed a treatment with anti-inflammatory drugs during the last 3 months
  • Having followed a treatment with amino acids during the last 3 months
  • Having followed a treatment(processing) with anabolic steroids during the last 3 months
  • Having participated in a program of body-building of lower limbs during the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Experimental: branched-chain amino acids (BCAA) supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluation of the muscular responsiveness
Time Frame: 24 MONTHS
24 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the effects of a supplementation in AAB
Time Frame: 24 MONTTHS
on the physiological aspects
24 MONTTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: jean pierre mattei, AP HM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 18, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-A00449-34
  • 2012-04 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuromuscular Electrical Stimulation

Clinical Trials on PLACEBO

3
Subscribe